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Advances in hepatocellular carcinoma at ASCO 2021
Dr. Laura Goff presents treatment updates in hepatocellular carcinoma (HCC) that were presented at the ASCO 2021 Annual Meeting.
Updated data from the phase 3 KEYNOTE-240 study demonstrated that overall survival, progression-free survival, and objective response rate were maintained over 3 years with pembrolizumab compared to placebo in patients with advanced HCC previously treated with sorafenib.
An exploratory analysis of IMBRAVE150 examined the association between best overall response and overall survival, as well as independent predictors of survival in patients with unresectable HCC treated with atezolizumab plus bevacizumab versus sorafenib. In the study treatment population, confirmed response by RECIST 1.1 and by HCC mRECIST were associated with improved overall survival. Data suggested that both confirmed response and stable disease are associated with improved clinical outcomes in patients treated with this regimen.
Lastly, a retrospective cohort study comparing sorafenib, and nivolumab as first-line systemic therapies for patients with advanced HCC and Child-Pugh class B cirrhosis found that nivolumab was associated with better overall survival as a first-line treatment.
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Laura W. Goff, MD is an Associate Professor at Vanderbilt University Medical Center in Nashville, Tennessee.
Dr. Goff discloses previous work with: Agios, ArQule; ASLAN Pharmaceuticals; Astellas Pharma; Basilea Pharmaceutica; BeiGene; Bristol Myers Squibb; Eli Lilly and Company; H3 Biomedicine; Incyte; Leap Therapeutics; Merck; Onyx Pharmaceuticals; Pfizer; SunPharma.
Dr. Laura Goff presents treatment updates in hepatocellular carcinoma (HCC) that were presented at the ASCO 2021 Annual Meeting.
Updated data from the phase 3 KEYNOTE-240 study demonstrated that overall survival, progression-free survival, and objective response rate were maintained over 3 years with pembrolizumab compared to placebo in patients with advanced HCC previously treated with sorafenib.
An exploratory analysis of IMBRAVE150 examined the association between best overall response and overall survival, as well as independent predictors of survival in patients with unresectable HCC treated with atezolizumab plus bevacizumab versus sorafenib. In the study treatment population, confirmed response by RECIST 1.1 and by HCC mRECIST were associated with improved overall survival. Data suggested that both confirmed response and stable disease are associated with improved clinical outcomes in patients treated with this regimen.
Lastly, a retrospective cohort study comparing sorafenib, and nivolumab as first-line systemic therapies for patients with advanced HCC and Child-Pugh class B cirrhosis found that nivolumab was associated with better overall survival as a first-line treatment.
--
Laura W. Goff, MD is an Associate Professor at Vanderbilt University Medical Center in Nashville, Tennessee.
Dr. Goff discloses previous work with: Agios, ArQule; ASLAN Pharmaceuticals; Astellas Pharma; Basilea Pharmaceutica; BeiGene; Bristol Myers Squibb; Eli Lilly and Company; H3 Biomedicine; Incyte; Leap Therapeutics; Merck; Onyx Pharmaceuticals; Pfizer; SunPharma.
Dr. Laura Goff presents treatment updates in hepatocellular carcinoma (HCC) that were presented at the ASCO 2021 Annual Meeting.
Updated data from the phase 3 KEYNOTE-240 study demonstrated that overall survival, progression-free survival, and objective response rate were maintained over 3 years with pembrolizumab compared to placebo in patients with advanced HCC previously treated with sorafenib.
An exploratory analysis of IMBRAVE150 examined the association between best overall response and overall survival, as well as independent predictors of survival in patients with unresectable HCC treated with atezolizumab plus bevacizumab versus sorafenib. In the study treatment population, confirmed response by RECIST 1.1 and by HCC mRECIST were associated with improved overall survival. Data suggested that both confirmed response and stable disease are associated with improved clinical outcomes in patients treated with this regimen.
Lastly, a retrospective cohort study comparing sorafenib, and nivolumab as first-line systemic therapies for patients with advanced HCC and Child-Pugh class B cirrhosis found that nivolumab was associated with better overall survival as a first-line treatment.
--
Laura W. Goff, MD is an Associate Professor at Vanderbilt University Medical Center in Nashville, Tennessee.
Dr. Goff discloses previous work with: Agios, ArQule; ASLAN Pharmaceuticals; Astellas Pharma; Basilea Pharmaceutica; BeiGene; Bristol Myers Squibb; Eli Lilly and Company; H3 Biomedicine; Incyte; Leap Therapeutics; Merck; Onyx Pharmaceuticals; Pfizer; SunPharma.

Top Abstracts in Locally Advanced NSCLC From ASCO 2021
Dr Thomas Stinchcombe, from Duke Cancer Center in Durham, North Carolina, highlights key abstracts in locally advanced non–small cell lung cancer (NSCLC) presented at the 2021 annual meeting of the American Society of Clinical Oncology.
First, he reviews the IMpower010 trial, which compares atezolizumab vs best supportive care in patients with surgically resected NSCLC who had received adjuvant chemotherapy.
He then discusses surgical outcomes from the CheckMate 816 trial in patients with resectable NSCLC who had been treated with nivolumab plus platinum-doublet chemotherapy vs chemotherapy alone.
Finally, Dr Stinchcombe discusses the IMPACT trial, which looked at adjuvant gefitinib vs cisplatin/vinorelbine in completely resected NSCLC patients with EGFR mutations.
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Thomas E. Stinchcombe, MD, Medical Oncology, Duke Cancer Center, Durham, North Carolina.
Thomas E. Stinchcombe, MD, has disclosed the following relevant financial relationships:
Received research funding from: Genentech/Roche; Blueprint Medicines; AstraZeneca
Received income in an amount equal to or greater than $250 from: Takeda; AstraZeneca; Genentech/Roche; Foundation Medicine; Pfizer; EMD Serono; Novartis; Daiichi Sankyo; Eli Lilly and Company; Medtronic.
Dr Thomas Stinchcombe, from Duke Cancer Center in Durham, North Carolina, highlights key abstracts in locally advanced non–small cell lung cancer (NSCLC) presented at the 2021 annual meeting of the American Society of Clinical Oncology.
First, he reviews the IMpower010 trial, which compares atezolizumab vs best supportive care in patients with surgically resected NSCLC who had received adjuvant chemotherapy.
He then discusses surgical outcomes from the CheckMate 816 trial in patients with resectable NSCLC who had been treated with nivolumab plus platinum-doublet chemotherapy vs chemotherapy alone.
Finally, Dr Stinchcombe discusses the IMPACT trial, which looked at adjuvant gefitinib vs cisplatin/vinorelbine in completely resected NSCLC patients with EGFR mutations.
--
Thomas E. Stinchcombe, MD, Medical Oncology, Duke Cancer Center, Durham, North Carolina.
Thomas E. Stinchcombe, MD, has disclosed the following relevant financial relationships:
Received research funding from: Genentech/Roche; Blueprint Medicines; AstraZeneca
Received income in an amount equal to or greater than $250 from: Takeda; AstraZeneca; Genentech/Roche; Foundation Medicine; Pfizer; EMD Serono; Novartis; Daiichi Sankyo; Eli Lilly and Company; Medtronic.
Dr Thomas Stinchcombe, from Duke Cancer Center in Durham, North Carolina, highlights key abstracts in locally advanced non–small cell lung cancer (NSCLC) presented at the 2021 annual meeting of the American Society of Clinical Oncology.
First, he reviews the IMpower010 trial, which compares atezolizumab vs best supportive care in patients with surgically resected NSCLC who had received adjuvant chemotherapy.
He then discusses surgical outcomes from the CheckMate 816 trial in patients with resectable NSCLC who had been treated with nivolumab plus platinum-doublet chemotherapy vs chemotherapy alone.
Finally, Dr Stinchcombe discusses the IMPACT trial, which looked at adjuvant gefitinib vs cisplatin/vinorelbine in completely resected NSCLC patients with EGFR mutations.
--
Thomas E. Stinchcombe, MD, Medical Oncology, Duke Cancer Center, Durham, North Carolina.
Thomas E. Stinchcombe, MD, has disclosed the following relevant financial relationships:
Received research funding from: Genentech/Roche; Blueprint Medicines; AstraZeneca
Received income in an amount equal to or greater than $250 from: Takeda; AstraZeneca; Genentech/Roche; Foundation Medicine; Pfizer; EMD Serono; Novartis; Daiichi Sankyo; Eli Lilly and Company; Medtronic.

Real-world CAR T outcomes for DLBCL mimic clinical trials
Data from a large French registry on a multicenter experience with chimeric antigen receptor T-cell (CAR T) therapy for aggressive lymphoma suggests that the favorable outcomes seen in clinical trials can be replicated in the real world.
Among 481 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with either of two commercially available CAR T products – tisagenlecleucel (Kymriah) or axicabtagene ciloleucel (Yescarta) – the duration of responses, progression-free survival (PFS), and overall survival (OS) rates at 6 months mirror those seen in clinical trials, reported Steven LeGouill, MD, PhD, from the University of Nantes (France), on behalf of colleagues in the DESCAR-T (Dispositive d’Evaluation et de Suivi des CAR-T) registry.
“CAR T has now become a standard of care in a lot of French centers, with more than 640 patients treated with CAR T in less than 2 years. The DESCAR-T real-life experience mimics the experience that had been previously by other real-life registries but also in clinical trials. We didn’t see new emerging toxicity signals in real life,” he said in an oral abstract session during the European Hematology Association annual congress (Abstract S216).
“I am convinced that a population registry about CAR T–treated patients is needed,” commented Pieter Sonneveld, MD, from Erasmus Medical Center in Rotterdam, the Netherlands, who was not involved in the study.
“Selection criteria for CAR T trials have been incredibly restrictive, and academic trials have not gained ground yet. It is important to collect and analyze more data, include non-trial patients and analyze long-term follow-up in order to determine the real effects of this innovative treatment in lymphoma and other diseases,” he said.
Dr. Sonneveld, EHA past president, was the moderator a briefing where Dr. LeGouill presented the DESCAR-T study findings.
Natalie Sophia Grover, MD, a leukemia and lymphoma specialist at the University of North Carolina at Chapel Hill, noted in an interview that “there have been several publications recently that have shown that these promising outcomes for these really refractory, high-risk patients with diffuse large B-cell lymphoma seem to be similar with what we’ve seen in trials, which is definitely exciting.”
She noted that the median time from CAR T order to treatment in the study, 50 days, was longer than in her experience.
“Generally, from collection to treatment is less than a month. Looking at that, I would have expected more patients not to make it CAR T, but nearly 90% of patients who had collections got treatment, which is pretty good. Those patients that didn’t make it to treatment had really poor outcomes,” she said.
Dr. Grover was not involved in the study.
More data, s’il vous plait
The DESCAR-T registry was created in response to a request from French health authorities for data beyond that provided in the EBMT patient registry. The health authorities asked for characterization of the CAR T–eligible population in an intention to treat, 15-year follow-up of both CAR T recipients and candidates who were not treated for whatever reasons, and a full accounting of previous lines of therapy.
Dr. LeGouill presented the first analysis of data from the registry involving 19 enrolling site and 647 patients with DLBCL for whom CAR T cells were ordered from January 2018 to March 2021.
Of the 647 candidates, 10 did not have CAR T ordered for reasons that included patient deaths or disease progression, infection, and patient refusal. An additional 30 patients either had leukapheresis performed or pending, and 607 had CAR T ordered.
Of the 607 patients, 53 did not receive CAR T infusions because of disease progression, death before product administration, manufacturing or leukapheresis failures, uncontrolled infections, patient choice, or progression of other malignancies.
That left 550 patients (85%) who received a CAR T product, either tisagenlecleucel (200 patients) or axicabtagene ciloleucel (350 patients).
Among all patients, the median age at CAR T order was 63 for patients who received tisagenlecleucel, and 65 for patients receiving axicabtagene ciloleucel. Patients 65 and older comprised 44% and 51% of the population, respectively.
Patients treated with each CAR T product had a median of three prior lines of therapy.
Manageable toxicities
Toxicities within 10 days of CAR T infusion included 418 cases among 515 patients (81.2%) of cytokine release syndrome, with most being grade 1 or 2 in severity; 44 patients had grade 3 or 4 CRS.
Any-grade neurotoxicity was seen in 184 patients (35.7%), primarily grade 1 or 2 in severity; 50 patients had grade 3 or greater neurotoxicity.
Of 427 patients with at least one CAR T–specific toxicity within 10 days, 139 (32.8%) required ICU admission, 325 (76,1%) were treated for CAR T–specific toxicities, 278 (65.1%) received tocilizumab, 13 (3%) received siltuximab, and 176 (41.2%) received corticosteroids.
Favorable outcomes
Overall response rates, at 1, 3, and 6 months post infusions were 70.6%, 56.3%, and 60%, respectively, with the majority of response at each time point being complete responses (CR).
The 6-month overall survival (OS) rate among all patients who were treated was 83.7%, compared with 5.5% for patients who did not receive CAR T infusions.
Progression-free survival (PFS) at 6 months was 44.5%, and 57.7% of patients had an ongoing response at the same time point.
Among patients who received bridging therapy between leukapheresis and CAR T infusion, the 6-month PFS was 58.4% for patients with either a CR, partial response, or stable disease, compared with 63.3% for patients who did not receive bridging therapy, and 29.8% for those with disease progression.
The respective 6 months OS rates were 87.4%, 82.3%, and 65.5%.
The results showed that patients who do not have at least stable disease at the time of CAR T infusion are at risk for early relapse, but approximately 30% of these patients still had long-term disease control, Dr. LeGouill said.
He acknowledged that longer follow-up will be need to see whether the plateaus in the PFS and OS curves the investigators observed can be maintained over time. Questions that still need to be answered include the impact of bridging therapy or disease status at the start of treatment on outcomes, and how to improve CAR T efficacy based on individual patient characteristics.
The registry will be extended to include data on patients treated with CAR T for mantle cell lymphoma and multiple myeloma, investigators announced.
The study is supported by participating centers and Gilead/Kite and Novartis. Dr. LeGouill disclosed advisory board activity and honoraria from the companies and others. Dr. Grover disclosed advisory board participating for Kite and others. Dr. Sonneveld has disclosed research grants and honoraria from several companies, not including Kite or Novartis.
Data from a large French registry on a multicenter experience with chimeric antigen receptor T-cell (CAR T) therapy for aggressive lymphoma suggests that the favorable outcomes seen in clinical trials can be replicated in the real world.
Among 481 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with either of two commercially available CAR T products – tisagenlecleucel (Kymriah) or axicabtagene ciloleucel (Yescarta) – the duration of responses, progression-free survival (PFS), and overall survival (OS) rates at 6 months mirror those seen in clinical trials, reported Steven LeGouill, MD, PhD, from the University of Nantes (France), on behalf of colleagues in the DESCAR-T (Dispositive d’Evaluation et de Suivi des CAR-T) registry.
“CAR T has now become a standard of care in a lot of French centers, with more than 640 patients treated with CAR T in less than 2 years. The DESCAR-T real-life experience mimics the experience that had been previously by other real-life registries but also in clinical trials. We didn’t see new emerging toxicity signals in real life,” he said in an oral abstract session during the European Hematology Association annual congress (Abstract S216).
“I am convinced that a population registry about CAR T–treated patients is needed,” commented Pieter Sonneveld, MD, from Erasmus Medical Center in Rotterdam, the Netherlands, who was not involved in the study.
“Selection criteria for CAR T trials have been incredibly restrictive, and academic trials have not gained ground yet. It is important to collect and analyze more data, include non-trial patients and analyze long-term follow-up in order to determine the real effects of this innovative treatment in lymphoma and other diseases,” he said.
Dr. Sonneveld, EHA past president, was the moderator a briefing where Dr. LeGouill presented the DESCAR-T study findings.
Natalie Sophia Grover, MD, a leukemia and lymphoma specialist at the University of North Carolina at Chapel Hill, noted in an interview that “there have been several publications recently that have shown that these promising outcomes for these really refractory, high-risk patients with diffuse large B-cell lymphoma seem to be similar with what we’ve seen in trials, which is definitely exciting.”
She noted that the median time from CAR T order to treatment in the study, 50 days, was longer than in her experience.
“Generally, from collection to treatment is less than a month. Looking at that, I would have expected more patients not to make it CAR T, but nearly 90% of patients who had collections got treatment, which is pretty good. Those patients that didn’t make it to treatment had really poor outcomes,” she said.
Dr. Grover was not involved in the study.
More data, s’il vous plait
The DESCAR-T registry was created in response to a request from French health authorities for data beyond that provided in the EBMT patient registry. The health authorities asked for characterization of the CAR T–eligible population in an intention to treat, 15-year follow-up of both CAR T recipients and candidates who were not treated for whatever reasons, and a full accounting of previous lines of therapy.
Dr. LeGouill presented the first analysis of data from the registry involving 19 enrolling site and 647 patients with DLBCL for whom CAR T cells were ordered from January 2018 to March 2021.
Of the 647 candidates, 10 did not have CAR T ordered for reasons that included patient deaths or disease progression, infection, and patient refusal. An additional 30 patients either had leukapheresis performed or pending, and 607 had CAR T ordered.
Of the 607 patients, 53 did not receive CAR T infusions because of disease progression, death before product administration, manufacturing or leukapheresis failures, uncontrolled infections, patient choice, or progression of other malignancies.
That left 550 patients (85%) who received a CAR T product, either tisagenlecleucel (200 patients) or axicabtagene ciloleucel (350 patients).
Among all patients, the median age at CAR T order was 63 for patients who received tisagenlecleucel, and 65 for patients receiving axicabtagene ciloleucel. Patients 65 and older comprised 44% and 51% of the population, respectively.
Patients treated with each CAR T product had a median of three prior lines of therapy.
Manageable toxicities
Toxicities within 10 days of CAR T infusion included 418 cases among 515 patients (81.2%) of cytokine release syndrome, with most being grade 1 or 2 in severity; 44 patients had grade 3 or 4 CRS.
Any-grade neurotoxicity was seen in 184 patients (35.7%), primarily grade 1 or 2 in severity; 50 patients had grade 3 or greater neurotoxicity.
Of 427 patients with at least one CAR T–specific toxicity within 10 days, 139 (32.8%) required ICU admission, 325 (76,1%) were treated for CAR T–specific toxicities, 278 (65.1%) received tocilizumab, 13 (3%) received siltuximab, and 176 (41.2%) received corticosteroids.
Favorable outcomes
Overall response rates, at 1, 3, and 6 months post infusions were 70.6%, 56.3%, and 60%, respectively, with the majority of response at each time point being complete responses (CR).
The 6-month overall survival (OS) rate among all patients who were treated was 83.7%, compared with 5.5% for patients who did not receive CAR T infusions.
Progression-free survival (PFS) at 6 months was 44.5%, and 57.7% of patients had an ongoing response at the same time point.
Among patients who received bridging therapy between leukapheresis and CAR T infusion, the 6-month PFS was 58.4% for patients with either a CR, partial response, or stable disease, compared with 63.3% for patients who did not receive bridging therapy, and 29.8% for those with disease progression.
The respective 6 months OS rates were 87.4%, 82.3%, and 65.5%.
The results showed that patients who do not have at least stable disease at the time of CAR T infusion are at risk for early relapse, but approximately 30% of these patients still had long-term disease control, Dr. LeGouill said.
He acknowledged that longer follow-up will be need to see whether the plateaus in the PFS and OS curves the investigators observed can be maintained over time. Questions that still need to be answered include the impact of bridging therapy or disease status at the start of treatment on outcomes, and how to improve CAR T efficacy based on individual patient characteristics.
The registry will be extended to include data on patients treated with CAR T for mantle cell lymphoma and multiple myeloma, investigators announced.
The study is supported by participating centers and Gilead/Kite and Novartis. Dr. LeGouill disclosed advisory board activity and honoraria from the companies and others. Dr. Grover disclosed advisory board participating for Kite and others. Dr. Sonneveld has disclosed research grants and honoraria from several companies, not including Kite or Novartis.
Data from a large French registry on a multicenter experience with chimeric antigen receptor T-cell (CAR T) therapy for aggressive lymphoma suggests that the favorable outcomes seen in clinical trials can be replicated in the real world.
Among 481 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with either of two commercially available CAR T products – tisagenlecleucel (Kymriah) or axicabtagene ciloleucel (Yescarta) – the duration of responses, progression-free survival (PFS), and overall survival (OS) rates at 6 months mirror those seen in clinical trials, reported Steven LeGouill, MD, PhD, from the University of Nantes (France), on behalf of colleagues in the DESCAR-T (Dispositive d’Evaluation et de Suivi des CAR-T) registry.
“CAR T has now become a standard of care in a lot of French centers, with more than 640 patients treated with CAR T in less than 2 years. The DESCAR-T real-life experience mimics the experience that had been previously by other real-life registries but also in clinical trials. We didn’t see new emerging toxicity signals in real life,” he said in an oral abstract session during the European Hematology Association annual congress (Abstract S216).
“I am convinced that a population registry about CAR T–treated patients is needed,” commented Pieter Sonneveld, MD, from Erasmus Medical Center in Rotterdam, the Netherlands, who was not involved in the study.
“Selection criteria for CAR T trials have been incredibly restrictive, and academic trials have not gained ground yet. It is important to collect and analyze more data, include non-trial patients and analyze long-term follow-up in order to determine the real effects of this innovative treatment in lymphoma and other diseases,” he said.
Dr. Sonneveld, EHA past president, was the moderator a briefing where Dr. LeGouill presented the DESCAR-T study findings.
Natalie Sophia Grover, MD, a leukemia and lymphoma specialist at the University of North Carolina at Chapel Hill, noted in an interview that “there have been several publications recently that have shown that these promising outcomes for these really refractory, high-risk patients with diffuse large B-cell lymphoma seem to be similar with what we’ve seen in trials, which is definitely exciting.”
She noted that the median time from CAR T order to treatment in the study, 50 days, was longer than in her experience.
“Generally, from collection to treatment is less than a month. Looking at that, I would have expected more patients not to make it CAR T, but nearly 90% of patients who had collections got treatment, which is pretty good. Those patients that didn’t make it to treatment had really poor outcomes,” she said.
Dr. Grover was not involved in the study.
More data, s’il vous plait
The DESCAR-T registry was created in response to a request from French health authorities for data beyond that provided in the EBMT patient registry. The health authorities asked for characterization of the CAR T–eligible population in an intention to treat, 15-year follow-up of both CAR T recipients and candidates who were not treated for whatever reasons, and a full accounting of previous lines of therapy.
Dr. LeGouill presented the first analysis of data from the registry involving 19 enrolling site and 647 patients with DLBCL for whom CAR T cells were ordered from January 2018 to March 2021.
Of the 647 candidates, 10 did not have CAR T ordered for reasons that included patient deaths or disease progression, infection, and patient refusal. An additional 30 patients either had leukapheresis performed or pending, and 607 had CAR T ordered.
Of the 607 patients, 53 did not receive CAR T infusions because of disease progression, death before product administration, manufacturing or leukapheresis failures, uncontrolled infections, patient choice, or progression of other malignancies.
That left 550 patients (85%) who received a CAR T product, either tisagenlecleucel (200 patients) or axicabtagene ciloleucel (350 patients).
Among all patients, the median age at CAR T order was 63 for patients who received tisagenlecleucel, and 65 for patients receiving axicabtagene ciloleucel. Patients 65 and older comprised 44% and 51% of the population, respectively.
Patients treated with each CAR T product had a median of three prior lines of therapy.
Manageable toxicities
Toxicities within 10 days of CAR T infusion included 418 cases among 515 patients (81.2%) of cytokine release syndrome, with most being grade 1 or 2 in severity; 44 patients had grade 3 or 4 CRS.
Any-grade neurotoxicity was seen in 184 patients (35.7%), primarily grade 1 or 2 in severity; 50 patients had grade 3 or greater neurotoxicity.
Of 427 patients with at least one CAR T–specific toxicity within 10 days, 139 (32.8%) required ICU admission, 325 (76,1%) were treated for CAR T–specific toxicities, 278 (65.1%) received tocilizumab, 13 (3%) received siltuximab, and 176 (41.2%) received corticosteroids.
Favorable outcomes
Overall response rates, at 1, 3, and 6 months post infusions were 70.6%, 56.3%, and 60%, respectively, with the majority of response at each time point being complete responses (CR).
The 6-month overall survival (OS) rate among all patients who were treated was 83.7%, compared with 5.5% for patients who did not receive CAR T infusions.
Progression-free survival (PFS) at 6 months was 44.5%, and 57.7% of patients had an ongoing response at the same time point.
Among patients who received bridging therapy between leukapheresis and CAR T infusion, the 6-month PFS was 58.4% for patients with either a CR, partial response, or stable disease, compared with 63.3% for patients who did not receive bridging therapy, and 29.8% for those with disease progression.
The respective 6 months OS rates were 87.4%, 82.3%, and 65.5%.
The results showed that patients who do not have at least stable disease at the time of CAR T infusion are at risk for early relapse, but approximately 30% of these patients still had long-term disease control, Dr. LeGouill said.
He acknowledged that longer follow-up will be need to see whether the plateaus in the PFS and OS curves the investigators observed can be maintained over time. Questions that still need to be answered include the impact of bridging therapy or disease status at the start of treatment on outcomes, and how to improve CAR T efficacy based on individual patient characteristics.
The registry will be extended to include data on patients treated with CAR T for mantle cell lymphoma and multiple myeloma, investigators announced.
The study is supported by participating centers and Gilead/Kite and Novartis. Dr. LeGouill disclosed advisory board activity and honoraria from the companies and others. Dr. Grover disclosed advisory board participating for Kite and others. Dr. Sonneveld has disclosed research grants and honoraria from several companies, not including Kite or Novartis.
FROM EHA 2021
New! Spotlight on medical power couples: Their extraordinary lives
When people started dying from lethal anthrax spores sent through the mail in 2001, infectious disease expert Jeannette Guarner, MD, was called to Florida and Connecticut to analyze the bodies. She and her pathology team investigated how the bacteria had entered the victims and examined tissue samples from across the country to discern the scale of the attacks.
After conducting autopsies and identifying that inhalation anthrax had caused the deaths, Dr. Guarner rushed home to Atlanta just in time for Thanksgiving. Exhausted, the beloved family chef still managed to cook the big turkey that holiday, but she enlisted help with dessert.
“She returned home on Thanksgiving at like three in the morning,” recalls Carlos del Rio, MD. “She said to me, ‘In order for us to have Thanksgiving, you have to be in charge of the pies.’ When I told my daughter, she said, ‘This is going to be a disaster! If mom’s not cooking, this is not going to be good.’”
“It didn’t turn out that bad,” Dr. Guarner laughs. “There was dessert.”
As two of the top infectious disease experts in the country, Dr. Guarner and Dr. del Rio are no strangers to juggling their personal lives around disease outbreaks, last-minute travel, and pressing research.
Former director of the clinical laboratory at Mexico’s National Cancer Institute, Dr. Guarner worked for the Centers for Disease Control and Prevention for 10 years, where she played an integral part in the discovery of SARS. She and her team identified that a coronavirus was in cultures taken from a health care worker who died after working in Asia and determined through molecular testing that the virus was different from any other coronaviruses at the time.
Dr. Guarner went on to search for the novel virus in tissue samples and determine that it was SARS that had caused the damage. She is now a professor in the department of pathology and laboratory medicine at Emory University, Atlanta, medical director of the clinical laboratory at Emory University Hospital Midtown, and vice chair for faculty affairs.
Dr. Del Rio, who served as director of the National AIDS Council of Mexico, is a distinguished professor of medicine in Emory University’s division of infectious diseases and a professor of global health and epidemiology in the Rollins School of Public Health at Emory University. He is also co-director of the Emory Center for AIDS Research and co-principal investigator of the Emory-CDC HIV Clinical Trials Unit and the Emory Vaccine and Treatment Evaluation Unit.
Dr. Del Rio’s work in HIV prevention and care has made great strides, including developing the concept for the HIV Care Continuum, a public health model that outlines the stages that HIV patients go through, from diagnosis to achieving viral suppression. Dr. Del Rio, who is foreign secretary of the National Academy of Medicine, has also worked on emerging infections such as pandemic influenza and was a member of the WHO Influenza A (H1N1) Clinical Advisory Group and of the CDC Influenza A Task Force during the 2009 pandemic.
Dr. Del Rio and Dr. Guarner met during medical school in Mexico City. At first, the two carpooled to classes, but when Dr. Guarner fell ill with hepatitis A, Dr. del Rio brought Dr. Guarner the class notes so she wouldn’t fall behind. The study buddies later became a couple and married just before coming to the United States for residency.
With their expertise in infectious disease, Dr. del Rio and Dr. Guarner have worked collaboratively in the past, but the couple says they’ve always maintained separate professional identities.
“We try to create our own spaces,” Dr. del Rio said. “You try to keep your personal and professional identity independent as much as possible. You don’t want people to say, ‘Oh, you got this or you’re doing this because you are married to this other person.’ You want, to a certain degree, intellectual independence.”
This has been easier in some ways because Dr. del Rio and Dr. Guarner have different last names. Over the years they have frequently encountered people who had no idea that they are married.
“One time, we were both down in the lab and Jeanette was discussing a case, and she started teasing me or poking me, making fun,” recalls Dr. del Rio. “Some of the ID fellows were like, ‘Oh my God, who the hell is this woman?’ They didn’t realize she was my wife.”
Since the COVID-19 outbreak, both Dr. Guarner and Dr. del Rio have been involved in different ways with the pandemic. Dr. Del Rio has seen patients, conducted clinical trials, and given hundreds of local and national interviews about the virus. As a laboratory director, Dr. Guarner has validated tests for the diagnosis of COVID-19 and counseled staff on exposure concerns.
“An important aspect has also been to make sure that our laboratory technologists understand the disease and the need for the different protection elements we have had to use in the hospital,” she said. “In many ways I have had to scale down fears the techs have had when handling specimens from these patients.”
In their own words
What was one of your most surprising discoveries?
Jeannette: During the anthrax attacks, we received lots of tissues on live patients, particularly skin biopsies from different parts of the country where pathologists had concerns that there was anthrax. From New York, we received more than 50 skin biopsies and discovered that the necrotic lesions suspected of anthrax had Rickettsia in them. In other words, we discovered that rickettsialpox – a mite-borne infectious disease – was circulating in the city, which was unknown at the time.
Describe a challenge that you overcame:
Carlos: When I was appointed as director of the National AIDS Council of Mexico (CONASIDA), I was quite young, only 32 years old. I had to learn to listen to others who had expertise and institutional memory, to respect their opinions, and at the same time to push for change. A huge challenge was the role of the Catholic Church and conservative groups that were adamantly against condom promotion. Thus, I learned how to advance policies based in science without being confrontational.
Have you ever been famous for anything other than your work?
Jeannette: In 2017, a tree fell on our house during Hurricane Irma. It fell right on my husband’s office a few minutes after he left the room. Fortunately, I have always been small and flexible, and I crawled through the rubble to save our valuables before they were ruined by the rain. Later, a local Atlanta TV news crew was in the neighborhood reporting on the damage, and I told them to come to our house if they wanted to see real damage. That night, we were on the local news.
Power couple Paul and Mary Klotman
When Mary Klotman, MD, was offered an opportunity with the National Institutes of Health in 1991, Paul Klotman, MD, didn’t hesitate to resign his post at Duke University, Durham, N.C., and join his wife in Washington. Paul says he wanted to support Mary’s aspirations, even though it meant an uncertain track for his own career.
Fortunately for the Klotmans, the move proved instrumental for both of their careers and spurred one of their proudest scientific breakthroughs.
At NIH, Mary was a member of the Public Health Service and worked in the laboratory of tumor cell biology, and Paul became chief of the institute’s molecular medicine section in the laboratory of developmental biology. Together, their work led to the first animal model of HIV-associated nephropathy using transgenic techniques. The Klotmans and their team demonstrated that HIV resides in and evolves separately in kidney cells, a critical step in HIV-associated kidney disease.
“That’s where our longstanding collaboration around HIV-associated nephropathy started,” Mary says. “Paul and I have a passion for research, and we’ve had the same grant together for 25 years.”
After their successful stint at NIH, the Klotmans next climbed the ranks at the Icahn School of Medicine at Mount Sinai, where Paul started as chief of the nephrology division and became chair of medicine, and Mary became chief of infectious diseases and co-director of Mount Sinai’s Global Health and Emerging Pathogens Institute.
Today, Mary and Paul are the first – and only – married couple in the United States to lead separate medical schools. Mary is dean and vice chancellor for health affairs at Duke, and Paul is president and executive dean of Baylor College of Medicine, Houston.
Despite their 1,100-mile separation, the Klotmans manage their relationship in an unconventional way that some might balk at: Every Friday, one spouse hops on a plane and travels to the other for a date night and weekend.
“When we started this crazy lifestyle, we committed to being together every weekend,” says Mary. “And in 10 years – before COVID – we missed only one weekend together.”
The Klotmans say the scheduled time together places a hard end to each work week and enables them to truly enjoy their quality time.
“Friday at noon, I’m on the plane going to Durham, and I know that in 2 hours I’m going to have a date with my wife,” Paul said. “There are institutions that we’ve run into that think you have to be 7 days a week on site. But Duke and Baylor have been very supportive [of our situation].”
No doubt, the arrangement means a lot of time in the air for the couple. Paul says he travels about 150,000 miles every year by plane.
Having dual leadership positions in academic medicine has kept the Klotmans tightly connected, and the couple says their strong partnership has contributed to their success.
“It’s really been helpful having a deep understanding of our career paths, because we’ve been able to understand when one of us needed to be really focused on work and the other one would step back a bit with the kids and vice versa,” Mary said.
“There’s no question that we wouldn’t be in the positions we are in now if it weren’t for the fact that we’ve had each other,” Paul said.
In their own words
What is a little-known title that you have?
Paul: Purse-carrier for my wife. When she is honored at a national meeting or event, she often stands up and hands me her purse. I now make sure I have on an appropriate outfit that matches the purse.
Tell us about your children.
Mary: We had a very traumatic first pregnancy that we lost. Six years later, we adopted our first child, which was an amazing blessing. Our second son was Duke’s first successful frozen embryo transfer.
Describe a memorable moment in your relationship.
Paul: As we were leaving for our honeymoon, Mary’s dad handed me this booklet. It was the receipts for Mary’s medical school loans for the next 10 years. He said, “Congratulations, she’s all yours!”
A version of this article first appeared on Medscape.com.
When people started dying from lethal anthrax spores sent through the mail in 2001, infectious disease expert Jeannette Guarner, MD, was called to Florida and Connecticut to analyze the bodies. She and her pathology team investigated how the bacteria had entered the victims and examined tissue samples from across the country to discern the scale of the attacks.
After conducting autopsies and identifying that inhalation anthrax had caused the deaths, Dr. Guarner rushed home to Atlanta just in time for Thanksgiving. Exhausted, the beloved family chef still managed to cook the big turkey that holiday, but she enlisted help with dessert.
“She returned home on Thanksgiving at like three in the morning,” recalls Carlos del Rio, MD. “She said to me, ‘In order for us to have Thanksgiving, you have to be in charge of the pies.’ When I told my daughter, she said, ‘This is going to be a disaster! If mom’s not cooking, this is not going to be good.’”
“It didn’t turn out that bad,” Dr. Guarner laughs. “There was dessert.”
As two of the top infectious disease experts in the country, Dr. Guarner and Dr. del Rio are no strangers to juggling their personal lives around disease outbreaks, last-minute travel, and pressing research.
Former director of the clinical laboratory at Mexico’s National Cancer Institute, Dr. Guarner worked for the Centers for Disease Control and Prevention for 10 years, where she played an integral part in the discovery of SARS. She and her team identified that a coronavirus was in cultures taken from a health care worker who died after working in Asia and determined through molecular testing that the virus was different from any other coronaviruses at the time.
Dr. Guarner went on to search for the novel virus in tissue samples and determine that it was SARS that had caused the damage. She is now a professor in the department of pathology and laboratory medicine at Emory University, Atlanta, medical director of the clinical laboratory at Emory University Hospital Midtown, and vice chair for faculty affairs.
Dr. Del Rio, who served as director of the National AIDS Council of Mexico, is a distinguished professor of medicine in Emory University’s division of infectious diseases and a professor of global health and epidemiology in the Rollins School of Public Health at Emory University. He is also co-director of the Emory Center for AIDS Research and co-principal investigator of the Emory-CDC HIV Clinical Trials Unit and the Emory Vaccine and Treatment Evaluation Unit.
Dr. Del Rio’s work in HIV prevention and care has made great strides, including developing the concept for the HIV Care Continuum, a public health model that outlines the stages that HIV patients go through, from diagnosis to achieving viral suppression. Dr. Del Rio, who is foreign secretary of the National Academy of Medicine, has also worked on emerging infections such as pandemic influenza and was a member of the WHO Influenza A (H1N1) Clinical Advisory Group and of the CDC Influenza A Task Force during the 2009 pandemic.
Dr. Del Rio and Dr. Guarner met during medical school in Mexico City. At first, the two carpooled to classes, but when Dr. Guarner fell ill with hepatitis A, Dr. del Rio brought Dr. Guarner the class notes so she wouldn’t fall behind. The study buddies later became a couple and married just before coming to the United States for residency.
With their expertise in infectious disease, Dr. del Rio and Dr. Guarner have worked collaboratively in the past, but the couple says they’ve always maintained separate professional identities.
“We try to create our own spaces,” Dr. del Rio said. “You try to keep your personal and professional identity independent as much as possible. You don’t want people to say, ‘Oh, you got this or you’re doing this because you are married to this other person.’ You want, to a certain degree, intellectual independence.”
This has been easier in some ways because Dr. del Rio and Dr. Guarner have different last names. Over the years they have frequently encountered people who had no idea that they are married.
“One time, we were both down in the lab and Jeanette was discussing a case, and she started teasing me or poking me, making fun,” recalls Dr. del Rio. “Some of the ID fellows were like, ‘Oh my God, who the hell is this woman?’ They didn’t realize she was my wife.”
Since the COVID-19 outbreak, both Dr. Guarner and Dr. del Rio have been involved in different ways with the pandemic. Dr. Del Rio has seen patients, conducted clinical trials, and given hundreds of local and national interviews about the virus. As a laboratory director, Dr. Guarner has validated tests for the diagnosis of COVID-19 and counseled staff on exposure concerns.
“An important aspect has also been to make sure that our laboratory technologists understand the disease and the need for the different protection elements we have had to use in the hospital,” she said. “In many ways I have had to scale down fears the techs have had when handling specimens from these patients.”
In their own words
What was one of your most surprising discoveries?
Jeannette: During the anthrax attacks, we received lots of tissues on live patients, particularly skin biopsies from different parts of the country where pathologists had concerns that there was anthrax. From New York, we received more than 50 skin biopsies and discovered that the necrotic lesions suspected of anthrax had Rickettsia in them. In other words, we discovered that rickettsialpox – a mite-borne infectious disease – was circulating in the city, which was unknown at the time.
Describe a challenge that you overcame:
Carlos: When I was appointed as director of the National AIDS Council of Mexico (CONASIDA), I was quite young, only 32 years old. I had to learn to listen to others who had expertise and institutional memory, to respect their opinions, and at the same time to push for change. A huge challenge was the role of the Catholic Church and conservative groups that were adamantly against condom promotion. Thus, I learned how to advance policies based in science without being confrontational.
Have you ever been famous for anything other than your work?
Jeannette: In 2017, a tree fell on our house during Hurricane Irma. It fell right on my husband’s office a few minutes after he left the room. Fortunately, I have always been small and flexible, and I crawled through the rubble to save our valuables before they were ruined by the rain. Later, a local Atlanta TV news crew was in the neighborhood reporting on the damage, and I told them to come to our house if they wanted to see real damage. That night, we were on the local news.
Power couple Paul and Mary Klotman
When Mary Klotman, MD, was offered an opportunity with the National Institutes of Health in 1991, Paul Klotman, MD, didn’t hesitate to resign his post at Duke University, Durham, N.C., and join his wife in Washington. Paul says he wanted to support Mary’s aspirations, even though it meant an uncertain track for his own career.
Fortunately for the Klotmans, the move proved instrumental for both of their careers and spurred one of their proudest scientific breakthroughs.
At NIH, Mary was a member of the Public Health Service and worked in the laboratory of tumor cell biology, and Paul became chief of the institute’s molecular medicine section in the laboratory of developmental biology. Together, their work led to the first animal model of HIV-associated nephropathy using transgenic techniques. The Klotmans and their team demonstrated that HIV resides in and evolves separately in kidney cells, a critical step in HIV-associated kidney disease.
“That’s where our longstanding collaboration around HIV-associated nephropathy started,” Mary says. “Paul and I have a passion for research, and we’ve had the same grant together for 25 years.”
After their successful stint at NIH, the Klotmans next climbed the ranks at the Icahn School of Medicine at Mount Sinai, where Paul started as chief of the nephrology division and became chair of medicine, and Mary became chief of infectious diseases and co-director of Mount Sinai’s Global Health and Emerging Pathogens Institute.
Today, Mary and Paul are the first – and only – married couple in the United States to lead separate medical schools. Mary is dean and vice chancellor for health affairs at Duke, and Paul is president and executive dean of Baylor College of Medicine, Houston.
Despite their 1,100-mile separation, the Klotmans manage their relationship in an unconventional way that some might balk at: Every Friday, one spouse hops on a plane and travels to the other for a date night and weekend.
“When we started this crazy lifestyle, we committed to being together every weekend,” says Mary. “And in 10 years – before COVID – we missed only one weekend together.”
The Klotmans say the scheduled time together places a hard end to each work week and enables them to truly enjoy their quality time.
“Friday at noon, I’m on the plane going to Durham, and I know that in 2 hours I’m going to have a date with my wife,” Paul said. “There are institutions that we’ve run into that think you have to be 7 days a week on site. But Duke and Baylor have been very supportive [of our situation].”
No doubt, the arrangement means a lot of time in the air for the couple. Paul says he travels about 150,000 miles every year by plane.
Having dual leadership positions in academic medicine has kept the Klotmans tightly connected, and the couple says their strong partnership has contributed to their success.
“It’s really been helpful having a deep understanding of our career paths, because we’ve been able to understand when one of us needed to be really focused on work and the other one would step back a bit with the kids and vice versa,” Mary said.
“There’s no question that we wouldn’t be in the positions we are in now if it weren’t for the fact that we’ve had each other,” Paul said.
In their own words
What is a little-known title that you have?
Paul: Purse-carrier for my wife. When she is honored at a national meeting or event, she often stands up and hands me her purse. I now make sure I have on an appropriate outfit that matches the purse.
Tell us about your children.
Mary: We had a very traumatic first pregnancy that we lost. Six years later, we adopted our first child, which was an amazing blessing. Our second son was Duke’s first successful frozen embryo transfer.
Describe a memorable moment in your relationship.
Paul: As we were leaving for our honeymoon, Mary’s dad handed me this booklet. It was the receipts for Mary’s medical school loans for the next 10 years. He said, “Congratulations, she’s all yours!”
A version of this article first appeared on Medscape.com.
When people started dying from lethal anthrax spores sent through the mail in 2001, infectious disease expert Jeannette Guarner, MD, was called to Florida and Connecticut to analyze the bodies. She and her pathology team investigated how the bacteria had entered the victims and examined tissue samples from across the country to discern the scale of the attacks.
After conducting autopsies and identifying that inhalation anthrax had caused the deaths, Dr. Guarner rushed home to Atlanta just in time for Thanksgiving. Exhausted, the beloved family chef still managed to cook the big turkey that holiday, but she enlisted help with dessert.
“She returned home on Thanksgiving at like three in the morning,” recalls Carlos del Rio, MD. “She said to me, ‘In order for us to have Thanksgiving, you have to be in charge of the pies.’ When I told my daughter, she said, ‘This is going to be a disaster! If mom’s not cooking, this is not going to be good.’”
“It didn’t turn out that bad,” Dr. Guarner laughs. “There was dessert.”
As two of the top infectious disease experts in the country, Dr. Guarner and Dr. del Rio are no strangers to juggling their personal lives around disease outbreaks, last-minute travel, and pressing research.
Former director of the clinical laboratory at Mexico’s National Cancer Institute, Dr. Guarner worked for the Centers for Disease Control and Prevention for 10 years, where she played an integral part in the discovery of SARS. She and her team identified that a coronavirus was in cultures taken from a health care worker who died after working in Asia and determined through molecular testing that the virus was different from any other coronaviruses at the time.
Dr. Guarner went on to search for the novel virus in tissue samples and determine that it was SARS that had caused the damage. She is now a professor in the department of pathology and laboratory medicine at Emory University, Atlanta, medical director of the clinical laboratory at Emory University Hospital Midtown, and vice chair for faculty affairs.
Dr. Del Rio, who served as director of the National AIDS Council of Mexico, is a distinguished professor of medicine in Emory University’s division of infectious diseases and a professor of global health and epidemiology in the Rollins School of Public Health at Emory University. He is also co-director of the Emory Center for AIDS Research and co-principal investigator of the Emory-CDC HIV Clinical Trials Unit and the Emory Vaccine and Treatment Evaluation Unit.
Dr. Del Rio’s work in HIV prevention and care has made great strides, including developing the concept for the HIV Care Continuum, a public health model that outlines the stages that HIV patients go through, from diagnosis to achieving viral suppression. Dr. Del Rio, who is foreign secretary of the National Academy of Medicine, has also worked on emerging infections such as pandemic influenza and was a member of the WHO Influenza A (H1N1) Clinical Advisory Group and of the CDC Influenza A Task Force during the 2009 pandemic.
Dr. Del Rio and Dr. Guarner met during medical school in Mexico City. At first, the two carpooled to classes, but when Dr. Guarner fell ill with hepatitis A, Dr. del Rio brought Dr. Guarner the class notes so she wouldn’t fall behind. The study buddies later became a couple and married just before coming to the United States for residency.
With their expertise in infectious disease, Dr. del Rio and Dr. Guarner have worked collaboratively in the past, but the couple says they’ve always maintained separate professional identities.
“We try to create our own spaces,” Dr. del Rio said. “You try to keep your personal and professional identity independent as much as possible. You don’t want people to say, ‘Oh, you got this or you’re doing this because you are married to this other person.’ You want, to a certain degree, intellectual independence.”
This has been easier in some ways because Dr. del Rio and Dr. Guarner have different last names. Over the years they have frequently encountered people who had no idea that they are married.
“One time, we were both down in the lab and Jeanette was discussing a case, and she started teasing me or poking me, making fun,” recalls Dr. del Rio. “Some of the ID fellows were like, ‘Oh my God, who the hell is this woman?’ They didn’t realize she was my wife.”
Since the COVID-19 outbreak, both Dr. Guarner and Dr. del Rio have been involved in different ways with the pandemic. Dr. Del Rio has seen patients, conducted clinical trials, and given hundreds of local and national interviews about the virus. As a laboratory director, Dr. Guarner has validated tests for the diagnosis of COVID-19 and counseled staff on exposure concerns.
“An important aspect has also been to make sure that our laboratory technologists understand the disease and the need for the different protection elements we have had to use in the hospital,” she said. “In many ways I have had to scale down fears the techs have had when handling specimens from these patients.”
In their own words
What was one of your most surprising discoveries?
Jeannette: During the anthrax attacks, we received lots of tissues on live patients, particularly skin biopsies from different parts of the country where pathologists had concerns that there was anthrax. From New York, we received more than 50 skin biopsies and discovered that the necrotic lesions suspected of anthrax had Rickettsia in them. In other words, we discovered that rickettsialpox – a mite-borne infectious disease – was circulating in the city, which was unknown at the time.
Describe a challenge that you overcame:
Carlos: When I was appointed as director of the National AIDS Council of Mexico (CONASIDA), I was quite young, only 32 years old. I had to learn to listen to others who had expertise and institutional memory, to respect their opinions, and at the same time to push for change. A huge challenge was the role of the Catholic Church and conservative groups that were adamantly against condom promotion. Thus, I learned how to advance policies based in science without being confrontational.
Have you ever been famous for anything other than your work?
Jeannette: In 2017, a tree fell on our house during Hurricane Irma. It fell right on my husband’s office a few minutes after he left the room. Fortunately, I have always been small and flexible, and I crawled through the rubble to save our valuables before they were ruined by the rain. Later, a local Atlanta TV news crew was in the neighborhood reporting on the damage, and I told them to come to our house if they wanted to see real damage. That night, we were on the local news.
Power couple Paul and Mary Klotman
When Mary Klotman, MD, was offered an opportunity with the National Institutes of Health in 1991, Paul Klotman, MD, didn’t hesitate to resign his post at Duke University, Durham, N.C., and join his wife in Washington. Paul says he wanted to support Mary’s aspirations, even though it meant an uncertain track for his own career.
Fortunately for the Klotmans, the move proved instrumental for both of their careers and spurred one of their proudest scientific breakthroughs.
At NIH, Mary was a member of the Public Health Service and worked in the laboratory of tumor cell biology, and Paul became chief of the institute’s molecular medicine section in the laboratory of developmental biology. Together, their work led to the first animal model of HIV-associated nephropathy using transgenic techniques. The Klotmans and their team demonstrated that HIV resides in and evolves separately in kidney cells, a critical step in HIV-associated kidney disease.
“That’s where our longstanding collaboration around HIV-associated nephropathy started,” Mary says. “Paul and I have a passion for research, and we’ve had the same grant together for 25 years.”
After their successful stint at NIH, the Klotmans next climbed the ranks at the Icahn School of Medicine at Mount Sinai, where Paul started as chief of the nephrology division and became chair of medicine, and Mary became chief of infectious diseases and co-director of Mount Sinai’s Global Health and Emerging Pathogens Institute.
Today, Mary and Paul are the first – and only – married couple in the United States to lead separate medical schools. Mary is dean and vice chancellor for health affairs at Duke, and Paul is president and executive dean of Baylor College of Medicine, Houston.
Despite their 1,100-mile separation, the Klotmans manage their relationship in an unconventional way that some might balk at: Every Friday, one spouse hops on a plane and travels to the other for a date night and weekend.
“When we started this crazy lifestyle, we committed to being together every weekend,” says Mary. “And in 10 years – before COVID – we missed only one weekend together.”
The Klotmans say the scheduled time together places a hard end to each work week and enables them to truly enjoy their quality time.
“Friday at noon, I’m on the plane going to Durham, and I know that in 2 hours I’m going to have a date with my wife,” Paul said. “There are institutions that we’ve run into that think you have to be 7 days a week on site. But Duke and Baylor have been very supportive [of our situation].”
No doubt, the arrangement means a lot of time in the air for the couple. Paul says he travels about 150,000 miles every year by plane.
Having dual leadership positions in academic medicine has kept the Klotmans tightly connected, and the couple says their strong partnership has contributed to their success.
“It’s really been helpful having a deep understanding of our career paths, because we’ve been able to understand when one of us needed to be really focused on work and the other one would step back a bit with the kids and vice versa,” Mary said.
“There’s no question that we wouldn’t be in the positions we are in now if it weren’t for the fact that we’ve had each other,” Paul said.
In their own words
What is a little-known title that you have?
Paul: Purse-carrier for my wife. When she is honored at a national meeting or event, she often stands up and hands me her purse. I now make sure I have on an appropriate outfit that matches the purse.
Tell us about your children.
Mary: We had a very traumatic first pregnancy that we lost. Six years later, we adopted our first child, which was an amazing blessing. Our second son was Duke’s first successful frozen embryo transfer.
Describe a memorable moment in your relationship.
Paul: As we were leaving for our honeymoon, Mary’s dad handed me this booklet. It was the receipts for Mary’s medical school loans for the next 10 years. He said, “Congratulations, she’s all yours!”
A version of this article first appeared on Medscape.com.
Even a pandemic can’t stop teens’ alcohol and marijuana use
Despite record-breaking decreases in perceived availability of alcohol and marijuana among 12th-grade students, their use of these substances did not change significantly during the COVID-19 pandemic, according to two surveys conducted in 2020.
Vaping, however, did not show the same pattern. A decline in use over the previous 30 days was seen between the two surveys – conducted from Feb. 11 to March 15 and July 16 to Aug. 10 – along with a perceived reduction in the supply of vaping devices, Richard A. Miech, PhD, and associates said in Drug and Alcohol Dependence.
“Last year brought dramatic changes to adolescents’ lives, as many teens remained home with parents and other family members full time,” Nora D. Volkow, director of the National Institute on Drug Abuse, said in a separate written statement. “It is striking that, despite this monumental shift and teens’ perceived decreases in availability of marijuana and alcohol, usage rates held steady for these substances. This indicates that teens were able to obtain them despite barriers caused by the pandemic and despite not being of age to legally purchase them.”
In the first poll, conducted as part of the Monitoring the Future survey largely before the national emergency was declared, 86% of 12th-graders said that it was “fairly easy” or “very easy” to get alcohol, but that dropped to 62% in the second survey. For marijuana, prevalence of that level of availability was 76% before and 59% during the pandemic, Dr. Miech of the University of Michigan, Ann Arbor, and associates reported.
These results “indicate the largest decreases in substance use availability ever recorded in the 46 consecutive years it has been monitored by Monitoring the Future,” the investigators wrote.
The prevalence of marijuana use in the past 30 days declined from 23% before the pandemic to 20% during, with the respective figures for binge drinking in the past 2 weeks at 17% and 13%, and neither of those reductions reached significance, they noted.
“Adolescents may redouble their substance procurement efforts so that they can continue using substances at the levels at which they used in the past. In addition, adolescents may move to more solitary substance use. Social distancing policies might even increase substance use to the extent that they lead to feelings of isolation and loneliness that some adolescents address through increased substance use,” they suggested.
This hypothesis does not apply to vaping. The significant decline in availability – 73% before and 63% during – was accompanied by a significant drop in prevalence of past 30-day use from 24% to 17%, based on the survey data, which came from 3,770 responses to the first poll and 582 to the second.
In the case of vaping, the decline in use may have been caused by the decreased “exposure to substance-using peer networks ... and adults who provide opportunities for youth to initiate and continue use of substances,” Dr. Miech and associates said.
The findings of this analysis “suggest that reducing adolescent substance use through attempts to restrict supply alone would be a difficult undertaking,” Dr. Miech said in the NIDA statement. “The best strategy is likely to be one that combines approaches to limit the supply of these substances with efforts to decrease demand, through educational and public health campaigns.”
The research was funded by a NIDA grant. The investigators did not declare any conflicts of interest.
Despite record-breaking decreases in perceived availability of alcohol and marijuana among 12th-grade students, their use of these substances did not change significantly during the COVID-19 pandemic, according to two surveys conducted in 2020.
Vaping, however, did not show the same pattern. A decline in use over the previous 30 days was seen between the two surveys – conducted from Feb. 11 to March 15 and July 16 to Aug. 10 – along with a perceived reduction in the supply of vaping devices, Richard A. Miech, PhD, and associates said in Drug and Alcohol Dependence.
“Last year brought dramatic changes to adolescents’ lives, as many teens remained home with parents and other family members full time,” Nora D. Volkow, director of the National Institute on Drug Abuse, said in a separate written statement. “It is striking that, despite this monumental shift and teens’ perceived decreases in availability of marijuana and alcohol, usage rates held steady for these substances. This indicates that teens were able to obtain them despite barriers caused by the pandemic and despite not being of age to legally purchase them.”
In the first poll, conducted as part of the Monitoring the Future survey largely before the national emergency was declared, 86% of 12th-graders said that it was “fairly easy” or “very easy” to get alcohol, but that dropped to 62% in the second survey. For marijuana, prevalence of that level of availability was 76% before and 59% during the pandemic, Dr. Miech of the University of Michigan, Ann Arbor, and associates reported.
These results “indicate the largest decreases in substance use availability ever recorded in the 46 consecutive years it has been monitored by Monitoring the Future,” the investigators wrote.
The prevalence of marijuana use in the past 30 days declined from 23% before the pandemic to 20% during, with the respective figures for binge drinking in the past 2 weeks at 17% and 13%, and neither of those reductions reached significance, they noted.
“Adolescents may redouble their substance procurement efforts so that they can continue using substances at the levels at which they used in the past. In addition, adolescents may move to more solitary substance use. Social distancing policies might even increase substance use to the extent that they lead to feelings of isolation and loneliness that some adolescents address through increased substance use,” they suggested.
This hypothesis does not apply to vaping. The significant decline in availability – 73% before and 63% during – was accompanied by a significant drop in prevalence of past 30-day use from 24% to 17%, based on the survey data, which came from 3,770 responses to the first poll and 582 to the second.
In the case of vaping, the decline in use may have been caused by the decreased “exposure to substance-using peer networks ... and adults who provide opportunities for youth to initiate and continue use of substances,” Dr. Miech and associates said.
The findings of this analysis “suggest that reducing adolescent substance use through attempts to restrict supply alone would be a difficult undertaking,” Dr. Miech said in the NIDA statement. “The best strategy is likely to be one that combines approaches to limit the supply of these substances with efforts to decrease demand, through educational and public health campaigns.”
The research was funded by a NIDA grant. The investigators did not declare any conflicts of interest.
Despite record-breaking decreases in perceived availability of alcohol and marijuana among 12th-grade students, their use of these substances did not change significantly during the COVID-19 pandemic, according to two surveys conducted in 2020.
Vaping, however, did not show the same pattern. A decline in use over the previous 30 days was seen between the two surveys – conducted from Feb. 11 to March 15 and July 16 to Aug. 10 – along with a perceived reduction in the supply of vaping devices, Richard A. Miech, PhD, and associates said in Drug and Alcohol Dependence.
“Last year brought dramatic changes to adolescents’ lives, as many teens remained home with parents and other family members full time,” Nora D. Volkow, director of the National Institute on Drug Abuse, said in a separate written statement. “It is striking that, despite this monumental shift and teens’ perceived decreases in availability of marijuana and alcohol, usage rates held steady for these substances. This indicates that teens were able to obtain them despite barriers caused by the pandemic and despite not being of age to legally purchase them.”
In the first poll, conducted as part of the Monitoring the Future survey largely before the national emergency was declared, 86% of 12th-graders said that it was “fairly easy” or “very easy” to get alcohol, but that dropped to 62% in the second survey. For marijuana, prevalence of that level of availability was 76% before and 59% during the pandemic, Dr. Miech of the University of Michigan, Ann Arbor, and associates reported.
These results “indicate the largest decreases in substance use availability ever recorded in the 46 consecutive years it has been monitored by Monitoring the Future,” the investigators wrote.
The prevalence of marijuana use in the past 30 days declined from 23% before the pandemic to 20% during, with the respective figures for binge drinking in the past 2 weeks at 17% and 13%, and neither of those reductions reached significance, they noted.
“Adolescents may redouble their substance procurement efforts so that they can continue using substances at the levels at which they used in the past. In addition, adolescents may move to more solitary substance use. Social distancing policies might even increase substance use to the extent that they lead to feelings of isolation and loneliness that some adolescents address through increased substance use,” they suggested.
This hypothesis does not apply to vaping. The significant decline in availability – 73% before and 63% during – was accompanied by a significant drop in prevalence of past 30-day use from 24% to 17%, based on the survey data, which came from 3,770 responses to the first poll and 582 to the second.
In the case of vaping, the decline in use may have been caused by the decreased “exposure to substance-using peer networks ... and adults who provide opportunities for youth to initiate and continue use of substances,” Dr. Miech and associates said.
The findings of this analysis “suggest that reducing adolescent substance use through attempts to restrict supply alone would be a difficult undertaking,” Dr. Miech said in the NIDA statement. “The best strategy is likely to be one that combines approaches to limit the supply of these substances with efforts to decrease demand, through educational and public health campaigns.”
The research was funded by a NIDA grant. The investigators did not declare any conflicts of interest.
FROM DRUG AND ALCOHOL DEPENDENCE
Nocturnal hypoglycemia halved with insulin degludec vs. glargine
Patients with type 1 diabetes who used insulin degludec as their basal insulin had fewer than half the number of nocturnal hypoglycemia events, compared with patients who used insulin glargine U100, in a head-to-head crossover study with 51 patients who had a history of nighttime hypoglycemia episodes.
Patients with type 1 diabetes who are “struggling with nocturnal hypoglycemia would benefit from insulin degludec treatment,” said Julie M. Brøsen, MD, at the annual scientific sessions of the American Diabetes Association.
Accumulating evidence for less hypoglycemia with insulin degludec
Results from several studies comparing insulin degludec (Tresiba), a second-generation, longer-acting insulin with more stable steady-state performance, with the first-generation basal insulin analogue glargine (Lantus), have built the case that degludec produces fewer hypoglycemia events.
The landmark SWITCH 1 crossover study published in 2017 showed in about 500 patients with type 1 diabetes and a risk factor for hypoglycemia that treatment with insulin degludec led to significantly few total hypoglycemia episodes and significantly fewer nocturnal episodes, compared with insulin glargine.
Next came similar findings from ReFLeCT, a multicenter observational study that followed 556 unselected patients with type 1 diabetes in routine practice settings who switched to insulin degludec following treatment with a different basal insulin. The results again showed a significant drop-off in total, nonsevere, severe, and nocturnal hypoglycemia events.
Homing in on higher-risk patients
The current study, HypoDeg (Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia), ran at 10 Danish centers and enrolled 149 adults with type 1 diabetes who had at least one episode of severe nocturnal hypoglycemia within the prior 2 years, focusing on patients most at risk for future nocturnal hypoglycemia events. In an unusual study design, researchers identified nocturnal hypoglycemic episodes with hourly venous blood samples drawn from a subcutaneous line.
They randomized the patients to basal insulin treatment with either insulin degludec or to insulin glargine U100, allowed their treatment to stabilize for 3 months, and then tallied nocturnal hypoglycemia events for 9 months. They then crossed patients to the alternative basal insulin and repeated the process.
Results from the full study have not yet appeared in published form but were in a pair of reports at the 2020 scientific sessions of the ADA.
One report included findings based on 136 episodes of severe hypoglycemia identified clinically and showed these events occurred 35% less often during treatment with insulin degludec, a significant difference. The overall finding was primarily driven by 48% fewer episodes of severe nocturnal hypoglycemia, but this difference was not significant.
The second report identified hypoglycemia events with continuous glucose monitoring in 74 of the study participants, which identified 193 episodes of nonsevere nocturnal hypoglycemia and found that treatment with insulin degludec cut the rate by 47%, primarily by reducing asymptomatic episodes.
Hourly blood draws track overnight hypoglycemia
The current study included 51 of the 149 HypoDeg patients who agreed to undergo overnight blood sampling and had this done at least once while treated with each of the two study insulins. (The study design called for two blood sampling nights for each willing patient during each of the two treatment periods.) The 51 patients had type 1 diabetes for an average of 28 years and an average age of 58 years. Two-thirds were men, their baseline A1c was 7.8%, and on average had 2.6 episodes of severe nocturnal hypoglycemia during the prior 2 years.
The researchers drew hourly blood specimens on a total of 196 nights from the 51 participating patients and identified 57 nights when blood glucose levels reached hypoglycemia thresholds in 33 patients. One-third of the events occurred when patients were on insulin degludec treatment, and two-thirds when they were on insulin glargine, reported Dr. Brøsen.
She presented three separate analyses of the data. One analysis focused on level 1 hypoglycemia events, when blood glucose dips to 70 mg/dL or less, which occurred 54% less often when patients were on insulin degludec. A second analysis looked at level 2 events, when blood glucose falls below 54 mg/dL, and treatment with insulin degludec cut this by 64% compared with insulin glargine. The third analysis focused on symptomatic events when blood glucose was 70 mg/dL or less, and treatment with insulin degludec linked with a 62% cut in this metric. All three between-group differences were significant.
Evidence supports already-changed practice
This new evidence “supports recommending” insulin degludec over insulin glargine, commented Bastiaan E. de Galan, MD, PhD, an endocrinologist and professor at Maastrict (the Netherlands) University Medical Center. The new results “extend those from previous trials in populations with type 1 diabetes that were unselected for the risk of hypoglycemia. In clinical practice, insulin degludec is already considered for patients who reported nocturnal hypoglycemia while on insulin glargine U100, but it’s great this study provides the scientific evidence,” said Dr. de Galan in an interview.
“The lower rate of nocturnal hypoglycemia with degludec, compared with glargine U100 is well established. Inpatient assessment of hypoglycemia with measurement of hourly plasma glucose allowed HypoDeg to provide stronger evidence than prior studies. The benefit of delgudec versus glargine U100 was significant and clinically meaningful, in hypo-prone patients who would benefit the most” by using insulin degludec, commented Gian Paolo Fadini, MD, an endocrinologist at the University of Padova (Italy), and a lead investigator on the ReFLeCT study.
But insulin degludec is not a completely silver bullet. Its prolonged duration of action and stability that may in part explain why it limits hypoglycemia events can also be a drawback: “It probably offers fewer options for flexibility. Any change in dose takes at least a day or 2 to settle, which may be unfavorable in certain circumstances,” noted Dr. de Galan.
“I wouldn’t recommend insulin degludec for all patients with type 1 diabetes. It’s an individual evaluation in each patient,” said Dr. Brøsen. “We will be looking into whether some patients are better off on insulin glargine.”
Cost makes a difference
Another, potentially more consequential flaw is insulin degludec’s relative expense.
“To date, use of degludec in routine practice has been limited by its cost, compared with older basal insulins,” observed Dr. Fadini in an interview. “In several countries, including the United States, degludec is substantially more expensive than glargine.”
The ADA’s Standards of Medical Care in Diabetes–2021 includes table 9.3 that lists the costs of various insulins and shows the median average wholesale price of insulin glargine U100 follow-on products as $190/vial, compared with a $407 price for a similar vial of insulin degludec.
Insulin degludec “is clearly superior from a hypoglycemia standpoint. Patients with type 1 diabetes like the reduction because hypoglycemia is scary, and dangerous. The main issue is cost, and the extent to which it may be covered by insurance,” commented Lisa Chow, MD, an endocrinologist at the University of Minnesota, Minneapolis. “We generally won’t prescribe degludec unless it is at a price affordable to the patient. We try to use patient assistance programs sponsored by the company [that markets insulin degludec: Novo Nordisk] to try to make it more affordable.”
Dr. Chow also highlighted that a new wrinkle has been introduction of a more concentrated formulation of insulin glargine, U300, which appears to cause less hypoglycemia than insulin glargine U100. Recent study results indicated that no significant difference exists in the incidence of hypoglycemia among patients treated with insulin glargine U300 and those treated with insulin degludec, such as findings from the BRIGHT trial, which included just over 900 patients, and in the CONCLUDE trial, which randomized more than 1,600 patients.
The HypoDeg study was sponsored by Novo Nordisk, the company that markets insulin degludec. Dr. Brøsen had no personal disclosures, but several of her coauthors were either Novo Nordisk employees or had financial relationships with the company. Dr. de Galan has received research funding from Novo Nordisk. Dr. Fadini has received lecture fees and research funding from Novo Nordisk, from Sanofi, the company that markets insulin glargine, and from several other companies. Dr. Chow has received research funding from Dexcom.
Patients with type 1 diabetes who used insulin degludec as their basal insulin had fewer than half the number of nocturnal hypoglycemia events, compared with patients who used insulin glargine U100, in a head-to-head crossover study with 51 patients who had a history of nighttime hypoglycemia episodes.
Patients with type 1 diabetes who are “struggling with nocturnal hypoglycemia would benefit from insulin degludec treatment,” said Julie M. Brøsen, MD, at the annual scientific sessions of the American Diabetes Association.
Accumulating evidence for less hypoglycemia with insulin degludec
Results from several studies comparing insulin degludec (Tresiba), a second-generation, longer-acting insulin with more stable steady-state performance, with the first-generation basal insulin analogue glargine (Lantus), have built the case that degludec produces fewer hypoglycemia events.
The landmark SWITCH 1 crossover study published in 2017 showed in about 500 patients with type 1 diabetes and a risk factor for hypoglycemia that treatment with insulin degludec led to significantly few total hypoglycemia episodes and significantly fewer nocturnal episodes, compared with insulin glargine.
Next came similar findings from ReFLeCT, a multicenter observational study that followed 556 unselected patients with type 1 diabetes in routine practice settings who switched to insulin degludec following treatment with a different basal insulin. The results again showed a significant drop-off in total, nonsevere, severe, and nocturnal hypoglycemia events.
Homing in on higher-risk patients
The current study, HypoDeg (Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia), ran at 10 Danish centers and enrolled 149 adults with type 1 diabetes who had at least one episode of severe nocturnal hypoglycemia within the prior 2 years, focusing on patients most at risk for future nocturnal hypoglycemia events. In an unusual study design, researchers identified nocturnal hypoglycemic episodes with hourly venous blood samples drawn from a subcutaneous line.
They randomized the patients to basal insulin treatment with either insulin degludec or to insulin glargine U100, allowed their treatment to stabilize for 3 months, and then tallied nocturnal hypoglycemia events for 9 months. They then crossed patients to the alternative basal insulin and repeated the process.
Results from the full study have not yet appeared in published form but were in a pair of reports at the 2020 scientific sessions of the ADA.
One report included findings based on 136 episodes of severe hypoglycemia identified clinically and showed these events occurred 35% less often during treatment with insulin degludec, a significant difference. The overall finding was primarily driven by 48% fewer episodes of severe nocturnal hypoglycemia, but this difference was not significant.
The second report identified hypoglycemia events with continuous glucose monitoring in 74 of the study participants, which identified 193 episodes of nonsevere nocturnal hypoglycemia and found that treatment with insulin degludec cut the rate by 47%, primarily by reducing asymptomatic episodes.
Hourly blood draws track overnight hypoglycemia
The current study included 51 of the 149 HypoDeg patients who agreed to undergo overnight blood sampling and had this done at least once while treated with each of the two study insulins. (The study design called for two blood sampling nights for each willing patient during each of the two treatment periods.) The 51 patients had type 1 diabetes for an average of 28 years and an average age of 58 years. Two-thirds were men, their baseline A1c was 7.8%, and on average had 2.6 episodes of severe nocturnal hypoglycemia during the prior 2 years.
The researchers drew hourly blood specimens on a total of 196 nights from the 51 participating patients and identified 57 nights when blood glucose levels reached hypoglycemia thresholds in 33 patients. One-third of the events occurred when patients were on insulin degludec treatment, and two-thirds when they were on insulin glargine, reported Dr. Brøsen.
She presented three separate analyses of the data. One analysis focused on level 1 hypoglycemia events, when blood glucose dips to 70 mg/dL or less, which occurred 54% less often when patients were on insulin degludec. A second analysis looked at level 2 events, when blood glucose falls below 54 mg/dL, and treatment with insulin degludec cut this by 64% compared with insulin glargine. The third analysis focused on symptomatic events when blood glucose was 70 mg/dL or less, and treatment with insulin degludec linked with a 62% cut in this metric. All three between-group differences were significant.
Evidence supports already-changed practice
This new evidence “supports recommending” insulin degludec over insulin glargine, commented Bastiaan E. de Galan, MD, PhD, an endocrinologist and professor at Maastrict (the Netherlands) University Medical Center. The new results “extend those from previous trials in populations with type 1 diabetes that were unselected for the risk of hypoglycemia. In clinical practice, insulin degludec is already considered for patients who reported nocturnal hypoglycemia while on insulin glargine U100, but it’s great this study provides the scientific evidence,” said Dr. de Galan in an interview.
“The lower rate of nocturnal hypoglycemia with degludec, compared with glargine U100 is well established. Inpatient assessment of hypoglycemia with measurement of hourly plasma glucose allowed HypoDeg to provide stronger evidence than prior studies. The benefit of delgudec versus glargine U100 was significant and clinically meaningful, in hypo-prone patients who would benefit the most” by using insulin degludec, commented Gian Paolo Fadini, MD, an endocrinologist at the University of Padova (Italy), and a lead investigator on the ReFLeCT study.
But insulin degludec is not a completely silver bullet. Its prolonged duration of action and stability that may in part explain why it limits hypoglycemia events can also be a drawback: “It probably offers fewer options for flexibility. Any change in dose takes at least a day or 2 to settle, which may be unfavorable in certain circumstances,” noted Dr. de Galan.
“I wouldn’t recommend insulin degludec for all patients with type 1 diabetes. It’s an individual evaluation in each patient,” said Dr. Brøsen. “We will be looking into whether some patients are better off on insulin glargine.”
Cost makes a difference
Another, potentially more consequential flaw is insulin degludec’s relative expense.
“To date, use of degludec in routine practice has been limited by its cost, compared with older basal insulins,” observed Dr. Fadini in an interview. “In several countries, including the United States, degludec is substantially more expensive than glargine.”
The ADA’s Standards of Medical Care in Diabetes–2021 includes table 9.3 that lists the costs of various insulins and shows the median average wholesale price of insulin glargine U100 follow-on products as $190/vial, compared with a $407 price for a similar vial of insulin degludec.
Insulin degludec “is clearly superior from a hypoglycemia standpoint. Patients with type 1 diabetes like the reduction because hypoglycemia is scary, and dangerous. The main issue is cost, and the extent to which it may be covered by insurance,” commented Lisa Chow, MD, an endocrinologist at the University of Minnesota, Minneapolis. “We generally won’t prescribe degludec unless it is at a price affordable to the patient. We try to use patient assistance programs sponsored by the company [that markets insulin degludec: Novo Nordisk] to try to make it more affordable.”
Dr. Chow also highlighted that a new wrinkle has been introduction of a more concentrated formulation of insulin glargine, U300, which appears to cause less hypoglycemia than insulin glargine U100. Recent study results indicated that no significant difference exists in the incidence of hypoglycemia among patients treated with insulin glargine U300 and those treated with insulin degludec, such as findings from the BRIGHT trial, which included just over 900 patients, and in the CONCLUDE trial, which randomized more than 1,600 patients.
The HypoDeg study was sponsored by Novo Nordisk, the company that markets insulin degludec. Dr. Brøsen had no personal disclosures, but several of her coauthors were either Novo Nordisk employees or had financial relationships with the company. Dr. de Galan has received research funding from Novo Nordisk. Dr. Fadini has received lecture fees and research funding from Novo Nordisk, from Sanofi, the company that markets insulin glargine, and from several other companies. Dr. Chow has received research funding from Dexcom.
Patients with type 1 diabetes who used insulin degludec as their basal insulin had fewer than half the number of nocturnal hypoglycemia events, compared with patients who used insulin glargine U100, in a head-to-head crossover study with 51 patients who had a history of nighttime hypoglycemia episodes.
Patients with type 1 diabetes who are “struggling with nocturnal hypoglycemia would benefit from insulin degludec treatment,” said Julie M. Brøsen, MD, at the annual scientific sessions of the American Diabetes Association.
Accumulating evidence for less hypoglycemia with insulin degludec
Results from several studies comparing insulin degludec (Tresiba), a second-generation, longer-acting insulin with more stable steady-state performance, with the first-generation basal insulin analogue glargine (Lantus), have built the case that degludec produces fewer hypoglycemia events.
The landmark SWITCH 1 crossover study published in 2017 showed in about 500 patients with type 1 diabetes and a risk factor for hypoglycemia that treatment with insulin degludec led to significantly few total hypoglycemia episodes and significantly fewer nocturnal episodes, compared with insulin glargine.
Next came similar findings from ReFLeCT, a multicenter observational study that followed 556 unselected patients with type 1 diabetes in routine practice settings who switched to insulin degludec following treatment with a different basal insulin. The results again showed a significant drop-off in total, nonsevere, severe, and nocturnal hypoglycemia events.
Homing in on higher-risk patients
The current study, HypoDeg (Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia), ran at 10 Danish centers and enrolled 149 adults with type 1 diabetes who had at least one episode of severe nocturnal hypoglycemia within the prior 2 years, focusing on patients most at risk for future nocturnal hypoglycemia events. In an unusual study design, researchers identified nocturnal hypoglycemic episodes with hourly venous blood samples drawn from a subcutaneous line.
They randomized the patients to basal insulin treatment with either insulin degludec or to insulin glargine U100, allowed their treatment to stabilize for 3 months, and then tallied nocturnal hypoglycemia events for 9 months. They then crossed patients to the alternative basal insulin and repeated the process.
Results from the full study have not yet appeared in published form but were in a pair of reports at the 2020 scientific sessions of the ADA.
One report included findings based on 136 episodes of severe hypoglycemia identified clinically and showed these events occurred 35% less often during treatment with insulin degludec, a significant difference. The overall finding was primarily driven by 48% fewer episodes of severe nocturnal hypoglycemia, but this difference was not significant.
The second report identified hypoglycemia events with continuous glucose monitoring in 74 of the study participants, which identified 193 episodes of nonsevere nocturnal hypoglycemia and found that treatment with insulin degludec cut the rate by 47%, primarily by reducing asymptomatic episodes.
Hourly blood draws track overnight hypoglycemia
The current study included 51 of the 149 HypoDeg patients who agreed to undergo overnight blood sampling and had this done at least once while treated with each of the two study insulins. (The study design called for two blood sampling nights for each willing patient during each of the two treatment periods.) The 51 patients had type 1 diabetes for an average of 28 years and an average age of 58 years. Two-thirds were men, their baseline A1c was 7.8%, and on average had 2.6 episodes of severe nocturnal hypoglycemia during the prior 2 years.
The researchers drew hourly blood specimens on a total of 196 nights from the 51 participating patients and identified 57 nights when blood glucose levels reached hypoglycemia thresholds in 33 patients. One-third of the events occurred when patients were on insulin degludec treatment, and two-thirds when they were on insulin glargine, reported Dr. Brøsen.
She presented three separate analyses of the data. One analysis focused on level 1 hypoglycemia events, when blood glucose dips to 70 mg/dL or less, which occurred 54% less often when patients were on insulin degludec. A second analysis looked at level 2 events, when blood glucose falls below 54 mg/dL, and treatment with insulin degludec cut this by 64% compared with insulin glargine. The third analysis focused on symptomatic events when blood glucose was 70 mg/dL or less, and treatment with insulin degludec linked with a 62% cut in this metric. All three between-group differences were significant.
Evidence supports already-changed practice
This new evidence “supports recommending” insulin degludec over insulin glargine, commented Bastiaan E. de Galan, MD, PhD, an endocrinologist and professor at Maastrict (the Netherlands) University Medical Center. The new results “extend those from previous trials in populations with type 1 diabetes that were unselected for the risk of hypoglycemia. In clinical practice, insulin degludec is already considered for patients who reported nocturnal hypoglycemia while on insulin glargine U100, but it’s great this study provides the scientific evidence,” said Dr. de Galan in an interview.
“The lower rate of nocturnal hypoglycemia with degludec, compared with glargine U100 is well established. Inpatient assessment of hypoglycemia with measurement of hourly plasma glucose allowed HypoDeg to provide stronger evidence than prior studies. The benefit of delgudec versus glargine U100 was significant and clinically meaningful, in hypo-prone patients who would benefit the most” by using insulin degludec, commented Gian Paolo Fadini, MD, an endocrinologist at the University of Padova (Italy), and a lead investigator on the ReFLeCT study.
But insulin degludec is not a completely silver bullet. Its prolonged duration of action and stability that may in part explain why it limits hypoglycemia events can also be a drawback: “It probably offers fewer options for flexibility. Any change in dose takes at least a day or 2 to settle, which may be unfavorable in certain circumstances,” noted Dr. de Galan.
“I wouldn’t recommend insulin degludec for all patients with type 1 diabetes. It’s an individual evaluation in each patient,” said Dr. Brøsen. “We will be looking into whether some patients are better off on insulin glargine.”
Cost makes a difference
Another, potentially more consequential flaw is insulin degludec’s relative expense.
“To date, use of degludec in routine practice has been limited by its cost, compared with older basal insulins,” observed Dr. Fadini in an interview. “In several countries, including the United States, degludec is substantially more expensive than glargine.”
The ADA’s Standards of Medical Care in Diabetes–2021 includes table 9.3 that lists the costs of various insulins and shows the median average wholesale price of insulin glargine U100 follow-on products as $190/vial, compared with a $407 price for a similar vial of insulin degludec.
Insulin degludec “is clearly superior from a hypoglycemia standpoint. Patients with type 1 diabetes like the reduction because hypoglycemia is scary, and dangerous. The main issue is cost, and the extent to which it may be covered by insurance,” commented Lisa Chow, MD, an endocrinologist at the University of Minnesota, Minneapolis. “We generally won’t prescribe degludec unless it is at a price affordable to the patient. We try to use patient assistance programs sponsored by the company [that markets insulin degludec: Novo Nordisk] to try to make it more affordable.”
Dr. Chow also highlighted that a new wrinkle has been introduction of a more concentrated formulation of insulin glargine, U300, which appears to cause less hypoglycemia than insulin glargine U100. Recent study results indicated that no significant difference exists in the incidence of hypoglycemia among patients treated with insulin glargine U300 and those treated with insulin degludec, such as findings from the BRIGHT trial, which included just over 900 patients, and in the CONCLUDE trial, which randomized more than 1,600 patients.
The HypoDeg study was sponsored by Novo Nordisk, the company that markets insulin degludec. Dr. Brøsen had no personal disclosures, but several of her coauthors were either Novo Nordisk employees or had financial relationships with the company. Dr. de Galan has received research funding from Novo Nordisk. Dr. Fadini has received lecture fees and research funding from Novo Nordisk, from Sanofi, the company that markets insulin glargine, and from several other companies. Dr. Chow has received research funding from Dexcom.
FROM ADA 2021
Calories may outweigh nutrients in diets for fatty liver
Intermittent calorie restriction offers only modest advantages over a low-carbohydrate, high-fat (LCHF) diet for treating nonalcoholic fatty liver disease (NAFLD), researchers say.
The intermittent diet offers more benefit for liver stiffness and LDL cholesterol, and might be easier to maintain, said Magnus Holmer, MD, head of the hepatology unit at the Karolinska Institute in Stockholm.
But the intermittent diet also has drawbacks and the differences between the two were slight, he said in an interview.
“They were more or less identically effective in reducing liver steatosis in NAFLD and also reducing body weight,” he said. “And from this, we can say that the composition of macronutrients such as fat or sugar seems to be less important than how many calories you eat.”
Dr. Holmer and colleagues presented their findings at the meeting sponsored by the European Association for the Study of the Liver and published them in JHEP Reports
While previous studies have shown that dieting can effectively treat NAFLD, researchers have debated whether popular LCHF diets might cause more harm than good.
At the same time, intermittent-calorie restriction diets have also been gaining in popularity, particularly the 5:2 diet in which participants eat normally for 5 days a week and restrict their calories the other 2 days.
How do the two diets compare?
To see if one was more effective than the other, the researchers recruited 74 people with NAFLD. They diagnosed the patients either by radiologic assessment or a combination of controlled attenuation parameter (CAP) greater than 280 dB/m and obesity, or a CAP greater than 280 dB/m, elevated ALT, and overweight. Sixteen of the patients were being treated with statins.
The researchers randomly assigned 25 people to an LCHF diet, 25 to a 5:2 diet, and 24 to standard care. The groups were similar in diet, age, body mass index, liver stiffness, and most other criteria at baseline, although there were more women in the standard-care group.
At the start of the study, the participants in the standard-care group consulted with a hepatologist who advised them to avoid sweets and saturated fats, eat three meals a day, and avoid large portions.
The researchers asked women in the 5:2 diet to eat up to 500 kcal/day each of 2 days per week and up to 2,000 kcal/day each of the other 5 days. They asked men in the group to eat up to 600 kcal/day each of 2 days per week and up to 2,400 kcal/day the other 5 days.
They provided all the 5:2 participants with recipes that followed the Nordic Nutrition Recommendations, an adaptation of the Mediterranean diet that emphasizes foods traditional in Nordic countries, particularly grains such as whole-grain rye, oats, and barley; fruits such as apples, pears, berries, and plums; root vegetables, cabbages, onions, peas, beans, fish, boiled potatoes, and dairy products; and the use of rapeseed (canola) oil. The calories provided in the recipes were composed of 45%-60% carbohydrates, 25% fat, and 10%-20% protein.
The researchers asked women in the LCHF diet to eat an average of 1,600 kcal/day and men to eat an average of 1,900 kcal/day. All the participants used recipes based on meat, fish, eggs, low-carbohydrate vegetables, and dairy fat. Participants avoided sugar, bread, pasta, rice, pies, potatoes, and fruit. The calories in the recipes were composed of 5%-10% carbohydrates, 50%-80% fat, and 15%-40% protein.
All the participants reported what they ate over the previous 3 days, both at the start of the study and after 12 weeks. Participants in the 5:2 and LCHF groups also received follow-up calls to report their past 24 hours of eating at 2, 4, 8, and 12 weeks, and also at week 6, when they visited a dietitian.
In addition, the researchers measured the participants’ linoleic acid and alpha-linolenic acid intake to verify that the participants’ diets were different among the groups.
After 12 weeks, all three groups lost a significant amount of liver fat, but the LCHF and 5:2 groups lost more than the standard care group. Liver stiffness decreased significantly in the 5:2 and standard care groups, but not in the LCHF group.
The differences in steatosis change between the standard care and LCHF groups was statistically significant (P = .001), as it was between the standard care and 5:2 groups (P = .029). The differences between the LCHF and 5:2 groups were not statistically significant for weight or steatosis, but they were statistically significant for liver stiffness.
In addition, the 5:2 group significantly reduced total and LDL cholesterol, while the standard care group did not. In the LCHF group, levels of LDL cholesterol, HDL cholesterol, and total cholesterol all increased.
The long-term implications of the cholesterol findings are unclear, Dr. Holmer said. He hopes to follow up on these patients after 18-24 months. But the initial cholesterol findings are perhaps enough to constitute a red flag for anyone with a history of cardiovascular disease.
Diet adherence
Only one person dropped out of the 5:2 group, compared with five in the LCHF group and four in the standard-care group. More people in the LCHF group reported adverse events, such as gastrointestinal upset.
“With LCHF, it’s a drastic change for most people,” Dr. Holmer said. “Many patients are a bit shocked when they realize how much fat they are supposed to eat for breakfast, for lunch, and for dinner. They might eat bacon and eggs for breakfast every day.” The diet could be challenging for people who want to reduce their consumption of meat for environmental reasons.
The 5:2 group offers the advantage that people can choose what they want to eat as long as they adhere to the calorie restrictions, he pointed out. Still, he cautioned that the diet would not work well for people with insulin-dependent diabetes because of the difficulty of adjusting insulin levels on fasting days. He also recommended against this diet for people with cirrhosis because they need to eat frequent meals.
LCHF and 5:2 diets can work
But for most people the good news is that a variety of diets will work to treat NAFLD, Dr. Holmer said.
“I begin with saying to my patients that this can be completely cured, as long as you’re able to lose weight,” he said. “Then the next question is, how are they going to go ahead with that task? And if they’re already interested in some sort of specific diet, then I can, based on these findings, encourage that.”
Stephen Harrison, MD, a visiting professor of hepatology at Radcliffe Department of Medicine, University of Oxford, England, said that longer-term results will be important. For example, it will be interesting to see if the diets had effects on ballooning or inflammation.
Another limitation of the study is that it is relatively small in size, he said. He pointed out that people with NAFLD should increase their physical activity as well as eating less.
Still, Dr. Harrison greeted the findings enthusiastically, saying: “This is an important study.”
It’s useful to compare two popular diets head to head, and it’s also encouraging to get confirmation that either one can work, he added.
The study was supported by grants from the Stockholm County Council, the Dietary Science Foundation (Kostfonden), the Skandia Research Foundation, and the Åke Wiberg Foundation. Dr. Holmer has disclosed no relevant financial relationships. Harrison is a consultant to Madrigal Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Intermittent calorie restriction offers only modest advantages over a low-carbohydrate, high-fat (LCHF) diet for treating nonalcoholic fatty liver disease (NAFLD), researchers say.
The intermittent diet offers more benefit for liver stiffness and LDL cholesterol, and might be easier to maintain, said Magnus Holmer, MD, head of the hepatology unit at the Karolinska Institute in Stockholm.
But the intermittent diet also has drawbacks and the differences between the two were slight, he said in an interview.
“They were more or less identically effective in reducing liver steatosis in NAFLD and also reducing body weight,” he said. “And from this, we can say that the composition of macronutrients such as fat or sugar seems to be less important than how many calories you eat.”
Dr. Holmer and colleagues presented their findings at the meeting sponsored by the European Association for the Study of the Liver and published them in JHEP Reports
While previous studies have shown that dieting can effectively treat NAFLD, researchers have debated whether popular LCHF diets might cause more harm than good.
At the same time, intermittent-calorie restriction diets have also been gaining in popularity, particularly the 5:2 diet in which participants eat normally for 5 days a week and restrict their calories the other 2 days.
How do the two diets compare?
To see if one was more effective than the other, the researchers recruited 74 people with NAFLD. They diagnosed the patients either by radiologic assessment or a combination of controlled attenuation parameter (CAP) greater than 280 dB/m and obesity, or a CAP greater than 280 dB/m, elevated ALT, and overweight. Sixteen of the patients were being treated with statins.
The researchers randomly assigned 25 people to an LCHF diet, 25 to a 5:2 diet, and 24 to standard care. The groups were similar in diet, age, body mass index, liver stiffness, and most other criteria at baseline, although there were more women in the standard-care group.
At the start of the study, the participants in the standard-care group consulted with a hepatologist who advised them to avoid sweets and saturated fats, eat three meals a day, and avoid large portions.
The researchers asked women in the 5:2 diet to eat up to 500 kcal/day each of 2 days per week and up to 2,000 kcal/day each of the other 5 days. They asked men in the group to eat up to 600 kcal/day each of 2 days per week and up to 2,400 kcal/day the other 5 days.
They provided all the 5:2 participants with recipes that followed the Nordic Nutrition Recommendations, an adaptation of the Mediterranean diet that emphasizes foods traditional in Nordic countries, particularly grains such as whole-grain rye, oats, and barley; fruits such as apples, pears, berries, and plums; root vegetables, cabbages, onions, peas, beans, fish, boiled potatoes, and dairy products; and the use of rapeseed (canola) oil. The calories provided in the recipes were composed of 45%-60% carbohydrates, 25% fat, and 10%-20% protein.
The researchers asked women in the LCHF diet to eat an average of 1,600 kcal/day and men to eat an average of 1,900 kcal/day. All the participants used recipes based on meat, fish, eggs, low-carbohydrate vegetables, and dairy fat. Participants avoided sugar, bread, pasta, rice, pies, potatoes, and fruit. The calories in the recipes were composed of 5%-10% carbohydrates, 50%-80% fat, and 15%-40% protein.
All the participants reported what they ate over the previous 3 days, both at the start of the study and after 12 weeks. Participants in the 5:2 and LCHF groups also received follow-up calls to report their past 24 hours of eating at 2, 4, 8, and 12 weeks, and also at week 6, when they visited a dietitian.
In addition, the researchers measured the participants’ linoleic acid and alpha-linolenic acid intake to verify that the participants’ diets were different among the groups.
After 12 weeks, all three groups lost a significant amount of liver fat, but the LCHF and 5:2 groups lost more than the standard care group. Liver stiffness decreased significantly in the 5:2 and standard care groups, but not in the LCHF group.
The differences in steatosis change between the standard care and LCHF groups was statistically significant (P = .001), as it was between the standard care and 5:2 groups (P = .029). The differences between the LCHF and 5:2 groups were not statistically significant for weight or steatosis, but they were statistically significant for liver stiffness.
In addition, the 5:2 group significantly reduced total and LDL cholesterol, while the standard care group did not. In the LCHF group, levels of LDL cholesterol, HDL cholesterol, and total cholesterol all increased.
The long-term implications of the cholesterol findings are unclear, Dr. Holmer said. He hopes to follow up on these patients after 18-24 months. But the initial cholesterol findings are perhaps enough to constitute a red flag for anyone with a history of cardiovascular disease.
Diet adherence
Only one person dropped out of the 5:2 group, compared with five in the LCHF group and four in the standard-care group. More people in the LCHF group reported adverse events, such as gastrointestinal upset.
“With LCHF, it’s a drastic change for most people,” Dr. Holmer said. “Many patients are a bit shocked when they realize how much fat they are supposed to eat for breakfast, for lunch, and for dinner. They might eat bacon and eggs for breakfast every day.” The diet could be challenging for people who want to reduce their consumption of meat for environmental reasons.
The 5:2 group offers the advantage that people can choose what they want to eat as long as they adhere to the calorie restrictions, he pointed out. Still, he cautioned that the diet would not work well for people with insulin-dependent diabetes because of the difficulty of adjusting insulin levels on fasting days. He also recommended against this diet for people with cirrhosis because they need to eat frequent meals.
LCHF and 5:2 diets can work
But for most people the good news is that a variety of diets will work to treat NAFLD, Dr. Holmer said.
“I begin with saying to my patients that this can be completely cured, as long as you’re able to lose weight,” he said. “Then the next question is, how are they going to go ahead with that task? And if they’re already interested in some sort of specific diet, then I can, based on these findings, encourage that.”
Stephen Harrison, MD, a visiting professor of hepatology at Radcliffe Department of Medicine, University of Oxford, England, said that longer-term results will be important. For example, it will be interesting to see if the diets had effects on ballooning or inflammation.
Another limitation of the study is that it is relatively small in size, he said. He pointed out that people with NAFLD should increase their physical activity as well as eating less.
Still, Dr. Harrison greeted the findings enthusiastically, saying: “This is an important study.”
It’s useful to compare two popular diets head to head, and it’s also encouraging to get confirmation that either one can work, he added.
The study was supported by grants from the Stockholm County Council, the Dietary Science Foundation (Kostfonden), the Skandia Research Foundation, and the Åke Wiberg Foundation. Dr. Holmer has disclosed no relevant financial relationships. Harrison is a consultant to Madrigal Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Intermittent calorie restriction offers only modest advantages over a low-carbohydrate, high-fat (LCHF) diet for treating nonalcoholic fatty liver disease (NAFLD), researchers say.
The intermittent diet offers more benefit for liver stiffness and LDL cholesterol, and might be easier to maintain, said Magnus Holmer, MD, head of the hepatology unit at the Karolinska Institute in Stockholm.
But the intermittent diet also has drawbacks and the differences between the two were slight, he said in an interview.
“They were more or less identically effective in reducing liver steatosis in NAFLD and also reducing body weight,” he said. “And from this, we can say that the composition of macronutrients such as fat or sugar seems to be less important than how many calories you eat.”
Dr. Holmer and colleagues presented their findings at the meeting sponsored by the European Association for the Study of the Liver and published them in JHEP Reports
While previous studies have shown that dieting can effectively treat NAFLD, researchers have debated whether popular LCHF diets might cause more harm than good.
At the same time, intermittent-calorie restriction diets have also been gaining in popularity, particularly the 5:2 diet in which participants eat normally for 5 days a week and restrict their calories the other 2 days.
How do the two diets compare?
To see if one was more effective than the other, the researchers recruited 74 people with NAFLD. They diagnosed the patients either by radiologic assessment or a combination of controlled attenuation parameter (CAP) greater than 280 dB/m and obesity, or a CAP greater than 280 dB/m, elevated ALT, and overweight. Sixteen of the patients were being treated with statins.
The researchers randomly assigned 25 people to an LCHF diet, 25 to a 5:2 diet, and 24 to standard care. The groups were similar in diet, age, body mass index, liver stiffness, and most other criteria at baseline, although there were more women in the standard-care group.
At the start of the study, the participants in the standard-care group consulted with a hepatologist who advised them to avoid sweets and saturated fats, eat three meals a day, and avoid large portions.
The researchers asked women in the 5:2 diet to eat up to 500 kcal/day each of 2 days per week and up to 2,000 kcal/day each of the other 5 days. They asked men in the group to eat up to 600 kcal/day each of 2 days per week and up to 2,400 kcal/day the other 5 days.
They provided all the 5:2 participants with recipes that followed the Nordic Nutrition Recommendations, an adaptation of the Mediterranean diet that emphasizes foods traditional in Nordic countries, particularly grains such as whole-grain rye, oats, and barley; fruits such as apples, pears, berries, and plums; root vegetables, cabbages, onions, peas, beans, fish, boiled potatoes, and dairy products; and the use of rapeseed (canola) oil. The calories provided in the recipes were composed of 45%-60% carbohydrates, 25% fat, and 10%-20% protein.
The researchers asked women in the LCHF diet to eat an average of 1,600 kcal/day and men to eat an average of 1,900 kcal/day. All the participants used recipes based on meat, fish, eggs, low-carbohydrate vegetables, and dairy fat. Participants avoided sugar, bread, pasta, rice, pies, potatoes, and fruit. The calories in the recipes were composed of 5%-10% carbohydrates, 50%-80% fat, and 15%-40% protein.
All the participants reported what they ate over the previous 3 days, both at the start of the study and after 12 weeks. Participants in the 5:2 and LCHF groups also received follow-up calls to report their past 24 hours of eating at 2, 4, 8, and 12 weeks, and also at week 6, when they visited a dietitian.
In addition, the researchers measured the participants’ linoleic acid and alpha-linolenic acid intake to verify that the participants’ diets were different among the groups.
After 12 weeks, all three groups lost a significant amount of liver fat, but the LCHF and 5:2 groups lost more than the standard care group. Liver stiffness decreased significantly in the 5:2 and standard care groups, but not in the LCHF group.
The differences in steatosis change between the standard care and LCHF groups was statistically significant (P = .001), as it was between the standard care and 5:2 groups (P = .029). The differences between the LCHF and 5:2 groups were not statistically significant for weight or steatosis, but they were statistically significant for liver stiffness.
In addition, the 5:2 group significantly reduced total and LDL cholesterol, while the standard care group did not. In the LCHF group, levels of LDL cholesterol, HDL cholesterol, and total cholesterol all increased.
The long-term implications of the cholesterol findings are unclear, Dr. Holmer said. He hopes to follow up on these patients after 18-24 months. But the initial cholesterol findings are perhaps enough to constitute a red flag for anyone with a history of cardiovascular disease.
Diet adherence
Only one person dropped out of the 5:2 group, compared with five in the LCHF group and four in the standard-care group. More people in the LCHF group reported adverse events, such as gastrointestinal upset.
“With LCHF, it’s a drastic change for most people,” Dr. Holmer said. “Many patients are a bit shocked when they realize how much fat they are supposed to eat for breakfast, for lunch, and for dinner. They might eat bacon and eggs for breakfast every day.” The diet could be challenging for people who want to reduce their consumption of meat for environmental reasons.
The 5:2 group offers the advantage that people can choose what they want to eat as long as they adhere to the calorie restrictions, he pointed out. Still, he cautioned that the diet would not work well for people with insulin-dependent diabetes because of the difficulty of adjusting insulin levels on fasting days. He also recommended against this diet for people with cirrhosis because they need to eat frequent meals.
LCHF and 5:2 diets can work
But for most people the good news is that a variety of diets will work to treat NAFLD, Dr. Holmer said.
“I begin with saying to my patients that this can be completely cured, as long as you’re able to lose weight,” he said. “Then the next question is, how are they going to go ahead with that task? And if they’re already interested in some sort of specific diet, then I can, based on these findings, encourage that.”
Stephen Harrison, MD, a visiting professor of hepatology at Radcliffe Department of Medicine, University of Oxford, England, said that longer-term results will be important. For example, it will be interesting to see if the diets had effects on ballooning or inflammation.
Another limitation of the study is that it is relatively small in size, he said. He pointed out that people with NAFLD should increase their physical activity as well as eating less.
Still, Dr. Harrison greeted the findings enthusiastically, saying: “This is an important study.”
It’s useful to compare two popular diets head to head, and it’s also encouraging to get confirmation that either one can work, he added.
The study was supported by grants from the Stockholm County Council, the Dietary Science Foundation (Kostfonden), the Skandia Research Foundation, and the Åke Wiberg Foundation. Dr. Holmer has disclosed no relevant financial relationships. Harrison is a consultant to Madrigal Pharmaceuticals.
A version of this article first appeared on Medscape.com.
EC approves cemiplimab for advanced or metastatic BCC after HHI therapy
The
The programmed death-1 (PD-1) inhibitor, which is being jointly developed by Regeneron and Sanofi under a global collaboration agreement, was approved by the Food and Drug Administration for this indication in the United States in February; the FDA granted full approval for its use in patients with locally advanced BCC and accelerated approval for use in patients with metastatic BCC.
The EC’s thumbs-up for cemiplimab as a treatment for BCC marks the third such approval for an advanced cancer in the European Union: The immunotherapy was concurrently approved by the EC for the first-line treatment of adults with advanced non–small cell lung cancer (NSCLC) whose tumor cells have ≥ 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations, and was approved in 2019 for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
The FDA granted approval of cemiplimab for NSCLC in February, and for CSCC in 2018.
The latest BCC approval is based on data from an ongoing, open-label, prospective phase 2 clinical trial of 119 patients with advanced BCC who were previously treated with an HHI. The objective response rates in cemiplimab-treated patients were 32% (partial responses in 25%; complete responses in 7%) in those with locally advanced BCC, and 29% (partial responses in 26%; complete responses in 3%) in those with metastatic BCC.
About 90% of all patients had a duration of response (DOR) of 6 months or longer. Median DOR was not reached in either group at median follow-up of 16 months for locally advanced BCC and 9 months for metastatic BCC.
The safety profile of cemiplimab has been generally consistent across approved indications. Serious adverse events have been reported in 30% of 816 patients from all four cemiplimab monotherapy pivotal trials, and these led to permanent discontinuation of treatment in 8% of patients.
Immune-related adverse reactions occurred in 22% of patients, and led to permanent discontinuation in 4%. The most common such reactions were hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and immune-related skin adverse reactions (2%).
Cemiplimab is administered by intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. The recommended dose is 350 mg.
A press release from Regeneron notes that research efforts with respect to cemiplimab – both as monotherapy and in combination with other agents – are focused on difficult-to-treat cancers, including advanced NSCLC, cervical cancer, and other solid tumors and blood cancers.
The
The programmed death-1 (PD-1) inhibitor, which is being jointly developed by Regeneron and Sanofi under a global collaboration agreement, was approved by the Food and Drug Administration for this indication in the United States in February; the FDA granted full approval for its use in patients with locally advanced BCC and accelerated approval for use in patients with metastatic BCC.
The EC’s thumbs-up for cemiplimab as a treatment for BCC marks the third such approval for an advanced cancer in the European Union: The immunotherapy was concurrently approved by the EC for the first-line treatment of adults with advanced non–small cell lung cancer (NSCLC) whose tumor cells have ≥ 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations, and was approved in 2019 for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
The FDA granted approval of cemiplimab for NSCLC in February, and for CSCC in 2018.
The latest BCC approval is based on data from an ongoing, open-label, prospective phase 2 clinical trial of 119 patients with advanced BCC who were previously treated with an HHI. The objective response rates in cemiplimab-treated patients were 32% (partial responses in 25%; complete responses in 7%) in those with locally advanced BCC, and 29% (partial responses in 26%; complete responses in 3%) in those with metastatic BCC.
About 90% of all patients had a duration of response (DOR) of 6 months or longer. Median DOR was not reached in either group at median follow-up of 16 months for locally advanced BCC and 9 months for metastatic BCC.
The safety profile of cemiplimab has been generally consistent across approved indications. Serious adverse events have been reported in 30% of 816 patients from all four cemiplimab monotherapy pivotal trials, and these led to permanent discontinuation of treatment in 8% of patients.
Immune-related adverse reactions occurred in 22% of patients, and led to permanent discontinuation in 4%. The most common such reactions were hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and immune-related skin adverse reactions (2%).
Cemiplimab is administered by intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. The recommended dose is 350 mg.
A press release from Regeneron notes that research efforts with respect to cemiplimab – both as monotherapy and in combination with other agents – are focused on difficult-to-treat cancers, including advanced NSCLC, cervical cancer, and other solid tumors and blood cancers.
The
The programmed death-1 (PD-1) inhibitor, which is being jointly developed by Regeneron and Sanofi under a global collaboration agreement, was approved by the Food and Drug Administration for this indication in the United States in February; the FDA granted full approval for its use in patients with locally advanced BCC and accelerated approval for use in patients with metastatic BCC.
The EC’s thumbs-up for cemiplimab as a treatment for BCC marks the third such approval for an advanced cancer in the European Union: The immunotherapy was concurrently approved by the EC for the first-line treatment of adults with advanced non–small cell lung cancer (NSCLC) whose tumor cells have ≥ 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations, and was approved in 2019 for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
The FDA granted approval of cemiplimab for NSCLC in February, and for CSCC in 2018.
The latest BCC approval is based on data from an ongoing, open-label, prospective phase 2 clinical trial of 119 patients with advanced BCC who were previously treated with an HHI. The objective response rates in cemiplimab-treated patients were 32% (partial responses in 25%; complete responses in 7%) in those with locally advanced BCC, and 29% (partial responses in 26%; complete responses in 3%) in those with metastatic BCC.
About 90% of all patients had a duration of response (DOR) of 6 months or longer. Median DOR was not reached in either group at median follow-up of 16 months for locally advanced BCC and 9 months for metastatic BCC.
The safety profile of cemiplimab has been generally consistent across approved indications. Serious adverse events have been reported in 30% of 816 patients from all four cemiplimab monotherapy pivotal trials, and these led to permanent discontinuation of treatment in 8% of patients.
Immune-related adverse reactions occurred in 22% of patients, and led to permanent discontinuation in 4%. The most common such reactions were hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and immune-related skin adverse reactions (2%).
Cemiplimab is administered by intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. The recommended dose is 350 mg.
A press release from Regeneron notes that research efforts with respect to cemiplimab – both as monotherapy and in combination with other agents – are focused on difficult-to-treat cancers, including advanced NSCLC, cervical cancer, and other solid tumors and blood cancers.
Daily reporting from the 2021 Society of Gynecologic Surgeons Annual Meeting
TUESDAY, 6/29/21. DAY 3 AT SGS
The third day of the annual SGS meeting started with several academic roundtables hosted by experts in the field. These authorities shared their knowledge on a range of topics including endometriosis, building an academic career, diversity and equity in the workplace, and scientific publishing. The general session got underway with additional oral and video presentations highlighting advancements in our field. This year’s SGS President Dr. Miles Murphy gave the annual presidential address. He spoke genuinely and humbly about our field. Whitney Ross, MD, (@WRossMD), referred to his speech on Twitter as “Best. Presidential. Address. Ever.” –a sentiment felt by many in the crowd!
This year’s Telinde Lecture was given by Janet Dombrowski, the first ever non-physician to present this lecture. She spoke on resiliency in a lecture titled, “Cultivating Resilience: The Power in Connection & Collaboration.” It was an insightful and wise presentation on the power of connection and how connection bolsters our resiliency. She challenged us to all break down “thinking habits” that isolate us into silos and get in the way of powerful connection and collaboration. She reminded us of the African greeting “Sawubona” (I see you) and “Sikhona” (Because you see me, I am here). A gentle reminder that we feel our existence most tangibly when we are seen by others—an idea consistent with other important themes of this conference, focused on diversity, equity, and inclusion of all. The morning session was rounded out with a panel discussion on “Novel GYN Office Procedure,” featuring Drs. Cecile Ferrando (@CFerrandoMD), Abbas Shobeiri (@ShobeiriAbbas), Andrea Pezzela, and Eric Sokol.
The afternoon was filled with leisure activities in beautiful Palm Springs, including the SGS Golf Tournament, mountain biking, aerial tramway tour, and hike. The weather even cooperated with slightly cooler temperatures (think 100℉ instead of 120℉)! The evening was filled with food, drinks, and the excitement around the annual “SGS’ Got Talent” show! Everyone was able to let down, show off their dance moves, and enjoy some of that much needed connection time!
Tomorrow is the last day of #SGS2021! Excited to round out the conference with continued learning.
MONDAY, 6/28/21. DAY 2 AT SGS
The sun is up and working hard here in Palm Springs, and so are we!
Welcome and introduction of new members
The general session started with a warm welcome to the 12 new SGS members. A special shout out to Dr. Kelly Wright who is a new SGS Member and won the #SGS2021 tweetup! She ranked as a top influencer, prolific tweeter, and made more than 250K impressions leading up to SGS! Way to represent @MigsRunner.
General scientific sessions
There were several excellent oral and video presentations throughout the morning session. A range of topics were discussed, including postoperative pain management, strategies for cost-effective surgery, and how racial and ethnic disparities play into our medical education and patient outcomes. Dr. Eva Welch gave a stellar video presentation on straight-stick sacrocolpopexy techniques for the savvy surgeon. I personally will be incorporating some of her needle management tricks!
After a brief break with some refreshments and a stroll around the exhibit hall, the second scientific session initiated with a transformative lecture. Dr. Mark Walters presented "Insights on Surgical Education: How Can I Help You Get Better" in the inaugural Mark D. Walters Lectureship. Dr. Walters shared his experience and insights on how to transform oneself from a good surgeon to an expert and from a teacher to a coach in the operating room. His dedication to our field, years of experience, and wisdom earned him a standing ovation! Additional oral and video presentations followed. Dr. J. Wong shared correlations between surgeon gender and ergonomic strain with laparoscopic devices. Female surgeons more often reported inappropriate fit and expressed physical discomfort compared with male surgeons. Injuries and ergonomic strain lead to less operating and even disability for some surgeons. It is past time for us to have better--we need instruments that fit our hands!
The afternoon session started with a panel on "Perspectives on Race in GYN Surgery." It was another insightful discussion with thought- and action-provoking knowledge. The afternoon session included the SGS Prize Video by Dr. Angela DiCarlo-Meacham on excision of a vulvar cyst.
Fellows' Pelvic Research Network
After adjourning of the scientific sessions, the fellow-ran, multicenter research network (FPRN) met to give updates. This diverse group of both AUGS-SGS and FMIGS-SGS offers mentorship and relationships that are important for future careers and research. The collaboration allows the study of rare outcomes that may not be feasible at single sites. Dr. Amanda Yunker, fellowship director at Vanderbilt University, gave an amazing history lesson on the fields of OB and GYN, and the evolution of gynecologic surgery. We then had fun assigning a "report card grade" on how MIGS is doing comparatively with other subspecialties in the realms of academics and research.
VideoFest
The late afternoon was concluded with a surgical video session. What an amazing and talented group we are here at SGS!
President's awards ceremony and reception
The scientific focused day was rounded out with an evening of honors, awards, and social time as we celebrated all the achievements of our peers and colleagues. The president's reception was filled with food, laughter, networking, and reconnecting with friends and colleagues. We are looking forward to another day of education tomorrow!
Follow @JennaRehmerMD, @GynSurgery, and #SGS2021 on Twitter for updates.
SUNDAY, 6/27/21. DAY 1 AT SGS
Hello live from sunny Palm Spring, CA, and the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS)! This year’s conference balances the long-awaited return to in-person events while simultaneously embracing virtual learning with their hybrid meeting format. You can follow me, @JennaRehmerMD, and #SGS2021 in real-time on Twitter.
Dismantling racism
We were incredibly fortunate to take a deep dive into dismantling racism in our personal and professional spheres. The postgraduate course was well researched and presented by Drs. Oluwateniola “Teni” Brown, Cassandra Carberry, Olivia Cardenas-Trowers (@otrowers_md), Annetta Madsen, Moiuri Siddique, and Blair Washington (@Dr_B_Washington). Each presentation provided a succinct and cohesive flow, taking us through what racism is, the historical and active structural racism in medicine, and the actions and steps of becoming anti-racist.
Dr. Brown discussed critical race theory. We learned that the engineered system of oppression is so advanced that it is often hidden in plain sight, and that one’s conscious awareness is not necessary in order to uphold the system of oppression. It is reinforced and supported with minimal effort. This is why not being racist is not enough; active anti-racism is needed to bring about change.
Fibroid management
Across the hall, Drs. Linda Bradley (@BradlelMD), Kimberly Kho (@KimberlyKho1), Cara King (@drcaraking), and Kelly Wright (@MigsRunner) broadened our armamentarium for uterine conservation in fibroid management. Dr. Bradley reviewed medical therapies, including novel treatments, as first-line or adjunct treatment options. Next, the course focused on surgical techniques for hysteroscopic myomectomies, optimization of minilaparotomy for myomectomy, and tissue extraction. Dr. King displayed true grit when giving her lecture from the airport after flight delays prevented her from being in person with us.
Multidisciplinary care within gyn surgery
In this virtual only postgraduate course, Drs. Risal Djohan (@DjohanMD), Cecile Ferrando (@CFerrandoMD), Marie Fidela Paraiso, Sandip Vasavada (@SandipVasavada), and Sarah Vogler showed us the importance of multidisciplinary care within gynecologic surgery practices. They explored how to streamline the approach so it complements your practice, how to co-bill for shared patient care, and tips and tricks for optimizing the surgical experience for the patient.
Industry presentations
Over lunch, Dr. Opoku-Akane presented on using ERAS (enhanced recovery after surgery) protocols for endometriosis and chronic pelvic pain and how to optimize the use of alternative surgical modalities for endometriosis. Following this, Drs. Albert Huany and Craig McCoy taught about a new technology using electrical stimulation to optimize visualization of the ureter.
Harnessing the power of social media
This workshop, organized by SGS Social Media Committee Chair Dr. Amy Park (@dramypark) showed us the importance of having an online identity for the sharing of ideas, networking, professional development, and education. We learned how to optimize our online bios, proper use of GYN ontology for hashtags, and how to maintain professionalism on social media. We reviewed the data on how sharing publications on social media improves altmetric scores and discussed how our social media influence may be tied to performance in the future.
Lessons in leadership
We rounded out the day with after-dinner dessert and drinks at the evening SGS Women’s Council presentation. We had the great honor of hearing from Lori Ryerker, CEO of Celanese Corporation, a Fortune 500 global company. She provided much wisdom on being a leader. She shared several keys to creating a successful work environment:
- being a leader that “provides an environment where people feel like they can bring their best selves every day” (and that being your best self is being your whole self, without reservations)
- allowing all genders, sexual orientations, races, ethnicities, and ages to show up together without reservations (because only then can people feel safe to be their best, because their best self is their true self).
It was a wonderful and successful kick-off to the meeting. I look forward to a full day tomorrow! Follow along as this year’s Fellow Scholars, Drs. Tara Brah (@TaraBrah), Amr El Haraki (@drharaki), Sheena Galhotra (@SheenaGalhotra), Meenal Misal (@meenalmisalMD), and yours truly, post live updates daily.
TUESDAY, 6/29/21. DAY 3 AT SGS
The third day of the annual SGS meeting started with several academic roundtables hosted by experts in the field. These authorities shared their knowledge on a range of topics including endometriosis, building an academic career, diversity and equity in the workplace, and scientific publishing. The general session got underway with additional oral and video presentations highlighting advancements in our field. This year’s SGS President Dr. Miles Murphy gave the annual presidential address. He spoke genuinely and humbly about our field. Whitney Ross, MD, (@WRossMD), referred to his speech on Twitter as “Best. Presidential. Address. Ever.” –a sentiment felt by many in the crowd!
This year’s Telinde Lecture was given by Janet Dombrowski, the first ever non-physician to present this lecture. She spoke on resiliency in a lecture titled, “Cultivating Resilience: The Power in Connection & Collaboration.” It was an insightful and wise presentation on the power of connection and how connection bolsters our resiliency. She challenged us to all break down “thinking habits” that isolate us into silos and get in the way of powerful connection and collaboration. She reminded us of the African greeting “Sawubona” (I see you) and “Sikhona” (Because you see me, I am here). A gentle reminder that we feel our existence most tangibly when we are seen by others—an idea consistent with other important themes of this conference, focused on diversity, equity, and inclusion of all. The morning session was rounded out with a panel discussion on “Novel GYN Office Procedure,” featuring Drs. Cecile Ferrando (@CFerrandoMD), Abbas Shobeiri (@ShobeiriAbbas), Andrea Pezzela, and Eric Sokol.
The afternoon was filled with leisure activities in beautiful Palm Springs, including the SGS Golf Tournament, mountain biking, aerial tramway tour, and hike. The weather even cooperated with slightly cooler temperatures (think 100℉ instead of 120℉)! The evening was filled with food, drinks, and the excitement around the annual “SGS’ Got Talent” show! Everyone was able to let down, show off their dance moves, and enjoy some of that much needed connection time!
Tomorrow is the last day of #SGS2021! Excited to round out the conference with continued learning.
MONDAY, 6/28/21. DAY 2 AT SGS
The sun is up and working hard here in Palm Springs, and so are we!
Welcome and introduction of new members
The general session started with a warm welcome to the 12 new SGS members. A special shout out to Dr. Kelly Wright who is a new SGS Member and won the #SGS2021 tweetup! She ranked as a top influencer, prolific tweeter, and made more than 250K impressions leading up to SGS! Way to represent @MigsRunner.
General scientific sessions
There were several excellent oral and video presentations throughout the morning session. A range of topics were discussed, including postoperative pain management, strategies for cost-effective surgery, and how racial and ethnic disparities play into our medical education and patient outcomes. Dr. Eva Welch gave a stellar video presentation on straight-stick sacrocolpopexy techniques for the savvy surgeon. I personally will be incorporating some of her needle management tricks!
After a brief break with some refreshments and a stroll around the exhibit hall, the second scientific session initiated with a transformative lecture. Dr. Mark Walters presented "Insights on Surgical Education: How Can I Help You Get Better" in the inaugural Mark D. Walters Lectureship. Dr. Walters shared his experience and insights on how to transform oneself from a good surgeon to an expert and from a teacher to a coach in the operating room. His dedication to our field, years of experience, and wisdom earned him a standing ovation! Additional oral and video presentations followed. Dr. J. Wong shared correlations between surgeon gender and ergonomic strain with laparoscopic devices. Female surgeons more often reported inappropriate fit and expressed physical discomfort compared with male surgeons. Injuries and ergonomic strain lead to less operating and even disability for some surgeons. It is past time for us to have better--we need instruments that fit our hands!
The afternoon session started with a panel on "Perspectives on Race in GYN Surgery." It was another insightful discussion with thought- and action-provoking knowledge. The afternoon session included the SGS Prize Video by Dr. Angela DiCarlo-Meacham on excision of a vulvar cyst.
Fellows' Pelvic Research Network
After adjourning of the scientific sessions, the fellow-ran, multicenter research network (FPRN) met to give updates. This diverse group of both AUGS-SGS and FMIGS-SGS offers mentorship and relationships that are important for future careers and research. The collaboration allows the study of rare outcomes that may not be feasible at single sites. Dr. Amanda Yunker, fellowship director at Vanderbilt University, gave an amazing history lesson on the fields of OB and GYN, and the evolution of gynecologic surgery. We then had fun assigning a "report card grade" on how MIGS is doing comparatively with other subspecialties in the realms of academics and research.
VideoFest
The late afternoon was concluded with a surgical video session. What an amazing and talented group we are here at SGS!
President's awards ceremony and reception
The scientific focused day was rounded out with an evening of honors, awards, and social time as we celebrated all the achievements of our peers and colleagues. The president's reception was filled with food, laughter, networking, and reconnecting with friends and colleagues. We are looking forward to another day of education tomorrow!
Follow @JennaRehmerMD, @GynSurgery, and #SGS2021 on Twitter for updates.
SUNDAY, 6/27/21. DAY 1 AT SGS
Hello live from sunny Palm Spring, CA, and the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS)! This year’s conference balances the long-awaited return to in-person events while simultaneously embracing virtual learning with their hybrid meeting format. You can follow me, @JennaRehmerMD, and #SGS2021 in real-time on Twitter.
Dismantling racism
We were incredibly fortunate to take a deep dive into dismantling racism in our personal and professional spheres. The postgraduate course was well researched and presented by Drs. Oluwateniola “Teni” Brown, Cassandra Carberry, Olivia Cardenas-Trowers (@otrowers_md), Annetta Madsen, Moiuri Siddique, and Blair Washington (@Dr_B_Washington). Each presentation provided a succinct and cohesive flow, taking us through what racism is, the historical and active structural racism in medicine, and the actions and steps of becoming anti-racist.
Dr. Brown discussed critical race theory. We learned that the engineered system of oppression is so advanced that it is often hidden in plain sight, and that one’s conscious awareness is not necessary in order to uphold the system of oppression. It is reinforced and supported with minimal effort. This is why not being racist is not enough; active anti-racism is needed to bring about change.
Fibroid management
Across the hall, Drs. Linda Bradley (@BradlelMD), Kimberly Kho (@KimberlyKho1), Cara King (@drcaraking), and Kelly Wright (@MigsRunner) broadened our armamentarium for uterine conservation in fibroid management. Dr. Bradley reviewed medical therapies, including novel treatments, as first-line or adjunct treatment options. Next, the course focused on surgical techniques for hysteroscopic myomectomies, optimization of minilaparotomy for myomectomy, and tissue extraction. Dr. King displayed true grit when giving her lecture from the airport after flight delays prevented her from being in person with us.
Multidisciplinary care within gyn surgery
In this virtual only postgraduate course, Drs. Risal Djohan (@DjohanMD), Cecile Ferrando (@CFerrandoMD), Marie Fidela Paraiso, Sandip Vasavada (@SandipVasavada), and Sarah Vogler showed us the importance of multidisciplinary care within gynecologic surgery practices. They explored how to streamline the approach so it complements your practice, how to co-bill for shared patient care, and tips and tricks for optimizing the surgical experience for the patient.
Industry presentations
Over lunch, Dr. Opoku-Akane presented on using ERAS (enhanced recovery after surgery) protocols for endometriosis and chronic pelvic pain and how to optimize the use of alternative surgical modalities for endometriosis. Following this, Drs. Albert Huany and Craig McCoy taught about a new technology using electrical stimulation to optimize visualization of the ureter.
Harnessing the power of social media
This workshop, organized by SGS Social Media Committee Chair Dr. Amy Park (@dramypark) showed us the importance of having an online identity for the sharing of ideas, networking, professional development, and education. We learned how to optimize our online bios, proper use of GYN ontology for hashtags, and how to maintain professionalism on social media. We reviewed the data on how sharing publications on social media improves altmetric scores and discussed how our social media influence may be tied to performance in the future.
Lessons in leadership
We rounded out the day with after-dinner dessert and drinks at the evening SGS Women’s Council presentation. We had the great honor of hearing from Lori Ryerker, CEO of Celanese Corporation, a Fortune 500 global company. She provided much wisdom on being a leader. She shared several keys to creating a successful work environment:
- being a leader that “provides an environment where people feel like they can bring their best selves every day” (and that being your best self is being your whole self, without reservations)
- allowing all genders, sexual orientations, races, ethnicities, and ages to show up together without reservations (because only then can people feel safe to be their best, because their best self is their true self).
It was a wonderful and successful kick-off to the meeting. I look forward to a full day tomorrow! Follow along as this year’s Fellow Scholars, Drs. Tara Brah (@TaraBrah), Amr El Haraki (@drharaki), Sheena Galhotra (@SheenaGalhotra), Meenal Misal (@meenalmisalMD), and yours truly, post live updates daily.
TUESDAY, 6/29/21. DAY 3 AT SGS
The third day of the annual SGS meeting started with several academic roundtables hosted by experts in the field. These authorities shared their knowledge on a range of topics including endometriosis, building an academic career, diversity and equity in the workplace, and scientific publishing. The general session got underway with additional oral and video presentations highlighting advancements in our field. This year’s SGS President Dr. Miles Murphy gave the annual presidential address. He spoke genuinely and humbly about our field. Whitney Ross, MD, (@WRossMD), referred to his speech on Twitter as “Best. Presidential. Address. Ever.” –a sentiment felt by many in the crowd!
This year’s Telinde Lecture was given by Janet Dombrowski, the first ever non-physician to present this lecture. She spoke on resiliency in a lecture titled, “Cultivating Resilience: The Power in Connection & Collaboration.” It was an insightful and wise presentation on the power of connection and how connection bolsters our resiliency. She challenged us to all break down “thinking habits” that isolate us into silos and get in the way of powerful connection and collaboration. She reminded us of the African greeting “Sawubona” (I see you) and “Sikhona” (Because you see me, I am here). A gentle reminder that we feel our existence most tangibly when we are seen by others—an idea consistent with other important themes of this conference, focused on diversity, equity, and inclusion of all. The morning session was rounded out with a panel discussion on “Novel GYN Office Procedure,” featuring Drs. Cecile Ferrando (@CFerrandoMD), Abbas Shobeiri (@ShobeiriAbbas), Andrea Pezzela, and Eric Sokol.
The afternoon was filled with leisure activities in beautiful Palm Springs, including the SGS Golf Tournament, mountain biking, aerial tramway tour, and hike. The weather even cooperated with slightly cooler temperatures (think 100℉ instead of 120℉)! The evening was filled with food, drinks, and the excitement around the annual “SGS’ Got Talent” show! Everyone was able to let down, show off their dance moves, and enjoy some of that much needed connection time!
Tomorrow is the last day of #SGS2021! Excited to round out the conference with continued learning.
MONDAY, 6/28/21. DAY 2 AT SGS
The sun is up and working hard here in Palm Springs, and so are we!
Welcome and introduction of new members
The general session started with a warm welcome to the 12 new SGS members. A special shout out to Dr. Kelly Wright who is a new SGS Member and won the #SGS2021 tweetup! She ranked as a top influencer, prolific tweeter, and made more than 250K impressions leading up to SGS! Way to represent @MigsRunner.
General scientific sessions
There were several excellent oral and video presentations throughout the morning session. A range of topics were discussed, including postoperative pain management, strategies for cost-effective surgery, and how racial and ethnic disparities play into our medical education and patient outcomes. Dr. Eva Welch gave a stellar video presentation on straight-stick sacrocolpopexy techniques for the savvy surgeon. I personally will be incorporating some of her needle management tricks!
After a brief break with some refreshments and a stroll around the exhibit hall, the second scientific session initiated with a transformative lecture. Dr. Mark Walters presented "Insights on Surgical Education: How Can I Help You Get Better" in the inaugural Mark D. Walters Lectureship. Dr. Walters shared his experience and insights on how to transform oneself from a good surgeon to an expert and from a teacher to a coach in the operating room. His dedication to our field, years of experience, and wisdom earned him a standing ovation! Additional oral and video presentations followed. Dr. J. Wong shared correlations between surgeon gender and ergonomic strain with laparoscopic devices. Female surgeons more often reported inappropriate fit and expressed physical discomfort compared with male surgeons. Injuries and ergonomic strain lead to less operating and even disability for some surgeons. It is past time for us to have better--we need instruments that fit our hands!
The afternoon session started with a panel on "Perspectives on Race in GYN Surgery." It was another insightful discussion with thought- and action-provoking knowledge. The afternoon session included the SGS Prize Video by Dr. Angela DiCarlo-Meacham on excision of a vulvar cyst.
Fellows' Pelvic Research Network
After adjourning of the scientific sessions, the fellow-ran, multicenter research network (FPRN) met to give updates. This diverse group of both AUGS-SGS and FMIGS-SGS offers mentorship and relationships that are important for future careers and research. The collaboration allows the study of rare outcomes that may not be feasible at single sites. Dr. Amanda Yunker, fellowship director at Vanderbilt University, gave an amazing history lesson on the fields of OB and GYN, and the evolution of gynecologic surgery. We then had fun assigning a "report card grade" on how MIGS is doing comparatively with other subspecialties in the realms of academics and research.
VideoFest
The late afternoon was concluded with a surgical video session. What an amazing and talented group we are here at SGS!
President's awards ceremony and reception
The scientific focused day was rounded out with an evening of honors, awards, and social time as we celebrated all the achievements of our peers and colleagues. The president's reception was filled with food, laughter, networking, and reconnecting with friends and colleagues. We are looking forward to another day of education tomorrow!
Follow @JennaRehmerMD, @GynSurgery, and #SGS2021 on Twitter for updates.
SUNDAY, 6/27/21. DAY 1 AT SGS
Hello live from sunny Palm Spring, CA, and the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS)! This year’s conference balances the long-awaited return to in-person events while simultaneously embracing virtual learning with their hybrid meeting format. You can follow me, @JennaRehmerMD, and #SGS2021 in real-time on Twitter.
Dismantling racism
We were incredibly fortunate to take a deep dive into dismantling racism in our personal and professional spheres. The postgraduate course was well researched and presented by Drs. Oluwateniola “Teni” Brown, Cassandra Carberry, Olivia Cardenas-Trowers (@otrowers_md), Annetta Madsen, Moiuri Siddique, and Blair Washington (@Dr_B_Washington). Each presentation provided a succinct and cohesive flow, taking us through what racism is, the historical and active structural racism in medicine, and the actions and steps of becoming anti-racist.
Dr. Brown discussed critical race theory. We learned that the engineered system of oppression is so advanced that it is often hidden in plain sight, and that one’s conscious awareness is not necessary in order to uphold the system of oppression. It is reinforced and supported with minimal effort. This is why not being racist is not enough; active anti-racism is needed to bring about change.
Fibroid management
Across the hall, Drs. Linda Bradley (@BradlelMD), Kimberly Kho (@KimberlyKho1), Cara King (@drcaraking), and Kelly Wright (@MigsRunner) broadened our armamentarium for uterine conservation in fibroid management. Dr. Bradley reviewed medical therapies, including novel treatments, as first-line or adjunct treatment options. Next, the course focused on surgical techniques for hysteroscopic myomectomies, optimization of minilaparotomy for myomectomy, and tissue extraction. Dr. King displayed true grit when giving her lecture from the airport after flight delays prevented her from being in person with us.
Multidisciplinary care within gyn surgery
In this virtual only postgraduate course, Drs. Risal Djohan (@DjohanMD), Cecile Ferrando (@CFerrandoMD), Marie Fidela Paraiso, Sandip Vasavada (@SandipVasavada), and Sarah Vogler showed us the importance of multidisciplinary care within gynecologic surgery practices. They explored how to streamline the approach so it complements your practice, how to co-bill for shared patient care, and tips and tricks for optimizing the surgical experience for the patient.
Industry presentations
Over lunch, Dr. Opoku-Akane presented on using ERAS (enhanced recovery after surgery) protocols for endometriosis and chronic pelvic pain and how to optimize the use of alternative surgical modalities for endometriosis. Following this, Drs. Albert Huany and Craig McCoy taught about a new technology using electrical stimulation to optimize visualization of the ureter.
Harnessing the power of social media
This workshop, organized by SGS Social Media Committee Chair Dr. Amy Park (@dramypark) showed us the importance of having an online identity for the sharing of ideas, networking, professional development, and education. We learned how to optimize our online bios, proper use of GYN ontology for hashtags, and how to maintain professionalism on social media. We reviewed the data on how sharing publications on social media improves altmetric scores and discussed how our social media influence may be tied to performance in the future.
Lessons in leadership
We rounded out the day with after-dinner dessert and drinks at the evening SGS Women’s Council presentation. We had the great honor of hearing from Lori Ryerker, CEO of Celanese Corporation, a Fortune 500 global company. She provided much wisdom on being a leader. She shared several keys to creating a successful work environment:
- being a leader that “provides an environment where people feel like they can bring their best selves every day” (and that being your best self is being your whole self, without reservations)
- allowing all genders, sexual orientations, races, ethnicities, and ages to show up together without reservations (because only then can people feel safe to be their best, because their best self is their true self).
It was a wonderful and successful kick-off to the meeting. I look forward to a full day tomorrow! Follow along as this year’s Fellow Scholars, Drs. Tara Brah (@TaraBrah), Amr El Haraki (@drharaki), Sheena Galhotra (@SheenaGalhotra), Meenal Misal (@meenalmisalMD), and yours truly, post live updates daily.
A ‘minor’ gesture to protect my patients
As of today, I’m still wearing a mask. And I have no desire to stop. I’ve been vaccinated. Everyone in my family and social circle has been vaccinated. But I’m still wearing one, at least inside (besides my house).
In my everyday life I see a fair number of patients. Because I’m in a medical office, not a grocery store, I still ask others to wear them.
Even vaccinated people (including myself) can be unknowing carriers. Five percent of vaccinated people can still develop a COVID-19 infection, with varying degrees of seriousness.
The COVID-19 virus, as viruses do, continues to change with time. This is nothing new. At of the time of this writing the delta variant is the one getting the most press, but there will be others. Sooner or later one will get around the defenses conferred by the vaccine.
Vaccines also can lose benefit over time. If there’s anything we’ve learned during the pandemic it’s that we have a lot to learn. Every year I get a flu vaccine based on anticipated flu strains for the coming year, and there’s no reason to think COVID-19 will be any different.
So, I’m still wearing a mask. It provides some protection for me, and it provides some protection for my patients (many of whom are immunocompromised). No one is saying it’s perfect, but on the scale of things I can do to help keep them safe it’s a pretty minor one.
I still wear a mask in stores, too. I don’t know who around me there has, or hasn’t, been vaccinated. Even if I’m not at risk, many of my patients are, so I don’t want to bring it back to the office.
I’m sure I’ll stop wearing it in the next few months, but I’m not there yet. Maybe I’m just overly cautious. Maybe it’s a good idea for now. But I’d rather give it a bit more time to make sure.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
As of today, I’m still wearing a mask. And I have no desire to stop. I’ve been vaccinated. Everyone in my family and social circle has been vaccinated. But I’m still wearing one, at least inside (besides my house).
In my everyday life I see a fair number of patients. Because I’m in a medical office, not a grocery store, I still ask others to wear them.
Even vaccinated people (including myself) can be unknowing carriers. Five percent of vaccinated people can still develop a COVID-19 infection, with varying degrees of seriousness.
The COVID-19 virus, as viruses do, continues to change with time. This is nothing new. At of the time of this writing the delta variant is the one getting the most press, but there will be others. Sooner or later one will get around the defenses conferred by the vaccine.
Vaccines also can lose benefit over time. If there’s anything we’ve learned during the pandemic it’s that we have a lot to learn. Every year I get a flu vaccine based on anticipated flu strains for the coming year, and there’s no reason to think COVID-19 will be any different.
So, I’m still wearing a mask. It provides some protection for me, and it provides some protection for my patients (many of whom are immunocompromised). No one is saying it’s perfect, but on the scale of things I can do to help keep them safe it’s a pretty minor one.
I still wear a mask in stores, too. I don’t know who around me there has, or hasn’t, been vaccinated. Even if I’m not at risk, many of my patients are, so I don’t want to bring it back to the office.
I’m sure I’ll stop wearing it in the next few months, but I’m not there yet. Maybe I’m just overly cautious. Maybe it’s a good idea for now. But I’d rather give it a bit more time to make sure.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
As of today, I’m still wearing a mask. And I have no desire to stop. I’ve been vaccinated. Everyone in my family and social circle has been vaccinated. But I’m still wearing one, at least inside (besides my house).
In my everyday life I see a fair number of patients. Because I’m in a medical office, not a grocery store, I still ask others to wear them.
Even vaccinated people (including myself) can be unknowing carriers. Five percent of vaccinated people can still develop a COVID-19 infection, with varying degrees of seriousness.
The COVID-19 virus, as viruses do, continues to change with time. This is nothing new. At of the time of this writing the delta variant is the one getting the most press, but there will be others. Sooner or later one will get around the defenses conferred by the vaccine.
Vaccines also can lose benefit over time. If there’s anything we’ve learned during the pandemic it’s that we have a lot to learn. Every year I get a flu vaccine based on anticipated flu strains for the coming year, and there’s no reason to think COVID-19 will be any different.
So, I’m still wearing a mask. It provides some protection for me, and it provides some protection for my patients (many of whom are immunocompromised). No one is saying it’s perfect, but on the scale of things I can do to help keep them safe it’s a pretty minor one.
I still wear a mask in stores, too. I don’t know who around me there has, or hasn’t, been vaccinated. Even if I’m not at risk, many of my patients are, so I don’t want to bring it back to the office.
I’m sure I’ll stop wearing it in the next few months, but I’m not there yet. Maybe I’m just overly cautious. Maybe it’s a good idea for now. But I’d rather give it a bit more time to make sure.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.