The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

A version of this article first appeared on Medscape.com.

Human leukocyte antigen (HLA)-mismatched hematopoetic stem cell microtransplantation (MST) has previously been evaluated in AML in combination with chemotherapy and suggests potential improvement in outcomes. Li et al evaluated MST combined with decitabine in patients with intermediate or high risk MDS compared to decitabine alone.  Out of 22 patients in the study, the cohort that received MST with decitabine had higher median OS (24 vs 14.2 months, p=0.04), although there was no statistical significant difference in overall response rate. There was no reported graft vs host disease, and adverse events were similar between the two groups. The main limitation of the study was the very small sample size; further prospective studies utilizing MST in MDS are needed to demonstrate benefit.

MDS patients often present with neutropenia and develop worsening neutropenia due to myelosuppression from HMA therapy, resulting in increased risk of infections including invasive fungal infection (IFI). Tey et al reported a retrospective analysis of the rate of IFI in patients with MDS or low blast count AML receiving azacitidine. Out of 117 patients, 61% received antifungal prophylaxis, either with posaconazole (n=70) or voriconazole (n=1). The IFI rate was 7.7% in the cohort with median time of onset of 74 days from start of azacitidine treatment (range 1-226); the IFI rate did not differ statistically between those receiving prophylaxis vs not (5.6% vs 10.9%, p=0.30). However, presence of neutropenia at three months of treatment was associated with increased IFI risk (HR 8.29, p=0.01), and IFI was associated with increased mortality in a multivariate analysis (HR 8.37, p<0.0001). Anti-fungal prophylaxis is currently standard practice for MDS patients who present or develop neutropenia; however, HMA treatment is associated with prolonged neutropenia due to myelosuppression and time to response. A more effective therapy with less myelosuppression is needed for treatment of MDS.

Human leukocyte antigen (HLA)-mismatched hematopoetic stem cell microtransplantation (MST) has previously been evaluated in AML in combination with chemotherapy and suggests potential improvement in outcomes. Li et al evaluated MST combined with decitabine in patients with intermediate or high risk MDS compared to decitabine alone.  Out of 22 patients in the study, the cohort that received MST with decitabine had higher median OS (24 vs 14.2 months, p=0.04), although there was no statistical significant difference in overall response rate. There was no reported graft vs host disease, and adverse events were similar between the two groups. The main limitation of the study was the very small sample size; further prospective studies utilizing MST in MDS are needed to demonstrate benefit.

MDS patients often present with neutropenia and develop worsening neutropenia due to myelosuppression from HMA therapy, resulting in increased risk of infections including invasive fungal infection (IFI). Tey et al reported a retrospective analysis of the rate of IFI in patients with MDS or low blast count AML receiving azacitidine. Out of 117 patients, 61% received antifungal prophylaxis, either with posaconazole (n=70) or voriconazole (n=1). The IFI rate was 7.7% in the cohort with median time of onset of 74 days from start of azacitidine treatment (range 1-226); the IFI rate did not differ statistically between those receiving prophylaxis vs not (5.6% vs 10.9%, p=0.30). However, presence of neutropenia at three months of treatment was associated with increased IFI risk (HR 8.29, p=0.01), and IFI was associated with increased mortality in a multivariate analysis (HR 8.37, p<0.0001). Anti-fungal prophylaxis is currently standard practice for MDS patients who present or develop neutropenia; however, HMA treatment is associated with prolonged neutropenia due to myelosuppression and time to response. A more effective therapy with less myelosuppression is needed for treatment of MDS.

Human leukocyte antigen (HLA)-mismatched hematopoetic stem cell microtransplantation (MST) has previously been evaluated in AML in combination with chemotherapy and suggests potential improvement in outcomes. Li et al evaluated MST combined with decitabine in patients with intermediate or high risk MDS compared to decitabine alone.  Out of 22 patients in the study, the cohort that received MST with decitabine had higher median OS (24 vs 14.2 months, p=0.04), although there was no statistical significant difference in overall response rate. There was no reported graft vs host disease, and adverse events were similar between the two groups. The main limitation of the study was the very small sample size; further prospective studies utilizing MST in MDS are needed to demonstrate benefit.

MDS patients often present with neutropenia and develop worsening neutropenia due to myelosuppression from HMA therapy, resulting in increased risk of infections including invasive fungal infection (IFI). Tey et al reported a retrospective analysis of the rate of IFI in patients with MDS or low blast count AML receiving azacitidine. Out of 117 patients, 61% received antifungal prophylaxis, either with posaconazole (n=70) or voriconazole (n=1). The IFI rate was 7.7% in the cohort with median time of onset of 74 days from start of azacitidine treatment (range 1-226); the IFI rate did not differ statistically between those receiving prophylaxis vs not (5.6% vs 10.9%, p=0.30). However, presence of neutropenia at three months of treatment was associated with increased IFI risk (HR 8.29, p=0.01), and IFI was associated with increased mortality in a multivariate analysis (HR 8.37, p<0.0001). Anti-fungal prophylaxis is currently standard practice for MDS patients who present or develop neutropenia; however, HMA treatment is associated with prolonged neutropenia due to myelosuppression and time to response. A more effective therapy with less myelosuppression is needed for treatment of MDS.

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

A version of this article first appeared on Medscape.com.

Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Sharing their personal experiences on social media can emphasize oncologists’ humanity and have substantive, beneficial effects on patient care, according to a presentation at the Collaboration for Outcomes using Social Media in Oncology (COSMO) inaugural meeting.

Mark A. Lewis, MD, explained to the COSMO meeting audience how storytelling on social media can educate and engage patients, advocates, and professional colleagues – advancing knowledge, dispelling misinformation, and promoting clinical research.

Dr. Lewis, an oncologist at Intermountain Healthcare in Salt Lake City, reflected on the bifid roles of oncologists as scientists engaged in life-long learning and humanists who can internalize and appreciate the unique character and circumstances of their patients.

Patients who have serious illnesses are necessarily aggregated by statistics. However, in an essay published in 2011, Dr. Lewis noted that “each individual patient partakes in a unique, irreproducible experiment where n = 1” (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).

Dr. Lewis highlighted the duality of individual data points on a survival curve as descriptors of common disease trajectories and treatment effects. However, those data points also conceal important narratives regarding the most highly valued aspects of the doctor-patient relationship and the impact of cancer treatment on patients’ lives.

In referring to the futuristic essay “Ars Brevis,” Dr. Lewis contrasted the humanism of oncology specialists in the present day with the fictional image of data-regurgitating robots programmed to maximize the efficiency of each patient encounter (J Clin Oncol. 2013 May 10;31[14]:1792-4).

Dr. Lewis reminded attendees that to practice medicine without using both “head and heart” undermines the inherent nature of medical care.

Unfortunately, that perspective may not match the public perception of oncologists. Dr. Lewis described his experience of typing “oncologists are” into an Internet search engine and seeing the auto-complete function prompt words such as “criminals,” “evil,” “murderers,” and “confused.”

Obviously, it is hard to establish a trusting patient-doctor relationship if that is the prima facie perception of the oncology specialty.
 

Dispelling myths and creating community via social media

A primary goal of consultation with a newly-diagnosed cancer patient is for the patient to feel that the oncologist will be there to take care of them, regardless of what the future holds.

Dr. Lewis has found that social media can potentially extend that feeling to a global community of patients, caregivers, and others seeking information relevant to a cancer diagnosis. He believes that oncologists have an opportunity to dispel myths and fears by being attentive to the real-life concerns of patients.

Dr. Lewis took advantage of this opportunity when he underwent a Whipple procedure (pancreaticoduodenectomy) for a pancreatic neuroendocrine tumor. He and the hospital’s media services staff “live-tweeted” his surgery and recovery.

With those tweets, Dr. Lewis demystified each step of a major surgical procedure. From messages he received on social media, Dr. Lewis knows he made the decision to have a Whipple procedure more acceptable to other patients.

His personal medical experience notwithstanding, Dr. Lewis acknowledged that every patient’s circumstances are unique.

Oncologists cannot possibly empathize with every circumstance. However, when they show sensitivity to personal elements of the cancer experience, they shed light on the complicated role they play in patient care and can facilitate good decision-making among patients across the globe.
 

Social media for professional development and patient care

The publication of his 2011 essay was gratifying for Dr. Lewis, but the finite number of comments he received thereafter illustrated the rather limited audience that traditional academic publications have and the laborious process for subsequent interaction (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).

First as an observer and later as a participant on social media, Dr. Lewis appreciated that teaching points and publications can be amplified by global distribution and the potential for informal bidirectional communication.

Social media platforms enable physicians to connect with a larger audience through participative communication, in which users develop, share, and react to content (N Engl J Med. 2009 Aug 13;361[7]:649-51).

Dr. Lewis reflected on how oncologists are challenged to sort through the thousands of oncology-focused publications annually. Through social media, one can see the studies on which the experts are commenting and appreciate the nuances that contextualize the results. Focused interactions with renowned doctors, at regular intervals, require little formality.

Online journal clubs enable the sharing of ideas, opinions, multimedia resources, and references across institutional and international borders (J Gen Intern Med. 2014 Oct;29[10]:1317-8).
 

Social media in oncology: Accomplishments and promise

The development of broadband Internet, wireless connectivity, and social media for peer-to-peer and general communication are among the major technological advances that have transformed medical communication.

As an organization, COSMO aims to describe, understand, and improve the use of social media to increase the penetration of evidence-based guidelines and research insights into clinical practice (Future Oncol. 2017 Jun;13[15]:1281-5).

At the inaugural COSMO meeting, areas of progress since COSMO’s inception in 2015 were highlighted, including:

• The involvement of cancer professionals and advocates in multiple distinctive platforms.
• The development of hashtag libraries to aggregate interest groups and topics.
• The refinement of strategies for engaging advocates with attention to inclusiveness.
• A steady trajectory of growth in tweeting at scientific conferences.

An overarching theme of the COSMO meeting was “authenticity,” a virtue that is easy to admire but requires conscious, consistent effort to achieve.

Disclosure of conflicts of interest and avoiding using social media simply as a recruitment tool for clinical trials are basic components of accurate self-representation.

In addition, Dr. Lewis advocated for sharing personal experiences in a component of social media posts so oncologists can show humanity as a feature of their professional online identity and inherent nature.

Dr. Lewis disclosed consultancy with Medscape/WebMD, which are owned by the same parent company as MDedge. He also disclosed relationships with Foundation Medicine, Natera, Exelixis, QED, HalioDX, and Ipsen.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Sharing their personal experiences on social media can emphasize oncologists’ humanity and have substantive, beneficial effects on patient care, according to a presentation at the Collaboration for Outcomes using Social Media in Oncology (COSMO) inaugural meeting.

Mark A. Lewis, MD, explained to the COSMO meeting audience how storytelling on social media can educate and engage patients, advocates, and professional colleagues – advancing knowledge, dispelling misinformation, and promoting clinical research.

Dr. Lewis, an oncologist at Intermountain Healthcare in Salt Lake City, reflected on the bifid roles of oncologists as scientists engaged in life-long learning and humanists who can internalize and appreciate the unique character and circumstances of their patients.

Patients who have serious illnesses are necessarily aggregated by statistics. However, in an essay published in 2011, Dr. Lewis noted that “each individual patient partakes in a unique, irreproducible experiment where n = 1” (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).

Dr. Lewis highlighted the duality of individual data points on a survival curve as descriptors of common disease trajectories and treatment effects. However, those data points also conceal important narratives regarding the most highly valued aspects of the doctor-patient relationship and the impact of cancer treatment on patients’ lives.

In referring to the futuristic essay “Ars Brevis,” Dr. Lewis contrasted the humanism of oncology specialists in the present day with the fictional image of data-regurgitating robots programmed to maximize the efficiency of each patient encounter (J Clin Oncol. 2013 May 10;31[14]:1792-4).

Dr. Lewis reminded attendees that to practice medicine without using both “head and heart” undermines the inherent nature of medical care.

Unfortunately, that perspective may not match the public perception of oncologists. Dr. Lewis described his experience of typing “oncologists are” into an Internet search engine and seeing the auto-complete function prompt words such as “criminals,” “evil,” “murderers,” and “confused.”

Obviously, it is hard to establish a trusting patient-doctor relationship if that is the prima facie perception of the oncology specialty.
 

Dispelling myths and creating community via social media

A primary goal of consultation with a newly-diagnosed cancer patient is for the patient to feel that the oncologist will be there to take care of them, regardless of what the future holds.

Dr. Lewis has found that social media can potentially extend that feeling to a global community of patients, caregivers, and others seeking information relevant to a cancer diagnosis. He believes that oncologists have an opportunity to dispel myths and fears by being attentive to the real-life concerns of patients.

Dr. Lewis took advantage of this opportunity when he underwent a Whipple procedure (pancreaticoduodenectomy) for a pancreatic neuroendocrine tumor. He and the hospital’s media services staff “live-tweeted” his surgery and recovery.

With those tweets, Dr. Lewis demystified each step of a major surgical procedure. From messages he received on social media, Dr. Lewis knows he made the decision to have a Whipple procedure more acceptable to other patients.

His personal medical experience notwithstanding, Dr. Lewis acknowledged that every patient’s circumstances are unique.

Oncologists cannot possibly empathize with every circumstance. However, when they show sensitivity to personal elements of the cancer experience, they shed light on the complicated role they play in patient care and can facilitate good decision-making among patients across the globe.
 

Social media for professional development and patient care

The publication of his 2011 essay was gratifying for Dr. Lewis, but the finite number of comments he received thereafter illustrated the rather limited audience that traditional academic publications have and the laborious process for subsequent interaction (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).

First as an observer and later as a participant on social media, Dr. Lewis appreciated that teaching points and publications can be amplified by global distribution and the potential for informal bidirectional communication.

Social media platforms enable physicians to connect with a larger audience through participative communication, in which users develop, share, and react to content (N Engl J Med. 2009 Aug 13;361[7]:649-51).

Dr. Lewis reflected on how oncologists are challenged to sort through the thousands of oncology-focused publications annually. Through social media, one can see the studies on which the experts are commenting and appreciate the nuances that contextualize the results. Focused interactions with renowned doctors, at regular intervals, require little formality.

Online journal clubs enable the sharing of ideas, opinions, multimedia resources, and references across institutional and international borders (J Gen Intern Med. 2014 Oct;29[10]:1317-8).
 

Social media in oncology: Accomplishments and promise

The development of broadband Internet, wireless connectivity, and social media for peer-to-peer and general communication are among the major technological advances that have transformed medical communication.

As an organization, COSMO aims to describe, understand, and improve the use of social media to increase the penetration of evidence-based guidelines and research insights into clinical practice (Future Oncol. 2017 Jun;13[15]:1281-5).

At the inaugural COSMO meeting, areas of progress since COSMO’s inception in 2015 were highlighted, including:

• The involvement of cancer professionals and advocates in multiple distinctive platforms.
• The development of hashtag libraries to aggregate interest groups and topics.
• The refinement of strategies for engaging advocates with attention to inclusiveness.
• A steady trajectory of growth in tweeting at scientific conferences.

An overarching theme of the COSMO meeting was “authenticity,” a virtue that is easy to admire but requires conscious, consistent effort to achieve.

Disclosure of conflicts of interest and avoiding using social media simply as a recruitment tool for clinical trials are basic components of accurate self-representation.

In addition, Dr. Lewis advocated for sharing personal experiences in a component of social media posts so oncologists can show humanity as a feature of their professional online identity and inherent nature.

Dr. Lewis disclosed consultancy with Medscape/WebMD, which are owned by the same parent company as MDedge. He also disclosed relationships with Foundation Medicine, Natera, Exelixis, QED, HalioDX, and Ipsen.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Sharing their personal experiences on social media can emphasize oncologists’ humanity and have substantive, beneficial effects on patient care, according to a presentation at the Collaboration for Outcomes using Social Media in Oncology (COSMO) inaugural meeting.

Mark A. Lewis, MD, explained to the COSMO meeting audience how storytelling on social media can educate and engage patients, advocates, and professional colleagues – advancing knowledge, dispelling misinformation, and promoting clinical research.

Dr. Lewis, an oncologist at Intermountain Healthcare in Salt Lake City, reflected on the bifid roles of oncologists as scientists engaged in life-long learning and humanists who can internalize and appreciate the unique character and circumstances of their patients.

Patients who have serious illnesses are necessarily aggregated by statistics. However, in an essay published in 2011, Dr. Lewis noted that “each individual patient partakes in a unique, irreproducible experiment where n = 1” (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).

Dr. Lewis highlighted the duality of individual data points on a survival curve as descriptors of common disease trajectories and treatment effects. However, those data points also conceal important narratives regarding the most highly valued aspects of the doctor-patient relationship and the impact of cancer treatment on patients’ lives.

In referring to the futuristic essay “Ars Brevis,” Dr. Lewis contrasted the humanism of oncology specialists in the present day with the fictional image of data-regurgitating robots programmed to maximize the efficiency of each patient encounter (J Clin Oncol. 2013 May 10;31[14]:1792-4).

Dr. Lewis reminded attendees that to practice medicine without using both “head and heart” undermines the inherent nature of medical care.

Unfortunately, that perspective may not match the public perception of oncologists. Dr. Lewis described his experience of typing “oncologists are” into an Internet search engine and seeing the auto-complete function prompt words such as “criminals,” “evil,” “murderers,” and “confused.”

Obviously, it is hard to establish a trusting patient-doctor relationship if that is the prima facie perception of the oncology specialty.
 

Dispelling myths and creating community via social media

A primary goal of consultation with a newly-diagnosed cancer patient is for the patient to feel that the oncologist will be there to take care of them, regardless of what the future holds.

Dr. Lewis has found that social media can potentially extend that feeling to a global community of patients, caregivers, and others seeking information relevant to a cancer diagnosis. He believes that oncologists have an opportunity to dispel myths and fears by being attentive to the real-life concerns of patients.

Dr. Lewis took advantage of this opportunity when he underwent a Whipple procedure (pancreaticoduodenectomy) for a pancreatic neuroendocrine tumor. He and the hospital’s media services staff “live-tweeted” his surgery and recovery.

With those tweets, Dr. Lewis demystified each step of a major surgical procedure. From messages he received on social media, Dr. Lewis knows he made the decision to have a Whipple procedure more acceptable to other patients.

His personal medical experience notwithstanding, Dr. Lewis acknowledged that every patient’s circumstances are unique.

Oncologists cannot possibly empathize with every circumstance. However, when they show sensitivity to personal elements of the cancer experience, they shed light on the complicated role they play in patient care and can facilitate good decision-making among patients across the globe.
 

Social media for professional development and patient care

The publication of his 2011 essay was gratifying for Dr. Lewis, but the finite number of comments he received thereafter illustrated the rather limited audience that traditional academic publications have and the laborious process for subsequent interaction (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).

First as an observer and later as a participant on social media, Dr. Lewis appreciated that teaching points and publications can be amplified by global distribution and the potential for informal bidirectional communication.

Social media platforms enable physicians to connect with a larger audience through participative communication, in which users develop, share, and react to content (N Engl J Med. 2009 Aug 13;361[7]:649-51).

Dr. Lewis reflected on how oncologists are challenged to sort through the thousands of oncology-focused publications annually. Through social media, one can see the studies on which the experts are commenting and appreciate the nuances that contextualize the results. Focused interactions with renowned doctors, at regular intervals, require little formality.

Online journal clubs enable the sharing of ideas, opinions, multimedia resources, and references across institutional and international borders (J Gen Intern Med. 2014 Oct;29[10]:1317-8).
 

Social media in oncology: Accomplishments and promise

The development of broadband Internet, wireless connectivity, and social media for peer-to-peer and general communication are among the major technological advances that have transformed medical communication.

As an organization, COSMO aims to describe, understand, and improve the use of social media to increase the penetration of evidence-based guidelines and research insights into clinical practice (Future Oncol. 2017 Jun;13[15]:1281-5).

At the inaugural COSMO meeting, areas of progress since COSMO’s inception in 2015 were highlighted, including:

• The involvement of cancer professionals and advocates in multiple distinctive platforms.
• The development of hashtag libraries to aggregate interest groups and topics.
• The refinement of strategies for engaging advocates with attention to inclusiveness.
• A steady trajectory of growth in tweeting at scientific conferences.

An overarching theme of the COSMO meeting was “authenticity,” a virtue that is easy to admire but requires conscious, consistent effort to achieve.

Disclosure of conflicts of interest and avoiding using social media simply as a recruitment tool for clinical trials are basic components of accurate self-representation.

In addition, Dr. Lewis advocated for sharing personal experiences in a component of social media posts so oncologists can show humanity as a feature of their professional online identity and inherent nature.

Dr. Lewis disclosed consultancy with Medscape/WebMD, which are owned by the same parent company as MDedge. He also disclosed relationships with Foundation Medicine, Natera, Exelixis, QED, HalioDX, and Ipsen.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Key clinical point: Combination of decitabine and human leukocyte antigen-mismatched hematopoietic stem cell microtransplantation (HLA-MST) could be an effective and safe treatment in patients with intermediate- or high-risk myelodysplastic syndrome (MDS).

Major finding: Overall survival was significantly higher in the decitabine and HLA-MST combination vs. decitabine alone group (24.00 vs. 14.13 months; hazard ratio, 0.32; P = .04). The incidence of hematological adverse events except thrombocytopenia and nonhematological adverse events was slightly lower in decitabine+HLA-MST vs. decitabine alone group.

Study details: Findings are from a retrospective study of 22 patients with intermediate- or high-risk MDS who were treated with decitabine (n=11) or decitabine and HLA-MST combination (n=11).

Disclosures: The study was funded by National Natural Science Foundation of China; the Science and Technology Planning Project of Guangdong Province, China; the Guangzhou Regenerative Medicine and Health Guangdong Laboratory; and the Project of Guangdong Province Traditional Chinese Medicine Bureau. The authors declared absence of any commercial or financial relationships during conduct of the study.

Source: Li MM et al. Front Oncol. 2021 Mar 31. doi: 10.3389/fonc.2021.628127.

Key clinical point: Combination of decitabine and human leukocyte antigen-mismatched hematopoietic stem cell microtransplantation (HLA-MST) could be an effective and safe treatment in patients with intermediate- or high-risk myelodysplastic syndrome (MDS).

Major finding: Overall survival was significantly higher in the decitabine and HLA-MST combination vs. decitabine alone group (24.00 vs. 14.13 months; hazard ratio, 0.32; P = .04). The incidence of hematological adverse events except thrombocytopenia and nonhematological adverse events was slightly lower in decitabine+HLA-MST vs. decitabine alone group.

Study details: Findings are from a retrospective study of 22 patients with intermediate- or high-risk MDS who were treated with decitabine (n=11) or decitabine and HLA-MST combination (n=11).

Disclosures: The study was funded by National Natural Science Foundation of China; the Science and Technology Planning Project of Guangdong Province, China; the Guangzhou Regenerative Medicine and Health Guangdong Laboratory; and the Project of Guangdong Province Traditional Chinese Medicine Bureau. The authors declared absence of any commercial or financial relationships during conduct of the study.

Source: Li MM et al. Front Oncol. 2021 Mar 31. doi: 10.3389/fonc.2021.628127.

Key clinical point: Combination of decitabine and human leukocyte antigen-mismatched hematopoietic stem cell microtransplantation (HLA-MST) could be an effective and safe treatment in patients with intermediate- or high-risk myelodysplastic syndrome (MDS).

Major finding: Overall survival was significantly higher in the decitabine and HLA-MST combination vs. decitabine alone group (24.00 vs. 14.13 months; hazard ratio, 0.32; P = .04). The incidence of hematological adverse events except thrombocytopenia and nonhematological adverse events was slightly lower in decitabine+HLA-MST vs. decitabine alone group.

Study details: Findings are from a retrospective study of 22 patients with intermediate- or high-risk MDS who were treated with decitabine (n=11) or decitabine and HLA-MST combination (n=11).

Disclosures: The study was funded by National Natural Science Foundation of China; the Science and Technology Planning Project of Guangdong Province, China; the Guangzhou Regenerative Medicine and Health Guangdong Laboratory; and the Project of Guangdong Province Traditional Chinese Medicine Bureau. The authors declared absence of any commercial or financial relationships during conduct of the study.

Source: Li MM et al. Front Oncol. 2021 Mar 31. doi: 10.3389/fonc.2021.628127.

Key clinical point: Higher doses of hypomethylating agents, azacytidine (AZA) and decitabine (DAC), can help achieve higher rates of transfusion independence (TI) in patients with low-risk myelodysplastic syndrome (MDS). However, benefits should be weighed against the risk for adverse events.

Major finding: TI rate was higher with AZA (75 mg/m²/day for 7 days) than other regimens (P less than .025). The rate of grade 3/4 anemia was higher (15.8% vs. 0.0%; P less than .0001) and that of diarrhea/constipation (6.9% vs. 25.0%; P = .002) was lower with DAC (20 mg/m²/day for 3 days) vs. AZA (75 mg/m²/day for 5 days).

Study details: Findings are from a meta-analysis of 19 prospective studies including 1,076 patients with low-risk MDS.

Disclosures: The study was funded by Beijing Natural Science Foundation, the Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences, and the Non-profit Central Research Institute Fund of CAMS. The authors declared no potential conflicts of interest.

Source: Wan Z et al. Aging (Albany NY). 2021 Mar 26. doi: 10.18632/aging.202767.

Key clinical point: Higher doses of hypomethylating agents, azacytidine (AZA) and decitabine (DAC), can help achieve higher rates of transfusion independence (TI) in patients with low-risk myelodysplastic syndrome (MDS). However, benefits should be weighed against the risk for adverse events.

Major finding: TI rate was higher with AZA (75 mg/m²/day for 7 days) than other regimens (P less than .025). The rate of grade 3/4 anemia was higher (15.8% vs. 0.0%; P less than .0001) and that of diarrhea/constipation (6.9% vs. 25.0%; P = .002) was lower with DAC (20 mg/m²/day for 3 days) vs. AZA (75 mg/m²/day for 5 days).

Study details: Findings are from a meta-analysis of 19 prospective studies including 1,076 patients with low-risk MDS.

Disclosures: The study was funded by Beijing Natural Science Foundation, the Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences, and the Non-profit Central Research Institute Fund of CAMS. The authors declared no potential conflicts of interest.

Source: Wan Z et al. Aging (Albany NY). 2021 Mar 26. doi: 10.18632/aging.202767.

Key clinical point: Higher doses of hypomethylating agents, azacytidine (AZA) and decitabine (DAC), can help achieve higher rates of transfusion independence (TI) in patients with low-risk myelodysplastic syndrome (MDS). However, benefits should be weighed against the risk for adverse events.

Major finding: TI rate was higher with AZA (75 mg/m²/day for 7 days) than other regimens (P less than .025). The rate of grade 3/4 anemia was higher (15.8% vs. 0.0%; P less than .0001) and that of diarrhea/constipation (6.9% vs. 25.0%; P = .002) was lower with DAC (20 mg/m²/day for 3 days) vs. AZA (75 mg/m²/day for 5 days).

Study details: Findings are from a meta-analysis of 19 prospective studies including 1,076 patients with low-risk MDS.

Disclosures: The study was funded by Beijing Natural Science Foundation, the Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences, and the Non-profit Central Research Institute Fund of CAMS. The authors declared no potential conflicts of interest.

Source: Wan Z et al. Aging (Albany NY). 2021 Mar 26. doi: 10.18632/aging.202767.

Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.

The statement was published online April 29 in Hypertension.

The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.

“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.

If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.

Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.

The writing group acknowledges that these goals can be hard to achieve and maintain over time.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.

“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.

The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.

In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.

“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.

The statement was published online April 29 in Hypertension.

The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.

“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.

If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.

Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.

The writing group acknowledges that these goals can be hard to achieve and maintain over time.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.

“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.

The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.

In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.

“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.

The statement was published online April 29 in Hypertension.

The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.

“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.

If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.

Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.

The writing group acknowledges that these goals can be hard to achieve and maintain over time.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.

“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.

The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.

In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.

“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: Bridging therapy with hypomethylating agents (HMAs) did not provide long-term survival benefit in patients with myelodysplastic syndrome (MDS) receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Major finding: Overall survival was not significantly different among patients who received HMAs vs. best supportive care before allo-HSCT (hazard ratio, 0.86; P = .32).

Study details: Findings are from a meta-analysis of 7 retrospective studies including 820 patients with MDS, of which 395 patients received HMAs before allo-HSCT and the remaining patients received best supportive care.

Disclosures: The study was funded by Youth Science Foundation of National Natural Science Foundation of China. The authors declared no potential conflicts of interest.

Source: Liu L et al. Clin Exp Med. 2021 Apr 17. doi: 10.1007/s10238-021-00712-0.

Key clinical point: Bridging therapy with hypomethylating agents (HMAs) did not provide long-term survival benefit in patients with myelodysplastic syndrome (MDS) receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Major finding: Overall survival was not significantly different among patients who received HMAs vs. best supportive care before allo-HSCT (hazard ratio, 0.86; P = .32).

Study details: Findings are from a meta-analysis of 7 retrospective studies including 820 patients with MDS, of which 395 patients received HMAs before allo-HSCT and the remaining patients received best supportive care.

Disclosures: The study was funded by Youth Science Foundation of National Natural Science Foundation of China. The authors declared no potential conflicts of interest.

Source: Liu L et al. Clin Exp Med. 2021 Apr 17. doi: 10.1007/s10238-021-00712-0.

Key clinical point: Bridging therapy with hypomethylating agents (HMAs) did not provide long-term survival benefit in patients with myelodysplastic syndrome (MDS) receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Major finding: Overall survival was not significantly different among patients who received HMAs vs. best supportive care before allo-HSCT (hazard ratio, 0.86; P = .32).

Study details: Findings are from a meta-analysis of 7 retrospective studies including 820 patients with MDS, of which 395 patients received HMAs before allo-HSCT and the remaining patients received best supportive care.

Disclosures: The study was funded by Youth Science Foundation of National Natural Science Foundation of China. The authors declared no potential conflicts of interest.

Source: Liu L et al. Clin Exp Med. 2021 Apr 17. doi: 10.1007/s10238-021-00712-0.