Head & Neck/Thyroid Cancers

A saliva test for detecting oropharyngeal cancer caused by human papillomavirus–16 (HPV-16) has scored a world first: It detected such a cancer in an asymptomatic adult.

If the finding can be replicated in a larger cohort of healthy asymptomatic individuals, widespread screening for HPV-16 – the main driver behind skyrocketing rates of oropharyngeal cancer – ­­­­­could be one step closer, the researchers suggested.

“Oropharyngeal squamous cell carcinomas often presents at a late stage with patients suffering huge morbidity as a result of treatment, [so] we must find strategies to detect these cancers earlier,” senior author Chamindie Punyadeera, PhD, Queensland University of Technology in Brisbane, Australia, told Medscape Medical News in an email.

“This study, for the first time, provides a solid scientific foundation to initiate a screening trial in high-risk individuals to detect HPV-driven oropharyngeal cancer, she added. “Saliva testing could be broadly implemented and [used] in a screening trial in the future,” she said.

The case report was published online March 31 in Frontiers in Oncology.

The saliva test was developed by Dr. Punyadeera and first author Kai Dun Tang, PhD, also from Queensland University of Technology. It is administered as an oral rinse: the individual swishes a saline solution around in his or her mouth for a minute or 2, and then spits the sample into a tube.
 

Prevalence Study

The saliva test was being scrutinized in an ongoing HPV-16 DNA prevalence study, which involved 650 healthy participants being tested for oral HPV-16 DNA.

“Of these, 3 have been identified to have persistent oral HPV-16 DNA infection,” the investigators reported.

After having approached these three participants, one middle-aged male who had been consistently HPV-16 DNA positive for a period of 36 months – and whose HPV-16 viral load had been steadily rising over time – was invited to attend an ear, nose, and throat clinic for assessment.

“Initial clinical examination of the oropharynx including palpation and white light revealed no significant abnormalities,” the researchers emphasized.

As Dr. Punyadeera explained, standard clinical assessment for oropharyngeal malignancy includes white light examination for masses, detection of irregularities or asymmetry of the underlying structures and palpation of the tonsil and tongue base.

Cross-sectional imaging with CT or MRI can be helpful as well, she said, but these imaging studies are unable to detect lesions smaller than a few millimeters in size.

In the case of this individual, salivary oral rinse samples had been collected at baseline, and again at 6, 12, and 36 months after study enrollment as well as 2 weeks after the patient decided to undergo a bilateral tonsillectomy.

DNA was extracted from the salivary oral rinse samples, as well as from the tonsillar tissue obtained after resection. HPV-16 DNA genotyping and viral loads were analyzed with a PCR assay.

Results from the salivary samples indicated that the patient’s HPV-16 DNA viral load had increased exponentially across the 36 months of follow-up, from 3.43 copies/50 ng at baseline to 1281.69 copies/50 ng at 36 months.

On surgery, the patient was found to have a 2 mm squamous cell carcinoma in the left tonsil, but all other oropharyngeal tissues were normal and HPV-16 DNA negative.

Two weeks after undergoing the tonsillectomy, the patient’s HPV-16 DNA viral load in the saliva samples became undetectable.

This case report demonstrates that salivary HPV can both detect smaller lesions than either clinical examination or even radiological investigation, and that the same salivary test can likely also be used to monitor treatment response, Dr. Punyadeera commented.
 

Long-term persistence

As researchers explained in their paper, long-term persistence of HPV-16 infection is most likely a prerequisite for the development of subsequent malignancy.

Unlike cervical cancer caused by HPV-16 infection, the natural history of HPV infection in the oropharyngeal cavity is not known.

However, clinical assessment of patients with either persistent HPV infection or microscopic carcinoma has failed to detect any identifiable abnormalities.

Thus, this is the first report of a histologically confirmed diagnosis of an asymptomatic occult oropharyngeal cancer detected by a screening test through serial measurements of HPV-16 DNA, the investigators emphasized.

The report also demonstrated that very early lesions can be eradicated with minimal morbidity. Unfortunately, most oropharyngeal cancer is currently diagnosed at much later stages, and surgical removal of these is often associated with significant disabilities including difficulties with swallowing and even communicating.

“It’s amazing to think that this man was cured of his disease with a 15-minute procedure which left him with no lasting issues at all,” Dr. Punyadeera commented. “We need to try and make this the norm, not the exception.

“So we must have a well-designed screening study using all the insights we have gained from this case. We owe it to patients to explore these findings to their fullest,” Dr. Punyadeera emphasized.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A saliva test for detecting oropharyngeal cancer caused by human papillomavirus–16 (HPV-16) has scored a world first: It detected such a cancer in an asymptomatic adult.

If the finding can be replicated in a larger cohort of healthy asymptomatic individuals, widespread screening for HPV-16 – the main driver behind skyrocketing rates of oropharyngeal cancer – ­­­­­could be one step closer, the researchers suggested.

“Oropharyngeal squamous cell carcinomas often presents at a late stage with patients suffering huge morbidity as a result of treatment, [so] we must find strategies to detect these cancers earlier,” senior author Chamindie Punyadeera, PhD, Queensland University of Technology in Brisbane, Australia, told Medscape Medical News in an email.

“This study, for the first time, provides a solid scientific foundation to initiate a screening trial in high-risk individuals to detect HPV-driven oropharyngeal cancer, she added. “Saliva testing could be broadly implemented and [used] in a screening trial in the future,” she said.

The case report was published online March 31 in Frontiers in Oncology.

The saliva test was developed by Dr. Punyadeera and first author Kai Dun Tang, PhD, also from Queensland University of Technology. It is administered as an oral rinse: the individual swishes a saline solution around in his or her mouth for a minute or 2, and then spits the sample into a tube.
 

Prevalence Study

The saliva test was being scrutinized in an ongoing HPV-16 DNA prevalence study, which involved 650 healthy participants being tested for oral HPV-16 DNA.

“Of these, 3 have been identified to have persistent oral HPV-16 DNA infection,” the investigators reported.

After having approached these three participants, one middle-aged male who had been consistently HPV-16 DNA positive for a period of 36 months – and whose HPV-16 viral load had been steadily rising over time – was invited to attend an ear, nose, and throat clinic for assessment.

“Initial clinical examination of the oropharynx including palpation and white light revealed no significant abnormalities,” the researchers emphasized.

As Dr. Punyadeera explained, standard clinical assessment for oropharyngeal malignancy includes white light examination for masses, detection of irregularities or asymmetry of the underlying structures and palpation of the tonsil and tongue base.

Cross-sectional imaging with CT or MRI can be helpful as well, she said, but these imaging studies are unable to detect lesions smaller than a few millimeters in size.

In the case of this individual, salivary oral rinse samples had been collected at baseline, and again at 6, 12, and 36 months after study enrollment as well as 2 weeks after the patient decided to undergo a bilateral tonsillectomy.

DNA was extracted from the salivary oral rinse samples, as well as from the tonsillar tissue obtained after resection. HPV-16 DNA genotyping and viral loads were analyzed with a PCR assay.

Results from the salivary samples indicated that the patient’s HPV-16 DNA viral load had increased exponentially across the 36 months of follow-up, from 3.43 copies/50 ng at baseline to 1281.69 copies/50 ng at 36 months.

On surgery, the patient was found to have a 2 mm squamous cell carcinoma in the left tonsil, but all other oropharyngeal tissues were normal and HPV-16 DNA negative.

Two weeks after undergoing the tonsillectomy, the patient’s HPV-16 DNA viral load in the saliva samples became undetectable.

This case report demonstrates that salivary HPV can both detect smaller lesions than either clinical examination or even radiological investigation, and that the same salivary test can likely also be used to monitor treatment response, Dr. Punyadeera commented.
 

Long-term persistence

As researchers explained in their paper, long-term persistence of HPV-16 infection is most likely a prerequisite for the development of subsequent malignancy.

Unlike cervical cancer caused by HPV-16 infection, the natural history of HPV infection in the oropharyngeal cavity is not known.

However, clinical assessment of patients with either persistent HPV infection or microscopic carcinoma has failed to detect any identifiable abnormalities.

Thus, this is the first report of a histologically confirmed diagnosis of an asymptomatic occult oropharyngeal cancer detected by a screening test through serial measurements of HPV-16 DNA, the investigators emphasized.

The report also demonstrated that very early lesions can be eradicated with minimal morbidity. Unfortunately, most oropharyngeal cancer is currently diagnosed at much later stages, and surgical removal of these is often associated with significant disabilities including difficulties with swallowing and even communicating.

“It’s amazing to think that this man was cured of his disease with a 15-minute procedure which left him with no lasting issues at all,” Dr. Punyadeera commented. “We need to try and make this the norm, not the exception.

“So we must have a well-designed screening study using all the insights we have gained from this case. We owe it to patients to explore these findings to their fullest,” Dr. Punyadeera emphasized.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A saliva test for detecting oropharyngeal cancer caused by human papillomavirus–16 (HPV-16) has scored a world first: It detected such a cancer in an asymptomatic adult.

If the finding can be replicated in a larger cohort of healthy asymptomatic individuals, widespread screening for HPV-16 – the main driver behind skyrocketing rates of oropharyngeal cancer – ­­­­­could be one step closer, the researchers suggested.

“Oropharyngeal squamous cell carcinomas often presents at a late stage with patients suffering huge morbidity as a result of treatment, [so] we must find strategies to detect these cancers earlier,” senior author Chamindie Punyadeera, PhD, Queensland University of Technology in Brisbane, Australia, told Medscape Medical News in an email.

“This study, for the first time, provides a solid scientific foundation to initiate a screening trial in high-risk individuals to detect HPV-driven oropharyngeal cancer, she added. “Saliva testing could be broadly implemented and [used] in a screening trial in the future,” she said.

The case report was published online March 31 in Frontiers in Oncology.

The saliva test was developed by Dr. Punyadeera and first author Kai Dun Tang, PhD, also from Queensland University of Technology. It is administered as an oral rinse: the individual swishes a saline solution around in his or her mouth for a minute or 2, and then spits the sample into a tube.
 

Prevalence Study

The saliva test was being scrutinized in an ongoing HPV-16 DNA prevalence study, which involved 650 healthy participants being tested for oral HPV-16 DNA.

“Of these, 3 have been identified to have persistent oral HPV-16 DNA infection,” the investigators reported.

After having approached these three participants, one middle-aged male who had been consistently HPV-16 DNA positive for a period of 36 months – and whose HPV-16 viral load had been steadily rising over time – was invited to attend an ear, nose, and throat clinic for assessment.

“Initial clinical examination of the oropharynx including palpation and white light revealed no significant abnormalities,” the researchers emphasized.

As Dr. Punyadeera explained, standard clinical assessment for oropharyngeal malignancy includes white light examination for masses, detection of irregularities or asymmetry of the underlying structures and palpation of the tonsil and tongue base.

Cross-sectional imaging with CT or MRI can be helpful as well, she said, but these imaging studies are unable to detect lesions smaller than a few millimeters in size.

In the case of this individual, salivary oral rinse samples had been collected at baseline, and again at 6, 12, and 36 months after study enrollment as well as 2 weeks after the patient decided to undergo a bilateral tonsillectomy.

DNA was extracted from the salivary oral rinse samples, as well as from the tonsillar tissue obtained after resection. HPV-16 DNA genotyping and viral loads were analyzed with a PCR assay.

Results from the salivary samples indicated that the patient’s HPV-16 DNA viral load had increased exponentially across the 36 months of follow-up, from 3.43 copies/50 ng at baseline to 1281.69 copies/50 ng at 36 months.

On surgery, the patient was found to have a 2 mm squamous cell carcinoma in the left tonsil, but all other oropharyngeal tissues were normal and HPV-16 DNA negative.

Two weeks after undergoing the tonsillectomy, the patient’s HPV-16 DNA viral load in the saliva samples became undetectable.

This case report demonstrates that salivary HPV can both detect smaller lesions than either clinical examination or even radiological investigation, and that the same salivary test can likely also be used to monitor treatment response, Dr. Punyadeera commented.
 

Long-term persistence

As researchers explained in their paper, long-term persistence of HPV-16 infection is most likely a prerequisite for the development of subsequent malignancy.

Unlike cervical cancer caused by HPV-16 infection, the natural history of HPV infection in the oropharyngeal cavity is not known.

However, clinical assessment of patients with either persistent HPV infection or microscopic carcinoma has failed to detect any identifiable abnormalities.

Thus, this is the first report of a histologically confirmed diagnosis of an asymptomatic occult oropharyngeal cancer detected by a screening test through serial measurements of HPV-16 DNA, the investigators emphasized.

The report also demonstrated that very early lesions can be eradicated with minimal morbidity. Unfortunately, most oropharyngeal cancer is currently diagnosed at much later stages, and surgical removal of these is often associated with significant disabilities including difficulties with swallowing and even communicating.

“It’s amazing to think that this man was cured of his disease with a 15-minute procedure which left him with no lasting issues at all,” Dr. Punyadeera commented. “We need to try and make this the norm, not the exception.

“So we must have a well-designed screening study using all the insights we have gained from this case. We owe it to patients to explore these findings to their fullest,” Dr. Punyadeera emphasized.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Anxiety and distress related to caring for a cancer patient who lives far away may be alleviated through an intervention that includes video-based coaching sessions with a nurse practitioner or social worker, a randomized study suggests.

AJ_Watt/E+

About 20% of long-distance caregivers had a significant reduction in anxiety and 25% had a significant reduction in distress when they received video coaching sessions, attended oncologist visits via video, and had access to a website specifically designed for their needs.

Adding the caregiver to oncologist office visits made the patients feel better supported and didn’t add a significant amount of time to the encounter, said Sara L. Douglas, PhD, RN, of Case Western Reserve University, Cleveland.

Taken together, these results suggest that fairly simple technologies can be leveraged to help caregivers cope with psychological strains related to supporting a patient who doesn’t live nearby, Dr. Douglas said.

Distance caregivers, defined as those who live an hour or more away from the patient, can experience high rates of distress and anxiety because they lack first-hand information or may have uncertainty about the patient’s current condition, according to Dr. Douglas and colleagues.

“Caregivers’ high rates of anxiety and distress have been found to have a negative impact not only upon their own health but upon their ability to provide high quality care to the patient,” Dr. Douglas said.

With this in mind, she and her colleagues conducted a 4-month study of distance caregivers. Dr. Douglas presented results from the study at the American Society of Clinical Oncology virtual scientific program during a press briefing in advance of the meeting. This year, ASCO’s annual meeting is split into two parts. The virtual scientific program will be presented online on May 29-31, and the virtual education program will be available Aug. 8-10.
 

Study details

The study enrolled 441 distance caregivers of cancer patients, and Dr. Douglas presented results in 311 of those caregivers. (Data in the presentation differ from the abstract.) The caregivers were, on average, 47 years of age. Most were female (72%), white (67%), the child of the patient (63%), currently employed (81%), and new to the distance caregiver role (89%).

The caregivers were randomized to one of three study arms.

One arm received the full intervention, which consisted of four video-coaching sessions with an advanced practice nurse or social worker, videoconference office visits with the physician and patient, and access to a website with information for cancer distance caregivers. A second arm received no video coaching but had access to the website and participated in video visits with the physician and patient. The third arm, which only received access to the website, served as the study’s control group.
 

Results

Dr. Douglas said that the full intervention had the biggest impact on caregivers’ distress and anxiety.

Among distance caregivers who received the full intervention, 19.2% had a significant reduction in anxiety (P = .03), as measured in online surveys before and after the intervention using the PROMIS Anxiety instrument. Furthermore, 24.8% of these caregivers had a significant reduction in distress (P = .02) from preintervention to post intervention, as measured by the National Comprehensive Cancer Network Distress Thermometer. Overall, distress and anxiety scores decreased in this arm.

Distance caregivers who only had physician-patient video visits and website access had a “moderate” reduction in distress and anxiety, Dr. Douglas said. Among these caregivers, 17.3% had an improvement in anxiety from baseline, and 19.8% had an improvement in distress. Overall, distress scores decreased, but anxiety scores increased slightly in this arm.

In the control arm, 13.1% of caregivers had an improvement in anxiety from baseline, and 18% had an improvement in distress. Overall, both anxiety and distress scores increased in this arm.

“While the full intervention yielded the best results for distance caregivers, we recognize that not all health care systems have the resources to provide individualized coaching sessions to distance caregivers,” Dr. Douglas said. “Therefore, it is worth noting that videoconference office visits alone are found to be of some benefit in improving distress and anxiety in this group of cancer caregivers.”

The study results suggest videoconferencing interventions can improve the emotional well-being of remote caregivers who provide “critical support” for cancer patients, said ASCO President Howard A. “Skip” Burris III, MD.

“As COVID-19 forces separation from loved ones and increases anxiety for people with cancer and their caregivers, providing emotional support virtually is more important than ever,” Dr. Burris said in a news release highlighting the study.

This study was funded by the National Institutes of Health and Case Comprehensive Cancer Center. Dr. Douglas reported having no disclosures. Other researchers involved in the study disclosed relationships with BridgeBio Pharma, Cardinal Health, Apexigen, Roche/Genentech, Seattle Genetics, Tesaro, Array BioPharma, Abbvie, Bristol-Myers Squibb, and Celgene. A full list of Dr. Burris’s financial disclosures is available on the ASCO website.

SOURCE: Douglas SL et al. ASCO 2020, Abstract 12123.

Anxiety and distress related to caring for a cancer patient who lives far away may be alleviated through an intervention that includes video-based coaching sessions with a nurse practitioner or social worker, a randomized study suggests.

AJ_Watt/E+

About 20% of long-distance caregivers had a significant reduction in anxiety and 25% had a significant reduction in distress when they received video coaching sessions, attended oncologist visits via video, and had access to a website specifically designed for their needs.

Adding the caregiver to oncologist office visits made the patients feel better supported and didn’t add a significant amount of time to the encounter, said Sara L. Douglas, PhD, RN, of Case Western Reserve University, Cleveland.

Taken together, these results suggest that fairly simple technologies can be leveraged to help caregivers cope with psychological strains related to supporting a patient who doesn’t live nearby, Dr. Douglas said.

Distance caregivers, defined as those who live an hour or more away from the patient, can experience high rates of distress and anxiety because they lack first-hand information or may have uncertainty about the patient’s current condition, according to Dr. Douglas and colleagues.

“Caregivers’ high rates of anxiety and distress have been found to have a negative impact not only upon their own health but upon their ability to provide high quality care to the patient,” Dr. Douglas said.

With this in mind, she and her colleagues conducted a 4-month study of distance caregivers. Dr. Douglas presented results from the study at the American Society of Clinical Oncology virtual scientific program during a press briefing in advance of the meeting. This year, ASCO’s annual meeting is split into two parts. The virtual scientific program will be presented online on May 29-31, and the virtual education program will be available Aug. 8-10.
 

Study details

The study enrolled 441 distance caregivers of cancer patients, and Dr. Douglas presented results in 311 of those caregivers. (Data in the presentation differ from the abstract.) The caregivers were, on average, 47 years of age. Most were female (72%), white (67%), the child of the patient (63%), currently employed (81%), and new to the distance caregiver role (89%).

The caregivers were randomized to one of three study arms.

One arm received the full intervention, which consisted of four video-coaching sessions with an advanced practice nurse or social worker, videoconference office visits with the physician and patient, and access to a website with information for cancer distance caregivers. A second arm received no video coaching but had access to the website and participated in video visits with the physician and patient. The third arm, which only received access to the website, served as the study’s control group.
 

Results

Dr. Douglas said that the full intervention had the biggest impact on caregivers’ distress and anxiety.

Among distance caregivers who received the full intervention, 19.2% had a significant reduction in anxiety (P = .03), as measured in online surveys before and after the intervention using the PROMIS Anxiety instrument. Furthermore, 24.8% of these caregivers had a significant reduction in distress (P = .02) from preintervention to post intervention, as measured by the National Comprehensive Cancer Network Distress Thermometer. Overall, distress and anxiety scores decreased in this arm.

Distance caregivers who only had physician-patient video visits and website access had a “moderate” reduction in distress and anxiety, Dr. Douglas said. Among these caregivers, 17.3% had an improvement in anxiety from baseline, and 19.8% had an improvement in distress. Overall, distress scores decreased, but anxiety scores increased slightly in this arm.

In the control arm, 13.1% of caregivers had an improvement in anxiety from baseline, and 18% had an improvement in distress. Overall, both anxiety and distress scores increased in this arm.

“While the full intervention yielded the best results for distance caregivers, we recognize that not all health care systems have the resources to provide individualized coaching sessions to distance caregivers,” Dr. Douglas said. “Therefore, it is worth noting that videoconference office visits alone are found to be of some benefit in improving distress and anxiety in this group of cancer caregivers.”

The study results suggest videoconferencing interventions can improve the emotional well-being of remote caregivers who provide “critical support” for cancer patients, said ASCO President Howard A. “Skip” Burris III, MD.

“As COVID-19 forces separation from loved ones and increases anxiety for people with cancer and their caregivers, providing emotional support virtually is more important than ever,” Dr. Burris said in a news release highlighting the study.

This study was funded by the National Institutes of Health and Case Comprehensive Cancer Center. Dr. Douglas reported having no disclosures. Other researchers involved in the study disclosed relationships with BridgeBio Pharma, Cardinal Health, Apexigen, Roche/Genentech, Seattle Genetics, Tesaro, Array BioPharma, Abbvie, Bristol-Myers Squibb, and Celgene. A full list of Dr. Burris’s financial disclosures is available on the ASCO website.

SOURCE: Douglas SL et al. ASCO 2020, Abstract 12123.

Anxiety and distress related to caring for a cancer patient who lives far away may be alleviated through an intervention that includes video-based coaching sessions with a nurse practitioner or social worker, a randomized study suggests.

AJ_Watt/E+

About 20% of long-distance caregivers had a significant reduction in anxiety and 25% had a significant reduction in distress when they received video coaching sessions, attended oncologist visits via video, and had access to a website specifically designed for their needs.

Adding the caregiver to oncologist office visits made the patients feel better supported and didn’t add a significant amount of time to the encounter, said Sara L. Douglas, PhD, RN, of Case Western Reserve University, Cleveland.

Taken together, these results suggest that fairly simple technologies can be leveraged to help caregivers cope with psychological strains related to supporting a patient who doesn’t live nearby, Dr. Douglas said.

Distance caregivers, defined as those who live an hour or more away from the patient, can experience high rates of distress and anxiety because they lack first-hand information or may have uncertainty about the patient’s current condition, according to Dr. Douglas and colleagues.

“Caregivers’ high rates of anxiety and distress have been found to have a negative impact not only upon their own health but upon their ability to provide high quality care to the patient,” Dr. Douglas said.

With this in mind, she and her colleagues conducted a 4-month study of distance caregivers. Dr. Douglas presented results from the study at the American Society of Clinical Oncology virtual scientific program during a press briefing in advance of the meeting. This year, ASCO’s annual meeting is split into two parts. The virtual scientific program will be presented online on May 29-31, and the virtual education program will be available Aug. 8-10.
 

Study details

The study enrolled 441 distance caregivers of cancer patients, and Dr. Douglas presented results in 311 of those caregivers. (Data in the presentation differ from the abstract.) The caregivers were, on average, 47 years of age. Most were female (72%), white (67%), the child of the patient (63%), currently employed (81%), and new to the distance caregiver role (89%).

The caregivers were randomized to one of three study arms.

One arm received the full intervention, which consisted of four video-coaching sessions with an advanced practice nurse or social worker, videoconference office visits with the physician and patient, and access to a website with information for cancer distance caregivers. A second arm received no video coaching but had access to the website and participated in video visits with the physician and patient. The third arm, which only received access to the website, served as the study’s control group.
 

Results

Dr. Douglas said that the full intervention had the biggest impact on caregivers’ distress and anxiety.

Among distance caregivers who received the full intervention, 19.2% had a significant reduction in anxiety (P = .03), as measured in online surveys before and after the intervention using the PROMIS Anxiety instrument. Furthermore, 24.8% of these caregivers had a significant reduction in distress (P = .02) from preintervention to post intervention, as measured by the National Comprehensive Cancer Network Distress Thermometer. Overall, distress and anxiety scores decreased in this arm.

Distance caregivers who only had physician-patient video visits and website access had a “moderate” reduction in distress and anxiety, Dr. Douglas said. Among these caregivers, 17.3% had an improvement in anxiety from baseline, and 19.8% had an improvement in distress. Overall, distress scores decreased, but anxiety scores increased slightly in this arm.

In the control arm, 13.1% of caregivers had an improvement in anxiety from baseline, and 18% had an improvement in distress. Overall, both anxiety and distress scores increased in this arm.

“While the full intervention yielded the best results for distance caregivers, we recognize that not all health care systems have the resources to provide individualized coaching sessions to distance caregivers,” Dr. Douglas said. “Therefore, it is worth noting that videoconference office visits alone are found to be of some benefit in improving distress and anxiety in this group of cancer caregivers.”

The study results suggest videoconferencing interventions can improve the emotional well-being of remote caregivers who provide “critical support” for cancer patients, said ASCO President Howard A. “Skip” Burris III, MD.

“As COVID-19 forces separation from loved ones and increases anxiety for people with cancer and their caregivers, providing emotional support virtually is more important than ever,” Dr. Burris said in a news release highlighting the study.

This study was funded by the National Institutes of Health and Case Comprehensive Cancer Center. Dr. Douglas reported having no disclosures. Other researchers involved in the study disclosed relationships with BridgeBio Pharma, Cardinal Health, Apexigen, Roche/Genentech, Seattle Genetics, Tesaro, Array BioPharma, Abbvie, Bristol-Myers Squibb, and Celgene. A full list of Dr. Burris’s financial disclosures is available on the ASCO website.

SOURCE: Douglas SL et al. ASCO 2020, Abstract 12123.

Traditionally at this time of year, everyone working in cancer turns their attention toward Chicago, and 40,000 or so travel to the city for the annual meeting of the American Society of Clinical Oncology (ASCO).

Not this year.

The McCormick Place convention center has been converted to a field hospital to cope with the ongoing COVID-19 pandemic. The cavernous meeting halls have been filled with makeshift wards with 750 acute care beds, as shown in a tweet from Toni Choueiri, MD, chief of genitourinary oncology at the Dana Farber Cancer Center in Boston.

But the annual meeting is still going ahead, having been transferred online.

“We have to remember that even though there’s a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer,” Richard Schilsky, MD, PhD, chief medical officer at ASCO, told Medscape Medical News.

“This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients,” he said.

The ASCO Virtual Scientific Program will take place over the weekend of May 30-31.

“We’re certainly hoping that we’re going to deliver a program that features all of the most important science that would have been presented in person in Chicago,” Schilsky commented in an interview.

Most of the presentations will be prerecorded and then streamed, which “we hope will mitigate any of the technical glitches that could come from trying to do a live broadcast of the meeting,” he said.

There will be 250 oral and 2500 poster presentations in 24 disease-based and specialty tracks.

The majority of the abstracts will be released online on May 13. The majority of the on-demand content will be released on May 29. Some of the abstracts will be highlighted at ASCO press briefings and released on those two dates.

But some of the material will be made available only on the weekend of the meeting. The opening session, plenaries featuring late-breaking abstracts, special highlights sessions, and other clinical science symposia will be broadcast on Saturday, May 30, and Sunday, May 31 (the schedule for the weekend program is available on the ASCO meeting website).

Among the plenary presentations are some clinical results that are likely to change practice immediately, Schilsky predicted. These include data to be presented in the following abstracts:

• Abstract LBA4 on the KEYNOTE-177 study comparing immunotherapy using pembrolizumab (Keytruda, Merck & Co) with chemotherapy in patients with metastatic colorectal cancer whose tumors show microsatellite instability or mismatch repair deficiency;
• Abstract LBA5 on the ADAURA study exploring osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after complete tumor reseaction in patients with early-stage non–small cell lung cancer whose tumors are EGFR mutation positive;
• Abstract LBA1 on the JAVELIN Bladder 100 study exploring maintenance avelumab (Bavencio, Merck and Pfizer) with best supportive care after platinum-based first-line chemotherapy in patients with advanced urothelial carcinoma.

However, some of the material that would have been part of the annual meeting, which includes mostly educational sessions and invited talks, has been moved to another event, the ASCO Educational Program, to be held in August 2020.

“So I suppose, in the grand scheme of things, the meeting is going to be compressed a little bit,” Schilsky commented. “Obviously, we can’t deliver all the interactions that happen in the hallways and everywhere else at the meeting that really gives so much energy to the meeting, but, at this moment in our history, probably getting the science out there is what’s most important.”
 

Virtual exhibition hall

There will also be a virtual exhibition hall, which will open on May 29.

“Just as there is a typical exhibit hall in the convention center,” Schilsky commented, most of the companies that were planning to be in Chicago have “now transitioned to creating a virtual booth that people who are participating in the virtual meeting can visit.

“I don’t know exactly how each company is going to use their time and their virtual space, and that’s part of the whole learning process here to see how this whole experiment is going to work out,” he added.

Unlike some of the other conferences that have gone virtual, in which access has been made available to everyone for free, registration is still required for the ASCO meeting. But the society notes that the registration fee has been discounted for nonmembers and has been waived for ASCO members. Also, the fee covers both the Virtual Scientific Program in May and the ASCO Educational Program in August.

Registrants will have access to video and slide presentations, as well as discussant commentaries, for 180 days.

The article first appeared on Medscape.com.

Traditionally at this time of year, everyone working in cancer turns their attention toward Chicago, and 40,000 or so travel to the city for the annual meeting of the American Society of Clinical Oncology (ASCO).

Not this year.

The McCormick Place convention center has been converted to a field hospital to cope with the ongoing COVID-19 pandemic. The cavernous meeting halls have been filled with makeshift wards with 750 acute care beds, as shown in a tweet from Toni Choueiri, MD, chief of genitourinary oncology at the Dana Farber Cancer Center in Boston.

But the annual meeting is still going ahead, having been transferred online.

“We have to remember that even though there’s a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer,” Richard Schilsky, MD, PhD, chief medical officer at ASCO, told Medscape Medical News.

“This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients,” he said.

The ASCO Virtual Scientific Program will take place over the weekend of May 30-31.

“We’re certainly hoping that we’re going to deliver a program that features all of the most important science that would have been presented in person in Chicago,” Schilsky commented in an interview.

Most of the presentations will be prerecorded and then streamed, which “we hope will mitigate any of the technical glitches that could come from trying to do a live broadcast of the meeting,” he said.

There will be 250 oral and 2500 poster presentations in 24 disease-based and specialty tracks.

The majority of the abstracts will be released online on May 13. The majority of the on-demand content will be released on May 29. Some of the abstracts will be highlighted at ASCO press briefings and released on those two dates.

But some of the material will be made available only on the weekend of the meeting. The opening session, plenaries featuring late-breaking abstracts, special highlights sessions, and other clinical science symposia will be broadcast on Saturday, May 30, and Sunday, May 31 (the schedule for the weekend program is available on the ASCO meeting website).

Among the plenary presentations are some clinical results that are likely to change practice immediately, Schilsky predicted. These include data to be presented in the following abstracts:

• Abstract LBA4 on the KEYNOTE-177 study comparing immunotherapy using pembrolizumab (Keytruda, Merck & Co) with chemotherapy in patients with metastatic colorectal cancer whose tumors show microsatellite instability or mismatch repair deficiency;
• Abstract LBA5 on the ADAURA study exploring osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after complete tumor reseaction in patients with early-stage non–small cell lung cancer whose tumors are EGFR mutation positive;
• Abstract LBA1 on the JAVELIN Bladder 100 study exploring maintenance avelumab (Bavencio, Merck and Pfizer) with best supportive care after platinum-based first-line chemotherapy in patients with advanced urothelial carcinoma.

However, some of the material that would have been part of the annual meeting, which includes mostly educational sessions and invited talks, has been moved to another event, the ASCO Educational Program, to be held in August 2020.

“So I suppose, in the grand scheme of things, the meeting is going to be compressed a little bit,” Schilsky commented. “Obviously, we can’t deliver all the interactions that happen in the hallways and everywhere else at the meeting that really gives so much energy to the meeting, but, at this moment in our history, probably getting the science out there is what’s most important.”
 

Virtual exhibition hall

There will also be a virtual exhibition hall, which will open on May 29.

“Just as there is a typical exhibit hall in the convention center,” Schilsky commented, most of the companies that were planning to be in Chicago have “now transitioned to creating a virtual booth that people who are participating in the virtual meeting can visit.

“I don’t know exactly how each company is going to use their time and their virtual space, and that’s part of the whole learning process here to see how this whole experiment is going to work out,” he added.

Unlike some of the other conferences that have gone virtual, in which access has been made available to everyone for free, registration is still required for the ASCO meeting. But the society notes that the registration fee has been discounted for nonmembers and has been waived for ASCO members. Also, the fee covers both the Virtual Scientific Program in May and the ASCO Educational Program in August.

Registrants will have access to video and slide presentations, as well as discussant commentaries, for 180 days.

The article first appeared on Medscape.com.

Traditionally at this time of year, everyone working in cancer turns their attention toward Chicago, and 40,000 or so travel to the city for the annual meeting of the American Society of Clinical Oncology (ASCO).

Not this year.

The McCormick Place convention center has been converted to a field hospital to cope with the ongoing COVID-19 pandemic. The cavernous meeting halls have been filled with makeshift wards with 750 acute care beds, as shown in a tweet from Toni Choueiri, MD, chief of genitourinary oncology at the Dana Farber Cancer Center in Boston.

But the annual meeting is still going ahead, having been transferred online.

“We have to remember that even though there’s a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer,” Richard Schilsky, MD, PhD, chief medical officer at ASCO, told Medscape Medical News.

“This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients,” he said.

The ASCO Virtual Scientific Program will take place over the weekend of May 30-31.

“We’re certainly hoping that we’re going to deliver a program that features all of the most important science that would have been presented in person in Chicago,” Schilsky commented in an interview.

Most of the presentations will be prerecorded and then streamed, which “we hope will mitigate any of the technical glitches that could come from trying to do a live broadcast of the meeting,” he said.

There will be 250 oral and 2500 poster presentations in 24 disease-based and specialty tracks.

The majority of the abstracts will be released online on May 13. The majority of the on-demand content will be released on May 29. Some of the abstracts will be highlighted at ASCO press briefings and released on those two dates.

But some of the material will be made available only on the weekend of the meeting. The opening session, plenaries featuring late-breaking abstracts, special highlights sessions, and other clinical science symposia will be broadcast on Saturday, May 30, and Sunday, May 31 (the schedule for the weekend program is available on the ASCO meeting website).

Among the plenary presentations are some clinical results that are likely to change practice immediately, Schilsky predicted. These include data to be presented in the following abstracts:

• Abstract LBA4 on the KEYNOTE-177 study comparing immunotherapy using pembrolizumab (Keytruda, Merck & Co) with chemotherapy in patients with metastatic colorectal cancer whose tumors show microsatellite instability or mismatch repair deficiency;
• Abstract LBA5 on the ADAURA study exploring osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after complete tumor reseaction in patients with early-stage non–small cell lung cancer whose tumors are EGFR mutation positive;
• Abstract LBA1 on the JAVELIN Bladder 100 study exploring maintenance avelumab (Bavencio, Merck and Pfizer) with best supportive care after platinum-based first-line chemotherapy in patients with advanced urothelial carcinoma.

However, some of the material that would have been part of the annual meeting, which includes mostly educational sessions and invited talks, has been moved to another event, the ASCO Educational Program, to be held in August 2020.

“So I suppose, in the grand scheme of things, the meeting is going to be compressed a little bit,” Schilsky commented. “Obviously, we can’t deliver all the interactions that happen in the hallways and everywhere else at the meeting that really gives so much energy to the meeting, but, at this moment in our history, probably getting the science out there is what’s most important.”
 

Virtual exhibition hall

There will also be a virtual exhibition hall, which will open on May 29.

“Just as there is a typical exhibit hall in the convention center,” Schilsky commented, most of the companies that were planning to be in Chicago have “now transitioned to creating a virtual booth that people who are participating in the virtual meeting can visit.

“I don’t know exactly how each company is going to use their time and their virtual space, and that’s part of the whole learning process here to see how this whole experiment is going to work out,” he added.

Unlike some of the other conferences that have gone virtual, in which access has been made available to everyone for free, registration is still required for the ASCO meeting. But the society notes that the registration fee has been discounted for nonmembers and has been waived for ASCO members. Also, the fee covers both the Virtual Scientific Program in May and the ASCO Educational Program in August.

Registrants will have access to video and slide presentations, as well as discussant commentaries, for 180 days.

The article first appeared on Medscape.com.

Selpercatinib (Retevmo) becomes the first targeted therapy to be approved by the US Food and Drug Administration (FDA) for use in patients with cancer who have certain tumors that have an alteration (mutation or fusion) in the RET gene.

The drug is indicated for use in RET-positive tumors found in the following:

• Non–small cell lung cancer (NSCLC) that has spread in adult patients
• Advanced medullary thyroid cancer (MTC) or MTC that has spread in adult and pediatric patients (older than 12 years) who require systemic therapy
• Thyroid cancer that requires systemic therapy and that has stopped responding to or is not appropriate for radioactive iodine therapy in adult and pediatric (older than 12 years) patients.

Before initiating treatment, a RET gene alteration must be determined via laboratory testing, the FDA emphasized. However, no FDA-approved test is currently available for detecting RET fusions/mutations.
 

Approval based on responses in open-label trial

This was an accelerated approval based on the overall response rate (ORR) and duration of response (DOR) seen in an open-label clinical trial (the phase 1/2 LIBRETTO-001 study), which involved patients with each of the three types of tumors.

All patients received selpercatinib 160 mg orally twice daily until disease progression or unacceptable toxicity occurred.

For this trial, identification of a RET gene alteration was prospectively determined in plasma or tumor tissue by local laboratories using next-generation sequencing, polymerase chain reaction testing, or fluorescence in situ hybridization, according to Eli Lilly, the company marketing selpercatinib. Immunohistochemistry was not used in the clinical trial.

Efficacy for NSCLC was evaluated in 105 adult patients with RET fusion-positive NSCLC who were previously treated with platinum chemotherapy. The ORR was 64%.

Efficacy was also evaluated in 39 patients with RET fusion-positive NSCLC who had not received any previous treatment. The ORR for these patients was 84%.

For both groups, among patients who responded to treatment, the response lasted more than 6 months.

“In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases,” LIBRETTO-001 lead investigator Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center in New York, N.Y., said in an Eli Lilly press release.

“The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy,” Dr. Drilon added.

About 1% to 2% of NSCLC tumors are thought to have a RET alteration.

The same trial also included patients with thyroid cancer.

Efficacy for MTC was evaluated in 55 adult and pediatric (older than 12 years) patients with advanced or metastatic RET-mutant MTC who had previously been treated with cabozantinib, vandetanib, or both. The ORR in these patients was 69%.

In addition, selpercatinib was evaluated in 88 patients with advanced or metastatic RET-mutant MTC who had not received prior treatment with cabozantinib or vandetanib. The ORR for these patients was 73%.

The trial also enrolled 19 patients with RET-positive thyroid cancer whose condition was refractory to radioactive iodine (RAI) treatment and who had received another prior systemic treatment. The ORR was 79%. Eight patients had received only RAI. The ORR for these patients was 100%.

In all the cases of thyroid cancer and lung cancer, among the patients who responded to treatment, the response lasted longer than 6 months.

“RET alterations account for the majority of medullary thyroid cancers and a meaningful percentage of other thyroid cancers,” Lori J. Wirth, MD, of Massachusetts General Hospital Cancer Center in Boston, noted in the company release.

A fact sheet from Eli Lilly notes that RET mutations are found in about 60% of sporadic MTC cases and in over 90% of familial MTC cases, and that RET fusions are found in approximately 10% to 20% of papillary thyroid cancers.

“For patients living with these cancers, the approval of selpercatinib means they now have a treatment option that selectively and potently inhibits RET,” Dr. Wirth commented. “Based on the published data for this new medicine, as well as my personal experience treating patients, this may be a good treatment option.”

In the LIBRETTO-001 trial, the rate of discontinuations because of adverse reactions (ARs) was 5%, the company reported. The most common ARs, including laboratory abnormalities (≥25%), were increased aspartate aminotransferase level, increased alanine aminotransferase level, increased glucose level, decreased leukocyte count, decreased albumin level, decreased calcium level, dry mouth, diarrhea, increased creatinine level, increased alkaline phosphatase level, hypertension, fatigue, edema, decreased platelet count, increased total cholesterol level, rash, decreased sodium levels, and constipation. The most frequent serious AR (≥2%) was pneumonia.

The FDA warned that selpercatinib can cause hepatotoxicity, elevation in blood pressure, QT prolongation, bleeding, and allergic reactions. It may also be toxic to a fetus or newborn baby so should not be taken by pregnant or breastfeeding women.

Selpercatinib is currently being assessed in two phase 3 confirmatory trials. LIBRETTO-431 will test the drug in previously untreated patients with RET-positive NSCLC. LIBRETTO-531 involves treatment-naive patients with RET-positive MTC.

The company that developed selpercaptinib, Loxo Oncology, was acquired by Eli Lilly last year in an $8 billion takeover. This drug was billed as the most promising asset in that deal, alongside oral BTK inhibitor LOXO-305, according to a report in Pharmaphorum.

Loxo developed Vitrakvi (larotrectinib), the first TRK inhibitor to reach the market, as well as the follow-up drug LOXO-195. Both were acquired by Bayer ahead of the Lilly takeover, that report notes.

This article first appeared on Medscape.com.

Selpercatinib (Retevmo) becomes the first targeted therapy to be approved by the US Food and Drug Administration (FDA) for use in patients with cancer who have certain tumors that have an alteration (mutation or fusion) in the RET gene.

The drug is indicated for use in RET-positive tumors found in the following:

• Non–small cell lung cancer (NSCLC) that has spread in adult patients
• Advanced medullary thyroid cancer (MTC) or MTC that has spread in adult and pediatric patients (older than 12 years) who require systemic therapy
• Thyroid cancer that requires systemic therapy and that has stopped responding to or is not appropriate for radioactive iodine therapy in adult and pediatric (older than 12 years) patients.

Before initiating treatment, a RET gene alteration must be determined via laboratory testing, the FDA emphasized. However, no FDA-approved test is currently available for detecting RET fusions/mutations.
 

Approval based on responses in open-label trial

This was an accelerated approval based on the overall response rate (ORR) and duration of response (DOR) seen in an open-label clinical trial (the phase 1/2 LIBRETTO-001 study), which involved patients with each of the three types of tumors.

All patients received selpercatinib 160 mg orally twice daily until disease progression or unacceptable toxicity occurred.

For this trial, identification of a RET gene alteration was prospectively determined in plasma or tumor tissue by local laboratories using next-generation sequencing, polymerase chain reaction testing, or fluorescence in situ hybridization, according to Eli Lilly, the company marketing selpercatinib. Immunohistochemistry was not used in the clinical trial.

Efficacy for NSCLC was evaluated in 105 adult patients with RET fusion-positive NSCLC who were previously treated with platinum chemotherapy. The ORR was 64%.

Efficacy was also evaluated in 39 patients with RET fusion-positive NSCLC who had not received any previous treatment. The ORR for these patients was 84%.

For both groups, among patients who responded to treatment, the response lasted more than 6 months.

“In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases,” LIBRETTO-001 lead investigator Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center in New York, N.Y., said in an Eli Lilly press release.

“The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy,” Dr. Drilon added.

About 1% to 2% of NSCLC tumors are thought to have a RET alteration.

The same trial also included patients with thyroid cancer.

Efficacy for MTC was evaluated in 55 adult and pediatric (older than 12 years) patients with advanced or metastatic RET-mutant MTC who had previously been treated with cabozantinib, vandetanib, or both. The ORR in these patients was 69%.

In addition, selpercatinib was evaluated in 88 patients with advanced or metastatic RET-mutant MTC who had not received prior treatment with cabozantinib or vandetanib. The ORR for these patients was 73%.

The trial also enrolled 19 patients with RET-positive thyroid cancer whose condition was refractory to radioactive iodine (RAI) treatment and who had received another prior systemic treatment. The ORR was 79%. Eight patients had received only RAI. The ORR for these patients was 100%.

In all the cases of thyroid cancer and lung cancer, among the patients who responded to treatment, the response lasted longer than 6 months.

“RET alterations account for the majority of medullary thyroid cancers and a meaningful percentage of other thyroid cancers,” Lori J. Wirth, MD, of Massachusetts General Hospital Cancer Center in Boston, noted in the company release.

A fact sheet from Eli Lilly notes that RET mutations are found in about 60% of sporadic MTC cases and in over 90% of familial MTC cases, and that RET fusions are found in approximately 10% to 20% of papillary thyroid cancers.

“For patients living with these cancers, the approval of selpercatinib means they now have a treatment option that selectively and potently inhibits RET,” Dr. Wirth commented. “Based on the published data for this new medicine, as well as my personal experience treating patients, this may be a good treatment option.”

In the LIBRETTO-001 trial, the rate of discontinuations because of adverse reactions (ARs) was 5%, the company reported. The most common ARs, including laboratory abnormalities (≥25%), were increased aspartate aminotransferase level, increased alanine aminotransferase level, increased glucose level, decreased leukocyte count, decreased albumin level, decreased calcium level, dry mouth, diarrhea, increased creatinine level, increased alkaline phosphatase level, hypertension, fatigue, edema, decreased platelet count, increased total cholesterol level, rash, decreased sodium levels, and constipation. The most frequent serious AR (≥2%) was pneumonia.

The FDA warned that selpercatinib can cause hepatotoxicity, elevation in blood pressure, QT prolongation, bleeding, and allergic reactions. It may also be toxic to a fetus or newborn baby so should not be taken by pregnant or breastfeeding women.

Selpercatinib is currently being assessed in two phase 3 confirmatory trials. LIBRETTO-431 will test the drug in previously untreated patients with RET-positive NSCLC. LIBRETTO-531 involves treatment-naive patients with RET-positive MTC.

The company that developed selpercaptinib, Loxo Oncology, was acquired by Eli Lilly last year in an $8 billion takeover. This drug was billed as the most promising asset in that deal, alongside oral BTK inhibitor LOXO-305, according to a report in Pharmaphorum.

Loxo developed Vitrakvi (larotrectinib), the first TRK inhibitor to reach the market, as well as the follow-up drug LOXO-195. Both were acquired by Bayer ahead of the Lilly takeover, that report notes.

This article first appeared on Medscape.com.

Selpercatinib (Retevmo) becomes the first targeted therapy to be approved by the US Food and Drug Administration (FDA) for use in patients with cancer who have certain tumors that have an alteration (mutation or fusion) in the RET gene.

The drug is indicated for use in RET-positive tumors found in the following:

• Non–small cell lung cancer (NSCLC) that has spread in adult patients
• Advanced medullary thyroid cancer (MTC) or MTC that has spread in adult and pediatric patients (older than 12 years) who require systemic therapy
• Thyroid cancer that requires systemic therapy and that has stopped responding to or is not appropriate for radioactive iodine therapy in adult and pediatric (older than 12 years) patients.

Before initiating treatment, a RET gene alteration must be determined via laboratory testing, the FDA emphasized. However, no FDA-approved test is currently available for detecting RET fusions/mutations.
 

Approval based on responses in open-label trial

This was an accelerated approval based on the overall response rate (ORR) and duration of response (DOR) seen in an open-label clinical trial (the phase 1/2 LIBRETTO-001 study), which involved patients with each of the three types of tumors.

All patients received selpercatinib 160 mg orally twice daily until disease progression or unacceptable toxicity occurred.

For this trial, identification of a RET gene alteration was prospectively determined in plasma or tumor tissue by local laboratories using next-generation sequencing, polymerase chain reaction testing, or fluorescence in situ hybridization, according to Eli Lilly, the company marketing selpercatinib. Immunohistochemistry was not used in the clinical trial.

Efficacy for NSCLC was evaluated in 105 adult patients with RET fusion-positive NSCLC who were previously treated with platinum chemotherapy. The ORR was 64%.

Efficacy was also evaluated in 39 patients with RET fusion-positive NSCLC who had not received any previous treatment. The ORR for these patients was 84%.

For both groups, among patients who responded to treatment, the response lasted more than 6 months.

“In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases,” LIBRETTO-001 lead investigator Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center in New York, N.Y., said in an Eli Lilly press release.

“The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy,” Dr. Drilon added.

About 1% to 2% of NSCLC tumors are thought to have a RET alteration.

The same trial also included patients with thyroid cancer.

Efficacy for MTC was evaluated in 55 adult and pediatric (older than 12 years) patients with advanced or metastatic RET-mutant MTC who had previously been treated with cabozantinib, vandetanib, or both. The ORR in these patients was 69%.

In addition, selpercatinib was evaluated in 88 patients with advanced or metastatic RET-mutant MTC who had not received prior treatment with cabozantinib or vandetanib. The ORR for these patients was 73%.

The trial also enrolled 19 patients with RET-positive thyroid cancer whose condition was refractory to radioactive iodine (RAI) treatment and who had received another prior systemic treatment. The ORR was 79%. Eight patients had received only RAI. The ORR for these patients was 100%.

In all the cases of thyroid cancer and lung cancer, among the patients who responded to treatment, the response lasted longer than 6 months.

“RET alterations account for the majority of medullary thyroid cancers and a meaningful percentage of other thyroid cancers,” Lori J. Wirth, MD, of Massachusetts General Hospital Cancer Center in Boston, noted in the company release.

A fact sheet from Eli Lilly notes that RET mutations are found in about 60% of sporadic MTC cases and in over 90% of familial MTC cases, and that RET fusions are found in approximately 10% to 20% of papillary thyroid cancers.

“For patients living with these cancers, the approval of selpercatinib means they now have a treatment option that selectively and potently inhibits RET,” Dr. Wirth commented. “Based on the published data for this new medicine, as well as my personal experience treating patients, this may be a good treatment option.”

In the LIBRETTO-001 trial, the rate of discontinuations because of adverse reactions (ARs) was 5%, the company reported. The most common ARs, including laboratory abnormalities (≥25%), were increased aspartate aminotransferase level, increased alanine aminotransferase level, increased glucose level, decreased leukocyte count, decreased albumin level, decreased calcium level, dry mouth, diarrhea, increased creatinine level, increased alkaline phosphatase level, hypertension, fatigue, edema, decreased platelet count, increased total cholesterol level, rash, decreased sodium levels, and constipation. The most frequent serious AR (≥2%) was pneumonia.

The FDA warned that selpercatinib can cause hepatotoxicity, elevation in blood pressure, QT prolongation, bleeding, and allergic reactions. It may also be toxic to a fetus or newborn baby so should not be taken by pregnant or breastfeeding women.

Selpercatinib is currently being assessed in two phase 3 confirmatory trials. LIBRETTO-431 will test the drug in previously untreated patients with RET-positive NSCLC. LIBRETTO-531 involves treatment-naive patients with RET-positive MTC.

The company that developed selpercaptinib, Loxo Oncology, was acquired by Eli Lilly last year in an $8 billion takeover. This drug was billed as the most promising asset in that deal, alongside oral BTK inhibitor LOXO-305, according to a report in Pharmaphorum.

Loxo developed Vitrakvi (larotrectinib), the first TRK inhibitor to reach the market, as well as the follow-up drug LOXO-195. Both were acquired by Bayer ahead of the Lilly takeover, that report notes.

This article first appeared on Medscape.com.

COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.

The case fatality rate was 28% (61/218) among cancer patients with COVID-19 and 14% (149/1,090) among matched noncancer patients with COVID-19 treated during the same time period in the same hospital system.

Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.

“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.

They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.

In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.

Deaths by cancer type

Among the 164 patients with solid tumors, case fatality rates were as follows:

• Pancreatic – 67% (2/3)
• Lung – 55% (6/11)
• Colorectal – 38% (8/21)
• Upper gastrointestinal – 38% (3/8)
• Gynecologic – 38% (5/13)
• Skin – 33% (1/3)
• Hepatobiliary – 29% (2/7)
• Bone/soft tissue – 20% (1/5)
• Genitourinary – 15% (7/46)
• Breast – 14% (4/28)
• Neurologic – 13% (1/8)
• Head and neck – 13% (1/8).

None of the three patients with neuroendocrine tumors died.

Among the 54 patients with hematologic malignancies, case fatality rates were as follows:

• Chronic myeloid leukemia – 100% (1/1)
• Hodgkin lymphoma – 60% (3/5)
• Myelodysplastic syndromes – 60% (3/5)
• Multiple myeloma – 38% (5/13)
• Non-Hodgkin lymphoma – 33% (5/15)
• Chronic lymphocytic leukemia – 33% (1/3)
• Myeloproliferative neoplasms – 29% (2/7).

None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.

Factors associated with increased mortality

The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.

Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.

“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.

Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.

Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
 

Proactive strategies moving forward

“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.

The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.

“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”

The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.

SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.

COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.

The case fatality rate was 28% (61/218) among cancer patients with COVID-19 and 14% (149/1,090) among matched noncancer patients with COVID-19 treated during the same time period in the same hospital system.

Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.

“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.

They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.

In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.

Deaths by cancer type

Among the 164 patients with solid tumors, case fatality rates were as follows:

• Pancreatic – 67% (2/3)
• Lung – 55% (6/11)
• Colorectal – 38% (8/21)
• Upper gastrointestinal – 38% (3/8)
• Gynecologic – 38% (5/13)
• Skin – 33% (1/3)
• Hepatobiliary – 29% (2/7)
• Bone/soft tissue – 20% (1/5)
• Genitourinary – 15% (7/46)
• Breast – 14% (4/28)
• Neurologic – 13% (1/8)
• Head and neck – 13% (1/8).

None of the three patients with neuroendocrine tumors died.

Among the 54 patients with hematologic malignancies, case fatality rates were as follows:

• Chronic myeloid leukemia – 100% (1/1)
• Hodgkin lymphoma – 60% (3/5)
• Myelodysplastic syndromes – 60% (3/5)
• Multiple myeloma – 38% (5/13)
• Non-Hodgkin lymphoma – 33% (5/15)
• Chronic lymphocytic leukemia – 33% (1/3)
• Myeloproliferative neoplasms – 29% (2/7).

None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.

Factors associated with increased mortality

The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.

Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.

“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.

Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.

Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
 

Proactive strategies moving forward

“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.

The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.

“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”

The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.

SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.

COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.

The case fatality rate was 28% (61/218) among cancer patients with COVID-19 and 14% (149/1,090) among matched noncancer patients with COVID-19 treated during the same time period in the same hospital system.

Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.

“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.

They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.

In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.

Deaths by cancer type

Among the 164 patients with solid tumors, case fatality rates were as follows:

• Pancreatic – 67% (2/3)
• Lung – 55% (6/11)
• Colorectal – 38% (8/21)
• Upper gastrointestinal – 38% (3/8)
• Gynecologic – 38% (5/13)
• Skin – 33% (1/3)
• Hepatobiliary – 29% (2/7)
• Bone/soft tissue – 20% (1/5)
• Genitourinary – 15% (7/46)
• Breast – 14% (4/28)
• Neurologic – 13% (1/8)
• Head and neck – 13% (1/8).

None of the three patients with neuroendocrine tumors died.

Among the 54 patients with hematologic malignancies, case fatality rates were as follows:

• Chronic myeloid leukemia – 100% (1/1)
• Hodgkin lymphoma – 60% (3/5)
• Myelodysplastic syndromes – 60% (3/5)
• Multiple myeloma – 38% (5/13)
• Non-Hodgkin lymphoma – 33% (5/15)
• Chronic lymphocytic leukemia – 33% (1/3)
• Myeloproliferative neoplasms – 29% (2/7).

None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.

Factors associated with increased mortality

The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.

Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.

“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.

Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.

Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
 

Proactive strategies moving forward

“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.

The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.

“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”

The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.

SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates.

As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns.

The authors calculate that there will be 6,270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.)

“The recorded underlying cause of these excess deaths may be cancer, COVID-19, or comorbidity (such as myocardial infarction),” Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe.

“Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic,” they emphasize.

The study was published on ResearchGate as a preprint and has not undergone peer review.

Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are “substantial uncertainties that this paper does not adequately communicate.” But others argued that this topic was important enough to warrant early release of the data.

Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents “a highly valuable contribution.”

“It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives,” he pointed out.

“Therefore, these COVID-19-related impacts will cost lives,” Bunce said.

“And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view,” he added.

In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that “restarting cancer services can’t come soon enough.”
 

“Resonably Argued Numerical Estimate”

“It’s well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis,” said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

“It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis,” he continued.

“This study is the first that I have seen that produces a reasonably argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA,” he added.

Declines in Urgent Referrals and Chemo Attendance

For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018.

The data revealed that there have been major declines in chemotherapy attendances. There has been, on average, a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed.

Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions.

On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5.

PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain.

Comorbidities Common

“Comorbidities were common in people with cancer,” the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two.

For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities.

“When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities,” the authors report.

“The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval,” they state.

“This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers,” the authors observe.

Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates.

As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns.

The authors calculate that there will be 6,270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.)

“The recorded underlying cause of these excess deaths may be cancer, COVID-19, or comorbidity (such as myocardial infarction),” Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe.

“Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic,” they emphasize.

The study was published on ResearchGate as a preprint and has not undergone peer review.

Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are “substantial uncertainties that this paper does not adequately communicate.” But others argued that this topic was important enough to warrant early release of the data.

Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents “a highly valuable contribution.”

“It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives,” he pointed out.

“Therefore, these COVID-19-related impacts will cost lives,” Bunce said.

“And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view,” he added.

In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that “restarting cancer services can’t come soon enough.”
 

“Resonably Argued Numerical Estimate”

“It’s well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis,” said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

“It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis,” he continued.

“This study is the first that I have seen that produces a reasonably argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA,” he added.

Declines in Urgent Referrals and Chemo Attendance

For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018.

The data revealed that there have been major declines in chemotherapy attendances. There has been, on average, a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed.

Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions.

On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5.

PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain.

Comorbidities Common

“Comorbidities were common in people with cancer,” the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two.

For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities.

“When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities,” the authors report.

“The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval,” they state.

“This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers,” the authors observe.

Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates.

As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns.

The authors calculate that there will be 6,270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.)

“The recorded underlying cause of these excess deaths may be cancer, COVID-19, or comorbidity (such as myocardial infarction),” Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe.

“Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic,” they emphasize.

The study was published on ResearchGate as a preprint and has not undergone peer review.

Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are “substantial uncertainties that this paper does not adequately communicate.” But others argued that this topic was important enough to warrant early release of the data.

Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents “a highly valuable contribution.”

“It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives,” he pointed out.

“Therefore, these COVID-19-related impacts will cost lives,” Bunce said.

“And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view,” he added.

In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that “restarting cancer services can’t come soon enough.”
 

“Resonably Argued Numerical Estimate”

“It’s well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis,” said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

“It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis,” he continued.

“This study is the first that I have seen that produces a reasonably argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA,” he added.

Declines in Urgent Referrals and Chemo Attendance

For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018.

The data revealed that there have been major declines in chemotherapy attendances. There has been, on average, a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed.

Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions.

On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5.

PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain.

Comorbidities Common

“Comorbidities were common in people with cancer,” the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two.

For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities.

“When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities,” the authors report.

“The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval,” they state.

“This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers,” the authors observe.

Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Cancer patients who received antitumor treatment within 14 days of COVID-19 diagnosis had an increased risk of severe events, according to data from three hospitals in Wuhan.

Patients with patchy consolidation at hospital admission also had an increased risk of severe events, defined as ICU admission, mechanical ventilation, or death.

However, these findings are limited by the small number of patients studied and the retrospective nature of the analysis, according to researchers.

Li Zhang, MD, PhD, of Tongji Hospital in Wuhan, China, presented this research at the AACR virtual meeting I. Some of the data were previously published in Annals of Oncology.

The researchers studied 28 patients with cancer among 1,276 patients with COVID-19 treated at three hospitals in Wuhan. The most common cancer types were lung (n = 7), esophageal (n = 4), and breast (n = 3). Patients had other gastrointestinal, gynecologic, genitourinary, and head and neck cancers as well.

The patients’ median age was 65 years (range, 56-70 years), 60.9% were men, 35.7% had stage IV cancer, and 28.6% had hospital-acquired COVID-19. Antitumor treatments included chemotherapy (n = 22), surgery (n = 21), radiotherapy (n = 21), targeted therapy (n = 5), and immune checkpoint inhibitors (n = 2).
 

COVID-19 treatment

Most patients (n = 22) received oxygen as their only respiratory intervention, although 10 received mechanical ventilation.

For systemic therapy, patients received antibiotic treatment (n = 23), corticosteroids (n = 15), intravenous immunoglobulin (n = 10), and tocilizumab (n = 1).

Antiviral treatments included umifenovir (n = 14), lopinavir/ritonavir (n = 10), ganciclovir (n = 9), ribavirin (n = 1), or a combination of antiviral drugs (n = 9).

“No cancer patients were enrolled in clinical trials, so no one received hydroxychloroquine or remdesivir,” Dr. Zhang noted.
 

Outcomes

In all, 15 patients (53.6%) had severe events. The median time from COVID-19 diagnosis to severe events was 7 days (range, 5-15 days).

A total of eight patients (28.6%) died – three with lung cancer, two with prostate cancer, one with liver cancer, one with rectal cancer, and one with testicular cancer.

Causes of death were acute respiratory distress syndrome (n = 5), septic shock (n = 1), suspected pulmonary embolism (n = 1), and acute myocardial infarction (n = 1).

By April 4, 14 patients had been discharged from the hospital, and 6 were still hospitalized. The median duration of hospitalization was 18.4 days for discharged patients and 29.4 days for patients still in hospital.

Follow-up CT scans showed improvement in 13 patients, no changes in 5 patients, and deterioration in 6 patients.
 

Factors associated with severe events

In a multivariable analysis, receiving antitumor treatment within 14 days of COVID-19 diagnosis was associated with severe events (hazard ratio, 4.079; P = .037).

However, only seven patients received antitumor treatments within 14 days of COVID-19 diagnosis – three chemotherapy, two targeted therapy, one radiotherapy, and one immune checkpoint inhibitor. Five of these seven patients had severe events.

Another factor associated with severe events in multivariable analysis was patchy consolidation on CT scan at admission (HR, 5.438; P = .01). Age and gender were not significantly associated with severe events.
 

Immune checkpoint inhibitors

Dr. Zhang and colleagues also analyzed a second group of cancer patients and their family members to determine if patients on immune checkpoint inhibitors have an increased risk of COVID-19.

This group included 124 cancer patients treated with immune checkpoint inhibitors for at least 2 months. The patients had a median age of 59 years (range, 54-65 years), and 61.8% were men. Most patients (95.2%) had stage IV cancer, and the most common cancers were lung (54.0%), esophageal (18.6%), and head and neck (10.7%).

In this group, only one cancer patient developed COVID-19 (via nosocomial infection). In another case, a patient’s spouse developed COVID-19, but the patient did not.

Dr. Zhang said this “limited information did not suggest cancer patients treated with immune checkpoint inhibitors were more vulnerable to COVID infection.”

Dr. Zhang and colleagues reported no conflicts of interest. This research was funded by the National Natural Science Foundation of China and Huazhong University of Science and Technology COVID-19 Rapid Response Call China.

[email protected]

SOURCE: Zhang L et al. Ann Oncol. 2020 Mar 26. doi: 10.1016/j.annonc.2020.03.296.

Cancer patients who received antitumor treatment within 14 days of COVID-19 diagnosis had an increased risk of severe events, according to data from three hospitals in Wuhan.

Patients with patchy consolidation at hospital admission also had an increased risk of severe events, defined as ICU admission, mechanical ventilation, or death.

However, these findings are limited by the small number of patients studied and the retrospective nature of the analysis, according to researchers.

Li Zhang, MD, PhD, of Tongji Hospital in Wuhan, China, presented this research at the AACR virtual meeting I. Some of the data were previously published in Annals of Oncology.

The researchers studied 28 patients with cancer among 1,276 patients with COVID-19 treated at three hospitals in Wuhan. The most common cancer types were lung (n = 7), esophageal (n = 4), and breast (n = 3). Patients had other gastrointestinal, gynecologic, genitourinary, and head and neck cancers as well.

The patients’ median age was 65 years (range, 56-70 years), 60.9% were men, 35.7% had stage IV cancer, and 28.6% had hospital-acquired COVID-19. Antitumor treatments included chemotherapy (n = 22), surgery (n = 21), radiotherapy (n = 21), targeted therapy (n = 5), and immune checkpoint inhibitors (n = 2).
 

COVID-19 treatment

Most patients (n = 22) received oxygen as their only respiratory intervention, although 10 received mechanical ventilation.

For systemic therapy, patients received antibiotic treatment (n = 23), corticosteroids (n = 15), intravenous immunoglobulin (n = 10), and tocilizumab (n = 1).

Antiviral treatments included umifenovir (n = 14), lopinavir/ritonavir (n = 10), ganciclovir (n = 9), ribavirin (n = 1), or a combination of antiviral drugs (n = 9).

“No cancer patients were enrolled in clinical trials, so no one received hydroxychloroquine or remdesivir,” Dr. Zhang noted.
 

Outcomes

In all, 15 patients (53.6%) had severe events. The median time from COVID-19 diagnosis to severe events was 7 days (range, 5-15 days).

A total of eight patients (28.6%) died – three with lung cancer, two with prostate cancer, one with liver cancer, one with rectal cancer, and one with testicular cancer.

Causes of death were acute respiratory distress syndrome (n = 5), septic shock (n = 1), suspected pulmonary embolism (n = 1), and acute myocardial infarction (n = 1).

By April 4, 14 patients had been discharged from the hospital, and 6 were still hospitalized. The median duration of hospitalization was 18.4 days for discharged patients and 29.4 days for patients still in hospital.

Follow-up CT scans showed improvement in 13 patients, no changes in 5 patients, and deterioration in 6 patients.
 

Factors associated with severe events

In a multivariable analysis, receiving antitumor treatment within 14 days of COVID-19 diagnosis was associated with severe events (hazard ratio, 4.079; P = .037).

However, only seven patients received antitumor treatments within 14 days of COVID-19 diagnosis – three chemotherapy, two targeted therapy, one radiotherapy, and one immune checkpoint inhibitor. Five of these seven patients had severe events.

Another factor associated with severe events in multivariable analysis was patchy consolidation on CT scan at admission (HR, 5.438; P = .01). Age and gender were not significantly associated with severe events.
 

Immune checkpoint inhibitors

Dr. Zhang and colleagues also analyzed a second group of cancer patients and their family members to determine if patients on immune checkpoint inhibitors have an increased risk of COVID-19.

This group included 124 cancer patients treated with immune checkpoint inhibitors for at least 2 months. The patients had a median age of 59 years (range, 54-65 years), and 61.8% were men. Most patients (95.2%) had stage IV cancer, and the most common cancers were lung (54.0%), esophageal (18.6%), and head and neck (10.7%).

In this group, only one cancer patient developed COVID-19 (via nosocomial infection). In another case, a patient’s spouse developed COVID-19, but the patient did not.

Dr. Zhang said this “limited information did not suggest cancer patients treated with immune checkpoint inhibitors were more vulnerable to COVID infection.”

Dr. Zhang and colleagues reported no conflicts of interest. This research was funded by the National Natural Science Foundation of China and Huazhong University of Science and Technology COVID-19 Rapid Response Call China.

[email protected]

SOURCE: Zhang L et al. Ann Oncol. 2020 Mar 26. doi: 10.1016/j.annonc.2020.03.296.

Cancer patients who received antitumor treatment within 14 days of COVID-19 diagnosis had an increased risk of severe events, according to data from three hospitals in Wuhan.

Patients with patchy consolidation at hospital admission also had an increased risk of severe events, defined as ICU admission, mechanical ventilation, or death.

However, these findings are limited by the small number of patients studied and the retrospective nature of the analysis, according to researchers.

Li Zhang, MD, PhD, of Tongji Hospital in Wuhan, China, presented this research at the AACR virtual meeting I. Some of the data were previously published in Annals of Oncology.

The researchers studied 28 patients with cancer among 1,276 patients with COVID-19 treated at three hospitals in Wuhan. The most common cancer types were lung (n = 7), esophageal (n = 4), and breast (n = 3). Patients had other gastrointestinal, gynecologic, genitourinary, and head and neck cancers as well.

The patients’ median age was 65 years (range, 56-70 years), 60.9% were men, 35.7% had stage IV cancer, and 28.6% had hospital-acquired COVID-19. Antitumor treatments included chemotherapy (n = 22), surgery (n = 21), radiotherapy (n = 21), targeted therapy (n = 5), and immune checkpoint inhibitors (n = 2).
 

COVID-19 treatment

Most patients (n = 22) received oxygen as their only respiratory intervention, although 10 received mechanical ventilation.

For systemic therapy, patients received antibiotic treatment (n = 23), corticosteroids (n = 15), intravenous immunoglobulin (n = 10), and tocilizumab (n = 1).

Antiviral treatments included umifenovir (n = 14), lopinavir/ritonavir (n = 10), ganciclovir (n = 9), ribavirin (n = 1), or a combination of antiviral drugs (n = 9).

“No cancer patients were enrolled in clinical trials, so no one received hydroxychloroquine or remdesivir,” Dr. Zhang noted.
 

Outcomes

In all, 15 patients (53.6%) had severe events. The median time from COVID-19 diagnosis to severe events was 7 days (range, 5-15 days).

A total of eight patients (28.6%) died – three with lung cancer, two with prostate cancer, one with liver cancer, one with rectal cancer, and one with testicular cancer.

Causes of death were acute respiratory distress syndrome (n = 5), septic shock (n = 1), suspected pulmonary embolism (n = 1), and acute myocardial infarction (n = 1).

By April 4, 14 patients had been discharged from the hospital, and 6 were still hospitalized. The median duration of hospitalization was 18.4 days for discharged patients and 29.4 days for patients still in hospital.

Follow-up CT scans showed improvement in 13 patients, no changes in 5 patients, and deterioration in 6 patients.
 

Factors associated with severe events

In a multivariable analysis, receiving antitumor treatment within 14 days of COVID-19 diagnosis was associated with severe events (hazard ratio, 4.079; P = .037).

However, only seven patients received antitumor treatments within 14 days of COVID-19 diagnosis – three chemotherapy, two targeted therapy, one radiotherapy, and one immune checkpoint inhibitor. Five of these seven patients had severe events.

Another factor associated with severe events in multivariable analysis was patchy consolidation on CT scan at admission (HR, 5.438; P = .01). Age and gender were not significantly associated with severe events.
 

Immune checkpoint inhibitors

Dr. Zhang and colleagues also analyzed a second group of cancer patients and their family members to determine if patients on immune checkpoint inhibitors have an increased risk of COVID-19.

This group included 124 cancer patients treated with immune checkpoint inhibitors for at least 2 months. The patients had a median age of 59 years (range, 54-65 years), and 61.8% were men. Most patients (95.2%) had stage IV cancer, and the most common cancers were lung (54.0%), esophageal (18.6%), and head and neck (10.7%).

In this group, only one cancer patient developed COVID-19 (via nosocomial infection). In another case, a patient’s spouse developed COVID-19, but the patient did not.

Dr. Zhang said this “limited information did not suggest cancer patients treated with immune checkpoint inhibitors were more vulnerable to COVID infection.”

Dr. Zhang and colleagues reported no conflicts of interest. This research was funded by the National Natural Science Foundation of China and Huazhong University of Science and Technology COVID-19 Rapid Response Call China.

[email protected]

SOURCE: Zhang L et al. Ann Oncol. 2020 Mar 26. doi: 10.1016/j.annonc.2020.03.296.

Cancer type, stage, and recent treatment may affect outcomes of COVID-19 in cancer patients, according to a study of patients from China.

The data showed that patients with hematologic malignancies and those with metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying.

On the other hand, patients with nonmetastatic cancer had outcomes comparable to those of noncancer patients with COVID-19.

Similarly, cancer patients who had recently undergone surgery or received immunotherapy were more likely to have poor outcomes, whereas cancer patients treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University in China, presented these results at the AACR virtual meeting I. The results also were published in Cancer Discovery.
 

Cancer vs. noncancer patients

The study included 105 cancer patients with COVID-19 who were treated from Jan. 1 to Feb. 24, 2020, at 14 hospitals in Wuhan, China. Patients had lung (20.95%), gastrointestinal (12.38%), breast (10.48%), and thyroid cancers (10.48%) as well as hematologic malignancies (8.57%). Dr. Cai and colleagues matched the COVID-19 cancer patients to 536 COVID-19 patients without cancer. Patients were matched by hospital, duration of hospitalization, and age.

“COVID-19 patients with cancer had higher risks of all severe outcomes,” Dr. Cai noted.

Compared with noncancer patients, the cancer patients had a higher risk of:

• Severe or critical COVID-19 symptoms – odds ratio, 2.79 (P < .01).
• Being admitted to the ICU – OR, 2.84 (P < .01).
• Requiring invasive mechanical ventilation – OR, 14 (P < .01).
• Death – OR, 2.34 (P = .03).

Cancer type and stage

Dr. Cai noted that outcomes were the worst among patients with hematologic malignancies and those with metastatic cancer (stage IV).

Compared with patients without cancer, those with hematologic malignancies had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• ICU admission – OR, 9.66 (P < .01).
• Invasive mechanical ventilation – OR, 38 (P < .01).
• Death – OR, 9.07 (P = .01).

Compared with patients without cancer, those with metastatic cancer had a higher risk of:

• Severe/critical symptoms – OR, 5.97 (P < .01).
• ICU admission – OR, 6.59 (P < 0.01).
• Invasive mechanical ventilation – OR, 55.42 (P < .01).
• Death – OR, 5.58 (P = .01).

On the other hand, outcomes in patients with nonmetastatic cancer were not significantly different from outcomes in patients without cancer (P > .05 for all outcomes).
 

Cancer treatment

The treatments cancer patients received within 40 days before the onset of COVID-19 symptoms were radiotherapy (12.26%), chemotherapy (14.15%), surgery (7.62%), targeted therapies (3.81%), and immunotherapy (5.71%).

Compared with patients without cancer, those who received immunotherapy had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• Death – OR, 9.07 (P = .04).

Patients who underwent surgery had a higher risk of:

• Severe/critical symptoms – OR, 8.84 (P < .01).
• ICU admission – OR, 7.24 (P = .02).
• Invasive mechanical ventilation – OR, 44.33 (P < .01).

Conversely, outcomes in cancer patients who received radiotherapy were not significantly different from outcomes in patients without cancer (P > .10 for all).

These results suggest that “postponing surgery should be considered in outbreak areas,” Dr. Cai said, adding that scheduled radiotherapy can go ahead but with “intensive protection and surveillance.”

Dr. Cai said it remains to be seen whether patients with early-stage cancer need to postpone their treatments during the COVID-19 pandemic or whether immunotherapy aggravates severe outcomes in cancer patients with COVID-19. For now, she said, cancer patients should have individualized treatment plans based on their tumor type and stage.

Dr. Cai disclosed no conflicts of interest. This study was supported by the National Natural Science Foundation of China, the Singapore Ministry of Health’s National Medical Research Council, the National Institutes of Health/National Heart, Lung, and Blood Institute, and the Xiu Research Fund.

[email protected]

SOURCE: Cai H. AACR 2020. Patients with cancer appear more vulnerable to SARS-COV-2: A multicenter study during the COVID-19 outbreak; Dai M et al. Cancer Discov. 2020 Apr 28. doi: 10.1158/2159-8290.CD-20-0422.

Cancer type, stage, and recent treatment may affect outcomes of COVID-19 in cancer patients, according to a study of patients from China.

The data showed that patients with hematologic malignancies and those with metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying.

On the other hand, patients with nonmetastatic cancer had outcomes comparable to those of noncancer patients with COVID-19.

Similarly, cancer patients who had recently undergone surgery or received immunotherapy were more likely to have poor outcomes, whereas cancer patients treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University in China, presented these results at the AACR virtual meeting I. The results also were published in Cancer Discovery.
 

Cancer vs. noncancer patients

The study included 105 cancer patients with COVID-19 who were treated from Jan. 1 to Feb. 24, 2020, at 14 hospitals in Wuhan, China. Patients had lung (20.95%), gastrointestinal (12.38%), breast (10.48%), and thyroid cancers (10.48%) as well as hematologic malignancies (8.57%). Dr. Cai and colleagues matched the COVID-19 cancer patients to 536 COVID-19 patients without cancer. Patients were matched by hospital, duration of hospitalization, and age.

“COVID-19 patients with cancer had higher risks of all severe outcomes,” Dr. Cai noted.

Compared with noncancer patients, the cancer patients had a higher risk of:

• Severe or critical COVID-19 symptoms – odds ratio, 2.79 (P < .01).
• Being admitted to the ICU – OR, 2.84 (P < .01).
• Requiring invasive mechanical ventilation – OR, 14 (P < .01).
• Death – OR, 2.34 (P = .03).

Cancer type and stage

Dr. Cai noted that outcomes were the worst among patients with hematologic malignancies and those with metastatic cancer (stage IV).

Compared with patients without cancer, those with hematologic malignancies had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• ICU admission – OR, 9.66 (P < .01).
• Invasive mechanical ventilation – OR, 38 (P < .01).
• Death – OR, 9.07 (P = .01).

Compared with patients without cancer, those with metastatic cancer had a higher risk of:

• Severe/critical symptoms – OR, 5.97 (P < .01).
• ICU admission – OR, 6.59 (P < 0.01).
• Invasive mechanical ventilation – OR, 55.42 (P < .01).
• Death – OR, 5.58 (P = .01).

On the other hand, outcomes in patients with nonmetastatic cancer were not significantly different from outcomes in patients without cancer (P > .05 for all outcomes).
 

Cancer treatment

The treatments cancer patients received within 40 days before the onset of COVID-19 symptoms were radiotherapy (12.26%), chemotherapy (14.15%), surgery (7.62%), targeted therapies (3.81%), and immunotherapy (5.71%).

Compared with patients without cancer, those who received immunotherapy had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• Death – OR, 9.07 (P = .04).

Patients who underwent surgery had a higher risk of:

• Severe/critical symptoms – OR, 8.84 (P < .01).
• ICU admission – OR, 7.24 (P = .02).
• Invasive mechanical ventilation – OR, 44.33 (P < .01).

Conversely, outcomes in cancer patients who received radiotherapy were not significantly different from outcomes in patients without cancer (P > .10 for all).

These results suggest that “postponing surgery should be considered in outbreak areas,” Dr. Cai said, adding that scheduled radiotherapy can go ahead but with “intensive protection and surveillance.”

Dr. Cai said it remains to be seen whether patients with early-stage cancer need to postpone their treatments during the COVID-19 pandemic or whether immunotherapy aggravates severe outcomes in cancer patients with COVID-19. For now, she said, cancer patients should have individualized treatment plans based on their tumor type and stage.

Dr. Cai disclosed no conflicts of interest. This study was supported by the National Natural Science Foundation of China, the Singapore Ministry of Health’s National Medical Research Council, the National Institutes of Health/National Heart, Lung, and Blood Institute, and the Xiu Research Fund.

[email protected]

SOURCE: Cai H. AACR 2020. Patients with cancer appear more vulnerable to SARS-COV-2: A multicenter study during the COVID-19 outbreak; Dai M et al. Cancer Discov. 2020 Apr 28. doi: 10.1158/2159-8290.CD-20-0422.

Cancer type, stage, and recent treatment may affect outcomes of COVID-19 in cancer patients, according to a study of patients from China.

The data showed that patients with hematologic malignancies and those with metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying.

On the other hand, patients with nonmetastatic cancer had outcomes comparable to those of noncancer patients with COVID-19.

Similarly, cancer patients who had recently undergone surgery or received immunotherapy were more likely to have poor outcomes, whereas cancer patients treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University in China, presented these results at the AACR virtual meeting I. The results also were published in Cancer Discovery.
 

Cancer vs. noncancer patients

The study included 105 cancer patients with COVID-19 who were treated from Jan. 1 to Feb. 24, 2020, at 14 hospitals in Wuhan, China. Patients had lung (20.95%), gastrointestinal (12.38%), breast (10.48%), and thyroid cancers (10.48%) as well as hematologic malignancies (8.57%). Dr. Cai and colleagues matched the COVID-19 cancer patients to 536 COVID-19 patients without cancer. Patients were matched by hospital, duration of hospitalization, and age.

“COVID-19 patients with cancer had higher risks of all severe outcomes,” Dr. Cai noted.

Compared with noncancer patients, the cancer patients had a higher risk of:

• Severe or critical COVID-19 symptoms – odds ratio, 2.79 (P < .01).
• Being admitted to the ICU – OR, 2.84 (P < .01).
• Requiring invasive mechanical ventilation – OR, 14 (P < .01).
• Death – OR, 2.34 (P = .03).

Cancer type and stage

Dr. Cai noted that outcomes were the worst among patients with hematologic malignancies and those with metastatic cancer (stage IV).

Compared with patients without cancer, those with hematologic malignancies had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• ICU admission – OR, 9.66 (P < .01).
• Invasive mechanical ventilation – OR, 38 (P < .01).
• Death – OR, 9.07 (P = .01).

Compared with patients without cancer, those with metastatic cancer had a higher risk of:

• Severe/critical symptoms – OR, 5.97 (P < .01).
• ICU admission – OR, 6.59 (P < 0.01).
• Invasive mechanical ventilation – OR, 55.42 (P < .01).
• Death – OR, 5.58 (P = .01).

On the other hand, outcomes in patients with nonmetastatic cancer were not significantly different from outcomes in patients without cancer (P > .05 for all outcomes).
 

Cancer treatment

The treatments cancer patients received within 40 days before the onset of COVID-19 symptoms were radiotherapy (12.26%), chemotherapy (14.15%), surgery (7.62%), targeted therapies (3.81%), and immunotherapy (5.71%).

Compared with patients without cancer, those who received immunotherapy had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• Death – OR, 9.07 (P = .04).

Patients who underwent surgery had a higher risk of:

• Severe/critical symptoms – OR, 8.84 (P < .01).
• ICU admission – OR, 7.24 (P = .02).
• Invasive mechanical ventilation – OR, 44.33 (P < .01).

Conversely, outcomes in cancer patients who received radiotherapy were not significantly different from outcomes in patients without cancer (P > .10 for all).

These results suggest that “postponing surgery should be considered in outbreak areas,” Dr. Cai said, adding that scheduled radiotherapy can go ahead but with “intensive protection and surveillance.”

Dr. Cai said it remains to be seen whether patients with early-stage cancer need to postpone their treatments during the COVID-19 pandemic or whether immunotherapy aggravates severe outcomes in cancer patients with COVID-19. For now, she said, cancer patients should have individualized treatment plans based on their tumor type and stage.

Dr. Cai disclosed no conflicts of interest. This study was supported by the National Natural Science Foundation of China, the Singapore Ministry of Health’s National Medical Research Council, the National Institutes of Health/National Heart, Lung, and Blood Institute, and the Xiu Research Fund.

[email protected]

SOURCE: Cai H. AACR 2020. Patients with cancer appear more vulnerable to SARS-COV-2: A multicenter study during the COVID-19 outbreak; Dai M et al. Cancer Discov. 2020 Apr 28. doi: 10.1158/2159-8290.CD-20-0422.

With a few notable exceptions, the majority of fine needle aspiration (FNA) biopsies of thyroid nodules should be delayed until the risk of COVID-19, and the burden on resources, has lessened, according to expert consensus.

copyright/Sebastian Kaulitzki/Fotolia

“Our group recommends that FNA biopsy of most asymptomatic thyroid nodules – taking into account the sonographic characteristics and patients’ clinical picture – be deferred to a later time, when risk of exposure to COVID-19 is more manageable and resource restriction is no longer a concern,” said the endocrinologists, writing in a guest editorial in Clinical Thyroidology.

All elective procedures have been canceled under guidance of the Centers for Disease Control and Prevention, in conjunction with the U.S. surgeon general, in response to the COVID-19 pandemic. However, thyroid nodule FNAs, though elective, fall into the category of being considered medically necessary and potentially prolonging life expectancy

Yet, with approximately 90% of asymptomatic thyroid nodules turning out to be benign and little evidence that early detection and treatment affects disease outcomes, there is a strong argument for deferral in most cases, stressed Ming Lee, MD, and colleagues, of the endocrinology division at Phoenix (Ariz.) Veterans Affairs Health Care System (PVAHCS), who convened a multidisciplinary meeting to address the urgent issue.

Patients should instead be interviewed by an endocrinologist (preferably via telehealth) to collect their clinical history as well as assess their perception of the disease and risk of malignancy, senior author S. Mitchell Harman, MD, chief of PVAHCS, said in an interview.

“The principal guiding factor should be the objectively assessed likelihood of malignancy of the individual patient’s nodule(s),” he said.

“In my opinion, we should also factor in the patient’s level of anxiety, since some patients are more sanguine about risk than others and our goal is to provide relief of anxiety as well as to determine need for, and course of, subsequent treatment,” Dr. Harman added. 

Vast majority of malignant thyroid nodules are DTC, which is ‘indolent’

Dr. Lee and colleagues noted that, even of the 10% of thyroid nodules that do prove to be malignant, the vast majority of these (90%) are differentiated thyroid cancers (DTC). In general, patients with DTC “follow an indolent course and have excellent outcomes.”

“There is little evidence that early detection and treatment of DTC significantly alters disease outcomes as the overall mortality rate for DTC has remained low, at around 0.5%,” they wrote.

They also noted that ultrasound features of thyroid nodules can help guide priority for the future timing of an FNA procedure, but should not be the sole basis for deciding on immediate thyroid FNA or surgery.

Exceptions to the rule

Exceptions for considering FNA include more urgent thyroid disease diagnoses, including those that are symptomatic:

Suspected medullary thyroid cancer

“Regarding medullary thyroid cancer (MTC), early diagnosis and surgery do significantly improve outcomes, therefore, delaying FNA of nodules harboring MTC could be potentially injurious,” the authors said.

They suggested, however, measuring calcitonin levels instead, which they noted “is still controversial” in the United States, but “we feel it would be justified in patients with thyroid nodules that would usually be indicated for FNA.”

Those with a family history of MTC, or nodules located in the posterior upper third of lateral lobes (the usual location of MTC), should have calcitonin levels measured.

If calcitonin levels are above 10 pg/mL, “FNA should be offered as early as possible.”

“Significantly elevated serum calcitonin levels (e.g., > 100 pg/mL) should be considered an indication for surgery without cytologic confirmation by FNA,” they added.

Anaplastic thyroid cancer

Anaplastic thyroid cancer, though rare, “is one of the few occasions when thyroid surgery should be performed on an urgent basis, as this condition can worsen very rapidly.

“Patients typically present with a rapidly enlarging thyroid mass that is associated with compressive symptoms, such as dysphagia and dyspnea,” they observed.

In this instance, although FNA is part of the preoperative work-up, it is often nondiagnostic and could require additional sampling.

“At the time of this pandemic, it is reasonable that after a multidisciplinary discussion, such patients with the appropriate clinical scenario be referred for thyroid surgery, with or without prior FNA, based on the team’s judgment,” the authors recommended.

Long-standing thyroid masses

These are usually large and/or closely associated with vital structures, such as the trachea and esophagus, and when such masses cause compressive symptoms, thyroid surgery typically is warranted.

And although prior FNA is helpful to obtain a cytologic diagnosis, as this may change the extent of surgery, it may not always be essential.

Broadly, symptomatic patients with compressive symptoms threatening vital structures can be directly referred to a surgeon, with the timing for surgery jointly decided based on the severity of symptoms, rapidity of disease progression, local COVID-19 status, and available resources.

“During the pandemic, we believe that the vast majority of thyroid FNAs should be considered optional, and extent of surgery can be determined by pathological analysis of frozen sections intraoperatively,” they wrote.

“The value of FNA in these situations is less compelling in the current COVID-19 setting, as the basis of decision for surgery has been already determined,” the authors explained.

If urgent FNA needed, screen patient for COVID-19 and use PPE

Should the need for an urgent thyroid FNA occur, patients should be screened and tested for COVID-19 by a clinician wearing personal protective equipment (PPE), said Dr. Lee and colleagues.

“It is crucial to carefully weigh the risks of COVID-19 exposure, availability of resources, and urgency of these procedures for each patient in our individual practice settings,” they noted.

As restrictions eventually loosen, precautions will still be necessary to some degree, Dr. Harman said.

“I do not consider FNA a ‘high-risk’ procedure in the era of COVID-19, since it does not routinely result in profuse aerosolization of respiratory fluids,” he said in an interview.

“However, patients do sometimes cough or choke due to pressure on the neck and the operator is, of necessity, very close to the patient’s face. Therefore, when we resume FNA, patients will be screened for symptoms of COVID-19 infection and both the operator and the patient will be masked,” Dr. Harman continued.

“We routinely wear gloves, [and] whether the operator will wear a surgical or an N95 mask, disposable gown, etc, will depend on CDC guidance and guidance received from our VA infectious disease experts as it is applied specifically to each patient evaluation.”

The authors have reported no relevant financial relationships.
 

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

With a few notable exceptions, the majority of fine needle aspiration (FNA) biopsies of thyroid nodules should be delayed until the risk of COVID-19, and the burden on resources, has lessened, according to expert consensus.

copyright/Sebastian Kaulitzki/Fotolia

“Our group recommends that FNA biopsy of most asymptomatic thyroid nodules – taking into account the sonographic characteristics and patients’ clinical picture – be deferred to a later time, when risk of exposure to COVID-19 is more manageable and resource restriction is no longer a concern,” said the endocrinologists, writing in a guest editorial in Clinical Thyroidology.

All elective procedures have been canceled under guidance of the Centers for Disease Control and Prevention, in conjunction with the U.S. surgeon general, in response to the COVID-19 pandemic. However, thyroid nodule FNAs, though elective, fall into the category of being considered medically necessary and potentially prolonging life expectancy

Yet, with approximately 90% of asymptomatic thyroid nodules turning out to be benign and little evidence that early detection and treatment affects disease outcomes, there is a strong argument for deferral in most cases, stressed Ming Lee, MD, and colleagues, of the endocrinology division at Phoenix (Ariz.) Veterans Affairs Health Care System (PVAHCS), who convened a multidisciplinary meeting to address the urgent issue.

Patients should instead be interviewed by an endocrinologist (preferably via telehealth) to collect their clinical history as well as assess their perception of the disease and risk of malignancy, senior author S. Mitchell Harman, MD, chief of PVAHCS, said in an interview.

“The principal guiding factor should be the objectively assessed likelihood of malignancy of the individual patient’s nodule(s),” he said.

“In my opinion, we should also factor in the patient’s level of anxiety, since some patients are more sanguine about risk than others and our goal is to provide relief of anxiety as well as to determine need for, and course of, subsequent treatment,” Dr. Harman added. 

Vast majority of malignant thyroid nodules are DTC, which is ‘indolent’

Dr. Lee and colleagues noted that, even of the 10% of thyroid nodules that do prove to be malignant, the vast majority of these (90%) are differentiated thyroid cancers (DTC). In general, patients with DTC “follow an indolent course and have excellent outcomes.”

“There is little evidence that early detection and treatment of DTC significantly alters disease outcomes as the overall mortality rate for DTC has remained low, at around 0.5%,” they wrote.

They also noted that ultrasound features of thyroid nodules can help guide priority for the future timing of an FNA procedure, but should not be the sole basis for deciding on immediate thyroid FNA or surgery.

Exceptions to the rule

Exceptions for considering FNA include more urgent thyroid disease diagnoses, including those that are symptomatic:

Suspected medullary thyroid cancer

“Regarding medullary thyroid cancer (MTC), early diagnosis and surgery do significantly improve outcomes, therefore, delaying FNA of nodules harboring MTC could be potentially injurious,” the authors said.

They suggested, however, measuring calcitonin levels instead, which they noted “is still controversial” in the United States, but “we feel it would be justified in patients with thyroid nodules that would usually be indicated for FNA.”

Those with a family history of MTC, or nodules located in the posterior upper third of lateral lobes (the usual location of MTC), should have calcitonin levels measured.

If calcitonin levels are above 10 pg/mL, “FNA should be offered as early as possible.”

“Significantly elevated serum calcitonin levels (e.g., > 100 pg/mL) should be considered an indication for surgery without cytologic confirmation by FNA,” they added.

Anaplastic thyroid cancer

Anaplastic thyroid cancer, though rare, “is one of the few occasions when thyroid surgery should be performed on an urgent basis, as this condition can worsen very rapidly.

“Patients typically present with a rapidly enlarging thyroid mass that is associated with compressive symptoms, such as dysphagia and dyspnea,” they observed.

In this instance, although FNA is part of the preoperative work-up, it is often nondiagnostic and could require additional sampling.

“At the time of this pandemic, it is reasonable that after a multidisciplinary discussion, such patients with the appropriate clinical scenario be referred for thyroid surgery, with or without prior FNA, based on the team’s judgment,” the authors recommended.

Long-standing thyroid masses

These are usually large and/or closely associated with vital structures, such as the trachea and esophagus, and when such masses cause compressive symptoms, thyroid surgery typically is warranted.

And although prior FNA is helpful to obtain a cytologic diagnosis, as this may change the extent of surgery, it may not always be essential.

Broadly, symptomatic patients with compressive symptoms threatening vital structures can be directly referred to a surgeon, with the timing for surgery jointly decided based on the severity of symptoms, rapidity of disease progression, local COVID-19 status, and available resources.

“During the pandemic, we believe that the vast majority of thyroid FNAs should be considered optional, and extent of surgery can be determined by pathological analysis of frozen sections intraoperatively,” they wrote.

“The value of FNA in these situations is less compelling in the current COVID-19 setting, as the basis of decision for surgery has been already determined,” the authors explained.

If urgent FNA needed, screen patient for COVID-19 and use PPE

Should the need for an urgent thyroid FNA occur, patients should be screened and tested for COVID-19 by a clinician wearing personal protective equipment (PPE), said Dr. Lee and colleagues.

“It is crucial to carefully weigh the risks of COVID-19 exposure, availability of resources, and urgency of these procedures for each patient in our individual practice settings,” they noted.

As restrictions eventually loosen, precautions will still be necessary to some degree, Dr. Harman said.

“I do not consider FNA a ‘high-risk’ procedure in the era of COVID-19, since it does not routinely result in profuse aerosolization of respiratory fluids,” he said in an interview.

“However, patients do sometimes cough or choke due to pressure on the neck and the operator is, of necessity, very close to the patient’s face. Therefore, when we resume FNA, patients will be screened for symptoms of COVID-19 infection and both the operator and the patient will be masked,” Dr. Harman continued.

“We routinely wear gloves, [and] whether the operator will wear a surgical or an N95 mask, disposable gown, etc, will depend on CDC guidance and guidance received from our VA infectious disease experts as it is applied specifically to each patient evaluation.”

The authors have reported no relevant financial relationships.
 

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

With a few notable exceptions, the majority of fine needle aspiration (FNA) biopsies of thyroid nodules should be delayed until the risk of COVID-19, and the burden on resources, has lessened, according to expert consensus.

copyright/Sebastian Kaulitzki/Fotolia

“Our group recommends that FNA biopsy of most asymptomatic thyroid nodules – taking into account the sonographic characteristics and patients’ clinical picture – be deferred to a later time, when risk of exposure to COVID-19 is more manageable and resource restriction is no longer a concern,” said the endocrinologists, writing in a guest editorial in Clinical Thyroidology.

All elective procedures have been canceled under guidance of the Centers for Disease Control and Prevention, in conjunction with the U.S. surgeon general, in response to the COVID-19 pandemic. However, thyroid nodule FNAs, though elective, fall into the category of being considered medically necessary and potentially prolonging life expectancy

Yet, with approximately 90% of asymptomatic thyroid nodules turning out to be benign and little evidence that early detection and treatment affects disease outcomes, there is a strong argument for deferral in most cases, stressed Ming Lee, MD, and colleagues, of the endocrinology division at Phoenix (Ariz.) Veterans Affairs Health Care System (PVAHCS), who convened a multidisciplinary meeting to address the urgent issue.

Patients should instead be interviewed by an endocrinologist (preferably via telehealth) to collect their clinical history as well as assess their perception of the disease and risk of malignancy, senior author S. Mitchell Harman, MD, chief of PVAHCS, said in an interview.

“The principal guiding factor should be the objectively assessed likelihood of malignancy of the individual patient’s nodule(s),” he said.

“In my opinion, we should also factor in the patient’s level of anxiety, since some patients are more sanguine about risk than others and our goal is to provide relief of anxiety as well as to determine need for, and course of, subsequent treatment,” Dr. Harman added. 

Vast majority of malignant thyroid nodules are DTC, which is ‘indolent’

Dr. Lee and colleagues noted that, even of the 10% of thyroid nodules that do prove to be malignant, the vast majority of these (90%) are differentiated thyroid cancers (DTC). In general, patients with DTC “follow an indolent course and have excellent outcomes.”

“There is little evidence that early detection and treatment of DTC significantly alters disease outcomes as the overall mortality rate for DTC has remained low, at around 0.5%,” they wrote.

They also noted that ultrasound features of thyroid nodules can help guide priority for the future timing of an FNA procedure, but should not be the sole basis for deciding on immediate thyroid FNA or surgery.

Exceptions to the rule

Exceptions for considering FNA include more urgent thyroid disease diagnoses, including those that are symptomatic:

Suspected medullary thyroid cancer

“Regarding medullary thyroid cancer (MTC), early diagnosis and surgery do significantly improve outcomes, therefore, delaying FNA of nodules harboring MTC could be potentially injurious,” the authors said.

They suggested, however, measuring calcitonin levels instead, which they noted “is still controversial” in the United States, but “we feel it would be justified in patients with thyroid nodules that would usually be indicated for FNA.”

Those with a family history of MTC, or nodules located in the posterior upper third of lateral lobes (the usual location of MTC), should have calcitonin levels measured.

If calcitonin levels are above 10 pg/mL, “FNA should be offered as early as possible.”

“Significantly elevated serum calcitonin levels (e.g., > 100 pg/mL) should be considered an indication for surgery without cytologic confirmation by FNA,” they added.

Anaplastic thyroid cancer

Anaplastic thyroid cancer, though rare, “is one of the few occasions when thyroid surgery should be performed on an urgent basis, as this condition can worsen very rapidly.

“Patients typically present with a rapidly enlarging thyroid mass that is associated with compressive symptoms, such as dysphagia and dyspnea,” they observed.

In this instance, although FNA is part of the preoperative work-up, it is often nondiagnostic and could require additional sampling.

“At the time of this pandemic, it is reasonable that after a multidisciplinary discussion, such patients with the appropriate clinical scenario be referred for thyroid surgery, with or without prior FNA, based on the team’s judgment,” the authors recommended.

Long-standing thyroid masses

These are usually large and/or closely associated with vital structures, such as the trachea and esophagus, and when such masses cause compressive symptoms, thyroid surgery typically is warranted.

And although prior FNA is helpful to obtain a cytologic diagnosis, as this may change the extent of surgery, it may not always be essential.

Broadly, symptomatic patients with compressive symptoms threatening vital structures can be directly referred to a surgeon, with the timing for surgery jointly decided based on the severity of symptoms, rapidity of disease progression, local COVID-19 status, and available resources.

“During the pandemic, we believe that the vast majority of thyroid FNAs should be considered optional, and extent of surgery can be determined by pathological analysis of frozen sections intraoperatively,” they wrote.

“The value of FNA in these situations is less compelling in the current COVID-19 setting, as the basis of decision for surgery has been already determined,” the authors explained.

If urgent FNA needed, screen patient for COVID-19 and use PPE

Should the need for an urgent thyroid FNA occur, patients should be screened and tested for COVID-19 by a clinician wearing personal protective equipment (PPE), said Dr. Lee and colleagues.

“It is crucial to carefully weigh the risks of COVID-19 exposure, availability of resources, and urgency of these procedures for each patient in our individual practice settings,” they noted.

As restrictions eventually loosen, precautions will still be necessary to some degree, Dr. Harman said.

“I do not consider FNA a ‘high-risk’ procedure in the era of COVID-19, since it does not routinely result in profuse aerosolization of respiratory fluids,” he said in an interview.

“However, patients do sometimes cough or choke due to pressure on the neck and the operator is, of necessity, very close to the patient’s face. Therefore, when we resume FNA, patients will be screened for symptoms of COVID-19 infection and both the operator and the patient will be masked,” Dr. Harman continued.

“We routinely wear gloves, [and] whether the operator will wear a surgical or an N95 mask, disposable gown, etc, will depend on CDC guidance and guidance received from our VA infectious disease experts as it is applied specifically to each patient evaluation.”

The authors have reported no relevant financial relationships.
 

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

The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.

“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.

“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
 

Care of COVID-free patients

For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.

“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.

Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.

The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
 

Trials halted or slowed

Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.

“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.

“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.

The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.

“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.

Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
 

Lessons from the front lines

Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.

Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.

Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.

“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.

The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.

“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
 

A view from Washington state

Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.

Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.

“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.

Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
 

ASCO resources

Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.

Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.

The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.

“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.

“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
 

Care of COVID-free patients

For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.

“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.

Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.

The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
 

Trials halted or slowed

Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.

“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.

“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.

The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.

“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.

Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
 

Lessons from the front lines

Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.

Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.

Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.

“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.

The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.

“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
 

A view from Washington state

Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.

Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.

“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.

Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
 

ASCO resources

Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.

Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.

The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.

“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.

“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
 

Care of COVID-free patients

For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.

“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.

Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.

The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
 

Trials halted or slowed

Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.

“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.

“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.

The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.

“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.

Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
 

Lessons from the front lines

Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.

Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.

Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.

“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.

The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.

“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
 

A view from Washington state

Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.

Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.

“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.

Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
 

ASCO resources

Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.

Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.