AVAHO

Medical oncologist Anne Chiang, MD, PhD, is scrambling to maintain cancer care in New Haven, Connecticut, while COVID-19 advances unrelentingly. As deputy chief medical officer of the Smilow Cancer Network, the largest cancer care delivery system in Connecticut and Rhode Island, she has no illusions about dodging what’s unfolding just 2 hours down the road in New York City.

“They’re trying their best to continue active cancer treatment but it’s getting harder,” she says of her colleagues in the thick of the pandemic. “We have to be prepared for it here.”

In anticipation of what’s coming, her team has just emptied the top three floors of the Smilow Cancer Hospital, moving 60 patients by ambulance and other medical transport to a different hospital nearby.

The move frees the Smilow Cancer hospital’s negative-pressure wards for the anticipated wave of COVID-19 patients. It will keep the virus sealed off from the rest of the hospital. But in other locations it’s harder to shield patients with cancer from the infection.

Around the state, Smilow Cancer Network’s affiliated hospitals are already treating a growing number of COVID-19 patients, especially at Greenwich Hospital, right on the border with New York state.

To protect patients with cancer, who are among the most vulnerable to the virus, oncologists are embracing telemedicine to allow most patients to stay home.

“We’re really concentrating on decreasing the risk to these patients, with a widespread massive-scale conversion to telehealth,” said Chiang. “This is something that, in the space of about a week, has transformed the care of our patients — it’s a really amazing transformation.”

If anything good comes out of the COVID-19 pandemic, it will be this global adoption of virtual healthcare.

Across the US border in Canada, the medical director of Toronto’s Princess Margaret Cancer Centre is directing a similar transformation.

“We have converted probably about 70% to 80% of our clinic visits to virtual visits,” says radiation oncologist Mary Gospodarowicz, MD.

“We have three priorities: number one, to keep our patients safe; number two, to keep our staff safe, because if staff are sick we won’t be treating anybody; and number three, to treat as many patients with cancer as possible.”

Gospodarowicz woke up last week to a local headline about a woman whose mastectomy had been canceled “because of the coronavirus.” The story exposed the many layers of the COVID-19 crisis. “A lot of hospitals have canceled elective surgeries,” she acknowledged. “For patients who have treatment or surgery deferred, we have a database and we’ll make sure we look after those patients eventually. We have a priority system, so low-risk prostate cancer, very low-risk breast cancer patients are waiting. All the urgent head and neck, breast, and other higher priority surgeries are still being done, but it just depends how it goes. The situation changes every day.”

It’s similar in Los Angeles, at the University of Southern California, says Elizabeth David, MD, a cardiothoracic surgeon with Keck Medicine.

“For thoracic, we just had a conference call with about 30 surgeons around the country going through really nitty-gritty specifics to help with our decision making about what could wait without detriment to the patient – hopefully – and what should be done now,” she told Medscape Medical News.

“There are some hospitals where they are not doing anything but life and death emergency operations, whereas we are still doing our emergent cancer operations in our institution, but we all know – and patients know – that could change from one day to the next. They may think they’re having surgery tomorrow but may get a call saying we can’t do it,” David said.

Many of David’s patients have non–small cell lung cancer, putting them at particular risk with a pulmonary infection like COVID-19. For now, she says delivery of postsurgical chemotherapy and radiotherapy has not been impacted in her area, but her videoconference discussions with patients are much longer – and harder – these days.

“I’ve been in practice a while now and I’ve had numerous conversations with patients this week that I never trained for, and I’ve never known anyone else who has. It’s really hard as a provider to know what to say,” she said.

In cardiothoracic surgery, David said guidance on clinical decision making is coming from the American College of Surgeons, Society of Thoracic Surgery, and American Association of Thoracic Surgeons. Yet, she says each patient is being assessed – and reassessed – individually.

“You have to balance the risk of delaying the intervention with supply issues, hospital exposure issues, the danger to the patient of being in the hospital environment – there’s just so many factors. We’re spending so much time talking through cases, and a lot of times we’re talking about cases we already talked about, but we’re just making sure that based on today’s numbers we should still be moving forward,” she commented.

In Connecticut, Chiang said treatment decisions are also mostly on a case-by-case basis at the moment, although more standardized guidelines are being worked out.

“Our disease teams have been really proactive in terms of offering alternative solutions to patients, creative ways to basically keep them out of the hospital and also reduce the immunosuppressive regimens that we give them,” she said.

Examples include offering endocrine therapy to patients who can’t get breast cancer surgery, or offering alternative drug regimens and dosing schedules. “At this point we haven’t needed to ration actual treatment – patients are continuing to get active therapy if that’s appropriate – it’s more about how can we protect them,” she said. “It’s a complex puzzle of moving pieces.”

In Toronto, Gospodarowicz says newly published medical and radiation oncology guidelines from France are the backbone of her hospital’s policy discussions about treating cancer and protecting patients from COVID-19.

While patients’ concerns are understandable, she says even in the current hot spots of infection, it’s encouraging to know that cancer patients are not being forgotten.

“I recently had email communication with a radiation oncologist in Brescia, one of the worst-affected areas in Italy, and he told me the radiotherapy department has been 60% to 70% capacity, so they still treat 70% these patients, just taking precautions and separating the COVID-positive and negative ones. When we read the stats it looks horrible, but life still goes on and people are still being treated,” she said.

Although telemedicine offers meaningful solutions to the COVID-19 crisis in North America, it may not be possible in other parts of the world.

Web consultations were only just approved in Brazil this week. “We are still discussing how to make it official and reimbursed,” says Rachel Riechelmann, MD, head of clinical oncology at AC Camargo Cancer Center in São Paulo.

To minimize infection risk for patients, Riechelmann says her hospital is doing the following: postponing surgeries in cases where there is good evidence of neoadjuvant treatment, such as total neoadjuvant therapy for rectal cancer; avoiding adjuvant chemo for stage 2 colon cancer; moving to hypofractionated radiotherapy if possible; adopting watchful waiting in grade 1 nonfunctional neuroendocrine tumors; and postponing follow-up visits.

“We do our best,” she wrote in an email. “We keep treating cancer if treatment cannot wait.”

Riechelmann’s center has just launched a trial of hydroxychloroquine and tocilizumab therapy in patients with cancer who have severe COVID-19 and acute respiratory distress syndrome (ARDS).

Meanwhile in New Haven, Chiang says for patients with cancer who are infected with COVID-19, her team is also prognosticating about the fair allocation of limited resources such as ventilators.

“If it ever gets to the point where somebody has to choose between a cancer patient and a noncancer patient in providing life support, it’s really important that people understand that cancer patients are doing very well nowadays and even with a diagnosis of cancer they can potentially live for many years, so that shouldn’t necessarily be a decision-point,” she emphasized.

This article first appeared on Medscape.com.

Medical oncologist Anne Chiang, MD, PhD, is scrambling to maintain cancer care in New Haven, Connecticut, while COVID-19 advances unrelentingly. As deputy chief medical officer of the Smilow Cancer Network, the largest cancer care delivery system in Connecticut and Rhode Island, she has no illusions about dodging what’s unfolding just 2 hours down the road in New York City.

“They’re trying their best to continue active cancer treatment but it’s getting harder,” she says of her colleagues in the thick of the pandemic. “We have to be prepared for it here.”

In anticipation of what’s coming, her team has just emptied the top three floors of the Smilow Cancer Hospital, moving 60 patients by ambulance and other medical transport to a different hospital nearby.

The move frees the Smilow Cancer hospital’s negative-pressure wards for the anticipated wave of COVID-19 patients. It will keep the virus sealed off from the rest of the hospital. But in other locations it’s harder to shield patients with cancer from the infection.

Around the state, Smilow Cancer Network’s affiliated hospitals are already treating a growing number of COVID-19 patients, especially at Greenwich Hospital, right on the border with New York state.

To protect patients with cancer, who are among the most vulnerable to the virus, oncologists are embracing telemedicine to allow most patients to stay home.

“We’re really concentrating on decreasing the risk to these patients, with a widespread massive-scale conversion to telehealth,” said Chiang. “This is something that, in the space of about a week, has transformed the care of our patients — it’s a really amazing transformation.”

If anything good comes out of the COVID-19 pandemic, it will be this global adoption of virtual healthcare.

Across the US border in Canada, the medical director of Toronto’s Princess Margaret Cancer Centre is directing a similar transformation.

“We have converted probably about 70% to 80% of our clinic visits to virtual visits,” says radiation oncologist Mary Gospodarowicz, MD.

“We have three priorities: number one, to keep our patients safe; number two, to keep our staff safe, because if staff are sick we won’t be treating anybody; and number three, to treat as many patients with cancer as possible.”

Gospodarowicz woke up last week to a local headline about a woman whose mastectomy had been canceled “because of the coronavirus.” The story exposed the many layers of the COVID-19 crisis. “A lot of hospitals have canceled elective surgeries,” she acknowledged. “For patients who have treatment or surgery deferred, we have a database and we’ll make sure we look after those patients eventually. We have a priority system, so low-risk prostate cancer, very low-risk breast cancer patients are waiting. All the urgent head and neck, breast, and other higher priority surgeries are still being done, but it just depends how it goes. The situation changes every day.”

It’s similar in Los Angeles, at the University of Southern California, says Elizabeth David, MD, a cardiothoracic surgeon with Keck Medicine.

“For thoracic, we just had a conference call with about 30 surgeons around the country going through really nitty-gritty specifics to help with our decision making about what could wait without detriment to the patient – hopefully – and what should be done now,” she told Medscape Medical News.

“There are some hospitals where they are not doing anything but life and death emergency operations, whereas we are still doing our emergent cancer operations in our institution, but we all know – and patients know – that could change from one day to the next. They may think they’re having surgery tomorrow but may get a call saying we can’t do it,” David said.

Many of David’s patients have non–small cell lung cancer, putting them at particular risk with a pulmonary infection like COVID-19. For now, she says delivery of postsurgical chemotherapy and radiotherapy has not been impacted in her area, but her videoconference discussions with patients are much longer – and harder – these days.

“I’ve been in practice a while now and I’ve had numerous conversations with patients this week that I never trained for, and I’ve never known anyone else who has. It’s really hard as a provider to know what to say,” she said.

In cardiothoracic surgery, David said guidance on clinical decision making is coming from the American College of Surgeons, Society of Thoracic Surgery, and American Association of Thoracic Surgeons. Yet, she says each patient is being assessed – and reassessed – individually.

“You have to balance the risk of delaying the intervention with supply issues, hospital exposure issues, the danger to the patient of being in the hospital environment – there’s just so many factors. We’re spending so much time talking through cases, and a lot of times we’re talking about cases we already talked about, but we’re just making sure that based on today’s numbers we should still be moving forward,” she commented.

In Connecticut, Chiang said treatment decisions are also mostly on a case-by-case basis at the moment, although more standardized guidelines are being worked out.

“Our disease teams have been really proactive in terms of offering alternative solutions to patients, creative ways to basically keep them out of the hospital and also reduce the immunosuppressive regimens that we give them,” she said.

Examples include offering endocrine therapy to patients who can’t get breast cancer surgery, or offering alternative drug regimens and dosing schedules. “At this point we haven’t needed to ration actual treatment – patients are continuing to get active therapy if that’s appropriate – it’s more about how can we protect them,” she said. “It’s a complex puzzle of moving pieces.”

In Toronto, Gospodarowicz says newly published medical and radiation oncology guidelines from France are the backbone of her hospital’s policy discussions about treating cancer and protecting patients from COVID-19.

While patients’ concerns are understandable, she says even in the current hot spots of infection, it’s encouraging to know that cancer patients are not being forgotten.

“I recently had email communication with a radiation oncologist in Brescia, one of the worst-affected areas in Italy, and he told me the radiotherapy department has been 60% to 70% capacity, so they still treat 70% these patients, just taking precautions and separating the COVID-positive and negative ones. When we read the stats it looks horrible, but life still goes on and people are still being treated,” she said.

Although telemedicine offers meaningful solutions to the COVID-19 crisis in North America, it may not be possible in other parts of the world.

Web consultations were only just approved in Brazil this week. “We are still discussing how to make it official and reimbursed,” says Rachel Riechelmann, MD, head of clinical oncology at AC Camargo Cancer Center in São Paulo.

To minimize infection risk for patients, Riechelmann says her hospital is doing the following: postponing surgeries in cases where there is good evidence of neoadjuvant treatment, such as total neoadjuvant therapy for rectal cancer; avoiding adjuvant chemo for stage 2 colon cancer; moving to hypofractionated radiotherapy if possible; adopting watchful waiting in grade 1 nonfunctional neuroendocrine tumors; and postponing follow-up visits.

“We do our best,” she wrote in an email. “We keep treating cancer if treatment cannot wait.”

Riechelmann’s center has just launched a trial of hydroxychloroquine and tocilizumab therapy in patients with cancer who have severe COVID-19 and acute respiratory distress syndrome (ARDS).

Meanwhile in New Haven, Chiang says for patients with cancer who are infected with COVID-19, her team is also prognosticating about the fair allocation of limited resources such as ventilators.

“If it ever gets to the point where somebody has to choose between a cancer patient and a noncancer patient in providing life support, it’s really important that people understand that cancer patients are doing very well nowadays and even with a diagnosis of cancer they can potentially live for many years, so that shouldn’t necessarily be a decision-point,” she emphasized.

This article first appeared on Medscape.com.

Medical oncologist Anne Chiang, MD, PhD, is scrambling to maintain cancer care in New Haven, Connecticut, while COVID-19 advances unrelentingly. As deputy chief medical officer of the Smilow Cancer Network, the largest cancer care delivery system in Connecticut and Rhode Island, she has no illusions about dodging what’s unfolding just 2 hours down the road in New York City.

“They’re trying their best to continue active cancer treatment but it’s getting harder,” she says of her colleagues in the thick of the pandemic. “We have to be prepared for it here.”

In anticipation of what’s coming, her team has just emptied the top three floors of the Smilow Cancer Hospital, moving 60 patients by ambulance and other medical transport to a different hospital nearby.

The move frees the Smilow Cancer hospital’s negative-pressure wards for the anticipated wave of COVID-19 patients. It will keep the virus sealed off from the rest of the hospital. But in other locations it’s harder to shield patients with cancer from the infection.

Around the state, Smilow Cancer Network’s affiliated hospitals are already treating a growing number of COVID-19 patients, especially at Greenwich Hospital, right on the border with New York state.

To protect patients with cancer, who are among the most vulnerable to the virus, oncologists are embracing telemedicine to allow most patients to stay home.

“We’re really concentrating on decreasing the risk to these patients, with a widespread massive-scale conversion to telehealth,” said Chiang. “This is something that, in the space of about a week, has transformed the care of our patients — it’s a really amazing transformation.”

If anything good comes out of the COVID-19 pandemic, it will be this global adoption of virtual healthcare.

Across the US border in Canada, the medical director of Toronto’s Princess Margaret Cancer Centre is directing a similar transformation.

“We have converted probably about 70% to 80% of our clinic visits to virtual visits,” says radiation oncologist Mary Gospodarowicz, MD.

“We have three priorities: number one, to keep our patients safe; number two, to keep our staff safe, because if staff are sick we won’t be treating anybody; and number three, to treat as many patients with cancer as possible.”

Gospodarowicz woke up last week to a local headline about a woman whose mastectomy had been canceled “because of the coronavirus.” The story exposed the many layers of the COVID-19 crisis. “A lot of hospitals have canceled elective surgeries,” she acknowledged. “For patients who have treatment or surgery deferred, we have a database and we’ll make sure we look after those patients eventually. We have a priority system, so low-risk prostate cancer, very low-risk breast cancer patients are waiting. All the urgent head and neck, breast, and other higher priority surgeries are still being done, but it just depends how it goes. The situation changes every day.”

It’s similar in Los Angeles, at the University of Southern California, says Elizabeth David, MD, a cardiothoracic surgeon with Keck Medicine.

“For thoracic, we just had a conference call with about 30 surgeons around the country going through really nitty-gritty specifics to help with our decision making about what could wait without detriment to the patient – hopefully – and what should be done now,” she told Medscape Medical News.

“There are some hospitals where they are not doing anything but life and death emergency operations, whereas we are still doing our emergent cancer operations in our institution, but we all know – and patients know – that could change from one day to the next. They may think they’re having surgery tomorrow but may get a call saying we can’t do it,” David said.

Many of David’s patients have non–small cell lung cancer, putting them at particular risk with a pulmonary infection like COVID-19. For now, she says delivery of postsurgical chemotherapy and radiotherapy has not been impacted in her area, but her videoconference discussions with patients are much longer – and harder – these days.

“I’ve been in practice a while now and I’ve had numerous conversations with patients this week that I never trained for, and I’ve never known anyone else who has. It’s really hard as a provider to know what to say,” she said.

In cardiothoracic surgery, David said guidance on clinical decision making is coming from the American College of Surgeons, Society of Thoracic Surgery, and American Association of Thoracic Surgeons. Yet, she says each patient is being assessed – and reassessed – individually.

“You have to balance the risk of delaying the intervention with supply issues, hospital exposure issues, the danger to the patient of being in the hospital environment – there’s just so many factors. We’re spending so much time talking through cases, and a lot of times we’re talking about cases we already talked about, but we’re just making sure that based on today’s numbers we should still be moving forward,” she commented.

In Connecticut, Chiang said treatment decisions are also mostly on a case-by-case basis at the moment, although more standardized guidelines are being worked out.

“Our disease teams have been really proactive in terms of offering alternative solutions to patients, creative ways to basically keep them out of the hospital and also reduce the immunosuppressive regimens that we give them,” she said.

Examples include offering endocrine therapy to patients who can’t get breast cancer surgery, or offering alternative drug regimens and dosing schedules. “At this point we haven’t needed to ration actual treatment – patients are continuing to get active therapy if that’s appropriate – it’s more about how can we protect them,” she said. “It’s a complex puzzle of moving pieces.”

In Toronto, Gospodarowicz says newly published medical and radiation oncology guidelines from France are the backbone of her hospital’s policy discussions about treating cancer and protecting patients from COVID-19.

While patients’ concerns are understandable, she says even in the current hot spots of infection, it’s encouraging to know that cancer patients are not being forgotten.

“I recently had email communication with a radiation oncologist in Brescia, one of the worst-affected areas in Italy, and he told me the radiotherapy department has been 60% to 70% capacity, so they still treat 70% these patients, just taking precautions and separating the COVID-positive and negative ones. When we read the stats it looks horrible, but life still goes on and people are still being treated,” she said.

Although telemedicine offers meaningful solutions to the COVID-19 crisis in North America, it may not be possible in other parts of the world.

Web consultations were only just approved in Brazil this week. “We are still discussing how to make it official and reimbursed,” says Rachel Riechelmann, MD, head of clinical oncology at AC Camargo Cancer Center in São Paulo.

To minimize infection risk for patients, Riechelmann says her hospital is doing the following: postponing surgeries in cases where there is good evidence of neoadjuvant treatment, such as total neoadjuvant therapy for rectal cancer; avoiding adjuvant chemo for stage 2 colon cancer; moving to hypofractionated radiotherapy if possible; adopting watchful waiting in grade 1 nonfunctional neuroendocrine tumors; and postponing follow-up visits.

“We do our best,” she wrote in an email. “We keep treating cancer if treatment cannot wait.”

Riechelmann’s center has just launched a trial of hydroxychloroquine and tocilizumab therapy in patients with cancer who have severe COVID-19 and acute respiratory distress syndrome (ARDS).

Meanwhile in New Haven, Chiang says for patients with cancer who are infected with COVID-19, her team is also prognosticating about the fair allocation of limited resources such as ventilators.

“If it ever gets to the point where somebody has to choose between a cancer patient and a noncancer patient in providing life support, it’s really important that people understand that cancer patients are doing very well nowadays and even with a diagnosis of cancer they can potentially live for many years, so that shouldn’t necessarily be a decision-point,” she emphasized.

This article first appeared on Medscape.com.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A new blood-based test performs well at detecting multiple types of cancers across stages and therefore has good potential for screening, according to a prospective case-control substudy.

Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.

The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.

Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.

Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.

Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.

Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).

The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.

Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.

“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”

“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”

Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
 

SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.

A new blood-based test performs well at detecting multiple types of cancers across stages and therefore has good potential for screening, according to a prospective case-control substudy.

Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.

The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.

Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.

Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.

Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.

Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).

The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.

Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.

“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”

“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”

Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
 

SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.

A new blood-based test performs well at detecting multiple types of cancers across stages and therefore has good potential for screening, according to a prospective case-control substudy.

Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.

The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.

Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.

Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.

Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.

Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).

The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.

Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.

“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”

“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”

Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
 

SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab plus chemotherapy “can be considered a new standard in ES-SCLC,” said Myung-Ju Ahn, MD, Sungkyunkwan University, Seoul, South Korea, last year at the European Society of Medical Oncology (ESMO) annual meeting, where he discussed results from the phase 3 trial known as CASPIAN.

The new approval is based on efficacy and safety data from that trial, conducted in patients with previously untreated ES-SCLC. In the experimental group (n = 268), durvalumab plus etoposide and a platinum agent (EP) was followed by maintenance durvalumab, and in the control group (n = 269) patients received the EP regimen alone.

Median overall survival (OS) was 13 months in the durvalumab plus chemotherapy group compared with 10.3 months in the chemotherapy alone group (hazard ratio 0.73; 95% confidence interval, 0.59-0.91; P = .0047).

Reporting these results, trial investigator Luis Paz-Ares, MD, Hospital Universitario 12 de Octubre, Madrid, put the new survival benefit in the context of standard treatments at the ESMO meeting last year.

“Initial response rates to etoposide plus a platinum are high, but responses are not durable and patients treated with EP typically relapse within 6 months of starting treatment with a median OS of approximately 10 months,” he said.

In addition to the primary endpoint of OS, additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR).

Median PFS was not statistically significant with immunotherapy; it was 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy group and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone group (HR, 0.78; 95% CI, 0.65-0.94).

The investigator-assessed ORR was 68% in the durvalumab plus chemotherapy group and 58% in the chemotherapy alone group.

The most common adverse reactions (≥ 20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia, according to the FDA.

At ESMO, Paz-Ares reported that rates of serious adverse events (AEs) were comparable at 30.9% and 36.1% for the durvalumab plus EP group vs. EP alone, respectively; rates of AEs leading to discontinuation were identical in both groups at 9.4%. Unsurprisingly, immune-mediated AEs were higher at 19.6% in the durvalumab combination group vs. 2.6% in the EP alone group.

In this setting, durvalumab is administered prior to chemotherapy on the same day. The recommended durvalumab dose (when administered with etoposide and carboplatin or cisplatin) is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single-agent maintenance therapy.

Durvalumab is already approved for metastatic non–small cell lung cancer in patients whose tumors have only spread in the chest, and is also approved for use in urothelial cancer.

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab plus chemotherapy “can be considered a new standard in ES-SCLC,” said Myung-Ju Ahn, MD, Sungkyunkwan University, Seoul, South Korea, last year at the European Society of Medical Oncology (ESMO) annual meeting, where he discussed results from the phase 3 trial known as CASPIAN.

The new approval is based on efficacy and safety data from that trial, conducted in patients with previously untreated ES-SCLC. In the experimental group (n = 268), durvalumab plus etoposide and a platinum agent (EP) was followed by maintenance durvalumab, and in the control group (n = 269) patients received the EP regimen alone.

Median overall survival (OS) was 13 months in the durvalumab plus chemotherapy group compared with 10.3 months in the chemotherapy alone group (hazard ratio 0.73; 95% confidence interval, 0.59-0.91; P = .0047).

Reporting these results, trial investigator Luis Paz-Ares, MD, Hospital Universitario 12 de Octubre, Madrid, put the new survival benefit in the context of standard treatments at the ESMO meeting last year.

“Initial response rates to etoposide plus a platinum are high, but responses are not durable and patients treated with EP typically relapse within 6 months of starting treatment with a median OS of approximately 10 months,” he said.

In addition to the primary endpoint of OS, additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR).

Median PFS was not statistically significant with immunotherapy; it was 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy group and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone group (HR, 0.78; 95% CI, 0.65-0.94).

The investigator-assessed ORR was 68% in the durvalumab plus chemotherapy group and 58% in the chemotherapy alone group.

The most common adverse reactions (≥ 20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia, according to the FDA.

At ESMO, Paz-Ares reported that rates of serious adverse events (AEs) were comparable at 30.9% and 36.1% for the durvalumab plus EP group vs. EP alone, respectively; rates of AEs leading to discontinuation were identical in both groups at 9.4%. Unsurprisingly, immune-mediated AEs were higher at 19.6% in the durvalumab combination group vs. 2.6% in the EP alone group.

In this setting, durvalumab is administered prior to chemotherapy on the same day. The recommended durvalumab dose (when administered with etoposide and carboplatin or cisplatin) is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single-agent maintenance therapy.

Durvalumab is already approved for metastatic non–small cell lung cancer in patients whose tumors have only spread in the chest, and is also approved for use in urothelial cancer.

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab plus chemotherapy “can be considered a new standard in ES-SCLC,” said Myung-Ju Ahn, MD, Sungkyunkwan University, Seoul, South Korea, last year at the European Society of Medical Oncology (ESMO) annual meeting, where he discussed results from the phase 3 trial known as CASPIAN.

The new approval is based on efficacy and safety data from that trial, conducted in patients with previously untreated ES-SCLC. In the experimental group (n = 268), durvalumab plus etoposide and a platinum agent (EP) was followed by maintenance durvalumab, and in the control group (n = 269) patients received the EP regimen alone.

Median overall survival (OS) was 13 months in the durvalumab plus chemotherapy group compared with 10.3 months in the chemotherapy alone group (hazard ratio 0.73; 95% confidence interval, 0.59-0.91; P = .0047).

Reporting these results, trial investigator Luis Paz-Ares, MD, Hospital Universitario 12 de Octubre, Madrid, put the new survival benefit in the context of standard treatments at the ESMO meeting last year.

“Initial response rates to etoposide plus a platinum are high, but responses are not durable and patients treated with EP typically relapse within 6 months of starting treatment with a median OS of approximately 10 months,” he said.

In addition to the primary endpoint of OS, additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR).

Median PFS was not statistically significant with immunotherapy; it was 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy group and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone group (HR, 0.78; 95% CI, 0.65-0.94).

The investigator-assessed ORR was 68% in the durvalumab plus chemotherapy group and 58% in the chemotherapy alone group.

The most common adverse reactions (≥ 20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia, according to the FDA.

At ESMO, Paz-Ares reported that rates of serious adverse events (AEs) were comparable at 30.9% and 36.1% for the durvalumab plus EP group vs. EP alone, respectively; rates of AEs leading to discontinuation were identical in both groups at 9.4%. Unsurprisingly, immune-mediated AEs were higher at 19.6% in the durvalumab combination group vs. 2.6% in the EP alone group.

In this setting, durvalumab is administered prior to chemotherapy on the same day. The recommended durvalumab dose (when administered with etoposide and carboplatin or cisplatin) is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single-agent maintenance therapy.

Durvalumab is already approved for metastatic non–small cell lung cancer in patients whose tumors have only spread in the chest, and is also approved for use in urothelial cancer.

This article first appeared on Medscape.com.

Ramping up health system capacity for the coming surge of U.S. COVID-19 cases requires a commitment to boosting safety, capacity, and communication, according to a physician leader and a health workforce expert.

Polly Pittman, PhD, is hearing a lot of concern among health care workers that it’s difficult to find definitive and accurate information about how best to protect themselves and their families, she said during a webinar by the Alliance for Health Policy titled Health System Capacity: Protecting Frontline Health Workers. “The knowledge base is evolving very quickly,” said Dr. Pittman, Fitzhugh Mullan Professor of Health Workforce Equity at the Milken Institute School of Public Health, George Washington University, Washington.

He noted that Permanente is “working hand in glove with state authorities throughout the country.” Efforts include establishing alternative sites for assessment and testing, as well as opening up closed hospitals and working with the National Guard and the Department of Defense to prepare mobile hospital units that can be deployed in areas with peak infection rates. “Having all of those options available to us is critically important,” he said.

To mitigate potential provider shortages, Dr. Pittman said, “All members of the care team could potentially do more” than their current licenses allow. Expanding the scope of practice for pharmacists, clinical laboratory staff, licensed practical nurses, and medical assistants can help with efficient care delivery.

Other measures include expedited licensing for near-graduates and nonpracticing foreign medical graduates, as well as relicensing for retired health care personnel and those who are not currently working directly with patients, she said.

Getting these things done “requires leadership on behalf of the licensing bodies,” as well as coordination with state regulatory authorities, Dr. Pittman pointed out.

Dr. Parodi called for state and federal governments to implement emergency declarations that suspend some existing health codes to achieve repurposing of staff. Getting these measures in place now will allow facilities “to be able to provide that in-time training now before the surge occurs. ... We are actively developing plans knowing that there’s going to be a need for more critical care.”

The game plan at Permanente, he said, is to repurpose critical care physicians to provide consultations to multiple hospitalists who are providing the bulk of frontline care. At the same time, they plan to repurpose other specialists to backfill the hospitalists, and to repurpose family medicine physicians to supplement staff in emergency departments and other frontline intake areas.

All the organizational measures being taken won’t be in vain if they increase preparedness for the long battle ahead, he said. “We need to double down on the work. ... We need to continue social distancing, and we’ve got to ramp up testing. Until we do that we have to hold the line on basic public health measures.”

Dr. Parodi is employed by Permanente. The panelists reported no disclosures relevant to the presentation, which was sponsored by the Alliance for Health Policy, the Commonwealth Fund, and the National Institute for Health Care Management Foundation.

[email protected]

Ramping up health system capacity for the coming surge of U.S. COVID-19 cases requires a commitment to boosting safety, capacity, and communication, according to a physician leader and a health workforce expert.

Polly Pittman, PhD, is hearing a lot of concern among health care workers that it’s difficult to find definitive and accurate information about how best to protect themselves and their families, she said during a webinar by the Alliance for Health Policy titled Health System Capacity: Protecting Frontline Health Workers. “The knowledge base is evolving very quickly,” said Dr. Pittman, Fitzhugh Mullan Professor of Health Workforce Equity at the Milken Institute School of Public Health, George Washington University, Washington.

He noted that Permanente is “working hand in glove with state authorities throughout the country.” Efforts include establishing alternative sites for assessment and testing, as well as opening up closed hospitals and working with the National Guard and the Department of Defense to prepare mobile hospital units that can be deployed in areas with peak infection rates. “Having all of those options available to us is critically important,” he said.

To mitigate potential provider shortages, Dr. Pittman said, “All members of the care team could potentially do more” than their current licenses allow. Expanding the scope of practice for pharmacists, clinical laboratory staff, licensed practical nurses, and medical assistants can help with efficient care delivery.

Other measures include expedited licensing for near-graduates and nonpracticing foreign medical graduates, as well as relicensing for retired health care personnel and those who are not currently working directly with patients, she said.

Getting these things done “requires leadership on behalf of the licensing bodies,” as well as coordination with state regulatory authorities, Dr. Pittman pointed out.

Dr. Parodi called for state and federal governments to implement emergency declarations that suspend some existing health codes to achieve repurposing of staff. Getting these measures in place now will allow facilities “to be able to provide that in-time training now before the surge occurs. ... We are actively developing plans knowing that there’s going to be a need for more critical care.”

The game plan at Permanente, he said, is to repurpose critical care physicians to provide consultations to multiple hospitalists who are providing the bulk of frontline care. At the same time, they plan to repurpose other specialists to backfill the hospitalists, and to repurpose family medicine physicians to supplement staff in emergency departments and other frontline intake areas.

All the organizational measures being taken won’t be in vain if they increase preparedness for the long battle ahead, he said. “We need to double down on the work. ... We need to continue social distancing, and we’ve got to ramp up testing. Until we do that we have to hold the line on basic public health measures.”

Dr. Parodi is employed by Permanente. The panelists reported no disclosures relevant to the presentation, which was sponsored by the Alliance for Health Policy, the Commonwealth Fund, and the National Institute for Health Care Management Foundation.

[email protected]

Ramping up health system capacity for the coming surge of U.S. COVID-19 cases requires a commitment to boosting safety, capacity, and communication, according to a physician leader and a health workforce expert.

Polly Pittman, PhD, is hearing a lot of concern among health care workers that it’s difficult to find definitive and accurate information about how best to protect themselves and their families, she said during a webinar by the Alliance for Health Policy titled Health System Capacity: Protecting Frontline Health Workers. “The knowledge base is evolving very quickly,” said Dr. Pittman, Fitzhugh Mullan Professor of Health Workforce Equity at the Milken Institute School of Public Health, George Washington University, Washington.

He noted that Permanente is “working hand in glove with state authorities throughout the country.” Efforts include establishing alternative sites for assessment and testing, as well as opening up closed hospitals and working with the National Guard and the Department of Defense to prepare mobile hospital units that can be deployed in areas with peak infection rates. “Having all of those options available to us is critically important,” he said.

To mitigate potential provider shortages, Dr. Pittman said, “All members of the care team could potentially do more” than their current licenses allow. Expanding the scope of practice for pharmacists, clinical laboratory staff, licensed practical nurses, and medical assistants can help with efficient care delivery.

Other measures include expedited licensing for near-graduates and nonpracticing foreign medical graduates, as well as relicensing for retired health care personnel and those who are not currently working directly with patients, she said.

Getting these things done “requires leadership on behalf of the licensing bodies,” as well as coordination with state regulatory authorities, Dr. Pittman pointed out.

Dr. Parodi called for state and federal governments to implement emergency declarations that suspend some existing health codes to achieve repurposing of staff. Getting these measures in place now will allow facilities “to be able to provide that in-time training now before the surge occurs. ... We are actively developing plans knowing that there’s going to be a need for more critical care.”

The game plan at Permanente, he said, is to repurpose critical care physicians to provide consultations to multiple hospitalists who are providing the bulk of frontline care. At the same time, they plan to repurpose other specialists to backfill the hospitalists, and to repurpose family medicine physicians to supplement staff in emergency departments and other frontline intake areas.

All the organizational measures being taken won’t be in vain if they increase preparedness for the long battle ahead, he said. “We need to double down on the work. ... We need to continue social distancing, and we’ve got to ramp up testing. Until we do that we have to hold the line on basic public health measures.”

Dr. Parodi is employed by Permanente. The panelists reported no disclosures relevant to the presentation, which was sponsored by the Alliance for Health Policy, the Commonwealth Fund, and the National Institute for Health Care Management Foundation.

[email protected]

US Department of Veterans Affairs (VA) Secretary Robert Wilkie is finding out what it means to be on wartime footing against a virus. He is overseeing the VA’s internal response to COVID-19 while deciding how to fulfil the VA’s fourth mission: providing reinforcement for the nation’s healthcare system in a national emergency. Meanwhile, he’s facing hostilities on a third front: criticism of his efforts so far.

In late February, when lawmakers asked whether the VA needed more resources to fight COVID-19, Wilkie said no. He told NPR on March 19 that “we are poised for the onslaught.” But on March 13, 2020, the VA was being attacked for not releasing a comprehensive emergency response to the incipient pandemic. Wilkie countered, “Before there was a single confirmed case in the US,” he wrote in a recent op-ed piece for Military Times, “the VA was already conducting emergency preparedness exercises.”

In the NPR interview, Wilkie said the VA had undertaken “a very aggressive public health response at an early stage.” Now, the VA has added other measures. The VA, he said, was the first health system to stop people from entering its facilities without being questioned or tested, and the first to adopt the “hard decision” of a no-visitor rule for veterans in nursing homes. Every veteran who comes to a VA facility with flu-like symptoms is screened. Further, via tweets and blog posts, Wilkie is “inviting” retired medical personnel back to work to help deal with the pandemic.

The VA is also the “buttress force,” Wilkie says, for the Federal Emergency Management Agency and the US Department of Health and Human Services if they need medical professionals for crises. “We plan for that every day,” he says. “We are gaming out emergency preparedness scenarios and we stand ready when the President needs us to expand our mission.” But in The American Prospect, Suzanne Gordon and Jasper Craven, both fellows at the Veterans Healthcare Policy Institute, write that “one quiet action is ominous”—the VA website has deleted any mention of the department’s credo of caring for civilians in times of crisis.

According to Gordon and Craven, on Wednesday Wilkie “came out of the woodwork” to express the department’s readiness to help in the crisis. The VA has established 19 emergency operations centers across the country, Wilkie says, and has stopped elective surgeries to free up thousands of beds. He touts the agency’s flexibility, saying it’s prepared to move resources around the country as needed. “Some veterans hospitals have not been impacted [by the virus],” Wilkie said. “So, I’m not going to keep 500 respirators in the middle of a state that has one veteran with the infection, when I can use that in Seattle or New Orleans, or New York City.”

Wilkie says the VA has stockpiled equipment and its supply chain is stable. However, in the NPR interview, Mary Louise Kelly said the NPR VA correspondent had been hearing complaints about lack of gear, such as masks. When pressed on his claim that the VA had adequate protective supplies, Wilkie said those complaints “have not reached us.” In fact, he said, “I can tell you that the arrangements that we have made on both the masks side and also on the testing side—we’re in a very good place.”

Nonetheless, on March 16, the employee unions representing nearly 350,000 VA healthcare workers issued a joint statement that called on VHA management to “work with us to ensure the nation’s VA health facilities can safely handle COVID-19.” It’s time, said Everett Kelley, National President of the American Federation of Government Employees, “for the VA to invite our members to the table, instead of kicking them off the property, so we can finally work together on a solution….”

“Instead of relaxing standards and efforts,” the unions said, “like we have seen the CDC do [in allowing healthcare workers to reuse facemasks and rely on simple surgical facemasks], “we need to be stepping it up.”

It all takes money. After weeks of debate, the US Senate has just released details of the $2 trillion coronavirus aid package. The US Department of Defense (DoD) seems about to get $10.5 billion in emergency funding and the VA another $19.6 billion. The money includes funding for National Guard deployments to help state governments respond to emerging health needs, the expansion of military hospitals and mobile medical centers if needed, and help with production of medical supplies. Nearly $16 billion will be used for direct care specifically in response to veterans’ health needs, covering treatment for COVID-19 in VA hospitals, community urgent care clinics and emergency departments; overtime for clinical staff; and purchase of protective equipment, tests, and other supplies.

Despite having one of the best telehealth systems in the US, the VA has also come under fire for its telehealth preparations to meet the current pandemic-related demand. Former VA Under Secretary of Health Kenneth Kizer wrote in an op-ed for Military Times, “Regrettably, so far, there is no coordinated strategy for ramping up and optimizing the use of telehealth to combat the growing epidemic in the US.” The relief package proposes $3 billion for new telemedicine efforts, including staffing and equipping mobile treatment sites.

In mid-March, the VA had 3,000 coronavirus test kits but still had not used roughly 90%, an article in Mother Jones charged. At a White house press conference around that time, Wilkie was asked how many veterans of those who needed to be tested had been. “We believe we’ve caught most of them,” he replied.

But that was in the early days of the crisis.

With results from the 322 tests administered by Mar. 18, the VA had confirmed five positive cases, was tracking 33 presumptive cases, and acknowledged the first veteran death linked to COVID-19. As of Mar. 26, the VA had administered roughly 7,500 COVID-19 tests nationwide.

Secretary Wilkie has promised that the department’s first focus will always be caring for veterans. In an interview with Military Times, he said, “We don’t release any beds if veterans are needing them. The veterans still are primary. We are a [health] bridge for the larger community, but that’s only after veterans are taken care of.”

US Department of Veterans Affairs (VA) Secretary Robert Wilkie is finding out what it means to be on wartime footing against a virus. He is overseeing the VA’s internal response to COVID-19 while deciding how to fulfil the VA’s fourth mission: providing reinforcement for the nation’s healthcare system in a national emergency. Meanwhile, he’s facing hostilities on a third front: criticism of his efforts so far.

In late February, when lawmakers asked whether the VA needed more resources to fight COVID-19, Wilkie said no. He told NPR on March 19 that “we are poised for the onslaught.” But on March 13, 2020, the VA was being attacked for not releasing a comprehensive emergency response to the incipient pandemic. Wilkie countered, “Before there was a single confirmed case in the US,” he wrote in a recent op-ed piece for Military Times, “the VA was already conducting emergency preparedness exercises.”

In the NPR interview, Wilkie said the VA had undertaken “a very aggressive public health response at an early stage.” Now, the VA has added other measures. The VA, he said, was the first health system to stop people from entering its facilities without being questioned or tested, and the first to adopt the “hard decision” of a no-visitor rule for veterans in nursing homes. Every veteran who comes to a VA facility with flu-like symptoms is screened. Further, via tweets and blog posts, Wilkie is “inviting” retired medical personnel back to work to help deal with the pandemic.

The VA is also the “buttress force,” Wilkie says, for the Federal Emergency Management Agency and the US Department of Health and Human Services if they need medical professionals for crises. “We plan for that every day,” he says. “We are gaming out emergency preparedness scenarios and we stand ready when the President needs us to expand our mission.” But in The American Prospect, Suzanne Gordon and Jasper Craven, both fellows at the Veterans Healthcare Policy Institute, write that “one quiet action is ominous”—the VA website has deleted any mention of the department’s credo of caring for civilians in times of crisis.

According to Gordon and Craven, on Wednesday Wilkie “came out of the woodwork” to express the department’s readiness to help in the crisis. The VA has established 19 emergency operations centers across the country, Wilkie says, and has stopped elective surgeries to free up thousands of beds. He touts the agency’s flexibility, saying it’s prepared to move resources around the country as needed. “Some veterans hospitals have not been impacted [by the virus],” Wilkie said. “So, I’m not going to keep 500 respirators in the middle of a state that has one veteran with the infection, when I can use that in Seattle or New Orleans, or New York City.”

Wilkie says the VA has stockpiled equipment and its supply chain is stable. However, in the NPR interview, Mary Louise Kelly said the NPR VA correspondent had been hearing complaints about lack of gear, such as masks. When pressed on his claim that the VA had adequate protective supplies, Wilkie said those complaints “have not reached us.” In fact, he said, “I can tell you that the arrangements that we have made on both the masks side and also on the testing side—we’re in a very good place.”

Nonetheless, on March 16, the employee unions representing nearly 350,000 VA healthcare workers issued a joint statement that called on VHA management to “work with us to ensure the nation’s VA health facilities can safely handle COVID-19.” It’s time, said Everett Kelley, National President of the American Federation of Government Employees, “for the VA to invite our members to the table, instead of kicking them off the property, so we can finally work together on a solution….”

“Instead of relaxing standards and efforts,” the unions said, “like we have seen the CDC do [in allowing healthcare workers to reuse facemasks and rely on simple surgical facemasks], “we need to be stepping it up.”

It all takes money. After weeks of debate, the US Senate has just released details of the $2 trillion coronavirus aid package. The US Department of Defense (DoD) seems about to get $10.5 billion in emergency funding and the VA another $19.6 billion. The money includes funding for National Guard deployments to help state governments respond to emerging health needs, the expansion of military hospitals and mobile medical centers if needed, and help with production of medical supplies. Nearly $16 billion will be used for direct care specifically in response to veterans’ health needs, covering treatment for COVID-19 in VA hospitals, community urgent care clinics and emergency departments; overtime for clinical staff; and purchase of protective equipment, tests, and other supplies.

Despite having one of the best telehealth systems in the US, the VA has also come under fire for its telehealth preparations to meet the current pandemic-related demand. Former VA Under Secretary of Health Kenneth Kizer wrote in an op-ed for Military Times, “Regrettably, so far, there is no coordinated strategy for ramping up and optimizing the use of telehealth to combat the growing epidemic in the US.” The relief package proposes $3 billion for new telemedicine efforts, including staffing and equipping mobile treatment sites.

In mid-March, the VA had 3,000 coronavirus test kits but still had not used roughly 90%, an article in Mother Jones charged. At a White house press conference around that time, Wilkie was asked how many veterans of those who needed to be tested had been. “We believe we’ve caught most of them,” he replied.

But that was in the early days of the crisis.

With results from the 322 tests administered by Mar. 18, the VA had confirmed five positive cases, was tracking 33 presumptive cases, and acknowledged the first veteran death linked to COVID-19. As of Mar. 26, the VA had administered roughly 7,500 COVID-19 tests nationwide.

Secretary Wilkie has promised that the department’s first focus will always be caring for veterans. In an interview with Military Times, he said, “We don’t release any beds if veterans are needing them. The veterans still are primary. We are a [health] bridge for the larger community, but that’s only after veterans are taken care of.”

US Department of Veterans Affairs (VA) Secretary Robert Wilkie is finding out what it means to be on wartime footing against a virus. He is overseeing the VA’s internal response to COVID-19 while deciding how to fulfil the VA’s fourth mission: providing reinforcement for the nation’s healthcare system in a national emergency. Meanwhile, he’s facing hostilities on a third front: criticism of his efforts so far.

In late February, when lawmakers asked whether the VA needed more resources to fight COVID-19, Wilkie said no. He told NPR on March 19 that “we are poised for the onslaught.” But on March 13, 2020, the VA was being attacked for not releasing a comprehensive emergency response to the incipient pandemic. Wilkie countered, “Before there was a single confirmed case in the US,” he wrote in a recent op-ed piece for Military Times, “the VA was already conducting emergency preparedness exercises.”

In the NPR interview, Wilkie said the VA had undertaken “a very aggressive public health response at an early stage.” Now, the VA has added other measures. The VA, he said, was the first health system to stop people from entering its facilities without being questioned or tested, and the first to adopt the “hard decision” of a no-visitor rule for veterans in nursing homes. Every veteran who comes to a VA facility with flu-like symptoms is screened. Further, via tweets and blog posts, Wilkie is “inviting” retired medical personnel back to work to help deal with the pandemic.

The VA is also the “buttress force,” Wilkie says, for the Federal Emergency Management Agency and the US Department of Health and Human Services if they need medical professionals for crises. “We plan for that every day,” he says. “We are gaming out emergency preparedness scenarios and we stand ready when the President needs us to expand our mission.” But in The American Prospect, Suzanne Gordon and Jasper Craven, both fellows at the Veterans Healthcare Policy Institute, write that “one quiet action is ominous”—the VA website has deleted any mention of the department’s credo of caring for civilians in times of crisis.

According to Gordon and Craven, on Wednesday Wilkie “came out of the woodwork” to express the department’s readiness to help in the crisis. The VA has established 19 emergency operations centers across the country, Wilkie says, and has stopped elective surgeries to free up thousands of beds. He touts the agency’s flexibility, saying it’s prepared to move resources around the country as needed. “Some veterans hospitals have not been impacted [by the virus],” Wilkie said. “So, I’m not going to keep 500 respirators in the middle of a state that has one veteran with the infection, when I can use that in Seattle or New Orleans, or New York City.”

Wilkie says the VA has stockpiled equipment and its supply chain is stable. However, in the NPR interview, Mary Louise Kelly said the NPR VA correspondent had been hearing complaints about lack of gear, such as masks. When pressed on his claim that the VA had adequate protective supplies, Wilkie said those complaints “have not reached us.” In fact, he said, “I can tell you that the arrangements that we have made on both the masks side and also on the testing side—we’re in a very good place.”

Nonetheless, on March 16, the employee unions representing nearly 350,000 VA healthcare workers issued a joint statement that called on VHA management to “work with us to ensure the nation’s VA health facilities can safely handle COVID-19.” It’s time, said Everett Kelley, National President of the American Federation of Government Employees, “for the VA to invite our members to the table, instead of kicking them off the property, so we can finally work together on a solution….”

“Instead of relaxing standards and efforts,” the unions said, “like we have seen the CDC do [in allowing healthcare workers to reuse facemasks and rely on simple surgical facemasks], “we need to be stepping it up.”

It all takes money. After weeks of debate, the US Senate has just released details of the $2 trillion coronavirus aid package. The US Department of Defense (DoD) seems about to get $10.5 billion in emergency funding and the VA another $19.6 billion. The money includes funding for National Guard deployments to help state governments respond to emerging health needs, the expansion of military hospitals and mobile medical centers if needed, and help with production of medical supplies. Nearly $16 billion will be used for direct care specifically in response to veterans’ health needs, covering treatment for COVID-19 in VA hospitals, community urgent care clinics and emergency departments; overtime for clinical staff; and purchase of protective equipment, tests, and other supplies.

Despite having one of the best telehealth systems in the US, the VA has also come under fire for its telehealth preparations to meet the current pandemic-related demand. Former VA Under Secretary of Health Kenneth Kizer wrote in an op-ed for Military Times, “Regrettably, so far, there is no coordinated strategy for ramping up and optimizing the use of telehealth to combat the growing epidemic in the US.” The relief package proposes $3 billion for new telemedicine efforts, including staffing and equipping mobile treatment sites.

In mid-March, the VA had 3,000 coronavirus test kits but still had not used roughly 90%, an article in Mother Jones charged. At a White house press conference around that time, Wilkie was asked how many veterans of those who needed to be tested had been. “We believe we’ve caught most of them,” he replied.

But that was in the early days of the crisis.

With results from the 322 tests administered by Mar. 18, the VA had confirmed five positive cases, was tracking 33 presumptive cases, and acknowledged the first veteran death linked to COVID-19. As of Mar. 26, the VA had administered roughly 7,500 COVID-19 tests nationwide.

Secretary Wilkie has promised that the department’s first focus will always be caring for veterans. In an interview with Military Times, he said, “We don’t release any beds if veterans are needing them. The veterans still are primary. We are a [health] bridge for the larger community, but that’s only after veterans are taken care of.”

As most 2020 medical conferences have, one by one, been canceled or rescheduled as virtual meetings in the time of a pandemic, some physicians and other healthcare professionals are wondering if this is the year that will change the scene forever.

Amid the choruses of resignation (“Unfortunately, it’s the right thing to do.”) and optimism (“See you next year!”), there have been plenty of voices describing another broad sentiment – that all was not well with medical meetings even before the coronavirus.

One dominant criticism is that there are too many meetings.

Indeed, there are many, many meetings. During 2005–2015, there were 30,000-plus medical meetings in the United States, according to a report from the Healthcare Convention and Exhibitors Association.

Most of those are of little value, tweeted Dhruv Khullar, MD, an internist at Weill Cornell Medicine, New York City (@DhruvKhullar): “One possible consequence of cancelling so many meetings due to #COVID19 is that we realize we probably don’t need most of them.”

The tweet was liked 1.9K times, which is high for a medical post. Comments were mostly in agreement, with some skepticism.

Michaela West, MD, PhD, a surgeon at North Memorial Health, Minneapolis, Minnesota, responded (@MichaelaWst): “Agree. COVID-19 may forever change our perspective regarding medical professional meetings.”

Nwando Olayiwola, MD, chair of family medicine, Ohio State University, Columbus, strongly agreed (@DrNwando): “This is the tweet I wish I tweeted.”

However, Kelly Swords, MD, MPH, urologist, University of California, San Diego, in a dissenting opinion, stated the obvious (@k_dagger): “Except there is no substitute for human interaction.”
 

Worth the Effort?

The cancellation of medical meetings has given those who regularly attend an opportunity to reassess their value and to question the worth of the effort involved in attending in person.

David Steensma, MD, hematologist-oncologist, Harvard Medical School, Boston, (@DavidSteensma) tweeted that he would like to scale back: “The present crisis is an opportunity to reassess what is actually necessary and rebalance [in terms of meetings].”

Travel to meetings is often unpleasant, said others.

Chris Palatucci, life sciences executive recruiter, Coulter Partners, Boston, tweeted (@LifeSciRcruitr): “I will die a happy man if I never get on another plane. Glorified bus travel.” He also believes that once the coronavirus crisis is over, its “silver lining” will be the realization that “40% of all meetings are unnecessary.”

Many professionals have welcomed the announcements that major conferences have been canceled and will be conducted virtually.

The latest change is from the American Society of Clinical Oncology (ASCO), whose annual meeting was to be held in Chicago at the end of May but will now be held online.

Virtual ASCO will be more manageable – and comfy, said Fumiko Ladd Chino, MD, radiation oncologist, Memorial Sloan Kettering Cancer Center, New York City.

She (@fumikochino) explained why in a recent tweet: “1) I will be finally able to see ALL OF THE PRESENTATIONS I wanted to see instead of wandering around feeling overwhelmed. 2) I will be able to FOCUS on the presentations and not searching for a power outlet. 3) PAJAMAS.”

Virtual meetings already beat real meetings, added Adriana Scheliga, MD, hematologist-oncologist, Brazilian National Cancer Institute (@linfopedia): “I’ve been saying this for a while. For me the best ASCO Meetings, for example, are the “virtual meetings!”

However, meetings in place are also very much about professional community and mutual support, reminds Susan E. Sedory, MA, executive director, Society of Interventional Radiology, which canceled its meeting March 6 in a multifaceted process described by Medscape Medical News.
 

Is This the Time to Evaluate Meetings?

Coming up soon is the first major conference to go virtual after being canceled – the American College of Cardiology (ACC), which has been one of the top 20 largest meetings in the United States by attendance.

This meeting, which was to have taken place in Chicago on March 28–30, will now occur online on those days. The ACC says it will stream all “live” sessions on demand and provide access to additional videos, abstracts, and slides for at least 90 days after the meeting. And it will be free to anyone with an Internet connection.

Medical meetings in distant locales may bounce back, as they have grown into a very big business. ASCO is illustrative.

The group’s first scientific annual meeting was held in 1965 in Philadelphia, with about 70 members and invited guests in attendance. Fast forward 50-plus years to 2019: there were 42,500 attendees, a 4.4% increase from 2018. Notably, the top countries in attendance in 2019 were the United States and China.

Not everyone is happy that canceled meetings are being held online in the middle of a pandemic.

“In a COVID-19 world, the brain cannot focus on nonviral topics,” said commentator John Mandrola, MD, Baptist Health, Louisville, Kentucky, in his regular column for Medscape Cardiology/theheart.org.

The virtual ACC meeting should be canceled or delayed – to mirror what is happening in the world, he argues. “In hospitals, we have postponed the elective to make room for the coming surge. Shouldn’t ACC do the same? After the crisis passes, we can have a virtual meeting with a proper discussion of the science,” he writes.

But #MedTwitter, with its collective constructive criticism of medical meetings, is perhaps proof that the brain can function – and arrive at clarity – when under pandemic duress.

“Am I the only one experiencing a certain relief at the cancellation of multiple trips and meetings, and vowing to let this revelation affect my decision making in the future,” tweeted Steven Joffe, MD, MPH, University of Pennsylvania, Philadelphia (@Steve Joffe).

Louise Perkins King, MD, a bioethicist at Harvard Medical School, responded to Joffe. Hoping not to “belittle” the suffering from the COVID-19 pandemic, she (@louise_p_king) addressed her healthcare colleagues: “...there is potential for us all to learn what is essential travel and burden and what is not from this. I hope it leads to lasting change.”

This article first appeared on Medscape.com.

As most 2020 medical conferences have, one by one, been canceled or rescheduled as virtual meetings in the time of a pandemic, some physicians and other healthcare professionals are wondering if this is the year that will change the scene forever.

Amid the choruses of resignation (“Unfortunately, it’s the right thing to do.”) and optimism (“See you next year!”), there have been plenty of voices describing another broad sentiment – that all was not well with medical meetings even before the coronavirus.

One dominant criticism is that there are too many meetings.

Indeed, there are many, many meetings. During 2005–2015, there were 30,000-plus medical meetings in the United States, according to a report from the Healthcare Convention and Exhibitors Association.

Most of those are of little value, tweeted Dhruv Khullar, MD, an internist at Weill Cornell Medicine, New York City (@DhruvKhullar): “One possible consequence of cancelling so many meetings due to #COVID19 is that we realize we probably don’t need most of them.”

The tweet was liked 1.9K times, which is high for a medical post. Comments were mostly in agreement, with some skepticism.

Michaela West, MD, PhD, a surgeon at North Memorial Health, Minneapolis, Minnesota, responded (@MichaelaWst): “Agree. COVID-19 may forever change our perspective regarding medical professional meetings.”

Nwando Olayiwola, MD, chair of family medicine, Ohio State University, Columbus, strongly agreed (@DrNwando): “This is the tweet I wish I tweeted.”

However, Kelly Swords, MD, MPH, urologist, University of California, San Diego, in a dissenting opinion, stated the obvious (@k_dagger): “Except there is no substitute for human interaction.”
 

Worth the Effort?

The cancellation of medical meetings has given those who regularly attend an opportunity to reassess their value and to question the worth of the effort involved in attending in person.

David Steensma, MD, hematologist-oncologist, Harvard Medical School, Boston, (@DavidSteensma) tweeted that he would like to scale back: “The present crisis is an opportunity to reassess what is actually necessary and rebalance [in terms of meetings].”

Travel to meetings is often unpleasant, said others.

Chris Palatucci, life sciences executive recruiter, Coulter Partners, Boston, tweeted (@LifeSciRcruitr): “I will die a happy man if I never get on another plane. Glorified bus travel.” He also believes that once the coronavirus crisis is over, its “silver lining” will be the realization that “40% of all meetings are unnecessary.”

Many professionals have welcomed the announcements that major conferences have been canceled and will be conducted virtually.

The latest change is from the American Society of Clinical Oncology (ASCO), whose annual meeting was to be held in Chicago at the end of May but will now be held online.

Virtual ASCO will be more manageable – and comfy, said Fumiko Ladd Chino, MD, radiation oncologist, Memorial Sloan Kettering Cancer Center, New York City.

She (@fumikochino) explained why in a recent tweet: “1) I will be finally able to see ALL OF THE PRESENTATIONS I wanted to see instead of wandering around feeling overwhelmed. 2) I will be able to FOCUS on the presentations and not searching for a power outlet. 3) PAJAMAS.”

Virtual meetings already beat real meetings, added Adriana Scheliga, MD, hematologist-oncologist, Brazilian National Cancer Institute (@linfopedia): “I’ve been saying this for a while. For me the best ASCO Meetings, for example, are the “virtual meetings!”

However, meetings in place are also very much about professional community and mutual support, reminds Susan E. Sedory, MA, executive director, Society of Interventional Radiology, which canceled its meeting March 6 in a multifaceted process described by Medscape Medical News.
 

Is This the Time to Evaluate Meetings?

Coming up soon is the first major conference to go virtual after being canceled – the American College of Cardiology (ACC), which has been one of the top 20 largest meetings in the United States by attendance.

This meeting, which was to have taken place in Chicago on March 28–30, will now occur online on those days. The ACC says it will stream all “live” sessions on demand and provide access to additional videos, abstracts, and slides for at least 90 days after the meeting. And it will be free to anyone with an Internet connection.

Medical meetings in distant locales may bounce back, as they have grown into a very big business. ASCO is illustrative.

The group’s first scientific annual meeting was held in 1965 in Philadelphia, with about 70 members and invited guests in attendance. Fast forward 50-plus years to 2019: there were 42,500 attendees, a 4.4% increase from 2018. Notably, the top countries in attendance in 2019 were the United States and China.

Not everyone is happy that canceled meetings are being held online in the middle of a pandemic.

“In a COVID-19 world, the brain cannot focus on nonviral topics,” said commentator John Mandrola, MD, Baptist Health, Louisville, Kentucky, in his regular column for Medscape Cardiology/theheart.org.

The virtual ACC meeting should be canceled or delayed – to mirror what is happening in the world, he argues. “In hospitals, we have postponed the elective to make room for the coming surge. Shouldn’t ACC do the same? After the crisis passes, we can have a virtual meeting with a proper discussion of the science,” he writes.

But #MedTwitter, with its collective constructive criticism of medical meetings, is perhaps proof that the brain can function – and arrive at clarity – when under pandemic duress.

“Am I the only one experiencing a certain relief at the cancellation of multiple trips and meetings, and vowing to let this revelation affect my decision making in the future,” tweeted Steven Joffe, MD, MPH, University of Pennsylvania, Philadelphia (@Steve Joffe).

Louise Perkins King, MD, a bioethicist at Harvard Medical School, responded to Joffe. Hoping not to “belittle” the suffering from the COVID-19 pandemic, she (@louise_p_king) addressed her healthcare colleagues: “...there is potential for us all to learn what is essential travel and burden and what is not from this. I hope it leads to lasting change.”

This article first appeared on Medscape.com.

As most 2020 medical conferences have, one by one, been canceled or rescheduled as virtual meetings in the time of a pandemic, some physicians and other healthcare professionals are wondering if this is the year that will change the scene forever.

Amid the choruses of resignation (“Unfortunately, it’s the right thing to do.”) and optimism (“See you next year!”), there have been plenty of voices describing another broad sentiment – that all was not well with medical meetings even before the coronavirus.

One dominant criticism is that there are too many meetings.

Indeed, there are many, many meetings. During 2005–2015, there were 30,000-plus medical meetings in the United States, according to a report from the Healthcare Convention and Exhibitors Association.

Most of those are of little value, tweeted Dhruv Khullar, MD, an internist at Weill Cornell Medicine, New York City (@DhruvKhullar): “One possible consequence of cancelling so many meetings due to #COVID19 is that we realize we probably don’t need most of them.”

The tweet was liked 1.9K times, which is high for a medical post. Comments were mostly in agreement, with some skepticism.

Michaela West, MD, PhD, a surgeon at North Memorial Health, Minneapolis, Minnesota, responded (@MichaelaWst): “Agree. COVID-19 may forever change our perspective regarding medical professional meetings.”

Nwando Olayiwola, MD, chair of family medicine, Ohio State University, Columbus, strongly agreed (@DrNwando): “This is the tweet I wish I tweeted.”

However, Kelly Swords, MD, MPH, urologist, University of California, San Diego, in a dissenting opinion, stated the obvious (@k_dagger): “Except there is no substitute for human interaction.”
 

Worth the Effort?

The cancellation of medical meetings has given those who regularly attend an opportunity to reassess their value and to question the worth of the effort involved in attending in person.

David Steensma, MD, hematologist-oncologist, Harvard Medical School, Boston, (@DavidSteensma) tweeted that he would like to scale back: “The present crisis is an opportunity to reassess what is actually necessary and rebalance [in terms of meetings].”

Travel to meetings is often unpleasant, said others.

Chris Palatucci, life sciences executive recruiter, Coulter Partners, Boston, tweeted (@LifeSciRcruitr): “I will die a happy man if I never get on another plane. Glorified bus travel.” He also believes that once the coronavirus crisis is over, its “silver lining” will be the realization that “40% of all meetings are unnecessary.”

Many professionals have welcomed the announcements that major conferences have been canceled and will be conducted virtually.

The latest change is from the American Society of Clinical Oncology (ASCO), whose annual meeting was to be held in Chicago at the end of May but will now be held online.

Virtual ASCO will be more manageable – and comfy, said Fumiko Ladd Chino, MD, radiation oncologist, Memorial Sloan Kettering Cancer Center, New York City.

She (@fumikochino) explained why in a recent tweet: “1) I will be finally able to see ALL OF THE PRESENTATIONS I wanted to see instead of wandering around feeling overwhelmed. 2) I will be able to FOCUS on the presentations and not searching for a power outlet. 3) PAJAMAS.”

Virtual meetings already beat real meetings, added Adriana Scheliga, MD, hematologist-oncologist, Brazilian National Cancer Institute (@linfopedia): “I’ve been saying this for a while. For me the best ASCO Meetings, for example, are the “virtual meetings!”

However, meetings in place are also very much about professional community and mutual support, reminds Susan E. Sedory, MA, executive director, Society of Interventional Radiology, which canceled its meeting March 6 in a multifaceted process described by Medscape Medical News.
 

Is This the Time to Evaluate Meetings?

Coming up soon is the first major conference to go virtual after being canceled – the American College of Cardiology (ACC), which has been one of the top 20 largest meetings in the United States by attendance.

This meeting, which was to have taken place in Chicago on March 28–30, will now occur online on those days. The ACC says it will stream all “live” sessions on demand and provide access to additional videos, abstracts, and slides for at least 90 days after the meeting. And it will be free to anyone with an Internet connection.

Medical meetings in distant locales may bounce back, as they have grown into a very big business. ASCO is illustrative.

The group’s first scientific annual meeting was held in 1965 in Philadelphia, with about 70 members and invited guests in attendance. Fast forward 50-plus years to 2019: there were 42,500 attendees, a 4.4% increase from 2018. Notably, the top countries in attendance in 2019 were the United States and China.

Not everyone is happy that canceled meetings are being held online in the middle of a pandemic.

“In a COVID-19 world, the brain cannot focus on nonviral topics,” said commentator John Mandrola, MD, Baptist Health, Louisville, Kentucky, in his regular column for Medscape Cardiology/theheart.org.

The virtual ACC meeting should be canceled or delayed – to mirror what is happening in the world, he argues. “In hospitals, we have postponed the elective to make room for the coming surge. Shouldn’t ACC do the same? After the crisis passes, we can have a virtual meeting with a proper discussion of the science,” he writes.

But #MedTwitter, with its collective constructive criticism of medical meetings, is perhaps proof that the brain can function – and arrive at clarity – when under pandemic duress.

“Am I the only one experiencing a certain relief at the cancellation of multiple trips and meetings, and vowing to let this revelation affect my decision making in the future,” tweeted Steven Joffe, MD, MPH, University of Pennsylvania, Philadelphia (@Steve Joffe).

Louise Perkins King, MD, a bioethicist at Harvard Medical School, responded to Joffe. Hoping not to “belittle” the suffering from the COVID-19 pandemic, she (@louise_p_king) addressed her healthcare colleagues: “...there is potential for us all to learn what is essential travel and burden and what is not from this. I hope it leads to lasting change.”

This article first appeared on Medscape.com.

At the end of 6 months of low-dose pomalidomide (Pomalyst), more than half of men who have sex with men had partial or complete clearance of long-standing, grade 3 anal lesions from human papillomavirus, irrespective of HIV status; the number increased to almost two-thirds when they were checked at 12 months, according to a 26-subject study said in video presentation of his research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

“Therapy induced durable and continuous clearance of anal HSIL [high-grade squamous intraepithelial lesions]. Further study in HPV-associated premalignancy is warranted to follow up this small, single arm study,” said study lead Mark Polizzotto, MD, PhD, head of the therapeutic and vaccine research program at the Kirby Institute in Sydney.

HPV anal lesions, and subsequent HSIL and progression to anal cancer, are prevalent among men who have sex with men. The risk increases with chronic lesions and concomitant HIV infection.

Pomalidomide is potentially a less painful alternative to options such as freezing and laser ablation, and it may have a lower rate of recurrence, but it’s expensive. Copays range upward from $5,000 for a month supply, according to GoodRx. Celgene, the maker of the drug, offers financial assistance.

Pomalidomide is a derivative of thalidomide that’s approved for multiple myeloma and also has shown effect against a viral lesion associated with HIV, Kaposi sarcoma. The drug is a T-cell activator, and since T-cell activation also is key to spontaneous anal HSIL clearance, Dr. Polizzotto and team wanted to take a look to see if it could help, he said.

The men in the study were at high risk for progression to anal cancer. With a median lesion duration of more than 3 years, and at least one case out past 7 years, spontaneous clearance wasn’t in the cards. The lesions were all grade 3 HSIL, which means severe dysplasia, and more than half of the subjects had HPV genotype 16, and the rest had other risky genotypes. Ten subjects also had HIV, which also increases the risk of anal cancer.

Pomalidomide was given in back-to-back cycles for 6 months, each consisting of 2 mg orally for 3 weeks, then 1 week off, along with a thrombolytic, usually aspirin, given the black box warning of blood clots. The dose was half the 5-mg cycle for Kaposi’s.

The overall response rate – complete clearance or a partial clearance of at least a 50% on high-resolution anoscopy – was 50% at 6 months (12/24), including four complete responses (4/15, 27%) in subjects without HIV, as well as four in the HIV group (4/9, 44%).

On follow-up at month 12, “we saw something we did not expect. Strikingly, with no additional therapy in the interim, we saw a deepening of response in a number of subjects.” The overall response rate climbed to 63% (15/24), including 33% complete response in the HIV-free group (5/15) and HIV-positive group (3/9).

Some did lose their response in the interim, however, and the study team is working to figure out if it was do to a recurrence or a new infection.

A general pattern of immune activation on treatment, including increased systemic CD4+ T-cell responses to HPV during therapy, supported the investigator’s hunch of an immunologic mechanism of action, Dr. Polizzotto said.

There were four instances of grade 3 neutropenia over eight treatment cycles, and one possibly related angina attack, but other than that, adverse reactions were generally mild and self-limited, mostly to grade 1 or 2 neutropenia, constipation, fatigue, and rash, with no idiosyncratic reactions in the HIV group or loss of viral suppression, and no discontinuations because of side effects.

The men in the study were aged 40-50 years, with a median age of 54 years; all but one were white. The median lesion involved a quarter of the anal ring, but sometimes more than half.

The work was funded by the Cancer Institute of New South Wales, the Australian National Health and Medical Research Council, and Celgene. Dr. Polizzotto disclosed patents with Celgene and research funding from the company.

[email protected]

SOURCE: Polizzotto M et al. CROI 2020. Abstract 70

At the end of 6 months of low-dose pomalidomide (Pomalyst), more than half of men who have sex with men had partial or complete clearance of long-standing, grade 3 anal lesions from human papillomavirus, irrespective of HIV status; the number increased to almost two-thirds when they were checked at 12 months, according to a 26-subject study said in video presentation of his research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

“Therapy induced durable and continuous clearance of anal HSIL [high-grade squamous intraepithelial lesions]. Further study in HPV-associated premalignancy is warranted to follow up this small, single arm study,” said study lead Mark Polizzotto, MD, PhD, head of the therapeutic and vaccine research program at the Kirby Institute in Sydney.

HPV anal lesions, and subsequent HSIL and progression to anal cancer, are prevalent among men who have sex with men. The risk increases with chronic lesions and concomitant HIV infection.

Pomalidomide is potentially a less painful alternative to options such as freezing and laser ablation, and it may have a lower rate of recurrence, but it’s expensive. Copays range upward from $5,000 for a month supply, according to GoodRx. Celgene, the maker of the drug, offers financial assistance.

Pomalidomide is a derivative of thalidomide that’s approved for multiple myeloma and also has shown effect against a viral lesion associated with HIV, Kaposi sarcoma. The drug is a T-cell activator, and since T-cell activation also is key to spontaneous anal HSIL clearance, Dr. Polizzotto and team wanted to take a look to see if it could help, he said.

The men in the study were at high risk for progression to anal cancer. With a median lesion duration of more than 3 years, and at least one case out past 7 years, spontaneous clearance wasn’t in the cards. The lesions were all grade 3 HSIL, which means severe dysplasia, and more than half of the subjects had HPV genotype 16, and the rest had other risky genotypes. Ten subjects also had HIV, which also increases the risk of anal cancer.

Pomalidomide was given in back-to-back cycles for 6 months, each consisting of 2 mg orally for 3 weeks, then 1 week off, along with a thrombolytic, usually aspirin, given the black box warning of blood clots. The dose was half the 5-mg cycle for Kaposi’s.

The overall response rate – complete clearance or a partial clearance of at least a 50% on high-resolution anoscopy – was 50% at 6 months (12/24), including four complete responses (4/15, 27%) in subjects without HIV, as well as four in the HIV group (4/9, 44%).

On follow-up at month 12, “we saw something we did not expect. Strikingly, with no additional therapy in the interim, we saw a deepening of response in a number of subjects.” The overall response rate climbed to 63% (15/24), including 33% complete response in the HIV-free group (5/15) and HIV-positive group (3/9).

Some did lose their response in the interim, however, and the study team is working to figure out if it was do to a recurrence or a new infection.

A general pattern of immune activation on treatment, including increased systemic CD4+ T-cell responses to HPV during therapy, supported the investigator’s hunch of an immunologic mechanism of action, Dr. Polizzotto said.

There were four instances of grade 3 neutropenia over eight treatment cycles, and one possibly related angina attack, but other than that, adverse reactions were generally mild and self-limited, mostly to grade 1 or 2 neutropenia, constipation, fatigue, and rash, with no idiosyncratic reactions in the HIV group or loss of viral suppression, and no discontinuations because of side effects.

The men in the study were aged 40-50 years, with a median age of 54 years; all but one were white. The median lesion involved a quarter of the anal ring, but sometimes more than half.

The work was funded by the Cancer Institute of New South Wales, the Australian National Health and Medical Research Council, and Celgene. Dr. Polizzotto disclosed patents with Celgene and research funding from the company.

[email protected]

SOURCE: Polizzotto M et al. CROI 2020. Abstract 70

At the end of 6 months of low-dose pomalidomide (Pomalyst), more than half of men who have sex with men had partial or complete clearance of long-standing, grade 3 anal lesions from human papillomavirus, irrespective of HIV status; the number increased to almost two-thirds when they were checked at 12 months, according to a 26-subject study said in video presentation of his research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

“Therapy induced durable and continuous clearance of anal HSIL [high-grade squamous intraepithelial lesions]. Further study in HPV-associated premalignancy is warranted to follow up this small, single arm study,” said study lead Mark Polizzotto, MD, PhD, head of the therapeutic and vaccine research program at the Kirby Institute in Sydney.

HPV anal lesions, and subsequent HSIL and progression to anal cancer, are prevalent among men who have sex with men. The risk increases with chronic lesions and concomitant HIV infection.

Pomalidomide is potentially a less painful alternative to options such as freezing and laser ablation, and it may have a lower rate of recurrence, but it’s expensive. Copays range upward from $5,000 for a month supply, according to GoodRx. Celgene, the maker of the drug, offers financial assistance.

Pomalidomide is a derivative of thalidomide that’s approved for multiple myeloma and also has shown effect against a viral lesion associated with HIV, Kaposi sarcoma. The drug is a T-cell activator, and since T-cell activation also is key to spontaneous anal HSIL clearance, Dr. Polizzotto and team wanted to take a look to see if it could help, he said.

The men in the study were at high risk for progression to anal cancer. With a median lesion duration of more than 3 years, and at least one case out past 7 years, spontaneous clearance wasn’t in the cards. The lesions were all grade 3 HSIL, which means severe dysplasia, and more than half of the subjects had HPV genotype 16, and the rest had other risky genotypes. Ten subjects also had HIV, which also increases the risk of anal cancer.

Pomalidomide was given in back-to-back cycles for 6 months, each consisting of 2 mg orally for 3 weeks, then 1 week off, along with a thrombolytic, usually aspirin, given the black box warning of blood clots. The dose was half the 5-mg cycle for Kaposi’s.

The overall response rate – complete clearance or a partial clearance of at least a 50% on high-resolution anoscopy – was 50% at 6 months (12/24), including four complete responses (4/15, 27%) in subjects without HIV, as well as four in the HIV group (4/9, 44%).

On follow-up at month 12, “we saw something we did not expect. Strikingly, with no additional therapy in the interim, we saw a deepening of response in a number of subjects.” The overall response rate climbed to 63% (15/24), including 33% complete response in the HIV-free group (5/15) and HIV-positive group (3/9).

Some did lose their response in the interim, however, and the study team is working to figure out if it was do to a recurrence or a new infection.

A general pattern of immune activation on treatment, including increased systemic CD4+ T-cell responses to HPV during therapy, supported the investigator’s hunch of an immunologic mechanism of action, Dr. Polizzotto said.

There were four instances of grade 3 neutropenia over eight treatment cycles, and one possibly related angina attack, but other than that, adverse reactions were generally mild and self-limited, mostly to grade 1 or 2 neutropenia, constipation, fatigue, and rash, with no idiosyncratic reactions in the HIV group or loss of viral suppression, and no discontinuations because of side effects.

The men in the study were aged 40-50 years, with a median age of 54 years; all but one were white. The median lesion involved a quarter of the anal ring, but sometimes more than half.

The work was funded by the Cancer Institute of New South Wales, the Australian National Health and Medical Research Council, and Celgene. Dr. Polizzotto disclosed patents with Celgene and research funding from the company.

[email protected]

SOURCE: Polizzotto M et al. CROI 2020. Abstract 70

Expression of three microRNAs (miR-155, miR-29a, and miR-27b) was detectable in patients with chronic lymphocytic leukemia (CLL) and in breast cancer (BC) patients, but not in healthy subjects, according to a molecular analysis of patients reported in Molecular Therapy Oncolytics. In addition, circulating microarrays were found to be able to differentiate between both CLL and BC patients and healthy subjects.

James Gathany/CDC

The researchers obtained blood samples from 15 CLL patients and tissue samples from 15 BC patients, all from a single center.

The use of quantitative reverse transcription polymerase chain reaction (qRT-PCR) demonstrated a significant increase in the expression of all three miRNAs in patients with BC and CLL, compared with respective healthy groups (P less than .001).

In BC patients, there was a significant difference between the expression of miR-155 and miR-29a (P less than .05), miR-155 and miR-27b (P less than .01), and miR-27b and miR-29a (P less than .001). In CLL patients, the qRT-PCR results showed a significant difference between expression of both miR-27b and miR-29a, compared with expression of miR-155 (P less than .001). In addition, there was a significant association between miR-155 and prevascular invasion (P = .013), but no significant association with other clinical variables (age, tumor grade, nuclear grade, tumor stage, tumor size, area of invasive component, tumor side, margin, or preneural invasion), according to the researchers.

Results also showed that elevated circulating miRNAs were BC specific and could differentiate BC tissues from the controls, and comparing expression of miRNAs between BC and CLL patients, there was also a significant difference for all miRNAs (P less than .001) between them.

“Our results suggest that miR-27b, miR-29a, and miR-155 could be potential new biomarkers for diagnosis, as well as a therapeutic target for CLL and BC,” the researchers concluded.

The authors reported that they had no competing interests.

[email protected]

SOURCE: Raeisi F et al. Mol Ther Oncolytics. 2020;16:230-7.

Expression of three microRNAs (miR-155, miR-29a, and miR-27b) was detectable in patients with chronic lymphocytic leukemia (CLL) and in breast cancer (BC) patients, but not in healthy subjects, according to a molecular analysis of patients reported in Molecular Therapy Oncolytics. In addition, circulating microarrays were found to be able to differentiate between both CLL and BC patients and healthy subjects.

James Gathany/CDC

The researchers obtained blood samples from 15 CLL patients and tissue samples from 15 BC patients, all from a single center.

The use of quantitative reverse transcription polymerase chain reaction (qRT-PCR) demonstrated a significant increase in the expression of all three miRNAs in patients with BC and CLL, compared with respective healthy groups (P less than .001).

In BC patients, there was a significant difference between the expression of miR-155 and miR-29a (P less than .05), miR-155 and miR-27b (P less than .01), and miR-27b and miR-29a (P less than .001). In CLL patients, the qRT-PCR results showed a significant difference between expression of both miR-27b and miR-29a, compared with expression of miR-155 (P less than .001). In addition, there was a significant association between miR-155 and prevascular invasion (P = .013), but no significant association with other clinical variables (age, tumor grade, nuclear grade, tumor stage, tumor size, area of invasive component, tumor side, margin, or preneural invasion), according to the researchers.

Results also showed that elevated circulating miRNAs were BC specific and could differentiate BC tissues from the controls, and comparing expression of miRNAs between BC and CLL patients, there was also a significant difference for all miRNAs (P less than .001) between them.

“Our results suggest that miR-27b, miR-29a, and miR-155 could be potential new biomarkers for diagnosis, as well as a therapeutic target for CLL and BC,” the researchers concluded.

The authors reported that they had no competing interests.

[email protected]

SOURCE: Raeisi F et al. Mol Ther Oncolytics. 2020;16:230-7.

Expression of three microRNAs (miR-155, miR-29a, and miR-27b) was detectable in patients with chronic lymphocytic leukemia (CLL) and in breast cancer (BC) patients, but not in healthy subjects, according to a molecular analysis of patients reported in Molecular Therapy Oncolytics. In addition, circulating microarrays were found to be able to differentiate between both CLL and BC patients and healthy subjects.

James Gathany/CDC

The researchers obtained blood samples from 15 CLL patients and tissue samples from 15 BC patients, all from a single center.

The use of quantitative reverse transcription polymerase chain reaction (qRT-PCR) demonstrated a significant increase in the expression of all three miRNAs in patients with BC and CLL, compared with respective healthy groups (P less than .001).

In BC patients, there was a significant difference between the expression of miR-155 and miR-29a (P less than .05), miR-155 and miR-27b (P less than .01), and miR-27b and miR-29a (P less than .001). In CLL patients, the qRT-PCR results showed a significant difference between expression of both miR-27b and miR-29a, compared with expression of miR-155 (P less than .001). In addition, there was a significant association between miR-155 and prevascular invasion (P = .013), but no significant association with other clinical variables (age, tumor grade, nuclear grade, tumor stage, tumor size, area of invasive component, tumor side, margin, or preneural invasion), according to the researchers.

Results also showed that elevated circulating miRNAs were BC specific and could differentiate BC tissues from the controls, and comparing expression of miRNAs between BC and CLL patients, there was also a significant difference for all miRNAs (P less than .001) between them.

“Our results suggest that miR-27b, miR-29a, and miR-155 could be potential new biomarkers for diagnosis, as well as a therapeutic target for CLL and BC,” the researchers concluded.

The authors reported that they had no competing interests.

[email protected]

SOURCE: Raeisi F et al. Mol Ther Oncolytics. 2020;16:230-7.