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First-in-class ADC ups survival in mTNBC
The first-in-class drug is directed at trophoblast cell surface antigen 2 (Trop-2), which is highly expressed in breast cancer. Research on the drug was presented at the European Society for Medical Oncology Virtual Congress 2020.
ASCENT randomly assigned more than 500 patients who had metastatic TNBC and who had experienced disease progression after a median of four lines of therapy to receive either SG or physician’s choice of chemotherapy. SG significantly improved median progression-free survival (5.6 vs 1.7 months; hazard ratio [HR], 0.41; P < .0001) and median overall survival (12.1 vs 6.7 months; HR, 0.48; P < .0001).
The response rate was 35% for SG vs 5% for chemotherapy (P < .0001).
The study was presented by Aditya Bardia, MD, MPH, a medical oncologist at Massachusetts General Hospital, Boston, Massachusetts.
He said that because the safety profile of SG is consistent with previous reports and the treatment discontinuation rate was low, the clinical benefit “confirms the use of sacituzumab govitecan” in metastatic TNBC. This was a reference to the fact that the drug previously received accelerated approval on the basis of early data.
Bardia added that ongoing studies are evaluating the use of SG in earlier lines of therapy, including neoadjuvant settings in combination with other targeted agents, as well as in hormone receptor–positive metastatic breast cancer. One such study is the phase 3 TROPiCS-02 study, which is actively accruing patients.
Invited discussant Fatima Cardoso, MD, director of the Breast Unit at Champalimaud Clinical Center, Lisbon, Portugal, said the treatment algorithm for the management of TNBC will need to be updated in light of these results.
“In my opinion, we should now add sacituzumab govitecan as a new treatment option for patients treated with two or more lines of therapy,” she said.
She noted that the study design raised some questions over the way such trials should be conducted and the future sequencing of treatments.
Objections to study design and execution
Discussant Cardoso said the choice of progression-free survival as the primary endpoint for the trial was not ideal.
“In the metastatic setting, and particularly for triple-negative breast cancer, where the median survival is quite low and where each line of treatment, particularly after the second line, has a short duration, the primary endpoint should have been overall survival,” she commented.
“Luckily, we saw some results, but we could have missed it,” Cardoso said. She made “a plea to make sure that overall survival is at least the co–primary endpoint” in the future.
Cardoso also said it was not clear to her why the trial had to be stopped. “For the current patients, if there is no crossover, there is no benefit in stopping the trial,” she said.
She went on: “For future patients, it’s better to have the final results sufficiently powered.” She noted that the benefit seen in ASCENT was “moderate” and “so not a substantial breakthrough.” She added that it was “important not to stop trials too early.”
On the positive side, Cardoso said the median number of previous lines of therapy was “quite remarkable for this subtype, and it is important then for us to discuss sequencing,” particularly given that so many patients received checkpoint inhibitors before entering the trial.
Safety and a focus on diarrhea
Investigator Bardia explained that SG is an antibody-drug conjugate directed at Trop-2, which is highly expressed in breast cancer.
The antibody is linked to SN-38, the active metabolite of irinotecan, via a hydrolyzable linker that makes internalization and enzymatic cleavage by tumor cells unnecessary.
Hydrolysis of the linker releases SN-38 both within the tumor cell and extracellularly to induce a so-called bystander effect, in which neighboring tumors cells may be killed even if they do not express Trop-2.
On the basis of positive results from phase 1/2 trial data, SG was granted accelerated approval by the US Food and Drug Administration for patients with metastatic TNBC who experience disease progression after at least two prior therapies.
ASCENT was therefore a phase 3 confirmatory study. Patients with metastatic TNBC who had received at least two prior chemotherapy regimens were randomly assigned in a 1:1 ratio to receive intravenous SG on days 1 and 8 of a 21-day cycle or to receive physician’s choice of treatment.
Physicians could choose eribulin, vinorelbine, gemcitabine, or capecitabine.
The patients continued receiving treatment until disease progression or unacceptable toxicity occurred. On the unanimous recommendation of the data safety monitoring committee, the trial was ended early because of “compelling evidence of efficacy.”
In all, 267 patients were randomly assigned to receive SG. Of those patients, 15 remain on treatment. Treatment was discontinued for 199 patients who experienced disease progression. In the control arm, 262 patients were included, none of whom are still on treatment; 166 discontinued because of disease progression.
The current analysis is limited to 235 patients in the SG group and, in the control arm, 233 patients who did not have brain metastases. Patients with brain metastases will be the subject of a later analysis.
All but one patient in both treatment groups were women. The median age was approximately 54 years. The median number of prior treatment regimens was four. All patients had previously received chemotherapy, and between 26% and 29% have taken checkpoint inhibitors.
By the data cutoff of March 11, 2020, patients had received a median of seven treatment cycles with SG. Progression-free survival was adjudicated by blind, independent central review. The median duration of response was of borderline significance, at 6.3 months vs 3.6 months (P = .057).
Bardia showed that the results were consistent among all subgroups, including subgroups determined on the basis of age, number of prior therapies, whether patients had received prior immune checkpoint therapy, and the presence of liver metastases.
With respect to safety, the important grade 3 or higher treatment-related adverse events were neutropenia (seen in 51% of SG patients vs 33% of patients in the control arm), diarrhea (10% vs <1%), leukopenia (10% vs 5%), anemia (8% vs 5%), and febrile neutropenia (6% vs 2%).
Despite the fact that the adverse event rate was higher with SG than with physician’s choice of chemotherapy, the percentage of such events that led to treatment discontinuation was numerically lower, at 4.7% vs 5.4%.
Cardoso highlighted the “substantial percentage” of patients with diarrhea and nausea in the trial and noted that “all grades” of these adverse events “affect quality of life.”
The focus therefore should be on patient education, prophylaxis, and “the early management of side effects,” she said.
This point was taken up in the postpresentation debate. Bardia said the high rate of diarrhea “likely relates to the toxic payload, which is SN-38, which is known to cause diarrhea.
“Loperamide or immodium prophylaxis can be used in patients who receive this drug, and in general, our experience with the use of sacituzumab govitecan is you can control the diarrhea,” Bardia said.
He added: “There is also a different side effect that occurs during the infusion of SG, which is abdominal cramping and diarrhea, and that’s more of a cholinergic reaction. For that, atropine is the best medication to use.”
The study was funded by Immunomedics Inc. Bardia has disclosed financial ties with Immunomedics and multiple other pharmaceutical companies. Cardoso has disclosed financial ties to multiple drug companies.
This article first appeared on Medscape.com.
The first-in-class drug is directed at trophoblast cell surface antigen 2 (Trop-2), which is highly expressed in breast cancer. Research on the drug was presented at the European Society for Medical Oncology Virtual Congress 2020.
ASCENT randomly assigned more than 500 patients who had metastatic TNBC and who had experienced disease progression after a median of four lines of therapy to receive either SG or physician’s choice of chemotherapy. SG significantly improved median progression-free survival (5.6 vs 1.7 months; hazard ratio [HR], 0.41; P < .0001) and median overall survival (12.1 vs 6.7 months; HR, 0.48; P < .0001).
The response rate was 35% for SG vs 5% for chemotherapy (P < .0001).
The study was presented by Aditya Bardia, MD, MPH, a medical oncologist at Massachusetts General Hospital, Boston, Massachusetts.
He said that because the safety profile of SG is consistent with previous reports and the treatment discontinuation rate was low, the clinical benefit “confirms the use of sacituzumab govitecan” in metastatic TNBC. This was a reference to the fact that the drug previously received accelerated approval on the basis of early data.
Bardia added that ongoing studies are evaluating the use of SG in earlier lines of therapy, including neoadjuvant settings in combination with other targeted agents, as well as in hormone receptor–positive metastatic breast cancer. One such study is the phase 3 TROPiCS-02 study, which is actively accruing patients.
Invited discussant Fatima Cardoso, MD, director of the Breast Unit at Champalimaud Clinical Center, Lisbon, Portugal, said the treatment algorithm for the management of TNBC will need to be updated in light of these results.
“In my opinion, we should now add sacituzumab govitecan as a new treatment option for patients treated with two or more lines of therapy,” she said.
She noted that the study design raised some questions over the way such trials should be conducted and the future sequencing of treatments.
Objections to study design and execution
Discussant Cardoso said the choice of progression-free survival as the primary endpoint for the trial was not ideal.
“In the metastatic setting, and particularly for triple-negative breast cancer, where the median survival is quite low and where each line of treatment, particularly after the second line, has a short duration, the primary endpoint should have been overall survival,” she commented.
“Luckily, we saw some results, but we could have missed it,” Cardoso said. She made “a plea to make sure that overall survival is at least the co–primary endpoint” in the future.
Cardoso also said it was not clear to her why the trial had to be stopped. “For the current patients, if there is no crossover, there is no benefit in stopping the trial,” she said.
She went on: “For future patients, it’s better to have the final results sufficiently powered.” She noted that the benefit seen in ASCENT was “moderate” and “so not a substantial breakthrough.” She added that it was “important not to stop trials too early.”
On the positive side, Cardoso said the median number of previous lines of therapy was “quite remarkable for this subtype, and it is important then for us to discuss sequencing,” particularly given that so many patients received checkpoint inhibitors before entering the trial.
Safety and a focus on diarrhea
Investigator Bardia explained that SG is an antibody-drug conjugate directed at Trop-2, which is highly expressed in breast cancer.
The antibody is linked to SN-38, the active metabolite of irinotecan, via a hydrolyzable linker that makes internalization and enzymatic cleavage by tumor cells unnecessary.
Hydrolysis of the linker releases SN-38 both within the tumor cell and extracellularly to induce a so-called bystander effect, in which neighboring tumors cells may be killed even if they do not express Trop-2.
On the basis of positive results from phase 1/2 trial data, SG was granted accelerated approval by the US Food and Drug Administration for patients with metastatic TNBC who experience disease progression after at least two prior therapies.
ASCENT was therefore a phase 3 confirmatory study. Patients with metastatic TNBC who had received at least two prior chemotherapy regimens were randomly assigned in a 1:1 ratio to receive intravenous SG on days 1 and 8 of a 21-day cycle or to receive physician’s choice of treatment.
Physicians could choose eribulin, vinorelbine, gemcitabine, or capecitabine.
The patients continued receiving treatment until disease progression or unacceptable toxicity occurred. On the unanimous recommendation of the data safety monitoring committee, the trial was ended early because of “compelling evidence of efficacy.”
In all, 267 patients were randomly assigned to receive SG. Of those patients, 15 remain on treatment. Treatment was discontinued for 199 patients who experienced disease progression. In the control arm, 262 patients were included, none of whom are still on treatment; 166 discontinued because of disease progression.
The current analysis is limited to 235 patients in the SG group and, in the control arm, 233 patients who did not have brain metastases. Patients with brain metastases will be the subject of a later analysis.
All but one patient in both treatment groups were women. The median age was approximately 54 years. The median number of prior treatment regimens was four. All patients had previously received chemotherapy, and between 26% and 29% have taken checkpoint inhibitors.
By the data cutoff of March 11, 2020, patients had received a median of seven treatment cycles with SG. Progression-free survival was adjudicated by blind, independent central review. The median duration of response was of borderline significance, at 6.3 months vs 3.6 months (P = .057).
Bardia showed that the results were consistent among all subgroups, including subgroups determined on the basis of age, number of prior therapies, whether patients had received prior immune checkpoint therapy, and the presence of liver metastases.
With respect to safety, the important grade 3 or higher treatment-related adverse events were neutropenia (seen in 51% of SG patients vs 33% of patients in the control arm), diarrhea (10% vs <1%), leukopenia (10% vs 5%), anemia (8% vs 5%), and febrile neutropenia (6% vs 2%).
Despite the fact that the adverse event rate was higher with SG than with physician’s choice of chemotherapy, the percentage of such events that led to treatment discontinuation was numerically lower, at 4.7% vs 5.4%.
Cardoso highlighted the “substantial percentage” of patients with diarrhea and nausea in the trial and noted that “all grades” of these adverse events “affect quality of life.”
The focus therefore should be on patient education, prophylaxis, and “the early management of side effects,” she said.
This point was taken up in the postpresentation debate. Bardia said the high rate of diarrhea “likely relates to the toxic payload, which is SN-38, which is known to cause diarrhea.
“Loperamide or immodium prophylaxis can be used in patients who receive this drug, and in general, our experience with the use of sacituzumab govitecan is you can control the diarrhea,” Bardia said.
He added: “There is also a different side effect that occurs during the infusion of SG, which is abdominal cramping and diarrhea, and that’s more of a cholinergic reaction. For that, atropine is the best medication to use.”
The study was funded by Immunomedics Inc. Bardia has disclosed financial ties with Immunomedics and multiple other pharmaceutical companies. Cardoso has disclosed financial ties to multiple drug companies.
This article first appeared on Medscape.com.
The first-in-class drug is directed at trophoblast cell surface antigen 2 (Trop-2), which is highly expressed in breast cancer. Research on the drug was presented at the European Society for Medical Oncology Virtual Congress 2020.
ASCENT randomly assigned more than 500 patients who had metastatic TNBC and who had experienced disease progression after a median of four lines of therapy to receive either SG or physician’s choice of chemotherapy. SG significantly improved median progression-free survival (5.6 vs 1.7 months; hazard ratio [HR], 0.41; P < .0001) and median overall survival (12.1 vs 6.7 months; HR, 0.48; P < .0001).
The response rate was 35% for SG vs 5% for chemotherapy (P < .0001).
The study was presented by Aditya Bardia, MD, MPH, a medical oncologist at Massachusetts General Hospital, Boston, Massachusetts.
He said that because the safety profile of SG is consistent with previous reports and the treatment discontinuation rate was low, the clinical benefit “confirms the use of sacituzumab govitecan” in metastatic TNBC. This was a reference to the fact that the drug previously received accelerated approval on the basis of early data.
Bardia added that ongoing studies are evaluating the use of SG in earlier lines of therapy, including neoadjuvant settings in combination with other targeted agents, as well as in hormone receptor–positive metastatic breast cancer. One such study is the phase 3 TROPiCS-02 study, which is actively accruing patients.
Invited discussant Fatima Cardoso, MD, director of the Breast Unit at Champalimaud Clinical Center, Lisbon, Portugal, said the treatment algorithm for the management of TNBC will need to be updated in light of these results.
“In my opinion, we should now add sacituzumab govitecan as a new treatment option for patients treated with two or more lines of therapy,” she said.
She noted that the study design raised some questions over the way such trials should be conducted and the future sequencing of treatments.
Objections to study design and execution
Discussant Cardoso said the choice of progression-free survival as the primary endpoint for the trial was not ideal.
“In the metastatic setting, and particularly for triple-negative breast cancer, where the median survival is quite low and where each line of treatment, particularly after the second line, has a short duration, the primary endpoint should have been overall survival,” she commented.
“Luckily, we saw some results, but we could have missed it,” Cardoso said. She made “a plea to make sure that overall survival is at least the co–primary endpoint” in the future.
Cardoso also said it was not clear to her why the trial had to be stopped. “For the current patients, if there is no crossover, there is no benefit in stopping the trial,” she said.
She went on: “For future patients, it’s better to have the final results sufficiently powered.” She noted that the benefit seen in ASCENT was “moderate” and “so not a substantial breakthrough.” She added that it was “important not to stop trials too early.”
On the positive side, Cardoso said the median number of previous lines of therapy was “quite remarkable for this subtype, and it is important then for us to discuss sequencing,” particularly given that so many patients received checkpoint inhibitors before entering the trial.
Safety and a focus on diarrhea
Investigator Bardia explained that SG is an antibody-drug conjugate directed at Trop-2, which is highly expressed in breast cancer.
The antibody is linked to SN-38, the active metabolite of irinotecan, via a hydrolyzable linker that makes internalization and enzymatic cleavage by tumor cells unnecessary.
Hydrolysis of the linker releases SN-38 both within the tumor cell and extracellularly to induce a so-called bystander effect, in which neighboring tumors cells may be killed even if they do not express Trop-2.
On the basis of positive results from phase 1/2 trial data, SG was granted accelerated approval by the US Food and Drug Administration for patients with metastatic TNBC who experience disease progression after at least two prior therapies.
ASCENT was therefore a phase 3 confirmatory study. Patients with metastatic TNBC who had received at least two prior chemotherapy regimens were randomly assigned in a 1:1 ratio to receive intravenous SG on days 1 and 8 of a 21-day cycle or to receive physician’s choice of treatment.
Physicians could choose eribulin, vinorelbine, gemcitabine, or capecitabine.
The patients continued receiving treatment until disease progression or unacceptable toxicity occurred. On the unanimous recommendation of the data safety monitoring committee, the trial was ended early because of “compelling evidence of efficacy.”
In all, 267 patients were randomly assigned to receive SG. Of those patients, 15 remain on treatment. Treatment was discontinued for 199 patients who experienced disease progression. In the control arm, 262 patients were included, none of whom are still on treatment; 166 discontinued because of disease progression.
The current analysis is limited to 235 patients in the SG group and, in the control arm, 233 patients who did not have brain metastases. Patients with brain metastases will be the subject of a later analysis.
All but one patient in both treatment groups were women. The median age was approximately 54 years. The median number of prior treatment regimens was four. All patients had previously received chemotherapy, and between 26% and 29% have taken checkpoint inhibitors.
By the data cutoff of March 11, 2020, patients had received a median of seven treatment cycles with SG. Progression-free survival was adjudicated by blind, independent central review. The median duration of response was of borderline significance, at 6.3 months vs 3.6 months (P = .057).
Bardia showed that the results were consistent among all subgroups, including subgroups determined on the basis of age, number of prior therapies, whether patients had received prior immune checkpoint therapy, and the presence of liver metastases.
With respect to safety, the important grade 3 or higher treatment-related adverse events were neutropenia (seen in 51% of SG patients vs 33% of patients in the control arm), diarrhea (10% vs <1%), leukopenia (10% vs 5%), anemia (8% vs 5%), and febrile neutropenia (6% vs 2%).
Despite the fact that the adverse event rate was higher with SG than with physician’s choice of chemotherapy, the percentage of such events that led to treatment discontinuation was numerically lower, at 4.7% vs 5.4%.
Cardoso highlighted the “substantial percentage” of patients with diarrhea and nausea in the trial and noted that “all grades” of these adverse events “affect quality of life.”
The focus therefore should be on patient education, prophylaxis, and “the early management of side effects,” she said.
This point was taken up in the postpresentation debate. Bardia said the high rate of diarrhea “likely relates to the toxic payload, which is SN-38, which is known to cause diarrhea.
“Loperamide or immodium prophylaxis can be used in patients who receive this drug, and in general, our experience with the use of sacituzumab govitecan is you can control the diarrhea,” Bardia said.
He added: “There is also a different side effect that occurs during the infusion of SG, which is abdominal cramping and diarrhea, and that’s more of a cholinergic reaction. For that, atropine is the best medication to use.”
The study was funded by Immunomedics Inc. Bardia has disclosed financial ties with Immunomedics and multiple other pharmaceutical companies. Cardoso has disclosed financial ties to multiple drug companies.
This article first appeared on Medscape.com.
FROM ESMO 2020
Study offers reassurance to postmenopausal women taking hormone therapy
References
- Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the Women’s Health Initiative randomized clinical trials. JAMA. 2020;32:369-380.
- The North American Menopause Society. Menopause Guidebook. 8th ed. www.menopause.org/publications/consumer-publications/-em-menopause-guidebook-em-8th-edition. Accessed September 25, 2020.
- US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force Recommendation Statement. JAMA. 2017;318:2224-2233.
References
- Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the Women’s Health Initiative randomized clinical trials. JAMA. 2020;32:369-380.
- The North American Menopause Society. Menopause Guidebook. 8th ed. www.menopause.org/publications/consumer-publications/-em-menopause-guidebook-em-8th-edition. Accessed September 25, 2020.
- US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force Recommendation Statement. JAMA. 2017;318:2224-2233.
References
- Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the Women’s Health Initiative randomized clinical trials. JAMA. 2020;32:369-380.
- The North American Menopause Society. Menopause Guidebook. 8th ed. www.menopause.org/publications/consumer-publications/-em-menopause-guidebook-em-8th-edition. Accessed September 25, 2020.
- US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force Recommendation Statement. JAMA. 2017;318:2224-2233.
CDC adds then retracts aerosols as main COVID-19 mode of transmission
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
Three-step approach may help relieve one of the itchiest vulvar conditions
A three-step approach may help relieve itch in patients with lichen simplex chronicus, “one of the itchiest conditions that we ever see on the vulva,” an expert advised at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.
For some patients, such as those with excessive sweating or underlying psoriasis, seeing a dermatologist may be beneficial, physicians at the meeting suggested.
Treatment should aim to optimize epithelial barrier function, reduce inflammation, and stop scratching, Lynette Margesson, MD, said in a lecture at the biennial meeting, which is held by the International Society for the Study of Vulvovaginal Disease (ISSVD). “With this condition, please look always for more than one problem.”
said Dr. Margesson, an obstetrician and gynecologist at Geisel School of Medicine at Dartmouth in Hanover, N.H. “It is because of chronic rubbing and scratching on top of something else.”
It may develop on top of atopic dermatitis, psoriasis, or contact dermatitis, as well as infection, lichen sclerosus, lichen planus, or neoplasia.
Lichen simplex chronicus is characterized by years of relentless itching, and patients may wake up at night scratching. The skin looks and feels leathery, and the condition can be localized or around the entire vulva. Heat, humidity, stress, and irritants may exacerbate the condition.
Patients often try to wash the rash away with scrubbers and cleansers, which only makes it worse, Dr. Margesson said.
To get patients better, improve barrier function, such as by controlling infections, reducing sweating, avoiding irritants, and stopping excessive hygiene. Immediate therapy may include soaks, cool compresses, and ointments.
A superpotent steroid taper (e.g., clobetasol 0.05% ointment), a prednisone taper, or intramuscular triamcinolone may reduce inflammation. Dr. Margesson usually uses clobetasol, although this treatment or halobetasol can burn if patients have open skin. In such cases, she uses prednisone or intramuscular triamcinolone.
Sedating medications may help patients stop scratching, especially at night. Hydroxyzine, doxepin, or amitriptyline 2-3 hours before bedtime can help. Scratching can be a form of obsessive-compulsive disorder, and a small dose of citalopram may help during the day. Patients with significant psychological factors can be difficult to manage and tend to relapse easily, Dr. Margesson said.
If lichen simplex chronicus recurs, test for infections and allergies. “Maybe they need a mild corticosteroid all the time, like 2.5% hydrocortisone to alternate with your superpotent steroid so you can use it longer without thinning the skin,” she suggested.
Although Dr. Margesson does not often treat hyperhidrosis, addressing excessive sweating can make a big difference for patients, she said.
If a gynecologist identifies a patient who may benefit from treatment of hyperhidrosis but has limited experience with medications for this condition, it might make sense to work with a dermatologist, Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., suggested during a panel discussion. Most dermatologists treat hyperhidrosis regularly, she said.
Dermatologists also may help treat patients with psoriasis who need systemic medication, Dr. Margesson said.
“In terms of ... doing the lab monitoring and knowing what side effects to look out for, your colleagues who use these medicines more are going to be more comfortable with that,” Dr. Venkatesan said. They also may have more experience navigating insurance denials to obtain a therapy. “Don’t think you are passing the buck to someone else. Sometimes that is the right thing to do, to get that help from someone else.”
Dr. Margesson is an author for UpToDate. Dr. Venkatesan had no conflicts of interest.
A three-step approach may help relieve itch in patients with lichen simplex chronicus, “one of the itchiest conditions that we ever see on the vulva,” an expert advised at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.
For some patients, such as those with excessive sweating or underlying psoriasis, seeing a dermatologist may be beneficial, physicians at the meeting suggested.
Treatment should aim to optimize epithelial barrier function, reduce inflammation, and stop scratching, Lynette Margesson, MD, said in a lecture at the biennial meeting, which is held by the International Society for the Study of Vulvovaginal Disease (ISSVD). “With this condition, please look always for more than one problem.”
said Dr. Margesson, an obstetrician and gynecologist at Geisel School of Medicine at Dartmouth in Hanover, N.H. “It is because of chronic rubbing and scratching on top of something else.”
It may develop on top of atopic dermatitis, psoriasis, or contact dermatitis, as well as infection, lichen sclerosus, lichen planus, or neoplasia.
Lichen simplex chronicus is characterized by years of relentless itching, and patients may wake up at night scratching. The skin looks and feels leathery, and the condition can be localized or around the entire vulva. Heat, humidity, stress, and irritants may exacerbate the condition.
Patients often try to wash the rash away with scrubbers and cleansers, which only makes it worse, Dr. Margesson said.
To get patients better, improve barrier function, such as by controlling infections, reducing sweating, avoiding irritants, and stopping excessive hygiene. Immediate therapy may include soaks, cool compresses, and ointments.
A superpotent steroid taper (e.g., clobetasol 0.05% ointment), a prednisone taper, or intramuscular triamcinolone may reduce inflammation. Dr. Margesson usually uses clobetasol, although this treatment or halobetasol can burn if patients have open skin. In such cases, she uses prednisone or intramuscular triamcinolone.
Sedating medications may help patients stop scratching, especially at night. Hydroxyzine, doxepin, or amitriptyline 2-3 hours before bedtime can help. Scratching can be a form of obsessive-compulsive disorder, and a small dose of citalopram may help during the day. Patients with significant psychological factors can be difficult to manage and tend to relapse easily, Dr. Margesson said.
If lichen simplex chronicus recurs, test for infections and allergies. “Maybe they need a mild corticosteroid all the time, like 2.5% hydrocortisone to alternate with your superpotent steroid so you can use it longer without thinning the skin,” she suggested.
Although Dr. Margesson does not often treat hyperhidrosis, addressing excessive sweating can make a big difference for patients, she said.
If a gynecologist identifies a patient who may benefit from treatment of hyperhidrosis but has limited experience with medications for this condition, it might make sense to work with a dermatologist, Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., suggested during a panel discussion. Most dermatologists treat hyperhidrosis regularly, she said.
Dermatologists also may help treat patients with psoriasis who need systemic medication, Dr. Margesson said.
“In terms of ... doing the lab monitoring and knowing what side effects to look out for, your colleagues who use these medicines more are going to be more comfortable with that,” Dr. Venkatesan said. They also may have more experience navigating insurance denials to obtain a therapy. “Don’t think you are passing the buck to someone else. Sometimes that is the right thing to do, to get that help from someone else.”
Dr. Margesson is an author for UpToDate. Dr. Venkatesan had no conflicts of interest.
A three-step approach may help relieve itch in patients with lichen simplex chronicus, “one of the itchiest conditions that we ever see on the vulva,” an expert advised at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.
For some patients, such as those with excessive sweating or underlying psoriasis, seeing a dermatologist may be beneficial, physicians at the meeting suggested.
Treatment should aim to optimize epithelial barrier function, reduce inflammation, and stop scratching, Lynette Margesson, MD, said in a lecture at the biennial meeting, which is held by the International Society for the Study of Vulvovaginal Disease (ISSVD). “With this condition, please look always for more than one problem.”
said Dr. Margesson, an obstetrician and gynecologist at Geisel School of Medicine at Dartmouth in Hanover, N.H. “It is because of chronic rubbing and scratching on top of something else.”
It may develop on top of atopic dermatitis, psoriasis, or contact dermatitis, as well as infection, lichen sclerosus, lichen planus, or neoplasia.
Lichen simplex chronicus is characterized by years of relentless itching, and patients may wake up at night scratching. The skin looks and feels leathery, and the condition can be localized or around the entire vulva. Heat, humidity, stress, and irritants may exacerbate the condition.
Patients often try to wash the rash away with scrubbers and cleansers, which only makes it worse, Dr. Margesson said.
To get patients better, improve barrier function, such as by controlling infections, reducing sweating, avoiding irritants, and stopping excessive hygiene. Immediate therapy may include soaks, cool compresses, and ointments.
A superpotent steroid taper (e.g., clobetasol 0.05% ointment), a prednisone taper, or intramuscular triamcinolone may reduce inflammation. Dr. Margesson usually uses clobetasol, although this treatment or halobetasol can burn if patients have open skin. In such cases, she uses prednisone or intramuscular triamcinolone.
Sedating medications may help patients stop scratching, especially at night. Hydroxyzine, doxepin, or amitriptyline 2-3 hours before bedtime can help. Scratching can be a form of obsessive-compulsive disorder, and a small dose of citalopram may help during the day. Patients with significant psychological factors can be difficult to manage and tend to relapse easily, Dr. Margesson said.
If lichen simplex chronicus recurs, test for infections and allergies. “Maybe they need a mild corticosteroid all the time, like 2.5% hydrocortisone to alternate with your superpotent steroid so you can use it longer without thinning the skin,” she suggested.
Although Dr. Margesson does not often treat hyperhidrosis, addressing excessive sweating can make a big difference for patients, she said.
If a gynecologist identifies a patient who may benefit from treatment of hyperhidrosis but has limited experience with medications for this condition, it might make sense to work with a dermatologist, Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., suggested during a panel discussion. Most dermatologists treat hyperhidrosis regularly, she said.
Dermatologists also may help treat patients with psoriasis who need systemic medication, Dr. Margesson said.
“In terms of ... doing the lab monitoring and knowing what side effects to look out for, your colleagues who use these medicines more are going to be more comfortable with that,” Dr. Venkatesan said. They also may have more experience navigating insurance denials to obtain a therapy. “Don’t think you are passing the buck to someone else. Sometimes that is the right thing to do, to get that help from someone else.”
Dr. Margesson is an author for UpToDate. Dr. Venkatesan had no conflicts of interest.
FROM ISSVD BIENNIAL CONFERENCE
Without Ginsburg, judicial threats to the ACA, reproductive rights heighten
On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”
I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”
Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”
Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil.
Let’s take them one at a time.
The ACA under fire – again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.
At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
Reproductive rights
A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.
Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.
And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.
For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.
“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”
I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”
Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”
Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil.
Let’s take them one at a time.
The ACA under fire – again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.
At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
Reproductive rights
A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.
Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.
And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.
For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.
“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”
I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”
Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”
Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil.
Let’s take them one at a time.
The ACA under fire – again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.
At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
Reproductive rights
A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.
Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.
And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.
For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.
“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Pembrolizumab combo flops in pretreated HR-positive, ERBB2-negative breast cancer
Key clinical point: Pembrolizumab plus eribulin did not outperform eribulin alone among patients with heavily pretreated, HR-positive, ERBB2-negative metastatic breast cancer.
Major finding: After a median of 10.5 months of follow-up, combination therapy did not improve PFS or OS in the intention-to-treat population or in the subgroup of PD-L1 positive patients.
Study details: Multicenter randomized trial of 88 patients with HR-positive, ERBB2-negative metastatic breast cancer who had received >2 lines of hormonal therapy and 0-2 lines of chemotherapy.
Disclosures: Merck & Co providing study funding and pembrolizumab. Eisai provided eribulin. Several investigators disclosed ties to Merck, Eisai, and other pharmaceutical companies.
Citation: Tolaney SM et al. Jama Oncol. 2020 Sep 3. doi: 10.1001/jamaoncol.2020.3524
Key clinical point: Pembrolizumab plus eribulin did not outperform eribulin alone among patients with heavily pretreated, HR-positive, ERBB2-negative metastatic breast cancer.
Major finding: After a median of 10.5 months of follow-up, combination therapy did not improve PFS or OS in the intention-to-treat population or in the subgroup of PD-L1 positive patients.
Study details: Multicenter randomized trial of 88 patients with HR-positive, ERBB2-negative metastatic breast cancer who had received >2 lines of hormonal therapy and 0-2 lines of chemotherapy.
Disclosures: Merck & Co providing study funding and pembrolizumab. Eisai provided eribulin. Several investigators disclosed ties to Merck, Eisai, and other pharmaceutical companies.
Citation: Tolaney SM et al. Jama Oncol. 2020 Sep 3. doi: 10.1001/jamaoncol.2020.3524
Key clinical point: Pembrolizumab plus eribulin did not outperform eribulin alone among patients with heavily pretreated, HR-positive, ERBB2-negative metastatic breast cancer.
Major finding: After a median of 10.5 months of follow-up, combination therapy did not improve PFS or OS in the intention-to-treat population or in the subgroup of PD-L1 positive patients.
Study details: Multicenter randomized trial of 88 patients with HR-positive, ERBB2-negative metastatic breast cancer who had received >2 lines of hormonal therapy and 0-2 lines of chemotherapy.
Disclosures: Merck & Co providing study funding and pembrolizumab. Eisai provided eribulin. Several investigators disclosed ties to Merck, Eisai, and other pharmaceutical companies.
Citation: Tolaney SM et al. Jama Oncol. 2020 Sep 3. doi: 10.1001/jamaoncol.2020.3524
Rheumatology feels impact of COVID-19 telehealth boom
Rheumatologists are seeing the number of telehealth visits skyrocket in their practices as the COVID-19 pandemic rages on and patients seek out alternatives to in-person visits. Telemedicine makes it easier for patients to connect with physicians, but not all patients have access to a computer or device. It also limits what a physician can do. Rheumatologists often rely on physical exams to make diagnoses and treatment decisions – an obstacle if you’re looking at patients through a computer screen.
Presenters at the 2020 Coalition of State Rheumatology Organizations’ state advocacy conference discussed the benefits and challenges of this mode of care in early September. Within weeks, the U.S. health system eliminated almost half of all medical care as the pandemic ramped up and things went virtual, said Larry Van Horn, PhD, MPH, a speaker at the CSRO conference. Still, “we are in uncharted territory with respect to how telehealth is being used. ... It’s being deployed everywhere, but it’s too early to tell how it’s affecting patient outcomes,” said Dr. Van Horn, founder and director of the Center of Health Care Market Innovation at Vanderbilt University, Nashville, Tenn.
Patients seem to like using telemedicine, observed New Jersey state Sen. Herb Conaway, MD, another presenter. “I think it’s here to stay, and it’s likely to expand going forward. But physicians and others are going to want to make sure it’s used appropriately.”
Some payers feel that telemedicine should be billed differently than brick and mortar visits, Dr. Conaway said. “Physicians feel differently about that, and so we’ll see how this goes, moving forward.”
Lately, there have been discussions of liability concerns associated with telemedicine, said CSRO President Madelaine A. Feldman, MD, who practices in New Orleans. “There are some things you can miss with virtual visits. Certain new patient visits may need to be done in person.”
The landscape of telehealth in rheumatology
Telehealth has directly affected the way rheumatologists do business. In a national survey of more than 1,100 adult patients, the American College of Rheumatology found that 66% are choosing telehealth for rheumatology visits, mainly to avoid exposure to the SARS-CoV-2 virus. This contrasts with a 52% decline in the percentage of patients who are currently seeing a rheumatologist since 2019. “The pandemic has altered almost every aspect of our rheumatology practices,” said ACR President Ellen Gravallese, MD in a statement. “It has impacted our patients’ lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.”
While many rheumatologists have resumed in-person visits, “others, like myself, are doing a hybrid,” Dr. Feldman said.
At the height of the pandemic in New York City, Elana J. Bernstein, MD’s practice relied entirely on telehealth visits. “We weren’t seeing any patients in the office for a couple of months. Now that things have reopened here, we’ve resumed face-to-face visits,” keeping some telehealth visits for patients who are still uncomfortable with in-person visits or who live far away, Dr. Bernstein, director of the scleroderma program at Columbia University, New York, said in an interview. She estimates that telehealth represents about 20%-30% of her practice right now.
Advantages, drawbacks of telehealth
For patients in underserved or geographically distant areas, telehealth means access to care, Kanika Monga, MD, of the University of Texas Health Science Center, Houston, said in an interview. During the COVID-19 public health crisis, “it has allowed the most vulnerable patient populations to continue receiving care at the click of a button.”
Virtual visits also improve patient care by improving follow-up and compliance, Dr. Monga continued. “For example, in our patient population, mobility can be a major issue because of the underlying disease. Telemedicine improves care for patients who struggle to make it to appointments.” It’s also more convenient for patients in her county that depend on arranged and/or public transportation and have to request a portion of their day off work for a doctor’s appointment.
But the virtual visit has its drawbacks. Different available platforms and their usability create challenges, Dr. Monga said. “Although some patients are tech-savvy, some are not. This is a challenge, especially when using platforms that have many steps involved.” Telemedicine also highlights general health inequities that already exist in some populations. Patients who are older, live in rural areas, are less educated, or are from a lower socioeconomic household might not have the technology or Internet connection available to enable telemedicine visits.
Telemedicine also complicates the physical examination, which is a central part of the diagnostic process, Dr. Bernstein said. Some components of the physical exam lend themselves to a video visit, such as evaluating for facial rashes or examining a patient’s digital ulcers. “But if you suspect the patient has rheumatoid arthritis, for example, you can’t examine the joints for swelling.” When seeing scleroderma patients over telemedicine, “I can’t perform the modified Rodnan skin score to assess for skin thickening, or auscultate the lungs for crackles. It’s also hard to assess a patient’s response to therapy over telemedicine,” Dr. Feldman added.
Some rheumatologists have sought out multiple pathways on telemedicine to provide more options for patients.
Christine Peoples, MD, clinical assistant professor of medicine at the University of Pittsburgh Medical Center, uses several telehealth options to reach patients that live in the largely rural area she serves. For her, telemedicine isn’t a novel concept. “I’ve been providing care through telemedicine for 6 years,” she said in an interview. Prior to COVID-19, her patients had gone to teleconsult centers for a telemedicine visit. With the onset of the COVID-19 pandemic, she expanded telehealth services to include more home video visits through the practice’s online medical record.
For care that can’t take place online, Dr. Peoples said she works with colleagues in orthopedics, which have far greater numbers than rheumatologists in Pennsylvania, to provide injections to patients. All of the teleconference centers are at local hospitals or outpatient community centers. Patients can go there to get an injection from another doctor, she said. Additionally, all of her practice’s locations at UPMC hospitals have infusion centers.
Adopting a ‘computer-side’ manner
Any practice offering telemedicine should be training their staff, as virtual meetings require certain skills, Dr. Peoples stressed. “You have to have experience as a rheumatologist, but you also have to have experience in telemedicine. Then it’s about merging those two skills.” Physicians need to be familiar with the technology and equipment. “I have a Bluetooth stethoscope that hears the heart and the lungs” of a patient during a virtual visit, she said.
Most importantly, physicians need to adopt a “computer-side” manner. “Make sure you have good eye contact on the screen, that you’re maintaining a good, professional relationship with the patient.” Training nurses to assist doctors during a telehealth visit is also key.
Dr. Peoples said UPMC has been training its fellows in telemedicine to adopt these skills.
Efforts to pay doctors for telehealth
As rheumatologists navigate the growing market for telehealth, questions remain about the long term payment outlook for these services.
For now, there appears to be reimbursement parity for telehealth visits, Dr. Feldman said. COVID-19’s public health emergency put into place certain flexibilities for telehealth. But some concerns remain about the commercial insurance sector. Whether private payers will continue paying the same amount as they do for in-person visits once the pandemic is over is unknown, Dr. Feldman added. “Insurance companies have had a boom in profits and should not be able to use ‘losses’ from COVID as an excuse for stopping pay parity for telehealth visits.”
David Allen, spokesperson for America’s Health Insurance Plans, said some plans are voluntarily offering telehealth payment parity during the public health emergency. “However, as a policy, AHIP does not support mandating that clinicians be paid the same amount for telehealth and in-person care,” Mr. Allen said, adding that AHIP hasn’t tallied how many insurance companies offer payment parity. “Too many variances exist between plans to make any kind of declarative statement on this.”
For her telemedicine visits at teleconsult centers, Dr. Peoples said compensation is comparable with traditional in-person visits. “Compensation is different for video visits where the patient is at home. However, these video visits are still reimbursed by most insurance plans.”
Federal payers and many states have taken actions on parity. Telehealth is seeing major legislative action at the state level, Kelly Hughes, a program director for the National Conference of State Legislatures, said during the CSRO meeting. All 50 states, the District of Columbia, and Puerto Rico have made revisions to telehealth policies during the COVID-19 pandemic to maintain access to health care services and to minimize potential exposure. Most of these are temporary modifications to address the pandemic, but some states are either adopting permanent changes or mulling over permanent changes to telehealth, Ms. Hughes said.
Modifications vary widely by state, but the top three trends include allowing reimbursement for phone calls (not requiring video), expanding the types of providers authorized to provide telehealth services, and allowing a relationship between a patient and provider to begin with a telehealth visit.
The Commonwealth Fund reports that at least 13 states have enacted payment parity laws in response to COVID-19. Another four had parity laws in place prior to the pandemic. “Many states have taken direct action via Medicaid policy; all but two issued specific guidance on the expansion or reimbursement of Medicaid-based telehealth services,” according to the Commonwealth Fund.
In Texas, where Dr. Monga practices. Gov. Greg Abbott (R) has temporarily waived regulations to lift certain telehealth restrictions. The Texas Department of Insurance under an emergency rule is directing state-regulated health plans to cover telemedicine visits at the same rate as in-person visits during the COVID-19 emergency declaration. “This has helped expand our telehealth options in Texas,” Dr. Monga said.
Medicare has also boosted coverage of telehealth services. “I appreciate that the Centers for Medicare & Medicaid Services has acknowledged the value of telehealth services by reimbursing for audio-only visits at the same rate as audiovisual and in-person evaluations during the public health emergency,” Dr. Monga said.
CMS has also proposed to expand telehealth access in its CY 2021 Physician Fee Schedule Proposed Rule. Additionally, the Department of Health & Human Services Office of Rights will not be penalizing physicians for HIPAA noncompliance for conducting visits through technologies such as FaceTime or Skype during COVID-19, she added.
While telehealth can’t replace all in-person visits in rheumatology, “it can certainly provide us with support during certain circumstances, as we have learned during the current health emergency,” Dr. Monga said. “I hope that even after this crisis has passed that parity for telehealth will be maintained and we can make permanent some of the current updates.”
Rheumatologists are seeing the number of telehealth visits skyrocket in their practices as the COVID-19 pandemic rages on and patients seek out alternatives to in-person visits. Telemedicine makes it easier for patients to connect with physicians, but not all patients have access to a computer or device. It also limits what a physician can do. Rheumatologists often rely on physical exams to make diagnoses and treatment decisions – an obstacle if you’re looking at patients through a computer screen.
Presenters at the 2020 Coalition of State Rheumatology Organizations’ state advocacy conference discussed the benefits and challenges of this mode of care in early September. Within weeks, the U.S. health system eliminated almost half of all medical care as the pandemic ramped up and things went virtual, said Larry Van Horn, PhD, MPH, a speaker at the CSRO conference. Still, “we are in uncharted territory with respect to how telehealth is being used. ... It’s being deployed everywhere, but it’s too early to tell how it’s affecting patient outcomes,” said Dr. Van Horn, founder and director of the Center of Health Care Market Innovation at Vanderbilt University, Nashville, Tenn.
Patients seem to like using telemedicine, observed New Jersey state Sen. Herb Conaway, MD, another presenter. “I think it’s here to stay, and it’s likely to expand going forward. But physicians and others are going to want to make sure it’s used appropriately.”
Some payers feel that telemedicine should be billed differently than brick and mortar visits, Dr. Conaway said. “Physicians feel differently about that, and so we’ll see how this goes, moving forward.”
Lately, there have been discussions of liability concerns associated with telemedicine, said CSRO President Madelaine A. Feldman, MD, who practices in New Orleans. “There are some things you can miss with virtual visits. Certain new patient visits may need to be done in person.”
The landscape of telehealth in rheumatology
Telehealth has directly affected the way rheumatologists do business. In a national survey of more than 1,100 adult patients, the American College of Rheumatology found that 66% are choosing telehealth for rheumatology visits, mainly to avoid exposure to the SARS-CoV-2 virus. This contrasts with a 52% decline in the percentage of patients who are currently seeing a rheumatologist since 2019. “The pandemic has altered almost every aspect of our rheumatology practices,” said ACR President Ellen Gravallese, MD in a statement. “It has impacted our patients’ lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.”
While many rheumatologists have resumed in-person visits, “others, like myself, are doing a hybrid,” Dr. Feldman said.
At the height of the pandemic in New York City, Elana J. Bernstein, MD’s practice relied entirely on telehealth visits. “We weren’t seeing any patients in the office for a couple of months. Now that things have reopened here, we’ve resumed face-to-face visits,” keeping some telehealth visits for patients who are still uncomfortable with in-person visits or who live far away, Dr. Bernstein, director of the scleroderma program at Columbia University, New York, said in an interview. She estimates that telehealth represents about 20%-30% of her practice right now.
Advantages, drawbacks of telehealth
For patients in underserved or geographically distant areas, telehealth means access to care, Kanika Monga, MD, of the University of Texas Health Science Center, Houston, said in an interview. During the COVID-19 public health crisis, “it has allowed the most vulnerable patient populations to continue receiving care at the click of a button.”
Virtual visits also improve patient care by improving follow-up and compliance, Dr. Monga continued. “For example, in our patient population, mobility can be a major issue because of the underlying disease. Telemedicine improves care for patients who struggle to make it to appointments.” It’s also more convenient for patients in her county that depend on arranged and/or public transportation and have to request a portion of their day off work for a doctor’s appointment.
But the virtual visit has its drawbacks. Different available platforms and their usability create challenges, Dr. Monga said. “Although some patients are tech-savvy, some are not. This is a challenge, especially when using platforms that have many steps involved.” Telemedicine also highlights general health inequities that already exist in some populations. Patients who are older, live in rural areas, are less educated, or are from a lower socioeconomic household might not have the technology or Internet connection available to enable telemedicine visits.
Telemedicine also complicates the physical examination, which is a central part of the diagnostic process, Dr. Bernstein said. Some components of the physical exam lend themselves to a video visit, such as evaluating for facial rashes or examining a patient’s digital ulcers. “But if you suspect the patient has rheumatoid arthritis, for example, you can’t examine the joints for swelling.” When seeing scleroderma patients over telemedicine, “I can’t perform the modified Rodnan skin score to assess for skin thickening, or auscultate the lungs for crackles. It’s also hard to assess a patient’s response to therapy over telemedicine,” Dr. Feldman added.
Some rheumatologists have sought out multiple pathways on telemedicine to provide more options for patients.
Christine Peoples, MD, clinical assistant professor of medicine at the University of Pittsburgh Medical Center, uses several telehealth options to reach patients that live in the largely rural area she serves. For her, telemedicine isn’t a novel concept. “I’ve been providing care through telemedicine for 6 years,” she said in an interview. Prior to COVID-19, her patients had gone to teleconsult centers for a telemedicine visit. With the onset of the COVID-19 pandemic, she expanded telehealth services to include more home video visits through the practice’s online medical record.
For care that can’t take place online, Dr. Peoples said she works with colleagues in orthopedics, which have far greater numbers than rheumatologists in Pennsylvania, to provide injections to patients. All of the teleconference centers are at local hospitals or outpatient community centers. Patients can go there to get an injection from another doctor, she said. Additionally, all of her practice’s locations at UPMC hospitals have infusion centers.
Adopting a ‘computer-side’ manner
Any practice offering telemedicine should be training their staff, as virtual meetings require certain skills, Dr. Peoples stressed. “You have to have experience as a rheumatologist, but you also have to have experience in telemedicine. Then it’s about merging those two skills.” Physicians need to be familiar with the technology and equipment. “I have a Bluetooth stethoscope that hears the heart and the lungs” of a patient during a virtual visit, she said.
Most importantly, physicians need to adopt a “computer-side” manner. “Make sure you have good eye contact on the screen, that you’re maintaining a good, professional relationship with the patient.” Training nurses to assist doctors during a telehealth visit is also key.
Dr. Peoples said UPMC has been training its fellows in telemedicine to adopt these skills.
Efforts to pay doctors for telehealth
As rheumatologists navigate the growing market for telehealth, questions remain about the long term payment outlook for these services.
For now, there appears to be reimbursement parity for telehealth visits, Dr. Feldman said. COVID-19’s public health emergency put into place certain flexibilities for telehealth. But some concerns remain about the commercial insurance sector. Whether private payers will continue paying the same amount as they do for in-person visits once the pandemic is over is unknown, Dr. Feldman added. “Insurance companies have had a boom in profits and should not be able to use ‘losses’ from COVID as an excuse for stopping pay parity for telehealth visits.”
David Allen, spokesperson for America’s Health Insurance Plans, said some plans are voluntarily offering telehealth payment parity during the public health emergency. “However, as a policy, AHIP does not support mandating that clinicians be paid the same amount for telehealth and in-person care,” Mr. Allen said, adding that AHIP hasn’t tallied how many insurance companies offer payment parity. “Too many variances exist between plans to make any kind of declarative statement on this.”
For her telemedicine visits at teleconsult centers, Dr. Peoples said compensation is comparable with traditional in-person visits. “Compensation is different for video visits where the patient is at home. However, these video visits are still reimbursed by most insurance plans.”
Federal payers and many states have taken actions on parity. Telehealth is seeing major legislative action at the state level, Kelly Hughes, a program director for the National Conference of State Legislatures, said during the CSRO meeting. All 50 states, the District of Columbia, and Puerto Rico have made revisions to telehealth policies during the COVID-19 pandemic to maintain access to health care services and to minimize potential exposure. Most of these are temporary modifications to address the pandemic, but some states are either adopting permanent changes or mulling over permanent changes to telehealth, Ms. Hughes said.
Modifications vary widely by state, but the top three trends include allowing reimbursement for phone calls (not requiring video), expanding the types of providers authorized to provide telehealth services, and allowing a relationship between a patient and provider to begin with a telehealth visit.
The Commonwealth Fund reports that at least 13 states have enacted payment parity laws in response to COVID-19. Another four had parity laws in place prior to the pandemic. “Many states have taken direct action via Medicaid policy; all but two issued specific guidance on the expansion or reimbursement of Medicaid-based telehealth services,” according to the Commonwealth Fund.
In Texas, where Dr. Monga practices. Gov. Greg Abbott (R) has temporarily waived regulations to lift certain telehealth restrictions. The Texas Department of Insurance under an emergency rule is directing state-regulated health plans to cover telemedicine visits at the same rate as in-person visits during the COVID-19 emergency declaration. “This has helped expand our telehealth options in Texas,” Dr. Monga said.
Medicare has also boosted coverage of telehealth services. “I appreciate that the Centers for Medicare & Medicaid Services has acknowledged the value of telehealth services by reimbursing for audio-only visits at the same rate as audiovisual and in-person evaluations during the public health emergency,” Dr. Monga said.
CMS has also proposed to expand telehealth access in its CY 2021 Physician Fee Schedule Proposed Rule. Additionally, the Department of Health & Human Services Office of Rights will not be penalizing physicians for HIPAA noncompliance for conducting visits through technologies such as FaceTime or Skype during COVID-19, she added.
While telehealth can’t replace all in-person visits in rheumatology, “it can certainly provide us with support during certain circumstances, as we have learned during the current health emergency,” Dr. Monga said. “I hope that even after this crisis has passed that parity for telehealth will be maintained and we can make permanent some of the current updates.”
Rheumatologists are seeing the number of telehealth visits skyrocket in their practices as the COVID-19 pandemic rages on and patients seek out alternatives to in-person visits. Telemedicine makes it easier for patients to connect with physicians, but not all patients have access to a computer or device. It also limits what a physician can do. Rheumatologists often rely on physical exams to make diagnoses and treatment decisions – an obstacle if you’re looking at patients through a computer screen.
Presenters at the 2020 Coalition of State Rheumatology Organizations’ state advocacy conference discussed the benefits and challenges of this mode of care in early September. Within weeks, the U.S. health system eliminated almost half of all medical care as the pandemic ramped up and things went virtual, said Larry Van Horn, PhD, MPH, a speaker at the CSRO conference. Still, “we are in uncharted territory with respect to how telehealth is being used. ... It’s being deployed everywhere, but it’s too early to tell how it’s affecting patient outcomes,” said Dr. Van Horn, founder and director of the Center of Health Care Market Innovation at Vanderbilt University, Nashville, Tenn.
Patients seem to like using telemedicine, observed New Jersey state Sen. Herb Conaway, MD, another presenter. “I think it’s here to stay, and it’s likely to expand going forward. But physicians and others are going to want to make sure it’s used appropriately.”
Some payers feel that telemedicine should be billed differently than brick and mortar visits, Dr. Conaway said. “Physicians feel differently about that, and so we’ll see how this goes, moving forward.”
Lately, there have been discussions of liability concerns associated with telemedicine, said CSRO President Madelaine A. Feldman, MD, who practices in New Orleans. “There are some things you can miss with virtual visits. Certain new patient visits may need to be done in person.”
The landscape of telehealth in rheumatology
Telehealth has directly affected the way rheumatologists do business. In a national survey of more than 1,100 adult patients, the American College of Rheumatology found that 66% are choosing telehealth for rheumatology visits, mainly to avoid exposure to the SARS-CoV-2 virus. This contrasts with a 52% decline in the percentage of patients who are currently seeing a rheumatologist since 2019. “The pandemic has altered almost every aspect of our rheumatology practices,” said ACR President Ellen Gravallese, MD in a statement. “It has impacted our patients’ lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.”
While many rheumatologists have resumed in-person visits, “others, like myself, are doing a hybrid,” Dr. Feldman said.
At the height of the pandemic in New York City, Elana J. Bernstein, MD’s practice relied entirely on telehealth visits. “We weren’t seeing any patients in the office for a couple of months. Now that things have reopened here, we’ve resumed face-to-face visits,” keeping some telehealth visits for patients who are still uncomfortable with in-person visits or who live far away, Dr. Bernstein, director of the scleroderma program at Columbia University, New York, said in an interview. She estimates that telehealth represents about 20%-30% of her practice right now.
Advantages, drawbacks of telehealth
For patients in underserved or geographically distant areas, telehealth means access to care, Kanika Monga, MD, of the University of Texas Health Science Center, Houston, said in an interview. During the COVID-19 public health crisis, “it has allowed the most vulnerable patient populations to continue receiving care at the click of a button.”
Virtual visits also improve patient care by improving follow-up and compliance, Dr. Monga continued. “For example, in our patient population, mobility can be a major issue because of the underlying disease. Telemedicine improves care for patients who struggle to make it to appointments.” It’s also more convenient for patients in her county that depend on arranged and/or public transportation and have to request a portion of their day off work for a doctor’s appointment.
But the virtual visit has its drawbacks. Different available platforms and their usability create challenges, Dr. Monga said. “Although some patients are tech-savvy, some are not. This is a challenge, especially when using platforms that have many steps involved.” Telemedicine also highlights general health inequities that already exist in some populations. Patients who are older, live in rural areas, are less educated, or are from a lower socioeconomic household might not have the technology or Internet connection available to enable telemedicine visits.
Telemedicine also complicates the physical examination, which is a central part of the diagnostic process, Dr. Bernstein said. Some components of the physical exam lend themselves to a video visit, such as evaluating for facial rashes or examining a patient’s digital ulcers. “But if you suspect the patient has rheumatoid arthritis, for example, you can’t examine the joints for swelling.” When seeing scleroderma patients over telemedicine, “I can’t perform the modified Rodnan skin score to assess for skin thickening, or auscultate the lungs for crackles. It’s also hard to assess a patient’s response to therapy over telemedicine,” Dr. Feldman added.
Some rheumatologists have sought out multiple pathways on telemedicine to provide more options for patients.
Christine Peoples, MD, clinical assistant professor of medicine at the University of Pittsburgh Medical Center, uses several telehealth options to reach patients that live in the largely rural area she serves. For her, telemedicine isn’t a novel concept. “I’ve been providing care through telemedicine for 6 years,” she said in an interview. Prior to COVID-19, her patients had gone to teleconsult centers for a telemedicine visit. With the onset of the COVID-19 pandemic, she expanded telehealth services to include more home video visits through the practice’s online medical record.
For care that can’t take place online, Dr. Peoples said she works with colleagues in orthopedics, which have far greater numbers than rheumatologists in Pennsylvania, to provide injections to patients. All of the teleconference centers are at local hospitals or outpatient community centers. Patients can go there to get an injection from another doctor, she said. Additionally, all of her practice’s locations at UPMC hospitals have infusion centers.
Adopting a ‘computer-side’ manner
Any practice offering telemedicine should be training their staff, as virtual meetings require certain skills, Dr. Peoples stressed. “You have to have experience as a rheumatologist, but you also have to have experience in telemedicine. Then it’s about merging those two skills.” Physicians need to be familiar with the technology and equipment. “I have a Bluetooth stethoscope that hears the heart and the lungs” of a patient during a virtual visit, she said.
Most importantly, physicians need to adopt a “computer-side” manner. “Make sure you have good eye contact on the screen, that you’re maintaining a good, professional relationship with the patient.” Training nurses to assist doctors during a telehealth visit is also key.
Dr. Peoples said UPMC has been training its fellows in telemedicine to adopt these skills.
Efforts to pay doctors for telehealth
As rheumatologists navigate the growing market for telehealth, questions remain about the long term payment outlook for these services.
For now, there appears to be reimbursement parity for telehealth visits, Dr. Feldman said. COVID-19’s public health emergency put into place certain flexibilities for telehealth. But some concerns remain about the commercial insurance sector. Whether private payers will continue paying the same amount as they do for in-person visits once the pandemic is over is unknown, Dr. Feldman added. “Insurance companies have had a boom in profits and should not be able to use ‘losses’ from COVID as an excuse for stopping pay parity for telehealth visits.”
David Allen, spokesperson for America’s Health Insurance Plans, said some plans are voluntarily offering telehealth payment parity during the public health emergency. “However, as a policy, AHIP does not support mandating that clinicians be paid the same amount for telehealth and in-person care,” Mr. Allen said, adding that AHIP hasn’t tallied how many insurance companies offer payment parity. “Too many variances exist between plans to make any kind of declarative statement on this.”
For her telemedicine visits at teleconsult centers, Dr. Peoples said compensation is comparable with traditional in-person visits. “Compensation is different for video visits where the patient is at home. However, these video visits are still reimbursed by most insurance plans.”
Federal payers and many states have taken actions on parity. Telehealth is seeing major legislative action at the state level, Kelly Hughes, a program director for the National Conference of State Legislatures, said during the CSRO meeting. All 50 states, the District of Columbia, and Puerto Rico have made revisions to telehealth policies during the COVID-19 pandemic to maintain access to health care services and to minimize potential exposure. Most of these are temporary modifications to address the pandemic, but some states are either adopting permanent changes or mulling over permanent changes to telehealth, Ms. Hughes said.
Modifications vary widely by state, but the top three trends include allowing reimbursement for phone calls (not requiring video), expanding the types of providers authorized to provide telehealth services, and allowing a relationship between a patient and provider to begin with a telehealth visit.
The Commonwealth Fund reports that at least 13 states have enacted payment parity laws in response to COVID-19. Another four had parity laws in place prior to the pandemic. “Many states have taken direct action via Medicaid policy; all but two issued specific guidance on the expansion or reimbursement of Medicaid-based telehealth services,” according to the Commonwealth Fund.
In Texas, where Dr. Monga practices. Gov. Greg Abbott (R) has temporarily waived regulations to lift certain telehealth restrictions. The Texas Department of Insurance under an emergency rule is directing state-regulated health plans to cover telemedicine visits at the same rate as in-person visits during the COVID-19 emergency declaration. “This has helped expand our telehealth options in Texas,” Dr. Monga said.
Medicare has also boosted coverage of telehealth services. “I appreciate that the Centers for Medicare & Medicaid Services has acknowledged the value of telehealth services by reimbursing for audio-only visits at the same rate as audiovisual and in-person evaluations during the public health emergency,” Dr. Monga said.
CMS has also proposed to expand telehealth access in its CY 2021 Physician Fee Schedule Proposed Rule. Additionally, the Department of Health & Human Services Office of Rights will not be penalizing physicians for HIPAA noncompliance for conducting visits through technologies such as FaceTime or Skype during COVID-19, she added.
While telehealth can’t replace all in-person visits in rheumatology, “it can certainly provide us with support during certain circumstances, as we have learned during the current health emergency,” Dr. Monga said. “I hope that even after this crisis has passed that parity for telehealth will be maintained and we can make permanent some of the current updates.”
Breast Cancer: 9/22/20
Efficacy of immunotherapy also depends on breast cancer subtype. Triple-negative and HER2-positive tumors have higher TMB and TILs compared to luminal subtype. A phase 2 study in 88 patients with metastatic HR-positive, ERBB2-negative breast cancer demonstrated no difference in PFS or ORR with pembrolizumab/eribulin versus eribulin alone, including the PD-L1 positive population. There was a trend towards greater immunotherapy benefit in the high TMB subgroup which is encouraging. Future research with novel agents that may augment immune response and/or alter tumor microenvironment are intriguing concepts.
First-line endocrine therapy plus CDK 4/6 inhibitor is considered standard of care for HR-positive metastatic breast cancer. A retrospective chart review evaluating everolimus plus endocrine therapy post-CDK 4/6 inhibitor demonstrated PFS of 4.2 months and ORR of 17%. Although benefit appears modest, mTOR inhibitor combinations remain a valuable treatment option for select patients. Chemotherapy is often reserved for rapidly progressive disease or visceral crisis, however, it is crucial to evaluate for endocrine resistance. Furthermore, additional research is warranted to determine interactions between PI3K/Akt/mTOR and downstream Cyclin D/CDK 4/6/Rb pathways and implications on treatment sequencing.
Trastuzumab therapy for 1 year is standard of care for early-stage HER2-positive breast cancer. A meta-analysis of 5 trials with 11,376 patients showed noninferiority of shorter duration trastuzumab compared to 1 year for DFS and OS and lower congestive heart failure rates with the former. Trastuzumab is well-tolerated, and although cardiac toxicity is often reversible, it can carry more severe consequences in patients with cardiac conditions. Shorter duration may be an option in patients with clinically lower risk disease (ER-positive, node-negative tumors) and significant cardiac risk factors, and represents a method of therapy de-escalation for the appropriate patient.
The COVID-19 pandemic has impacted oncology healthcare delivery models and cancer patients have poorer outcomes from COVID-19. A survey study of Brazilian breast cancer specialists demonstrated changing practices for early-stage breast cancer as the pandemic progressed. For HR-positive tumors with low ki-67, 48% would recommend NET for postmenopausal women, while 34% would recommend NET for those with high ki-67. There is limited data regarding NET for pre-menopausal women. Genomic assays may have an evolving role to identify patients who may be appropriate candidates for neoadjuvant therapy versus upfront surgery. Strategies to decrease treatment complications and effectively utilize resources are essential during the COVID-19 pandemic.
Erin Roesch, MD
The Cleveland Clinic
References:
Zhu L, Narloch, JL, Onkar S, et al. Metastatic breast cancers have reduced immune cell recruitment but harbor increased macrophages relative to their matched primary tumors. J Immunother Cancer 2019; 7:265.
Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: An analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol. 2020; 6(5):676–684.
Schmid P, Adams S, Rugo HS, et al. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). J Clin Oncol 2019; 37S:ASCO #1003.
Cortes J, Cescon DW, Rugo HS, et al. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. J Clin Oncol 2020;38S:ASCO #1000.
Martinello R, Becco P, Vici P, et al. Trastuzumab-related cardiotoxicity in patients with nonlimiting cardiac comorbidity. Breast J 2019; 25(3):444-449.
Liang W, Guan W, Chen R, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol 2020; 21(3):335-337.
Efficacy of immunotherapy also depends on breast cancer subtype. Triple-negative and HER2-positive tumors have higher TMB and TILs compared to luminal subtype. A phase 2 study in 88 patients with metastatic HR-positive, ERBB2-negative breast cancer demonstrated no difference in PFS or ORR with pembrolizumab/eribulin versus eribulin alone, including the PD-L1 positive population. There was a trend towards greater immunotherapy benefit in the high TMB subgroup which is encouraging. Future research with novel agents that may augment immune response and/or alter tumor microenvironment are intriguing concepts.
First-line endocrine therapy plus CDK 4/6 inhibitor is considered standard of care for HR-positive metastatic breast cancer. A retrospective chart review evaluating everolimus plus endocrine therapy post-CDK 4/6 inhibitor demonstrated PFS of 4.2 months and ORR of 17%. Although benefit appears modest, mTOR inhibitor combinations remain a valuable treatment option for select patients. Chemotherapy is often reserved for rapidly progressive disease or visceral crisis, however, it is crucial to evaluate for endocrine resistance. Furthermore, additional research is warranted to determine interactions between PI3K/Akt/mTOR and downstream Cyclin D/CDK 4/6/Rb pathways and implications on treatment sequencing.
Trastuzumab therapy for 1 year is standard of care for early-stage HER2-positive breast cancer. A meta-analysis of 5 trials with 11,376 patients showed noninferiority of shorter duration trastuzumab compared to 1 year for DFS and OS and lower congestive heart failure rates with the former. Trastuzumab is well-tolerated, and although cardiac toxicity is often reversible, it can carry more severe consequences in patients with cardiac conditions. Shorter duration may be an option in patients with clinically lower risk disease (ER-positive, node-negative tumors) and significant cardiac risk factors, and represents a method of therapy de-escalation for the appropriate patient.
The COVID-19 pandemic has impacted oncology healthcare delivery models and cancer patients have poorer outcomes from COVID-19. A survey study of Brazilian breast cancer specialists demonstrated changing practices for early-stage breast cancer as the pandemic progressed. For HR-positive tumors with low ki-67, 48% would recommend NET for postmenopausal women, while 34% would recommend NET for those with high ki-67. There is limited data regarding NET for pre-menopausal women. Genomic assays may have an evolving role to identify patients who may be appropriate candidates for neoadjuvant therapy versus upfront surgery. Strategies to decrease treatment complications and effectively utilize resources are essential during the COVID-19 pandemic.
Erin Roesch, MD
The Cleveland Clinic
References:
Zhu L, Narloch, JL, Onkar S, et al. Metastatic breast cancers have reduced immune cell recruitment but harbor increased macrophages relative to their matched primary tumors. J Immunother Cancer 2019; 7:265.
Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: An analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol. 2020; 6(5):676–684.
Schmid P, Adams S, Rugo HS, et al. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). J Clin Oncol 2019; 37S:ASCO #1003.
Cortes J, Cescon DW, Rugo HS, et al. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. J Clin Oncol 2020;38S:ASCO #1000.
Martinello R, Becco P, Vici P, et al. Trastuzumab-related cardiotoxicity in patients with nonlimiting cardiac comorbidity. Breast J 2019; 25(3):444-449.
Liang W, Guan W, Chen R, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol 2020; 21(3):335-337.
Efficacy of immunotherapy also depends on breast cancer subtype. Triple-negative and HER2-positive tumors have higher TMB and TILs compared to luminal subtype. A phase 2 study in 88 patients with metastatic HR-positive, ERBB2-negative breast cancer demonstrated no difference in PFS or ORR with pembrolizumab/eribulin versus eribulin alone, including the PD-L1 positive population. There was a trend towards greater immunotherapy benefit in the high TMB subgroup which is encouraging. Future research with novel agents that may augment immune response and/or alter tumor microenvironment are intriguing concepts.
First-line endocrine therapy plus CDK 4/6 inhibitor is considered standard of care for HR-positive metastatic breast cancer. A retrospective chart review evaluating everolimus plus endocrine therapy post-CDK 4/6 inhibitor demonstrated PFS of 4.2 months and ORR of 17%. Although benefit appears modest, mTOR inhibitor combinations remain a valuable treatment option for select patients. Chemotherapy is often reserved for rapidly progressive disease or visceral crisis, however, it is crucial to evaluate for endocrine resistance. Furthermore, additional research is warranted to determine interactions between PI3K/Akt/mTOR and downstream Cyclin D/CDK 4/6/Rb pathways and implications on treatment sequencing.
Trastuzumab therapy for 1 year is standard of care for early-stage HER2-positive breast cancer. A meta-analysis of 5 trials with 11,376 patients showed noninferiority of shorter duration trastuzumab compared to 1 year for DFS and OS and lower congestive heart failure rates with the former. Trastuzumab is well-tolerated, and although cardiac toxicity is often reversible, it can carry more severe consequences in patients with cardiac conditions. Shorter duration may be an option in patients with clinically lower risk disease (ER-positive, node-negative tumors) and significant cardiac risk factors, and represents a method of therapy de-escalation for the appropriate patient.
The COVID-19 pandemic has impacted oncology healthcare delivery models and cancer patients have poorer outcomes from COVID-19. A survey study of Brazilian breast cancer specialists demonstrated changing practices for early-stage breast cancer as the pandemic progressed. For HR-positive tumors with low ki-67, 48% would recommend NET for postmenopausal women, while 34% would recommend NET for those with high ki-67. There is limited data regarding NET for pre-menopausal women. Genomic assays may have an evolving role to identify patients who may be appropriate candidates for neoadjuvant therapy versus upfront surgery. Strategies to decrease treatment complications and effectively utilize resources are essential during the COVID-19 pandemic.
Erin Roesch, MD
The Cleveland Clinic
References:
Zhu L, Narloch, JL, Onkar S, et al. Metastatic breast cancers have reduced immune cell recruitment but harbor increased macrophages relative to their matched primary tumors. J Immunother Cancer 2019; 7:265.
Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: An analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol. 2020; 6(5):676–684.
Schmid P, Adams S, Rugo HS, et al. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). J Clin Oncol 2019; 37S:ASCO #1003.
Cortes J, Cescon DW, Rugo HS, et al. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. J Clin Oncol 2020;38S:ASCO #1000.
Martinello R, Becco P, Vici P, et al. Trastuzumab-related cardiotoxicity in patients with nonlimiting cardiac comorbidity. Breast J 2019; 25(3):444-449.
Liang W, Guan W, Chen R, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol 2020; 21(3):335-337.
Sarcoidosis can co-occur in older patients with breast cancer
Key clinical point: Sarcoidosis can develop after breast cancer and requires histologic confirmation.
Major finding: Twenty of 429 (4.9%) women with sarcoidosis had breast cancer, which usually was diagnosed first. Sarcoidosis was diagnosed at a median age of 53.9 years, most often involved the lungs and central lymph nodes, and was asymptomatic in half of cases.
Study details: Single-center retrospective study of 1,000 sarcoidosis cases.
Disclosures: The study was not funded. The investigators reported having no conflicts.
Citation: Papanikolaou IC et al. Resp Med Case Rep. 2020 Aug 13. doi: 10.1016/j.rmcr.2020.101190
Key clinical point: Sarcoidosis can develop after breast cancer and requires histologic confirmation.
Major finding: Twenty of 429 (4.9%) women with sarcoidosis had breast cancer, which usually was diagnosed first. Sarcoidosis was diagnosed at a median age of 53.9 years, most often involved the lungs and central lymph nodes, and was asymptomatic in half of cases.
Study details: Single-center retrospective study of 1,000 sarcoidosis cases.
Disclosures: The study was not funded. The investigators reported having no conflicts.
Citation: Papanikolaou IC et al. Resp Med Case Rep. 2020 Aug 13. doi: 10.1016/j.rmcr.2020.101190
Key clinical point: Sarcoidosis can develop after breast cancer and requires histologic confirmation.
Major finding: Twenty of 429 (4.9%) women with sarcoidosis had breast cancer, which usually was diagnosed first. Sarcoidosis was diagnosed at a median age of 53.9 years, most often involved the lungs and central lymph nodes, and was asymptomatic in half of cases.
Study details: Single-center retrospective study of 1,000 sarcoidosis cases.
Disclosures: The study was not funded. The investigators reported having no conflicts.
Citation: Papanikolaou IC et al. Resp Med Case Rep. 2020 Aug 13. doi: 10.1016/j.rmcr.2020.101190
Everolimus after palbociclib of modest value in metastatic HR+ HER2- breast cancer
Key clinical point: The mTOR inhibitor everolimus performed modestly when sequenced after palbociclib in metastatic HR+ HER2- breast cancer.
Major finding: Median PFS on everolimus was 4.2 months. ORR was 17.1% (all partial responses).
Study details: Two-center retrospective chart review of 41 patients who received everolimus combinations after their metastatic HR+ HER2- breast cancer progressed on palbociclib.
Disclosures: The National Cancer Institute provided funding. Four of the investigators disclosed ties to Novartis, Pfizer, and other pharmaceutical companies.
Citation: Dhakal A et al. Breast Cancer (Auckl). 2020 Jul 23. doi: 10.1177/1178223420944864
Key clinical point: The mTOR inhibitor everolimus performed modestly when sequenced after palbociclib in metastatic HR+ HER2- breast cancer.
Major finding: Median PFS on everolimus was 4.2 months. ORR was 17.1% (all partial responses).
Study details: Two-center retrospective chart review of 41 patients who received everolimus combinations after their metastatic HR+ HER2- breast cancer progressed on palbociclib.
Disclosures: The National Cancer Institute provided funding. Four of the investigators disclosed ties to Novartis, Pfizer, and other pharmaceutical companies.
Citation: Dhakal A et al. Breast Cancer (Auckl). 2020 Jul 23. doi: 10.1177/1178223420944864
Key clinical point: The mTOR inhibitor everolimus performed modestly when sequenced after palbociclib in metastatic HR+ HER2- breast cancer.
Major finding: Median PFS on everolimus was 4.2 months. ORR was 17.1% (all partial responses).
Study details: Two-center retrospective chart review of 41 patients who received everolimus combinations after their metastatic HR+ HER2- breast cancer progressed on palbociclib.
Disclosures: The National Cancer Institute provided funding. Four of the investigators disclosed ties to Novartis, Pfizer, and other pharmaceutical companies.
Citation: Dhakal A et al. Breast Cancer (Auckl). 2020 Jul 23. doi: 10.1177/1178223420944864