COVID-19 News

The first report on responses to COVID-19 vaccination among patients with cancer suggests that, for these patients, the immune response that occurs after the first dose of vaccine is reduced, in comparison with the response that occurs in healthy individuals.

The new findings, which are soon to be published as a preprint, cast doubt on the current U.K. policy of delaying the second dose of the vaccine.

Delaying the second dose can leave most patients with cancer wholly or partially unprotected, according to the researchers. Moreover, such a delay has implications for transmission of SARS-CoV-2 in the cancer patient’s environs as well as for the evolution of virus variants that could be of concern, the researchers concluded.

The data come from a British study that included 151 patients with cancer and 54 healthy control persons. All participants received the COVID-19 mRNA BNT162b2 vaccine (Pfizer-BioNTech).

This vaccine requires two doses. The first few participants in this study were given the second dose 21 days after they had received the first dose, but then national guidelines changed, and the remaining participants had to wait 12 weeks to receive their second dose.

The researchers reported that, among health controls, the immune efficacy of the first dose was very high (97% efficacious). By contrast, among patients with solid tumors, the immune efficacy of a single dose was strikingly low (39%), and it was even lower in patients with hematologic malignancies (13%).

The second dose of vaccine greatly and rapidly increased the immune efficacy in patients with solid tumors (95% within 2 weeks of receiving the second dose), the researchers added.

Too few patients with hematologic cancers had received the second dose before the study ended for clear conclusions to be drawn. Nevertheless, the available data suggest that 50% of patients with hematologic cancers who had received the booster at day 21 were seropositive at 5 weeks vs. only 8% of those who had not received the booster.

“Our data provide the first real-world evidence of immune efficacy following one dose of the Pfizer vaccine in immunocompromised patient populations [and] clearly show that the poor one-dose efficacy in cancer patients can be rescued with an early booster at day 21,” commented senior author Sheeba Irshad, MD, senior clinical lecturer, King’s College London.

“Based on our findings, we would recommend an urgent review of the vaccine strategy for clinically extremely vulnerable groups. Until then, it is important that cancer patients continue to observe all public health measures in place, such as social distancing and shielding when attending hospitals, even after vaccination,” Dr. Irshad added.

The paper, with first author Leticia Monin-Aldama, PhD, is scheduled to appear on the preprint server medRxiv. It has not undergone peer review. The paper was distributed to journalists, with comments from experts not involved in the study, by the UK Science Media Centre.

These data are “of immediate importance” to patients with cancer, commented Shoba Amarnath, PhD, Newcastle University research fellow, Laboratory of T-cell Regulation, Newcastle University Center for Cancer, Newcastle upon Tyne, England.

“These findings are consistent with our understanding. … We know that the immune system within cancer patients is compromised as compared to healthy controls,” Dr. Amarnath said. “The data in the study support the notion that, in solid cancer patients, a considerable delay in second dose will extend the period when cancer patients are at risk of SARS-CoV-2 infection.”

Although more data are required, “this study does raise the issue of whether patients with cancer, other diseases, or those undergoing therapies that affect the body’s immune response should be fast-tracked for their second vaccine dose,” commented Lawrence Young, PhD, professor of molecular oncology and director of the Warwick Cancer Research Center, University of Warwick, Coventry, England.

Stephen Evans, MSc, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, underlined that the study is “essentially” observational and “inevitable limitations must be taken into account.

“Nevertheless, these results do suggest that the vaccines may well not protect those patients with cancer as well as those without cancer,” Mr. Evans said. He added that it is “important that this population continues to observe all COVID-19–associated measures, such as social distancing and shielding when attending hospitals, even after vaccination.”

Study details

Previous studies have shown that some patients with cancer have prolonged responses to SARS-CoV-2 infection, with ongoing immune dysregulation, inefficient seroconversion, and prolonged viral shedding.

There are few data, however, on how these patients respond to COVID-19 vaccination. The authors point out that, among the 18,860 individuals who received the Pfizer vaccine during its development trials, “none with an active oncological diagnosis was included.”

To investigate this issue, they launched the SARS-CoV-2 for Cancer Patients (SOAP-02) study.

The 151 patients with cancer who participated in this study were mostly elderly, the authors noted (75% were older than 65 years; the median age was 73 years). The majority (63%) had solid-tumor malignancies. Of those, 8% had late-stage disease and had been living with their cancer for more than 24 months.

The healthy control persons were vaccine-eligible primary health care workers who were not age matched to the cancer patients.

All participants received the first dose of vaccine; 31 (of 151) patients with cancer and 16 (of 54) healthy control persons received the second dose on day 21.

The remaining participants were scheduled to receive their second dose 12 weeks later (after the study ended), in line with the changes in the national guidelines.

The team reported that, approximately 21 days after receiving the first vaccine dose, the immune efficacy of the vaccine was estimated to be 97% among healthy control persons vs. 39% for patients with solid tumors and only 13% for those with hematologic malignancies (P < .0001 for both).

T-cell responses, as assessed via interferon-gamma and/or interleukin-2 production, were observed in 82% of healthy control persons, 71% of patients with solid tumors, and 50% of those with hematologic cancers.

Vaccine boosting at day 21 resulted in immune efficacy of 100% for healthy control persons and 95% for patients with solid tumors. In contrast, only 43% of those who did not receive the second dose were seropositive 2 weeks later.

Further analysis suggested that participants who did not have a serologic response were “spread evenly” across different cancer types, but the reduced responses were more frequent among patients who had received the vaccine within 15 days of cancer treatment, especially chemotherapy, and had undergone intensive treatments.

The SOAP study is sponsored by King’s College London and Guy’s and St. Thomas Trust Foundation NHS Trust. It is funded from grants from the KCL Charity, Cancer Research UK, and program grants from Breast Cancer Now. The investigators have disclosed no relevant financial relationships.

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

The first report on responses to COVID-19 vaccination among patients with cancer suggests that, for these patients, the immune response that occurs after the first dose of vaccine is reduced, in comparison with the response that occurs in healthy individuals.

The new findings, which are soon to be published as a preprint, cast doubt on the current U.K. policy of delaying the second dose of the vaccine.

Delaying the second dose can leave most patients with cancer wholly or partially unprotected, according to the researchers. Moreover, such a delay has implications for transmission of SARS-CoV-2 in the cancer patient’s environs as well as for the evolution of virus variants that could be of concern, the researchers concluded.

The data come from a British study that included 151 patients with cancer and 54 healthy control persons. All participants received the COVID-19 mRNA BNT162b2 vaccine (Pfizer-BioNTech).

This vaccine requires two doses. The first few participants in this study were given the second dose 21 days after they had received the first dose, but then national guidelines changed, and the remaining participants had to wait 12 weeks to receive their second dose.

The researchers reported that, among health controls, the immune efficacy of the first dose was very high (97% efficacious). By contrast, among patients with solid tumors, the immune efficacy of a single dose was strikingly low (39%), and it was even lower in patients with hematologic malignancies (13%).

The second dose of vaccine greatly and rapidly increased the immune efficacy in patients with solid tumors (95% within 2 weeks of receiving the second dose), the researchers added.

Too few patients with hematologic cancers had received the second dose before the study ended for clear conclusions to be drawn. Nevertheless, the available data suggest that 50% of patients with hematologic cancers who had received the booster at day 21 were seropositive at 5 weeks vs. only 8% of those who had not received the booster.

“Our data provide the first real-world evidence of immune efficacy following one dose of the Pfizer vaccine in immunocompromised patient populations [and] clearly show that the poor one-dose efficacy in cancer patients can be rescued with an early booster at day 21,” commented senior author Sheeba Irshad, MD, senior clinical lecturer, King’s College London.

“Based on our findings, we would recommend an urgent review of the vaccine strategy for clinically extremely vulnerable groups. Until then, it is important that cancer patients continue to observe all public health measures in place, such as social distancing and shielding when attending hospitals, even after vaccination,” Dr. Irshad added.

The paper, with first author Leticia Monin-Aldama, PhD, is scheduled to appear on the preprint server medRxiv. It has not undergone peer review. The paper was distributed to journalists, with comments from experts not involved in the study, by the UK Science Media Centre.

These data are “of immediate importance” to patients with cancer, commented Shoba Amarnath, PhD, Newcastle University research fellow, Laboratory of T-cell Regulation, Newcastle University Center for Cancer, Newcastle upon Tyne, England.

“These findings are consistent with our understanding. … We know that the immune system within cancer patients is compromised as compared to healthy controls,” Dr. Amarnath said. “The data in the study support the notion that, in solid cancer patients, a considerable delay in second dose will extend the period when cancer patients are at risk of SARS-CoV-2 infection.”

Although more data are required, “this study does raise the issue of whether patients with cancer, other diseases, or those undergoing therapies that affect the body’s immune response should be fast-tracked for their second vaccine dose,” commented Lawrence Young, PhD, professor of molecular oncology and director of the Warwick Cancer Research Center, University of Warwick, Coventry, England.

Stephen Evans, MSc, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, underlined that the study is “essentially” observational and “inevitable limitations must be taken into account.

“Nevertheless, these results do suggest that the vaccines may well not protect those patients with cancer as well as those without cancer,” Mr. Evans said. He added that it is “important that this population continues to observe all COVID-19–associated measures, such as social distancing and shielding when attending hospitals, even after vaccination.”

Study details

Previous studies have shown that some patients with cancer have prolonged responses to SARS-CoV-2 infection, with ongoing immune dysregulation, inefficient seroconversion, and prolonged viral shedding.

There are few data, however, on how these patients respond to COVID-19 vaccination. The authors point out that, among the 18,860 individuals who received the Pfizer vaccine during its development trials, “none with an active oncological diagnosis was included.”

To investigate this issue, they launched the SARS-CoV-2 for Cancer Patients (SOAP-02) study.

The 151 patients with cancer who participated in this study were mostly elderly, the authors noted (75% were older than 65 years; the median age was 73 years). The majority (63%) had solid-tumor malignancies. Of those, 8% had late-stage disease and had been living with their cancer for more than 24 months.

The healthy control persons were vaccine-eligible primary health care workers who were not age matched to the cancer patients.

All participants received the first dose of vaccine; 31 (of 151) patients with cancer and 16 (of 54) healthy control persons received the second dose on day 21.

The remaining participants were scheduled to receive their second dose 12 weeks later (after the study ended), in line with the changes in the national guidelines.

The team reported that, approximately 21 days after receiving the first vaccine dose, the immune efficacy of the vaccine was estimated to be 97% among healthy control persons vs. 39% for patients with solid tumors and only 13% for those with hematologic malignancies (P < .0001 for both).

T-cell responses, as assessed via interferon-gamma and/or interleukin-2 production, were observed in 82% of healthy control persons, 71% of patients with solid tumors, and 50% of those with hematologic cancers.

Vaccine boosting at day 21 resulted in immune efficacy of 100% for healthy control persons and 95% for patients with solid tumors. In contrast, only 43% of those who did not receive the second dose were seropositive 2 weeks later.

Further analysis suggested that participants who did not have a serologic response were “spread evenly” across different cancer types, but the reduced responses were more frequent among patients who had received the vaccine within 15 days of cancer treatment, especially chemotherapy, and had undergone intensive treatments.

The SOAP study is sponsored by King’s College London and Guy’s and St. Thomas Trust Foundation NHS Trust. It is funded from grants from the KCL Charity, Cancer Research UK, and program grants from Breast Cancer Now. The investigators have disclosed no relevant financial relationships.

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

The first report on responses to COVID-19 vaccination among patients with cancer suggests that, for these patients, the immune response that occurs after the first dose of vaccine is reduced, in comparison with the response that occurs in healthy individuals.

The new findings, which are soon to be published as a preprint, cast doubt on the current U.K. policy of delaying the second dose of the vaccine.

Delaying the second dose can leave most patients with cancer wholly or partially unprotected, according to the researchers. Moreover, such a delay has implications for transmission of SARS-CoV-2 in the cancer patient’s environs as well as for the evolution of virus variants that could be of concern, the researchers concluded.

The data come from a British study that included 151 patients with cancer and 54 healthy control persons. All participants received the COVID-19 mRNA BNT162b2 vaccine (Pfizer-BioNTech).

This vaccine requires two doses. The first few participants in this study were given the second dose 21 days after they had received the first dose, but then national guidelines changed, and the remaining participants had to wait 12 weeks to receive their second dose.

The researchers reported that, among health controls, the immune efficacy of the first dose was very high (97% efficacious). By contrast, among patients with solid tumors, the immune efficacy of a single dose was strikingly low (39%), and it was even lower in patients with hematologic malignancies (13%).

The second dose of vaccine greatly and rapidly increased the immune efficacy in patients with solid tumors (95% within 2 weeks of receiving the second dose), the researchers added.

Too few patients with hematologic cancers had received the second dose before the study ended for clear conclusions to be drawn. Nevertheless, the available data suggest that 50% of patients with hematologic cancers who had received the booster at day 21 were seropositive at 5 weeks vs. only 8% of those who had not received the booster.

“Our data provide the first real-world evidence of immune efficacy following one dose of the Pfizer vaccine in immunocompromised patient populations [and] clearly show that the poor one-dose efficacy in cancer patients can be rescued with an early booster at day 21,” commented senior author Sheeba Irshad, MD, senior clinical lecturer, King’s College London.

“Based on our findings, we would recommend an urgent review of the vaccine strategy for clinically extremely vulnerable groups. Until then, it is important that cancer patients continue to observe all public health measures in place, such as social distancing and shielding when attending hospitals, even after vaccination,” Dr. Irshad added.

The paper, with first author Leticia Monin-Aldama, PhD, is scheduled to appear on the preprint server medRxiv. It has not undergone peer review. The paper was distributed to journalists, with comments from experts not involved in the study, by the UK Science Media Centre.

These data are “of immediate importance” to patients with cancer, commented Shoba Amarnath, PhD, Newcastle University research fellow, Laboratory of T-cell Regulation, Newcastle University Center for Cancer, Newcastle upon Tyne, England.

“These findings are consistent with our understanding. … We know that the immune system within cancer patients is compromised as compared to healthy controls,” Dr. Amarnath said. “The data in the study support the notion that, in solid cancer patients, a considerable delay in second dose will extend the period when cancer patients are at risk of SARS-CoV-2 infection.”

Although more data are required, “this study does raise the issue of whether patients with cancer, other diseases, or those undergoing therapies that affect the body’s immune response should be fast-tracked for their second vaccine dose,” commented Lawrence Young, PhD, professor of molecular oncology and director of the Warwick Cancer Research Center, University of Warwick, Coventry, England.

Stephen Evans, MSc, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, underlined that the study is “essentially” observational and “inevitable limitations must be taken into account.

“Nevertheless, these results do suggest that the vaccines may well not protect those patients with cancer as well as those without cancer,” Mr. Evans said. He added that it is “important that this population continues to observe all COVID-19–associated measures, such as social distancing and shielding when attending hospitals, even after vaccination.”

Study details

Previous studies have shown that some patients with cancer have prolonged responses to SARS-CoV-2 infection, with ongoing immune dysregulation, inefficient seroconversion, and prolonged viral shedding.

There are few data, however, on how these patients respond to COVID-19 vaccination. The authors point out that, among the 18,860 individuals who received the Pfizer vaccine during its development trials, “none with an active oncological diagnosis was included.”

To investigate this issue, they launched the SARS-CoV-2 for Cancer Patients (SOAP-02) study.

The 151 patients with cancer who participated in this study were mostly elderly, the authors noted (75% were older than 65 years; the median age was 73 years). The majority (63%) had solid-tumor malignancies. Of those, 8% had late-stage disease and had been living with their cancer for more than 24 months.

The healthy control persons were vaccine-eligible primary health care workers who were not age matched to the cancer patients.

All participants received the first dose of vaccine; 31 (of 151) patients with cancer and 16 (of 54) healthy control persons received the second dose on day 21.

The remaining participants were scheduled to receive their second dose 12 weeks later (after the study ended), in line with the changes in the national guidelines.

The team reported that, approximately 21 days after receiving the first vaccine dose, the immune efficacy of the vaccine was estimated to be 97% among healthy control persons vs. 39% for patients with solid tumors and only 13% for those with hematologic malignancies (P < .0001 for both).

T-cell responses, as assessed via interferon-gamma and/or interleukin-2 production, were observed in 82% of healthy control persons, 71% of patients with solid tumors, and 50% of those with hematologic cancers.

Vaccine boosting at day 21 resulted in immune efficacy of 100% for healthy control persons and 95% for patients with solid tumors. In contrast, only 43% of those who did not receive the second dose were seropositive 2 weeks later.

Further analysis suggested that participants who did not have a serologic response were “spread evenly” across different cancer types, but the reduced responses were more frequent among patients who had received the vaccine within 15 days of cancer treatment, especially chemotherapy, and had undergone intensive treatments.

The SOAP study is sponsored by King’s College London and Guy’s and St. Thomas Trust Foundation NHS Trust. It is funded from grants from the KCL Charity, Cancer Research UK, and program grants from Breast Cancer Now. The investigators have disclosed no relevant financial relationships.

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

The Biden Administration launched the first phase of the Federally Qualified Health Center (FQHC) Program for COVID-19 Vaccination. Beginning February 15, FQHCs (including centers in the Urban Indian Health Program) began directly receiving vaccines.

                The announcement coincided with a boost in vaccine supply for states, Tribes, and territories. In early February, the Biden Administration announced it would expand vaccine supply to 11 million doses nationwide, a 28% increase since January 20, when President Biden took office. According to a White House fact sheet, “The Administration is committing to maintaining this as the minimum supply level for the next three weeks, and we will continue to work with manufacturers in their efforts to ramp up supply.”

                In February, President Biden and Vice President Harris travelled to Arizona and toured a vaccination site at State Farm Stadium in Glendale. Arizona, one of the first states to reach out for federal help from the new administration, has 15 counties and 22 Tribes with sovereign lands in the state. Those 37 entities work collaboratively with the Federal Emergency Management Agency (FEMA), said Major General Michael McGuire, head of the Arizona National Guard.

                In his remarks during the tour, President Biden addressed equity, saying, “[I]t really does matter that we have access to the people who are most in need [and are] most affected by the COVID crisis, dying at faster rates, getting sick at faster rates, …but not being able to get into the mix. …Equity is a big thing.”

                To that end, one of the programs under way is to stand up four vaccination centers for the Navajo Nation. Tammy Littrell, Acting Regional Administrator for FEMA, said the centers will help increase tribal members’ access to vaccination, as well as take the burden off from having to drive in “austere winter conditions.”

                In addition to more vaccines, Indian Health Services (IHS) is allocating $1 billion it received to help with COVID-19 response. Of the $1 billion, $790 million will go to testing, contact tracing, containment, and mitigation, among other things. Another $210 million will support IHS, tribal, and urban Indian health programs for vaccine-related activities to ensure broad-based distribution, access, and vaccine coverage. The money is part of the fifth round of supplemental COVID-19 funding from the Coronavirus Response and Relief Supplemental Appropriations Act. The funds transferred so far amount to nearly $3 billion.

                According to IHS, the money can be used to scale up testing by public health, academic, commercial, and hospital laboratories, as well as community-based testing sites, mobile testing units, healthcare facilities, and other entities engaged in COVID-19 testing. The funds are also legally available to lease or purchase non-federally owned facilities to improve COVID-19 preparedness and response capability.

The Biden Administration launched the first phase of the Federally Qualified Health Center (FQHC) Program for COVID-19 Vaccination. Beginning February 15, FQHCs (including centers in the Urban Indian Health Program) began directly receiving vaccines.

                The announcement coincided with a boost in vaccine supply for states, Tribes, and territories. In early February, the Biden Administration announced it would expand vaccine supply to 11 million doses nationwide, a 28% increase since January 20, when President Biden took office. According to a White House fact sheet, “The Administration is committing to maintaining this as the minimum supply level for the next three weeks, and we will continue to work with manufacturers in their efforts to ramp up supply.”

                In February, President Biden and Vice President Harris travelled to Arizona and toured a vaccination site at State Farm Stadium in Glendale. Arizona, one of the first states to reach out for federal help from the new administration, has 15 counties and 22 Tribes with sovereign lands in the state. Those 37 entities work collaboratively with the Federal Emergency Management Agency (FEMA), said Major General Michael McGuire, head of the Arizona National Guard.

                In his remarks during the tour, President Biden addressed equity, saying, “[I]t really does matter that we have access to the people who are most in need [and are] most affected by the COVID crisis, dying at faster rates, getting sick at faster rates, …but not being able to get into the mix. …Equity is a big thing.”

                To that end, one of the programs under way is to stand up four vaccination centers for the Navajo Nation. Tammy Littrell, Acting Regional Administrator for FEMA, said the centers will help increase tribal members’ access to vaccination, as well as take the burden off from having to drive in “austere winter conditions.”

                In addition to more vaccines, Indian Health Services (IHS) is allocating $1 billion it received to help with COVID-19 response. Of the $1 billion, $790 million will go to testing, contact tracing, containment, and mitigation, among other things. Another $210 million will support IHS, tribal, and urban Indian health programs for vaccine-related activities to ensure broad-based distribution, access, and vaccine coverage. The money is part of the fifth round of supplemental COVID-19 funding from the Coronavirus Response and Relief Supplemental Appropriations Act. The funds transferred so far amount to nearly $3 billion.

                According to IHS, the money can be used to scale up testing by public health, academic, commercial, and hospital laboratories, as well as community-based testing sites, mobile testing units, healthcare facilities, and other entities engaged in COVID-19 testing. The funds are also legally available to lease or purchase non-federally owned facilities to improve COVID-19 preparedness and response capability.

The Biden Administration launched the first phase of the Federally Qualified Health Center (FQHC) Program for COVID-19 Vaccination. Beginning February 15, FQHCs (including centers in the Urban Indian Health Program) began directly receiving vaccines.

                The announcement coincided with a boost in vaccine supply for states, Tribes, and territories. In early February, the Biden Administration announced it would expand vaccine supply to 11 million doses nationwide, a 28% increase since January 20, when President Biden took office. According to a White House fact sheet, “The Administration is committing to maintaining this as the minimum supply level for the next three weeks, and we will continue to work with manufacturers in their efforts to ramp up supply.”

                In February, President Biden and Vice President Harris travelled to Arizona and toured a vaccination site at State Farm Stadium in Glendale. Arizona, one of the first states to reach out for federal help from the new administration, has 15 counties and 22 Tribes with sovereign lands in the state. Those 37 entities work collaboratively with the Federal Emergency Management Agency (FEMA), said Major General Michael McGuire, head of the Arizona National Guard.

                In his remarks during the tour, President Biden addressed equity, saying, “[I]t really does matter that we have access to the people who are most in need [and are] most affected by the COVID crisis, dying at faster rates, getting sick at faster rates, …but not being able to get into the mix. …Equity is a big thing.”

                To that end, one of the programs under way is to stand up four vaccination centers for the Navajo Nation. Tammy Littrell, Acting Regional Administrator for FEMA, said the centers will help increase tribal members’ access to vaccination, as well as take the burden off from having to drive in “austere winter conditions.”

                In addition to more vaccines, Indian Health Services (IHS) is allocating $1 billion it received to help with COVID-19 response. Of the $1 billion, $790 million will go to testing, contact tracing, containment, and mitigation, among other things. Another $210 million will support IHS, tribal, and urban Indian health programs for vaccine-related activities to ensure broad-based distribution, access, and vaccine coverage. The money is part of the fifth round of supplemental COVID-19 funding from the Coronavirus Response and Relief Supplemental Appropriations Act. The funds transferred so far amount to nearly $3 billion.

                According to IHS, the money can be used to scale up testing by public health, academic, commercial, and hospital laboratories, as well as community-based testing sites, mobile testing units, healthcare facilities, and other entities engaged in COVID-19 testing. The funds are also legally available to lease or purchase non-federally owned facilities to improve COVID-19 preparedness and response capability.

A third of patients with COVID-19 and thoracic malignancies die, according to updated results from the TERAVOLT registry.

The risk of death was similar across racial and ethnic groups. Factors associated with an increased risk of death were male sex, older age, worse performance scores, and four or more metastatic sites.

“Death rates remain high at 33%, underscoring the importance of COVID-19 vaccination in patients with thoracic cancers, when available,” said Umit Tapan, MD, of Boston University.

Dr. Tapan presented the TERAVOLT update at the 2020 World Congress on Lung Cancer (Abstract P09.18), which was rescheduled for January 2021.

The TERAVOLT registry is a multicenter, observational study with a cross-sectional component and a longitudinal cohort component.

The registry includes patients who have thoracic cancers – non–small cell lung cancer (NSCLC), small cell lung cancer, mesothelioma, thymic epithelial tumors, and other pulmonary neuroendocrine neoplasms – and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms.

Clinical data were extracted from medical records of consecutive patients from Jan. 1, 2020, and will be collected until the end of pandemic, as declared by the World Health Organization. Data collected include demographics, oncologic history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes.

“The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus,” Dr. Tapan said.

Data from TERAVOLT were previously presented at AACR, ASCO, and ESMO last year, as well as published in The Lancet Oncology.

Updated results

Dr. Tapan presented data on 1,011 patients from 120 centers in 19 countries. The patients’ median age was 68 years (range, 28-95 years), and more than half were male (58%). Most patients (72%) were White, 20% were Hispanic/Latino, and 8% were Black/African American.

Most patients had NSCLC (82%), and most had stage IV disease (68%). Patients had received a median of one prior line of therapy.

As in earlier reports of TERAVOLT data, the mortality rate was 33%.

In a multivariate analysis, the following characteristics were associated with an increased risk of death:

• Male sex (odds ratio, 1.4).
• Older age (per 10 years; OR, 1.21).
• Performance score of 1 (OR, 1.73), 2 (OR, 4.74), and 3/4 (OR, 10.7).
• Four or more metastatic sites (OR, 3.05).

The following characteristics were associated with an increased risk of hospitalization in a multivariate analysis:

• Male sex (OR, 1.67).
• Older age (per 10 years; OR, 1.24).
• Performance score of 2 (OR, 4.47) and 3/4 (OR, 9.63).
• Four or more metastatic sites (OR, 4.0).
• Thymic carcinoma (OR, 3.58).
• Receiving radiation (OR, 2.1).

Race and ethnicity did not seem to affect the risk of death or hospitalization, “but we plan to conduct further analysis,” Dr. Tapan said.

Roxana Reyes, MD, of Hospital Clínic de Barcelona, said her hospital sees patients with lung cancer at high risk for COVID-19, but there is no screening program in place.

“We use medical consultations to focus on early diagnosis. We treat COVID-19 complications but lose a lot of patients. There is an opportunity to be found to find these patients sooner,” Dr. Reyes said.

She noted that COVID-19 will likely last a long time, and therefore “we have to protect against it and continue to diagnose lung cancer at earlier stages.”

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. Dr. Tapan has no relevant disclosures. The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer.

A third of patients with COVID-19 and thoracic malignancies die, according to updated results from the TERAVOLT registry.

The risk of death was similar across racial and ethnic groups. Factors associated with an increased risk of death were male sex, older age, worse performance scores, and four or more metastatic sites.

“Death rates remain high at 33%, underscoring the importance of COVID-19 vaccination in patients with thoracic cancers, when available,” said Umit Tapan, MD, of Boston University.

Dr. Tapan presented the TERAVOLT update at the 2020 World Congress on Lung Cancer (Abstract P09.18), which was rescheduled for January 2021.

The TERAVOLT registry is a multicenter, observational study with a cross-sectional component and a longitudinal cohort component.

The registry includes patients who have thoracic cancers – non–small cell lung cancer (NSCLC), small cell lung cancer, mesothelioma, thymic epithelial tumors, and other pulmonary neuroendocrine neoplasms – and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms.

Clinical data were extracted from medical records of consecutive patients from Jan. 1, 2020, and will be collected until the end of pandemic, as declared by the World Health Organization. Data collected include demographics, oncologic history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes.

“The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus,” Dr. Tapan said.

Data from TERAVOLT were previously presented at AACR, ASCO, and ESMO last year, as well as published in The Lancet Oncology.

Updated results

Dr. Tapan presented data on 1,011 patients from 120 centers in 19 countries. The patients’ median age was 68 years (range, 28-95 years), and more than half were male (58%). Most patients (72%) were White, 20% were Hispanic/Latino, and 8% were Black/African American.

Most patients had NSCLC (82%), and most had stage IV disease (68%). Patients had received a median of one prior line of therapy.

As in earlier reports of TERAVOLT data, the mortality rate was 33%.

In a multivariate analysis, the following characteristics were associated with an increased risk of death:

• Male sex (odds ratio, 1.4).
• Older age (per 10 years; OR, 1.21).
• Performance score of 1 (OR, 1.73), 2 (OR, 4.74), and 3/4 (OR, 10.7).
• Four or more metastatic sites (OR, 3.05).

The following characteristics were associated with an increased risk of hospitalization in a multivariate analysis:

• Male sex (OR, 1.67).
• Older age (per 10 years; OR, 1.24).
• Performance score of 2 (OR, 4.47) and 3/4 (OR, 9.63).
• Four or more metastatic sites (OR, 4.0).
• Thymic carcinoma (OR, 3.58).
• Receiving radiation (OR, 2.1).

Race and ethnicity did not seem to affect the risk of death or hospitalization, “but we plan to conduct further analysis,” Dr. Tapan said.

Roxana Reyes, MD, of Hospital Clínic de Barcelona, said her hospital sees patients with lung cancer at high risk for COVID-19, but there is no screening program in place.

“We use medical consultations to focus on early diagnosis. We treat COVID-19 complications but lose a lot of patients. There is an opportunity to be found to find these patients sooner,” Dr. Reyes said.

She noted that COVID-19 will likely last a long time, and therefore “we have to protect against it and continue to diagnose lung cancer at earlier stages.”

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. Dr. Tapan has no relevant disclosures. The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer.

A third of patients with COVID-19 and thoracic malignancies die, according to updated results from the TERAVOLT registry.

The risk of death was similar across racial and ethnic groups. Factors associated with an increased risk of death were male sex, older age, worse performance scores, and four or more metastatic sites.

“Death rates remain high at 33%, underscoring the importance of COVID-19 vaccination in patients with thoracic cancers, when available,” said Umit Tapan, MD, of Boston University.

Dr. Tapan presented the TERAVOLT update at the 2020 World Congress on Lung Cancer (Abstract P09.18), which was rescheduled for January 2021.

The TERAVOLT registry is a multicenter, observational study with a cross-sectional component and a longitudinal cohort component.

The registry includes patients who have thoracic cancers – non–small cell lung cancer (NSCLC), small cell lung cancer, mesothelioma, thymic epithelial tumors, and other pulmonary neuroendocrine neoplasms – and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms.

Clinical data were extracted from medical records of consecutive patients from Jan. 1, 2020, and will be collected until the end of pandemic, as declared by the World Health Organization. Data collected include demographics, oncologic history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes.

“The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus,” Dr. Tapan said.

Data from TERAVOLT were previously presented at AACR, ASCO, and ESMO last year, as well as published in The Lancet Oncology.

Updated results

Dr. Tapan presented data on 1,011 patients from 120 centers in 19 countries. The patients’ median age was 68 years (range, 28-95 years), and more than half were male (58%). Most patients (72%) were White, 20% were Hispanic/Latino, and 8% were Black/African American.

Most patients had NSCLC (82%), and most had stage IV disease (68%). Patients had received a median of one prior line of therapy.

As in earlier reports of TERAVOLT data, the mortality rate was 33%.

In a multivariate analysis, the following characteristics were associated with an increased risk of death:

• Male sex (odds ratio, 1.4).
• Older age (per 10 years; OR, 1.21).
• Performance score of 1 (OR, 1.73), 2 (OR, 4.74), and 3/4 (OR, 10.7).
• Four or more metastatic sites (OR, 3.05).

The following characteristics were associated with an increased risk of hospitalization in a multivariate analysis:

• Male sex (OR, 1.67).
• Older age (per 10 years; OR, 1.24).
• Performance score of 2 (OR, 4.47) and 3/4 (OR, 9.63).
• Four or more metastatic sites (OR, 4.0).
• Thymic carcinoma (OR, 3.58).
• Receiving radiation (OR, 2.1).

Race and ethnicity did not seem to affect the risk of death or hospitalization, “but we plan to conduct further analysis,” Dr. Tapan said.

Roxana Reyes, MD, of Hospital Clínic de Barcelona, said her hospital sees patients with lung cancer at high risk for COVID-19, but there is no screening program in place.

“We use medical consultations to focus on early diagnosis. We treat COVID-19 complications but lose a lot of patients. There is an opportunity to be found to find these patients sooner,” Dr. Reyes said.

She noted that COVID-19 will likely last a long time, and therefore “we have to protect against it and continue to diagnose lung cancer at earlier stages.”

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. Dr. Tapan has no relevant disclosures. The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer.

Hospital volumes, which had largely recovered in September after crashing last spring, are dropping again, according to new data from Strata Decision Technologies, a Chicago-based analytics firm.

For the 2 weeks that ended Nov. 28, inpatient admissions were 6.2% below what they’d been on Nov. 14 and 2.1% below what they’d been on Oct. 28. Compared with the same intervals in 2019, admissions were off 4.4% for the 14-day period and 3.7% for the 30-day period.

Although those aren’t large percentages, Strata’s report, based on data from about 275 client hospitals, notes that what kept the volumes up was the increasing number of COVID-19 cases. If COVID-19 cases are not considered, admissions would have been down “double digits,” said Steve Lefar, executive director of StrataDataScience, a division of Strata Decision Technologies, in an interview with this news organization.

“Hip and knee replacements, cardiac procedures, and other procedures are significantly down year over year. Infectious disease cases, in contrast, have skyrocketed,” Mr. Lefar said. “Many things went way down that hadn’t fully recovered. It’s COVID-19 that really brought the volume back up.”

Observation and emergency department visits also dropped from already low levels. For the 2 weeks that ended Nov. 28, observation visits were off 8.4%; for the previous month, 10.1%. Compared with 2019, they were down 22.3% and 18.6%, respectively.

ED visits fell 3.7% for the 2-week period, 0.6% for the month. They dropped 21% and 18.7%, respectively, compared with those periods from the previous year.

What these data reflect, Mr. Lefar said, is that people have avoided EDs and are staying away from them more than ever because of COVID-19 fears. This behavior could be problematic for people who have concerning symptoms, such as chest pains, that should be evaluated by an ED physician, he noted.

Daily outpatient visits were down 18.4% for the 14-day period and 9.3% for the 30-day period. But, compared with 2019, ambulatory visits increased 5.8% for the 2-week period and 4.7% for the previous month.
 

Long-term trends

The outpatient visit data should be viewed in the context of the overall trend since the pandemic began. Strata broke down service lines for the period between March 20 and Nov. 7. The analysis shows that evaluation and management (E/M) encounters, the largest outpatient visit category, fell 58% during this period, compared with the same interval in 2019. Visits for diabetes, hypertension, and minor acute infections and injuries were also way down.

Mr. Lefar observed that the E/M visit category was only for in-person visits, which many patients have ditched in favor of telehealth encounters. At the same time, he noted, “people are going in less for chronic disease visits. So there’s an interplay between less in-person visits, more telehealth, and maybe people going to other sites that aren’t on the hospital campus. But people are going less [to outpatient clinics].”

In the year-to-year comparison, volume was down substantially in other service lines, including cancer (–9.2%), cardiology (–20%), dermatology (–31%), endocrine (–18.8%), ENT (–42.5%), gastroenterology (–24.3%), nephrology (–15%), obstetrics (–15.6%), orthopedics (–28.2%), and general surgery (–22.2%). Major procedures decreased by 21.8%.

In contrast, the infectious disease category jumped 86% over 2019, and “other infectious and parasitic diseases” – i.e., COVID-19 – soared 222%.

There was a much bigger crash in admissions, observation visits, and ED visits last spring than in November, the report shows. “What happened nationally last spring is that everyone shut down,” Mr. Lefar explained. “All the electives were canceled. Even cancer surgery was shut down, along with many other procedures. That’s what drove that crash. But the provider community quickly learned that this is going to be a long haul, and we’re going to have to reopen. We’re going to do it safely, but we’re going to make sure people get the necessary care. We can’t put off cancer care or colonoscopies and other screenings that save lives.”
 

System starts to break down

The current wave of COVID-19, however, is beginning to change the definition of necessary care, he said. “Hospitals are reaching the breaking point between staff exhaustion and hospital capacity reaching its limit. In Texas, hospitals are starting to shut down certain essential non-COVID care. They’re turning away some nonurgent cases – the electives that were starting to come back.”

How about nonurgent COVID cases? Mr. Lefar said there’s evidence that some of those patients are also being diverted. “Some experts speculate that the turn-away rate of people with confirmed COVID is starting to go up, and hospitals are sending them home with oxygen or an oxygen meter and saying, ‘If it gets worse, come back.’ They just don’t have the critical care capacity – and that should scare the heck out of everybody.”

Strata doesn’t yet have the data to confirm this, he said, “but it appears that some people are being sent home. This may be partly because providers are better at telling which patients are acute, and there are better things they can send them home with. It’s not necessarily worse care, but we don’t know. But we’re definitely seeing a higher send-home rate of patients showing up with COVID.”

Hospital profit margins are cratering again, because the COVID-19 cases aren’t generating nearly as much profit as the lucrative procedures that, in many cases, have been put off, Mr. Lefar said. “Even though CMS is paying 20% more for verified COVID-19 patients, we know that the costs on these patients are much higher than expected, so they’re not making much money on these cases.”

For about a third of hospitals, margins are currently negative, he said. That is about the same percentage as in September. In April, 60% of health systems were losing money, he added. “The CARES Act saved some of them,” he noted.
 

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

Hospital volumes, which had largely recovered in September after crashing last spring, are dropping again, according to new data from Strata Decision Technologies, a Chicago-based analytics firm.

For the 2 weeks that ended Nov. 28, inpatient admissions were 6.2% below what they’d been on Nov. 14 and 2.1% below what they’d been on Oct. 28. Compared with the same intervals in 2019, admissions were off 4.4% for the 14-day period and 3.7% for the 30-day period.

Although those aren’t large percentages, Strata’s report, based on data from about 275 client hospitals, notes that what kept the volumes up was the increasing number of COVID-19 cases. If COVID-19 cases are not considered, admissions would have been down “double digits,” said Steve Lefar, executive director of StrataDataScience, a division of Strata Decision Technologies, in an interview with this news organization.

“Hip and knee replacements, cardiac procedures, and other procedures are significantly down year over year. Infectious disease cases, in contrast, have skyrocketed,” Mr. Lefar said. “Many things went way down that hadn’t fully recovered. It’s COVID-19 that really brought the volume back up.”

Observation and emergency department visits also dropped from already low levels. For the 2 weeks that ended Nov. 28, observation visits were off 8.4%; for the previous month, 10.1%. Compared with 2019, they were down 22.3% and 18.6%, respectively.

ED visits fell 3.7% for the 2-week period, 0.6% for the month. They dropped 21% and 18.7%, respectively, compared with those periods from the previous year.

What these data reflect, Mr. Lefar said, is that people have avoided EDs and are staying away from them more than ever because of COVID-19 fears. This behavior could be problematic for people who have concerning symptoms, such as chest pains, that should be evaluated by an ED physician, he noted.

Daily outpatient visits were down 18.4% for the 14-day period and 9.3% for the 30-day period. But, compared with 2019, ambulatory visits increased 5.8% for the 2-week period and 4.7% for the previous month.
 

Long-term trends

The outpatient visit data should be viewed in the context of the overall trend since the pandemic began. Strata broke down service lines for the period between March 20 and Nov. 7. The analysis shows that evaluation and management (E/M) encounters, the largest outpatient visit category, fell 58% during this period, compared with the same interval in 2019. Visits for diabetes, hypertension, and minor acute infections and injuries were also way down.

Mr. Lefar observed that the E/M visit category was only for in-person visits, which many patients have ditched in favor of telehealth encounters. At the same time, he noted, “people are going in less for chronic disease visits. So there’s an interplay between less in-person visits, more telehealth, and maybe people going to other sites that aren’t on the hospital campus. But people are going less [to outpatient clinics].”

In the year-to-year comparison, volume was down substantially in other service lines, including cancer (–9.2%), cardiology (–20%), dermatology (–31%), endocrine (–18.8%), ENT (–42.5%), gastroenterology (–24.3%), nephrology (–15%), obstetrics (–15.6%), orthopedics (–28.2%), and general surgery (–22.2%). Major procedures decreased by 21.8%.

In contrast, the infectious disease category jumped 86% over 2019, and “other infectious and parasitic diseases” – i.e., COVID-19 – soared 222%.

There was a much bigger crash in admissions, observation visits, and ED visits last spring than in November, the report shows. “What happened nationally last spring is that everyone shut down,” Mr. Lefar explained. “All the electives were canceled. Even cancer surgery was shut down, along with many other procedures. That’s what drove that crash. But the provider community quickly learned that this is going to be a long haul, and we’re going to have to reopen. We’re going to do it safely, but we’re going to make sure people get the necessary care. We can’t put off cancer care or colonoscopies and other screenings that save lives.”
 

System starts to break down

The current wave of COVID-19, however, is beginning to change the definition of necessary care, he said. “Hospitals are reaching the breaking point between staff exhaustion and hospital capacity reaching its limit. In Texas, hospitals are starting to shut down certain essential non-COVID care. They’re turning away some nonurgent cases – the electives that were starting to come back.”

How about nonurgent COVID cases? Mr. Lefar said there’s evidence that some of those patients are also being diverted. “Some experts speculate that the turn-away rate of people with confirmed COVID is starting to go up, and hospitals are sending them home with oxygen or an oxygen meter and saying, ‘If it gets worse, come back.’ They just don’t have the critical care capacity – and that should scare the heck out of everybody.”

Strata doesn’t yet have the data to confirm this, he said, “but it appears that some people are being sent home. This may be partly because providers are better at telling which patients are acute, and there are better things they can send them home with. It’s not necessarily worse care, but we don’t know. But we’re definitely seeing a higher send-home rate of patients showing up with COVID.”

Hospital profit margins are cratering again, because the COVID-19 cases aren’t generating nearly as much profit as the lucrative procedures that, in many cases, have been put off, Mr. Lefar said. “Even though CMS is paying 20% more for verified COVID-19 patients, we know that the costs on these patients are much higher than expected, so they’re not making much money on these cases.”

For about a third of hospitals, margins are currently negative, he said. That is about the same percentage as in September. In April, 60% of health systems were losing money, he added. “The CARES Act saved some of them,” he noted.
 

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

Hospital volumes, which had largely recovered in September after crashing last spring, are dropping again, according to new data from Strata Decision Technologies, a Chicago-based analytics firm.

For the 2 weeks that ended Nov. 28, inpatient admissions were 6.2% below what they’d been on Nov. 14 and 2.1% below what they’d been on Oct. 28. Compared with the same intervals in 2019, admissions were off 4.4% for the 14-day period and 3.7% for the 30-day period.

Although those aren’t large percentages, Strata’s report, based on data from about 275 client hospitals, notes that what kept the volumes up was the increasing number of COVID-19 cases. If COVID-19 cases are not considered, admissions would have been down “double digits,” said Steve Lefar, executive director of StrataDataScience, a division of Strata Decision Technologies, in an interview with this news organization.

“Hip and knee replacements, cardiac procedures, and other procedures are significantly down year over year. Infectious disease cases, in contrast, have skyrocketed,” Mr. Lefar said. “Many things went way down that hadn’t fully recovered. It’s COVID-19 that really brought the volume back up.”

Observation and emergency department visits also dropped from already low levels. For the 2 weeks that ended Nov. 28, observation visits were off 8.4%; for the previous month, 10.1%. Compared with 2019, they were down 22.3% and 18.6%, respectively.

ED visits fell 3.7% for the 2-week period, 0.6% for the month. They dropped 21% and 18.7%, respectively, compared with those periods from the previous year.

What these data reflect, Mr. Lefar said, is that people have avoided EDs and are staying away from them more than ever because of COVID-19 fears. This behavior could be problematic for people who have concerning symptoms, such as chest pains, that should be evaluated by an ED physician, he noted.

Daily outpatient visits were down 18.4% for the 14-day period and 9.3% for the 30-day period. But, compared with 2019, ambulatory visits increased 5.8% for the 2-week period and 4.7% for the previous month.
 

Long-term trends

The outpatient visit data should be viewed in the context of the overall trend since the pandemic began. Strata broke down service lines for the period between March 20 and Nov. 7. The analysis shows that evaluation and management (E/M) encounters, the largest outpatient visit category, fell 58% during this period, compared with the same interval in 2019. Visits for diabetes, hypertension, and minor acute infections and injuries were also way down.

Mr. Lefar observed that the E/M visit category was only for in-person visits, which many patients have ditched in favor of telehealth encounters. At the same time, he noted, “people are going in less for chronic disease visits. So there’s an interplay between less in-person visits, more telehealth, and maybe people going to other sites that aren’t on the hospital campus. But people are going less [to outpatient clinics].”

In the year-to-year comparison, volume was down substantially in other service lines, including cancer (–9.2%), cardiology (–20%), dermatology (–31%), endocrine (–18.8%), ENT (–42.5%), gastroenterology (–24.3%), nephrology (–15%), obstetrics (–15.6%), orthopedics (–28.2%), and general surgery (–22.2%). Major procedures decreased by 21.8%.

In contrast, the infectious disease category jumped 86% over 2019, and “other infectious and parasitic diseases” – i.e., COVID-19 – soared 222%.

There was a much bigger crash in admissions, observation visits, and ED visits last spring than in November, the report shows. “What happened nationally last spring is that everyone shut down,” Mr. Lefar explained. “All the electives were canceled. Even cancer surgery was shut down, along with many other procedures. That’s what drove that crash. But the provider community quickly learned that this is going to be a long haul, and we’re going to have to reopen. We’re going to do it safely, but we’re going to make sure people get the necessary care. We can’t put off cancer care or colonoscopies and other screenings that save lives.”
 

System starts to break down

The current wave of COVID-19, however, is beginning to change the definition of necessary care, he said. “Hospitals are reaching the breaking point between staff exhaustion and hospital capacity reaching its limit. In Texas, hospitals are starting to shut down certain essential non-COVID care. They’re turning away some nonurgent cases – the electives that were starting to come back.”

How about nonurgent COVID cases? Mr. Lefar said there’s evidence that some of those patients are also being diverted. “Some experts speculate that the turn-away rate of people with confirmed COVID is starting to go up, and hospitals are sending them home with oxygen or an oxygen meter and saying, ‘If it gets worse, come back.’ They just don’t have the critical care capacity – and that should scare the heck out of everybody.”

Strata doesn’t yet have the data to confirm this, he said, “but it appears that some people are being sent home. This may be partly because providers are better at telling which patients are acute, and there are better things they can send them home with. It’s not necessarily worse care, but we don’t know. But we’re definitely seeing a higher send-home rate of patients showing up with COVID.”

Hospital profit margins are cratering again, because the COVID-19 cases aren’t generating nearly as much profit as the lucrative procedures that, in many cases, have been put off, Mr. Lefar said. “Even though CMS is paying 20% more for verified COVID-19 patients, we know that the costs on these patients are much higher than expected, so they’re not making much money on these cases.”

For about a third of hospitals, margins are currently negative, he said. That is about the same percentage as in September. In April, 60% of health systems were losing money, he added. “The CARES Act saved some of them,” he noted.
 

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