CANCER-COVID-19 MORTALITY AND GUIDELINES

AACR 2020 — Registry data suggest an "unexpectedly high" mortality rate among patients with lung cancer who develop COVID-19, according to a presenter at the AACR virtual meeting I.

Data from the TERAVOLT registry showed a 34.6% mortality rate among 200 patients with COVID-19 and lung cancer, according to Marina Chiara Garassino, MD, of Fondazione IRCCS Instituto Nazionale dei Tumor in Milan, Italy, who presented the data at the meeting in a session on cancer and COVID-19.

Cancer patients infected with COVID-19 have been reported to be at increased risk of death, but the magnitude of increase is uncertain.

Patients with lung cancer may be particularly vulnerable because of older age, tobacco use, preexisting cardiopulmonary comorbidities, and the immunosuppressive effects of treatment.

The global TERAVOLT registry was begun in late March 2020 to provide outcome data for coronavirus infections in thoracic cancer patients specifically. It is hoped that the data collected will guide patient management and define factors influencing morbidity and mortality.

Dr Garassino said that institutions from 21 countries have joined the TERAVOLT registry thus far. Currently, about 17 new patients with thoracic cancer and laboratory confirmed or clinically suspected COVID-19 are added to the registry each week.

As of April 12, 2020, there were 200 patients included in the registry. Their median age was 68 years, and 70.5% were men. Non–small cell lung cancer was the histology in 75.5% and small cell lung cancer in 14.5% of patients. Most patients (73.5%) had stage IV disease. Approximately 27% of patients had at least three comorbid conditions.

About 74% of patients were on current cancer treatment, with 19% on tyrosine kinase inhibitors alone, 32.7% on chemotherapy alone, 23.1% on immunotherapy alone, and 13.6% on chemotherapy plus immunotherapy.

In all, 152 patients (76.0%) were hospitalized. However, 91.2% of patients were not admitted to the ICU, either because of a shortage of equipment or institutional policy.

The most common complications were pneumonia/pneumonitis (79.6%), acute respiratory distress syndrome (26.8%), multiorgan failure (7.6%), and sepsis(5.1%). A total of 66 patients (34.6%) died. Most deaths were attributed to COVID-19 and not the underlying cancer, Dr. Garassino said.

A univariate analysis showed no association between cancer treatment and an increased risk of hospitalization or death. However, Dr. Garassino and colleagues are collecting more data to confirm these results. In a multivariate analysis, no factors were associated with the risk of death, although data from a larger number of patients may shed more light on that issue.

TERAVOLT will continue to collect and provide data to identify characteristics associated with severe COVID-19–related illness, to guide physicians with information applicable to patients with thoracic malignancies, tailored to individual risk.

Like the COVID-19 and Cancer Consortium and the ESMO CoCare registry, TERAVOLT represents a way for the patient care and translational science communities to share lessons from the COVID-19 pandemic.

AACR plans to help share those lessons as well, in another session on COVID-19 and cancer at the AACR virtual meeting II in June and at a conference on COVID-19 and cancer in July, according to session moderator Antoni Ribas, MD, PhD, of the University of California, Los Angeles.

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

This story originally appeared on MDedge.com.

The majority of patients who have cancer or are suspected of having cancer are not accessing healthcare services in the United Kingdom or the United States because of the COVID-19 pandemic, the first report of its kind estimates. As a result, there will be an excess of deaths among patients who have cancer and multiple comorbidities in both countries during the current coronavirus emergency, the report warns. The authors calculate that there will be 6270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients in the United States. (In the United States, the estimated excess number of deaths applies only to patients older than 40 years, they note.) "The recorded underlying cause of these excess deaths may be cancer, COVID-19 or comorbidity (such as myocardial infarction)," Alvina Lai, PhD, University College London, United Kingdom, and colleagues observe. "Our data have highlighted how cancer patients with multimorbidity are a particularly at-risk group during the current pandemic," they emphasize. The study was published on ResearchGate as a preprint and has not undergone peer review. Commenting on the study on the UK Science Media Center, several experts emphasized the lack of peer review, noting that interpretation of these data needs to be further refined on the basis of that input. One expert suggested that there are "substantial uncertainties that this paper does not adequately communicate." But others argued that this topic was important enough to warrant early release of the data. Chris Bunce, PhD, University of Birmingham, United Kingdom, said this study represents "a highly valuable contribution." "It is universally accepted that early diagnosis and treatment and adherence to treatment regimens saves lives," he pointed out. "Therefore, these COVID-19-related impacts will cost lives," Bunce said. "And if this information is to influence cancer care and guide policy during the COVID-19 crisis, then it is important that the findings are disseminated and discussed immediately, warranting their release ahead of peer view," he added. In a Medscape UK commentary, oncologist Karol Sikora, MD, PhD, argues that "restarting cancer services can't come soon enough." "Resonably Argued Numerical Estimate" "It's well known that there have been considerable changes in the provision of health care for many conditions, including cancers, as a result of all the measures to deal with the COVID-19 crisis," said Kevin McConway, PhD, professor emeritus of applied statistics, the Open University, Milton Keynes, United Kingdom.

Σελίδα 2 από 2 "It seems inevitable that there will be increased deaths in cancer patients if they are infected with the virus or because of changes in the health services available to them, and quite possibly also from socio-economic effects of the responses to the crisis," he continued. "This study is the first that I have seen that produces a reasonably-argued numerical estimate of the number of excess deaths of people with cancer arising from these factors in the UK and the USA," he added. Declines in Urgent Referrals and Chemo Attendance For the study, the team used DATA-CAN, the UK National Health Data Research Hub for Cancer, to assess weekly returns for urgent cancer referrals for early diagnosis and also chemotherapy attendances for hospitals in Leeds, London, and Northern Ireland going back to 2018. The data revealed that there have been major declines in chemotherapy attendances. There has been on average a 60% decrease from prepandemic levels in eight hospitals in the three regions that were assessed. Urgent cancer referrals have dropped by an average of 76% compared to prepandemic levels in the three regions. On the conservative assumption that the COVID-19 pandemic will only affect patients with newly diagnosed cancer (incident cases), the researchers estimate that the proportion of the population affected by the emergency (PAE) is 40% and that the relative impact of the emergency (RIE) is 1.5. PAE is a summary measure of exposure to the adverse health consequences of the emergency; RIE is a summary measure of the combined impact on mortality of infection, health service change, physical distancing, and economic downturn, the authors explain. Comorbidities Common "Comorbidities were common in people with cancer," the study authors note. For example, more than one quarter of the study population had at least one comorbidity; more than 14% had two. For incident cancers, the number of excess deaths steadily increased in conjunction with an increase in the number of comorbidities, such that more than 80% of deaths occurred in patients with one or more comorbidities. "When considering both prevalent and incident cancers together with a COVID-19 PAE of 40%, we estimated 17,991 excess deaths at a RIE of 1.5; 78.1% of these deaths occur in patients with ≥1 comorbidities," the authors report. "The excess risk of death in people living with cancer during the COVID-19 emergency may be due not only to COVID-19 infection, but also to the unintended health consequences of changes in health service provision, the physical or psychological effects of social distancing, and economic upheaval," they state. "This is the first study demonstrating profound recent changes in cancer care delivery in multiple centers," the authors observe. Lai has disclosed no relevant financial relationships. Several coauthors have various relationships with industry, as listed in their article. The commentators have disclosed no relevant financial relationships. The study is available for download from the ResearchGate website. Follow Medscape Oncology on Twitter for more cancer news: @MedscapeOnc.

More than 80,000 diagnoses of five common cancers may be missed or delayed by early June because of disruptions to health care caused by the COVID-19 pandemic, according to a report by the IQVIA Institute for Human Data Science looking at trends in the United States.

Screening and monitoring tests for breast, prostate, colorectal, cervical, and lung cancer were down 39%-90% in early April, compared with the baseline month of February, according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.

These findings are based on data from IQVIA's medical claims database, which includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.

The data suggest that, at current positivity rates, there could be 36,000 missed or delayed diagnoses of breast cancer during the 3-month period from early March through early June. Estimates for missed diagnoses of the four other cancers analyzed include 450 for lung cancer, 2,500 for cervical cancer, 18,800 for colorectal cancer, and 22,600 for prostate cancer.

The authors project a total of 22 million canceled or delayed tests for the five cancers over the 3-month period ending June 5, based on a comparison of claims data for early April with the February baseline. Catching up on this backlog will be problematic, according to the authors.

"Current excess health care capacity ... would require providers to shift priorities to make time and space in schedules and facilities as well as the cooperation of patients to return to health care providers," the authors wrote. "Both of these could be further disrupted by economic factors or reintroduction of social distancing in a reemergence of the outbreak."

The report was produced by the IQVIA Institute for Human Data Science without industry or government funding.

SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.

Patients with cancer who were infected with COVID-19 were much more likely to die from the disease than those without cancer, according to research from physician-researchers at Montefiore Health System and Albert Einstein College of Medicine. Their findings were published by Mehta et al in Cancer Discovery.

“Our findings emphasize the need to prevent patients with cancer from contracting COVID-19 and—if they do—to identify and closely monitor these individuals for dangerous symptoms,” said Vikas Mehta, MD, MPH, a co–lead author of the study, a surgical oncologist at Montefiore, and Associate Professor of Otorhinolaryngology/Head and Neck Surgery at Einstein. “We hope that our findings can inform states and communities that have not yet been so severely struck by this pandemic about the unique vulnerability patients with cancer face.”

Photo credit: Getty

Study Results

The study involved 218 patients with cancer who tested positive for COVID-19 from March 18 to April 8, 2020, at Montefiore Medical Center in the Bronx, New York—one of the regions in the United States hit hardest by the pandemic. A total of 61 patients with cancer died from COVID-19, a dramatically high case fatality rate of 28%. The mortality rate for COVID-19 in the United States is 5.8%, according to the World Health Organization.

“A key element is that mortality appears to be more closely related to frailty, age, and comorbidities than to active therapy for cancer,” said co–senior author Balazs Halmos, MD, MS, Director of the Multidisciplinary Thoracic Oncology Program at Montefiore and Professor of Medicine at Einstein.

“Our data suggest that we should not stop lifesaving cancer therapies, but rather, develop strategies to minimize potential COVID-19 exposures and reevaluate therapies for our most vulnerable cancer populations,” explained co–senior author Amit Verma, MBBS, Director of the Division of Hemato-Oncology at Montefiore and Professor of Medicine and of Developmental and Molecular biology at Einstein.

The time period during which these patients were treated was earlier in the epidemic, when testing was almost exclusively done in sicker, symptomatic patients who required hospitalization. This may partially explain the high fatality rate within the study’s cancer population. However, even when compared to mortality rates in patients without cancer at Montefiore and across New York City during the same time period, patients with cancer demonstrated a significantly higher risk of dying from COVID-19.

As a group, patients infected with COVID-19 who had hematologic cancers, such as leukemia and lymphoma, had the highest mortality rate: 37% (20 of 54 patients). For patients with solid malignancies, the mortality rate was 25% (41 of 164). Differences were observed among specific solid cancers: the mortality rate for patients with lung cancer was 55%; for those with colorectal cancer, it was 38%; for those with breast cancer, 14%; and for those with prostate cancer, 20%.

Certain underlying conditions—older age, hypertension, heart disease, and chronic lung disease—were significantly associated with increased mortality among patients with cancer infected with COVID-19.

A detailed analysis of patients with cancer who died from COVID-19 shows that more than half of these individuals—37 of 61—had been in places with a higher risk of exposure to COVID-19—such as nursing homes, hospitals, or emergency departments—within the 30 days before being diagnosed with COVID-19. This was before widespread social distancing had been implemented.

Montefiore has already changed clinical practice as a result of the study’s findings. The center now uses telemedicine and early and aggressive social distancing for patients with cancer, and has opened a dedicated cancer outpatient and inpatient clinical service. It has also instituted bilingual peer counseling and deployed social workers and food deliveries to its at-risk population.

The study authors concluded, “These data suggest the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population.”

Disclosure: For full disclosures of the study authors, visit cancerdiscovery.aacrjournals.org.

ESMO makes suggestions about trimming the duration of adjuvant trastuzumabto 6 months, as in the PERSEPHONE study, and modifying the schedule of luteinizing hormone–releasing hormone agonist administration, in an effort to reduce patient exposure to health care personnel (and vice versa). The guidelines recommend continuing clinical trials if benefits to patients outweigh risks and trials can be modified to enhance patient safety while preserving study endpoint evaluations. Lower-Priority Situations ESMO pointedly assigns a low priority to follow-up of patients who are at high risk of relapse but lack signs or symptoms of relapse. Like other groups, ESMO recommends that patients with equivocal (i.e., BIRADS 3) screening mammograms should have 6-month follow-up imaging in preference to immediate core needle biopsy of the area(s) of concern. ESMO uses age to assign priority for postponing adjuvant breast radiation in patients with low- to moderate-risk lesions. However, the guidelines stop surprisingly short of recommending that adjuvant radiation be withheld for older patients with low-risk, stage I, hormonally sensitive, HER2-negative breast cancers who receive endocrine therapy. Bottom Line The pragmatic adjustments ESMO suggests address the challenges of evaluating and treating breast cancer patients during the COVID-19 pandemic. The guidelines protect each patient's right to care and safety as well as protecting the safety of caregivers. The guidelines will likely heighten patients' satisfaction with care and decrease concern about adequacy of timely evaluation and treatment. Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest. For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube. This story originally appeared on MDedge.com.

Σελίδα 2 από 2 Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. ESMO's breast cancer guidelines expand upon guidelines issued by other groups, addressing a broad spectrum of patient profiles and providing a creative array of treatment options in COVID-19–era clinical practice. As with ESMO's other disease-focused COVID-19 guidelines, the breast cancer guidelines are organized by priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment. High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening. Medium-priority recommendations apply to patients for whom delaying care beyond 6 weeks would probably lower the likelihood of a significant benefit from the intervention. Low-priority recommendations apply to patients for whom services can be delayed for the duration of the COVID-19 pandemic. Personalized Care and High-Priority Situations ESMO's guidelines suggest that multidisciplinary tumor boards should guide decisions about the urgency of care for individual patients, given the complexity of breast cancer biology, the multiplicity of evidence-based treatments, and the possibility of cure or durable high-quality remissions. The guidelines deliver a clear message that prepandemic discussions about delivering personalized care are even more important now. ESMO prioritizes investigating high-risk screening mammography results (i.e., BIRADS 5), lumps noted on breast self-examination, clinical evidence of local-regional recurrence, and breast cancer in pregnant women. Making these scenarios “high priority” will facilitate the best long-term outcomes in time-sensitive scenarios and improve patient satisfaction with care. Modifications to Consider ESMO provides explicit options for treatment of common breast cancer profiles in which short-term modifications of standard management strategies can safely be considered. Given the generally long natural history of most breast cancer subtypes, these temporary modifications are unlikely to compromise long-term outcomes. For patients with a new diagnosis of localized breast cancer, the guidelines recommend neoadjuvant chemotherapy, targeted therapy, or hormonal therapy to achieve optimal breast cancer outcomes and safely delay surgery or radiotherapy. In the metastatic setting, ESMO advises providers to consider: