ABSTRACT
Background: SARS-CoV-2 is associated with diverse clinical presentations ranging from asymptomatic infection to lethal complications. Small studies have suggested inferior outcomes in patients (pts) on active cancer treatment. This finding was not independently validated in our prior report on 928 pts, which included treatments administered within 4 weeks of COVID-19 diagnosis. Here, we examine outcomes related to systemic cancer treatment within one year of lab-confirmed SARS-CoV-2 infection in an expanded cohort. Method(s): The COVID-19 and Cancer Consortium (CCC19) registry (NCT04354701) was queried for pts ever receiving systemic treatment. Treatment type, cancer type, stage, and COVID-19 outcomes were examined. Pts were stratified by time from last treatment administration: <2 wk, 2-4 wk, 1-3 mo, or 3-12 mo. Standardized incidence ratios (SIR) of mortality by treatment type and timing were calculated. Result(s): As of 31 July 2020, we analyzed 3920 pts;42% received systemic anti-cancer treatment within 12 mo (Table). 159 distinct medications were administered. The highest rate of COVID-19-associated complications were observed in pts treated within 1-3 months prior to COVID-19;all-cause mortality in this group was 26%. 30-day mortality by most recent treatment type was 20% for chemotherapy, 18% for immunotherapy, 17% for chemoradiotherapy, 29% for chemoimmunotherapy, 20% for targeted therapy, and 11% for endocrine therapy. SIR of mortality was highest for chemoimmunotherapy or chemotherapy <2 wks, and lowest for endocrine treatments. A high SIR was also found for targeted agents within 3-12 mo. Pts untreated in the year prior to COVID-19 diagnosis had a mortality of 14%. [Formula presented] Conclusion(s): 30-day mortality was highest amongst cancer pts treated 1-3 months prior to COVID-19 diagnosis and those treated with chemoimmunotherapy. Except for endocrine therapy, mortality for subgroups was numerically higher than in pts untreated within a year prior to COVID-19 diagnosis. Clinical trial identification: NCT04354701. Legal entity responsible for the study: The COVID-19 and Cancer Consortium (CCC19). Funding(s): National Cancer Institute (P30 CA068485). Disclosure: T.M. Wise-Draper: Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca;Research grant/Funding (self): BMS;Research grant/Funding (self): Tesaro/GSK;Advisory/Consultancy: Shattuck Labs;Leadership role, Travel/Accommodation/Expenses, HNC POA Lead: Caris Life Sciences;Research grant/Funding (self), Travel/Accommodation/Expenses: Merck;Travel/Accommodation/Expenses: Eli Lilly;Travel/Accommodation/Expenses: Bexion. A. Elkrief: Research grant/Funding (self): AstraZeneca. B.I. Rini: Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Merck;Advisory/Consultancy, Research grant/Funding (self): Roche;Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy, Research grant/Funding (self): AVEO;Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: BMS;Advisory/Consultancy: arravive;Advisory/Consultancy: 3D medicines;Advisory/Consultancy: Synthorx;Advisory/Consultancy: Surface Oncology;Shareholder/Stockholder/Stock options: PTC Therapeutics;Research grant/Funding (self): AstraZeneca. D.B. Johnson: Advisory/Consultancy: Array Biopharma;Advisory/Consultancy, Research grant/Funding (self): BMS;Advisory/Consultancy: Janssen;Advisory/Consultancy: Merck;Advisory/Consultancy: Novartis;Research grant/Funding (self): Incyte;Leadership role: ASCO melanoma scientific committee chair;Leadership role: NCCN Melanoma committee. G. Lopes: Honoraria (self), Travel/Accommodation/Expenses: Boehringer Ingelheim;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): AstraZeneca;Research grant/Funding (institution): Merck;Research grant/Funding (institution): EMD Serono;Research gr
ABSTRACT
Background: Hospitalized cancer patients (pts) with COVID-19 have a severe disease course and high mortality. Pts with lung cancer, hematologic malignancies and metastatic disease may be at higher risk. Detailed prospective inpatient data may help to identify those at greatest risk for poor outcomes. Methods: NCCAPS is a longitudinal study aiming to accrue 2,000 cancer pts undergoing treatment for hematologic malignancy or solid tumor with COVID-19. For pts' first COVID-19 hospitalization, clinical data, research blood specimens and imaging are collected, and additional clinical data are collected during subsequent hospitalizations. Results: As of Jan. 22, 2021, among 757 enrolled adult patients from 204 sites, 124 (16.3%) reported at least one hospitalization for COVID-19, and discharge data was available for 98 hospitalizations in 88 patients. The median age was 67 (range 21-93, 1Q:56, 3Q:72), 35/88 (40%) were female. The most common malignancies in hospitalized adult pts were lymphoma (18.2%), lung cancer (15.9%) and multiple myeloma (10.2%). The most common presenting symptoms were shortness of breath (65%), fatigue/malaise (64%), and fever (49%). 8/88 (9%) pts were neutropenic (ANC < 1000) at presentation;17/88 (19%) were thrombocytopenic. Median length of stay was 6.5 days (range 1-41, 1Q:4, 3Q:12). Among those hospitalized, 20/88 (22.7%) received care in the ICU or high dependency unit, with a median ICU stay of 7 days (range 1- 22, 1Q:2.5, 3Q:9.5);of those admitted to the ICU, 25% (5/20) received invasive mechanical ventilation. Of those in whom inpatient medications were recorded (n = 63), 63% received corticosteroids, 46% received remdesivir, and 14% received convalescent plasma. One pt received bamlanivimab and 2 patients received tocilizumab. Most (46/63;73%) received anticoagulation, primarily prophylactic low molecular weight heparin;11/63 (17%) received therapeutic dose anticoagulation. Inpatient D-dimer values were recorded in 43 inpatients, 26 of whom had multiple measurements. 16/98 hospitalizations ended with death (16%). Conclusions: Preliminary analysis of NCCAPS data reveals that inpatient hospital admission is common among oncology patients with COVID-19 and mortality rates appear high within this cohort. Hematologic malignancies and lung cancer are the most common underlying diagnoses in patients requiring hospitalization. Corticosteroids and anti-coagulation were the most commonly used therapies. Despite high rates of ICU admission, invasive mechanical ventilation may be instituted less often in an oncology cohort. These observations may inform decisions about vaccine policy and decisions to limit life sustaining treatment.
ABSTRACT
Background: Patients (pts) with cancer are at increased risk of SARS-CoV-2 infection and severe COVID-19 disease. Longitudinal followup is needed to characterize the severity, sequelae and outcomes in pts with cancer who develop COVID-19. Methods: NCCAPS is a prospective, longitudinal study (NCT04387656) aiming to accrue 2,000 pts with cancer undergoing active treatment or prior stem cell transplant for hematologic or solid tumor malignancy. Adult patients are eligible to enroll within 14 days of their first positive SARS-CoV-2 test;pediatric patients may also enroll retrospectively. Clinical data, patient-reported outcomes, blood specimens, and imaging are collected for up to 2 years. This abstract provides initial baseline and 2-month follow-up data. Results: As of Jan 22, 2021, 585 pts (552 adults and 33 pediatric pts) had complete baseline data and of these pts, 215 adults had 2 months of complete follow-up data. 23.4% of adults and 42.4% of pediatric pts were of nonWhite race and/or Hispanic/Latinx ethnicity. The most common cancer diagnoses were breast (19.6%), lung (9.9%) and multiple myeloma (8.9%) in adults and acute leukemia (AML/ALL;63.6%) in children. The most recent treatment was chemotherapy in 38.2%, immunotherapy in 9.6%, and radiation in 5.4%. Median time from positive SARS-CoV-2 test to study enrollment was 10.5 days in adults and 18 days in pediatric pts. Preliminary analysis of plasma cytokines will be presented. At enrollment, 84.6% of adults had COVID-19 symptoms. 55.9% reported symptoms 2 weeks after their positive SARSCoV-2 test;this fell to 39.0% at 1 month and 28.8% at 2 months (see Table). Of the 215 adults with complete data at 2 months, sequelae included pulmonary (n=22, 10%), cardiovascular (n=12, 6%) thromboembolic (n=9, 4%), bleeding (n=9, 4%) and gastrointestinal (n=11, 5%). 144 (67%) reported at least one cancer treatment disruption in the first 2 months, most commonly delayed therapy (n=98;46%).Of the 348 adults with baseline data and SARS-CoV-2 test date prior to Nov 23, 2020, 6.3% had died (median time from SARS-CoV-2 test to death: 27 days), and 22.1% reported at least one hospitalization for COVID-19. No deaths were reported in the pediatric population. Conclusion: Cancer pts with COVID-19 report ongoing symptoms after acute infection and a substantial number develop sequelae. Cancer treatment disruptions are common in the initial months following SARS-CoV-2 infection. Longer follow-up will inform whether these treatment disruptions are associated with adverse outcomes. (Table Presented).
ABSTRACT
BACKGROUND: Patients with cancer may be at high risk of adverse outcomes from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We analyzed a cohort of patients with cancer and coronavirus 2019 (COVID-19) reported to the COVID-19 and Cancer Consortium (CCC19) to identify prognostic clinical factors, including laboratory measurements and anticancer therapies. PATIENTS AND METHODS: Patients with active or historical cancer and a laboratory-confirmed SARS-CoV-2 diagnosis recorded between 17 March and 18 November 2020 were included. The primary outcome was COVID-19 severity measured on an ordinal scale (uncomplicated, hospitalized, admitted to intensive care unit, mechanically ventilated, died within 30 days). Multivariable regression models included demographics, cancer status, anticancer therapy and timing, COVID-19-directed therapies, and laboratory measurements (among hospitalized patients). RESULTS: A total of 4966 patients were included (median age 66 years, 51% female, 50% non-Hispanic white); 2872 (58%) were hospitalized and 695 (14%) died; 61% had cancer that was present, diagnosed, or treated within the year prior to COVID-19 diagnosis. Older age, male sex, obesity, cardiovascular and pulmonary comorbidities, renal disease, diabetes mellitus, non-Hispanic black race, Hispanic ethnicity, worse Eastern Cooperative Oncology Group performance status, recent cytotoxic chemotherapy, and hematologic malignancy were associated with higher COVID-19 severity. Among hospitalized patients, low or high absolute lymphocyte count; high absolute neutrophil count; low platelet count; abnormal creatinine; troponin; lactate dehydrogenase; and C-reactive protein were associated with higher COVID-19 severity. Patients diagnosed early in the COVID-19 pandemic (January-April 2020) had worse outcomes than those diagnosed later. Specific anticancer therapies (e.g. R-CHOP, platinum combined with etoposide, and DNA methyltransferase inhibitors) were associated with high 30-day all-cause mortality. CONCLUSIONS: Clinical factors (e.g. older age, hematological malignancy, recent chemotherapy) and laboratory measurements were associated with poor outcomes among patients with cancer and COVID-19. Although further studies are needed, caution may be required in utilizing particular anticancer therapies. CLINICAL TRIAL IDENTIFIER: NCT04354701.
Subject(s)
COVID-19 , Neoplasms , Aged , COVID-19 Testing , Female , Humans , Male , Neoplasms/drug therapy , Neoplasms/epidemiology , Pandemics , SARS-CoV-2ABSTRACT
SARS-CoV-2 and the resulting disease, COVID-19, has led to a global pandemic with broad impact on the deliveryof medical care. Cancer patients may be especially vulnerable to both infection and adverse outcomes from COVIDdue to a number of factors including advanced age, immunosuppression from disease and/or anticancer therapy, and heightened interaction with the medical system. Several cohort studies have been launched to more fullyunderstand risk factors for death and other adverse outcomes in patients with active or remote cancer. CCC-19 is acohort study involving more than 100 institutions that enter data into a REDCaP database regarding patientdemographics, cancer type and treatment details, and outcome of COVID infection. All patients have documentedSARS-CoV-2 PCR positive and/or clinical symptoms consistent with COVID, in addition to an ongoing or past historyof invasive malignancy. The initial analysis of this cohort study (n=928;Kuderer et al., Lancet 2020) demonstrated a13% mortality rate and revealed several factors associated with an increased mortality including advanced age, male gender, greater number of comorbidities, worse ECOG performance status, and progressive cancer. Recentcancer surgery and receipt of cytotoxic or other systemic anticancer therapy was not associated with worseoutcome, although small patient numbers in some subsets precluded definitive conclusions. At present, there areapproximately 3,000 patients entered into this database and updated analyses will be presented. In addition to thiseffort, a number of other societies have created similar databases including ASH, ASCO, and ESMO. Thesecomplementary efforts will allow a global assessment of the impact of COVID on cancer patients including mortalityand adverse outcomes in addition to cancer-specific outcomes. Last, the NCI COVID-19 in Cancer Patients Study(NCCAPS) is a prospective study in patients with active cancer and recent SARS-CoV-2 infection. This 2,000-patient study is open to accrual and will prospectively define both the impact of COVID on cancer and also cancerstatus and treatment on COVID outcome. In addition, biospecimen collection in this study will examine geneticpredisposition, cytokine and coagulopathic parameters, and serologic outcomes. Collectively, these retrospectiveand prospective efforts will enable a more granular understanding of COVID in cancer patients to enable bothappropriate cancer care delivery and improvement in outcomes in cancer patients with COVID infection.
ABSTRACT
Background: There are limited data on COVID-19 in patients with cancer. We characterize the outcomes of patients with cancer and COVID-19 and identify potential prognostic factors. Methods: The COVID- 19 and Cancer Consortium (CCC19) cohort study includes patients with active or prior hematologic or invasive solid malignancies reported across academic and community sites. Results: We included 1,018 cases accrued March-April 2020. Median age was 66 years (range, 18-90). Breast (20%) and prostate (16%) cancers were most prevalent;43% of patients were on active anti-cancer treatment. At time of data analysis, 106 patients (10.4%) have died and 26% met the composite outcome of death, severe illness requiring hospitalization, and/or mechanical ventilation. In multivariable logistic regression analysis, independent factors associated with increased 30- day mortality were age, male sex, former smoking, ECOG performance status (2 versus 0/1: partially adjusted odds ratio (pAOR) 2.74, 95% CI 1.31-5.7;3/4 versus 0/1: pAOR 5.34, 95% CI 2.44-11.69), active malignancy (stable/responding, pAOR 1.93, 95% CI 1.06-3.5;progressing, pAOR 3.79, 95% CI 1.78-8.08), and receipt of azithromycin and hydroxychloroquine. Tumor type, race/ethnicity, obesity, number of comorbidities, recent surgery, and type of active cancer therapy were not significant factors for mortality. Conclusions: All-cause 30-day mortality and severe illness in this cohort were significantly higher than previously reported for the general population and were associated with general risk factors as well as those unique to patients with cancer. Cancer type and treatment were not independently associated with increased 30-day mortality. Longer follow-up is needed to better understand the impact of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.