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Background: Despite mitigation and treatment strategies, COVID-19 continues to negatively impact patients (pts) with cancer. Identifying factors that remain consistently associated with morbidity and mortality is critical for risk identification and care delivery. Methods: Using CCC19 registry data through 12/31/2021 we report clinical outcomes (30-day case fatality rate [CFR], mechanical ventilation use (MV), intensive care unit admission (ICU), and hospitalization) in adult pts with cancer and laboratory confirmed SARS-CoV-2, stratified by patient, cancer, and treatment-related factors. Results: In this cohort of 11,417 pts (with 4% reported vaccination prior to COVID-19), 55% required hospitalization, 15% ICU, 9% MV, and 12% died. Overall outcome rates remained similar for 2020 and 2021 (Table). Hydroxychloroquine was utilized in 11% and other anti-COVID-19 drugs (remdesivir, tocilizumab, convalescent plasma, and/or steroids) in 30%. Higher CFRs were observed in older age, males, Black race, smoking (14%), comorbidities (pulmonary [17%], diabetes mellitus [16%], cardiovascular [19%], renal [21%]), ECOG performance status 2+ (31%), co-infection (25%), especially fungal (35%), and initial presentation with severe COVID-19 (48%). Pts with hematologic malignancy, active/ progressing cancer status, or receiving systemic anti-cancer therapy within 1-3 months prior to COVID-19 also had worse CFRs. CFRs were similar across anti-cancer modalities. Other outcomes (ICU, MV, hospitalization) followed similar distributions by pt characteristics. Conclusions: Unfavorable outcome rates continue to remain high over 2 years, despite fewer case reports in 2021 owing to multiple factors (e.g., pandemic dynamics, respondent fatigue, overwhelmed healthcare systems). Pts with specific socio-demographics, performance status, comorbidities, type and status of cancer, immunosuppressive therapies, and COVID-19 severity at presentation experienced worse COVID-19 severity;and these factors should be further examined through multivariable modeling. Understanding epidemiological features, patient and cancer-related factors, and impact of anti-COVID-19 interventions can help inform risk stratification and interpretation of results from clinical trials.
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: Patients (pts) with cancer have a high risk of venous thromboembolic (VTE) complications, further enhanced by anti-cancer treatments, specifically hormonal therapies, targeted therapies (VEGF inhibitors, other TKIs) and immune checkpoint inhibitors (ICIs). We hypothesized that high-risk therapies would predispose pts with cancer and COVID-19 to higher risk of VTE complications. Methods: CCC19 is the largest international registry (NCT04354701) recording outcomes of pts with cancer and COVID-19. The registry was queried for hospitalized pts who developed VTE and received systemic cancer treatment in the year prior to COVID-19. Incidence of VTE was analyzed as the primary endpoint;30-day any cause mortality & need for ICU admission at baseline were secondary endpoints in pts with and without VTE respectively. Pts were stratified by treatment type and time from last treatment dose: <2 wk, 2-4 wk, 1-3 months (mos), 3-12 mos. Results: As of February 9th 2021, 4217 hospitalized pts with complications data were present in the registry. 1867 (44%) pts had received systemic anti-cancer therapy within the year prior to COVID-19 and were analyzed. There were a total of 186 (10%) VTE events. Of these, VTE incidence was 141 (10.5%) in pts with solid tumors and 57 (9%) in pts with hematologic malignancies. Overall 30-day mortality was 20% and 22% in pts with and without VTE respectively, while direct admission to ICU at presentation was seen in 17% and 10% of pts with and without VTE, respectively. Treatment timing and drug exposures are below (Table). Receipt of systemic anti-cancer treatment within 3 mos vs 3-12 mos was associated with increased rate of VTE, OR 2.44, 95% CI 1.18-5.84, p=0.011 (univariate Fisher test). Conclusions: We describe the incidence of VTE events in pts with cancer and COVID-19 with recent systemic cancer therapy. ICI and VEGFi were associated with numerically higher rates of VTE;other examined drugs and drug classes were not. Timing of therapy appears to modify risk of VTE. Although retrospective, with possible selection and confounding biases, our analysis suggests that factors other than anticancer drug exposures may drive VTE events in this population.
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
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.