Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study.

BACKGROUND: COVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct. PATIENTS AND METHODS: This prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States between December 2019 and June 2021. The primary objective was to assess the enrollment on, accrual to, and activation of oncology therapeutic clinical trials during the pandemic using an institution-wide cohort of (i) new patient accruals to oncological trials, (ii) a manually curated cohort of patients with cancer, and (ii) a dataset of new trial activations. RESULTS: The institution-wide cohort included 4756 new patients enrolled to clinical trials from December 2019 to June 2021. A major decrease in the numbers of new patient accruals (-46%) was seen early in the pandemic, followed by a progressive recovery and return to higher-than-normal levels (+2.6%). A similar pattern (from -23.6% to +30.4%) was observed among 467 newly activated trials from June 2019 to June 2021. A more pronounced decline in new accruals was seen among academically sponsored trials (versus industry sponsored trials) (P < 0.05). In the manually curated cohort, which included 2361 patients with cancer, non-white patients tended to be more likely taken off trial in the early pandemic period (adjusted odds ratio: 2.60; 95% confidence interval 1.00-6.63), and substantial pandemic-related deviations were recorded. CONCLUSIONS: Substantial disruptions in clinical trial activities were observed early during the pandemic, with a gradual recovery during ensuing time periods, both from an enrollment and an activation standpoint. The observed decline was more prominent among academically sponsored trials, and racial disparities were seen among people taken off trial.

Disruption to care of patients with thoracic malignancies: A COVID-19 and cancer outcomes study

Introduction: Patients with thoracic malignancies are susceptible to severe outcomes from coronavirus disease 2019 (COVID-19). The aim of this study was to evaluate the disruption to care of patients with thoracic malignancies during the COVID-19 pandemic. Methods: The COVID-19 and Cancer Outcomes Study (CCOS) is a multicenter prospective cohort study comprised of adult patients with a current or past history of hematological malignancy or invasive solid tumor who had an outpatient medical oncology visit on the index week between March 2 and March 6, 2020 at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai in New York, NY (MSSM) or the Dana-Farber Cancer Institute in Boston, MA (DFCI). An electronic data capture platform was used to collect patient-, cancer-, and treatment-related variables during the three months prior to the index week (the baseline period) and the following three months (the pandemic period). Two-by-three contingency tables with Fisher's exact tests were computed. All tests were two-tailed and considered statistically significant for p<0.05. All analyses were done in the R statistical environment (v3.6.1). Results: The overall cohort included 2365 patients, of which 313 had thoracic malignancies, 1578 had other solid tumors, and 474 had hematological malignancies. At a median follow-up of 84 days (95% confidence interval, 82-84), 13 patients with thoracic malignancies (4.1%) had developed COVID-19 (vs. other solid: 63 [4.0%] and hematological: 52 [11.0%];p<0.001). When comparing data from the pandemic period to the baseline period, patients with thoracic malignancies had a decrease in the number of in-person outpatient visits (thoracic: 209 [66.8%] vs. other solid: 749 [47.5%] vs. hematological: 260 [54.9%];p<0.001) and an increase in the number of telehealth visits (thoracic: 126 [40.3%] vs. other solid: 465 [29.5%] vs. hematological: 168 [35.4%];p<0.001). During the pandemic period, 33 (10.5%) patients with thoracic malignancies experienced treatment delays due to the pandemic (vs. other solid: 127 [8.0%] and hematological: 79 [16.7%];p<0.001), and 26 (8.3%) patients with thoracic malignancies experienced delays in cancer imaging or diagnostic procedures (vs. other solid: 63 [4.0%] and hematological: 26 [5.5%];p=0.003). Discussion: In this prospective cohort study, patients with thoracic malignancies were not at increased risk of developing COVID-19 compared to patients with other cancers, but experienced significant cancer care disruption during the COVID-19 pandemic with a higher likelihood of decreased in-person visits and increased telehealth visits compared to patients with other malignancies. Focused efforts to ensure continuity of care for this vulnerable patient population are warranted.

Disparities in cancer during the COVID-19 pandemic: COVID-19 and cancer outcomes study (CCOS)

Background: The COVID-19 pandemic has rapidly altered cancer care. However, the ways in which it has done so and the associated impact at the individual and societal levels remains poorly defined. Methods: CCOS is a multicenter prospective cohort study designed to define the impact of the pandemic on cancer care delivery and outcomes. The CCOS cohort comprised consecutive outpatients with cancer seen at two US cancer centers from March 2 to March 6, 2020 (index visit). Data was collected at baseline, retrospectively from the preceding 3 months, and prospectively at 3-month follow up. Per patient changes in numbers of visits were compared using Wilcoxon signed rank tests. Correlates of increases in telehealth visits and decreases in in-person visits were evaluated using multivariable logistic regression models. Adjusted Odds ratios [aOR] and 95% confidence intervals (CI) were reported. Results: Of 2365 included patients, 1219 (51.6%) had a decrease in in-person visit frequency during the pandemic period relative to the preceding 3 months. Conversely, 760 (32.2%) had an increased frequency of telehealth visits (decrease in in-person and increase in telehealth visits;both p<0.01). 128 (5.4%) patients developed COVID-19. Compared to White patients, Black and Hispanic patients were less likely to have telehealth visits, had no significant change in frequency of in-person visits, and were more likely to develop COVID-19 (Table). [Formula presented] Conclusions: Significant disruptions to routine cancer care were observed during the pandemic period relative to the prior 3 months. Racial and ethnic barriers to the adoption of telehealth, and related socioeconomic factors, place these vulnerable populations simultaneously at disproportionate risk for decreased cancer-related visits and COVID infection, thereby exacerbating existing racial and ethnic health disparities. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: D. Doroshow: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen;Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim;Honoraria (self), Advisory/Consultancy: Athenaeum Partners;Honoraria (self), Advisory/Consultancy: Boston Healthcare Associates. A.L. Schmidt: Travel/Accommodation/Expenses: Pfizer;Travel/Accommodation/Expenses: Astellas. Z. Bakouny: Non-remunerated activity/ies: Bristol Myers Squibb;Research grant/Funding (self): Genentech/ImCore. M.M. Awad: Advisory/Consultancy, Research grant/Funding (self): Bristol Myers Squibb;Advisory/Consultancy, Research grant/Funding (self): Lilly;Advisory/Consultancy, Research grant/Funding (self): AstraZeneca;Advisory/Consultancy, Research grant/Funding (self): Genentech;Advisory/Consultancy: Merck;Advisory/Consultancy: Achilles;Advisory/Consultancy: AbbVie. R. Haddad: Advisory/Consultancy, Research grant/Funding (self): Bristol Myers Squibb;Advisory/Consultancy, Research grant/Funding (self): Merck;Advisory/Consultancy, Research grant/Funding (self): Pfizer;Advisory/Consultancy, Research grant/Funding (self): Genentech;Advisory/Consultancy, Research grant/Funding (self): AstraZeneca;Advisory/Consultancy, Research grant/Funding (self): GlaxoSmithKline. M.D. Galsky: Shareholder/Stockholder/Stock options: Rappta Therapeutics;Honoraria (self): BioMotiv;Honoraria (self): Janssen;Honoraria (self): Dendreon;Honoraria (self): Merck;Honoraria (self): GlaxoSmithKline;Honoraria (self): Lilly;Honoraria (self): Astellas Pharma;Honoraria (self): Genentech;Honoraria (self): Bristol-Myers Squibb;Honoraria (self): Novartis;Honoraria (self): Pfizer;Honoraria (self): EMD Serono;Honoraria (self): AstraZeneca;Honoraria (self): Seattle Genetics;Honoraria (self): Incyte;Honoraria (self): Alleron Therapeutics;Honoraria (self): Dracen;Honoraria (self): Inovio Pharmaceuticals;Honoraria (self): NuMab;Honoraria (self): Dragonfly Therapeutics;Honoraria (institution): Janssen Oncology;Honoraria (institution): Dendreon;Honoraria (institution): Novartis;Honoraria (institu ion): Bristol-Myers Squibb;Honoraria (institution): Merck;Honoraria (institution): AstraZeneca;Honoraria (institution): Genentech/Roche. T.K. Choueiri: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AstraZeneca;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Alexion;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bayer;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): BristolMyersSquibb;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Cerulean;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Eisai;Honoraria (self), Research grant/Funding (self): Foundation Medicine;Honoraria (self), Research grant/Funding (self): Exelixis;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Ipsen;Research grant/Funding (self): 16 Tracon;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Genentech;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Roche;Honoraria (self), Research grant/Funding (self): Roche Products Limited;Honoraria (self), Research grant/Funding (self): Hoffman-LaRoche;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): GlaxoSmithKline;Advisory/Consultancy, Research grant/Funding (self): Lilly;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Novartis;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Peloton;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Pfizer;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Prometheus labs;Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Corvus;Research grant/Funding (self): Calithera;Research grant/Funding (self): Analysis Group;Honoraria (self), Research grant/Funding (self): Sanofi/Aventis;Research grant/Funding (self): Takeda;Honoraria (self), Advisory/Consultancy: EMD Serono;Honoraria (self), Advisory/Consultancy: UpToDate;Honoraria (self): NCCN;Honoraria (self), Advisory/Consultancy, Dr. Choueiri reports research support from AstraZeneca, Alexion, Bayer, Bristol Myers Squibb/ER Squibb and sons LLC, Cerulean, Eisai, Foundation Medicine Inc., Exelixis, Ipsen, 16 Tracon, Genentech, Roche, Roche Products Limited, F. Hoffmann-La Roche, GlaxoSmithKline, Lilly, Merck, Novartis, Peloton, Pfizer, Prometheus Labs, Corvus, Calithera, Analysis Group, Sanofi/Aventis, Takeda;Honoraria: AstraZeneca, Alexion, Sanofi/Aventis, Bayer, Bristol Myers-Squibb/ER Squibb and sons LLC, Cerulean, Eisai, Foundation Medicine Inc., Exelixis, Genentech, Roche, Roche Products Limited, F. Hoffmann-La Roche, GlaxoSmithKline, Merck, Novartis, Peloton, Pfizer, EMD Serono, Prometheus Labs, Corvus, Ipsen, Up-to-Date, NCCN, Analysis Group, NCCN, Michael J. Hennessy (MJH) Associates, Inc (Healthcare Communications Company with several brands such as OnClive, PeerView and PER), Research to Practice, L-path, Kidney Cancer Journal, Clinical Care Options, Platform Q, Navinata Healthcare, Harborside Press, American Society of Me: Analysis Group. All other authors have declared no conflicts of interest.