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Objective: The COVID-19 pandemic led to immediate changes in cancer clinical trial conduct. The primary aims of this study were to summarize the impact of the pandemic on Alliance for Clinical Trials in Oncology (Alliance) enrollment, protocol deviations, COVID-19 events (positive or presumptive-positive COVID test), and premature study discontinuation rates. Methods: Enrollment trends were examined from January 2019 (pre COVID-19 pandemic) through 2022. Data were captured for protocol deviations and premature treatment and study discontinuation events across all Alliance protocols using a centralized Medidata Rave database, and summarized from January 1, 2020, through June 30, 2022. Descriptive statistics and graphical techniques are used to summarize observed trends. Results: Overall enrollment across Alliance trials decreased during the COVID-19 pandemic and remained below pre-pandemic levels in 2022. Racial and ethnic demographics of enrolled patients did not change substantially. 4805 protocol deviations were reported on 2745 unique patients, with at least one protocol deviation reported by 618 sites and 77 unique trials. Commonly reported deviations were telemedicine visits (n=2167, 45%) and late/missed study procedures (n=2150, 45%). A total of 826 COVID-19 events were reported in 659 unique patients. Of an estimated 18,000 enrolled patients, only 68 withdrew from treatment and 45 withdrew from study due to COVID-19. Conclusion: A centralized COVID-19 database enabled a comprehensive assessment of the impact of the pandemic across Alliance trials. COVID-19 led to an immediate decline in enrollment across all patient populations. While the number of trials open to patient accrual remained stable, several large, adjuvant studies completed accrual during this period, which contributed to accrual decline. Telemedicine usage was notable, and both COVID-19 events and study discontinuation due to COVID-19 were rare.
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INTRODUCTION: Chronic lymphocytic leukemia (CLL) commonly affects older adults. However, few studies have examined the relationship between baseline geriatric domains and clinical outcomes in this population. Here, we aim to evaluate the use of a comprehensive geriatric assessment in older (>65 years) untreated patients with CLL to predict outcomes. MATERIALS AND METHODS: We conducted a planned analysis of 369 patients with CLL age 65 or older treated in a phase 3 randomized trial of bendamustine plus rituximab versus ibrutinib plus rituximab versus ibrutinib alone (A041202). Patients underwent evaluations of geriatric domains including functional status, psychological status, social activity, cognition, social support, and nutritional status. We examined associations among baseline geriatric domains with grade 3+ adverse events using multivariable logistic regression and overall survival (OS) and progression-free survival (PFS) using multivariable Cox regression models. RESULTS: In this study, the median age was 71 years (range: 65-87). In the combined multivariable model, the following geriatric domains were significantly associated with PFS: Medical Outcomes Study (MOS) - social activities survey score (hazard ratio [HR] [95% confidence interval (CI)] 0.974(0.961, 0.988), p = 0.0002) and nutritional status (≥5% weight loss in the preceding six months: (HR [95% CI] 2.717[1.696, 4.354], p < 0.001). MOS - social activities score [HR (95% CI) 0.978(0.958, 0.999), p = 0.038] was associated with OS. No geriatric domains were significantly associated with toxicity. There were no statistically significant interactions between geriatric domains and treatment. DISCUSSION: Geriatric domains of social activity and nutritional status were associated with OS and/or PFS in older adults with CLL. These findings highlight the importance of assessing geriatric domains to identify high-risk patients with CLL who may benefit from additional support during treatment.