Assessing eligibility for non-intensive chemotherapy (IC) randomized clinical trials (RCT) in patients (pts) with newly diagnosed (ND) AML from the Connect Myeloid Disease Registry

7029 Background: Pts with AML in RCTs often do not reflect the population seen in clinical practice due to strict eligibility criteria. This study evaluated criteria from a recent RCT of non-IC against a broad cohort of real-world pts with AML from the Connect ® Myeloid Disease Registry (NCT01688011). Methods: Pts were stratified into 3 groups based on the non-IC phase 3 VIALE-A trial eligibility criteria: 1) “eligible” pts who would have met all VIALE-A inclusion criteria; 2) “unfit” pts who would have been ineligible for VIALE-A due to ≥ 1 of the following: abnormal liver/kidney function, high ECOG, recent prior malignancy, comorbidities score ≥ 2 by ACE-27, hepatic grade ≥ 1, AIDS grade ≥ 1; 3) “fit” pts who would have been ineligible for VIALE-A because they would have qualified for IC (defined as: ≤ 74 y of age, low ECOG, no apparent cardiovascular/renal comorbidities, and did not meet any criteria in #2). Baseline characteristics were summarized by eligibility group. Overall survival (OS) by group was estimated using the Kaplan–Meier method. Induction regimens were categorized as IC (any regimens containing 7+3, MEC, CLAG, FLAG) or venetoclax (VEN)-based. Hazard ratios (HRs) for induction regimens among each group were estimated using Cox models adjusted for age, ELN risk, ECOG, frailty score, and comorbidity index. Results: Of 734 enrolled pts with AML (Dec 2021), most were male (61%) and white (84%); median age 71 y (range 55–97). Only 26% of pts (n = 192) were eligible for a non-IC RCT, 45% (n = 327) were ineligible due to unfitness, and 29% (n = 215) were ineligible due to overall fitness. The main reason for non-IC RCT ineligibility was high overall comorbidity grade (n = 265 [36%]). Fit pts intended to undergo transplant more often compared with unfit pts. Median OS for eligible, unfit, and fit pts were 14, 10, and 22 months, respectively. Among unfit pts, those receiving IC had significantly longer OS compared with pts receiving a VEN-based regimen (median OS 14 vs 6 months, respectively; HR: 0.51, 95% CI: 0.27–0.98, P = 0.042; Table). Eligible pts who received IC tended to have shorter median OS (13 months) vs pts who received VEN-based therapies (23 months; not sig.). Conclusions: The majority of pts with ND AML in the Registry would have been ineligible for a non-IC RCT due to being too fit or unfit. Pts ineligible for an RCT due to unfitness but who received IC maintained an OS benefit vs those receiving VEN-based therapies. This analysis suggests that non-IC RCTs may be excluding pts who appear unfit but can potentially tolerate IC and experience improved survival outcomes. Clinical trial information: NCT01688011. [Table: see text

Implications for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic: A Connect Myeloid Registry study

7021 Background: For patients (pts) with AML, timely treatment is critical. The COVID-19 pandemic broadly disrupted healthcare (eg, decreased blood donations), possibly causing delays in AML treatment and care. To determine the extent of the COVID-19 impact on AML, this analysis examines the effect of the pandemic on managing pts with AML in the Connect Myeloid Registry (NCT01688011). Methods: The Registry is a large, US, multicenter, prospective, observational cohort study that includes newly diagnosed pts with AML aged ≥55 y. Pt characteristics (including assessment for transplant) were analyzed from December 2013 to March 2020 (from Registry opening to the start of the pandemic; Period 1), from March 2020 to May 2021 (during major healthcare disruptions; Period 2), and from May 2021 to January 2022 (resource stabilization and increased vaccine availability; Period 3). Monthly COVID-19 incidence was calculated per weekly US government data (CDC COVID Data Tracker; 2023). Rates of visits (office, remote) and transfusions were calculated by monthly events/person-year. Overall survival (OS) was estimated using the Kaplan-Meier method. Results: In this analysis, 650 pts were included in Period 1, 87 pts in Period 2, and 36 pts in Period 3; demographics and baseline characteristics were balanced across periods. Prior to the COVID-19 pandemic (Period 1), 25.1% of pts were not assessed for transplant; however, after the onset of the pandemic, this increased (45.5% and 44.4% in Periods 2 and 3, respectively). When monthly US COVID-19 cases increased, in-person visits and transfusion rates generally decreased in the Registry (Table). The proportion of pts receiving oral-containing induction regimens was 49.4% (40/81) in Period 1 (starting in January 2019, due to FDA approval of venetoclax in November 2018) and 50.6% (44/87) in Period 2, with a slight increase to 63.9% (23/36) in Period 3. No significant differences in OS by period were observed. Conclusions: In this analysis of pts with AML in the real-world setting, a pattern of increased COVID-19 cases in the US was accompanied by fewer transfusions, fewer in-person visits, and fewer assessments for stem cell transplantation, without a significant impact on OS. Clinical trial information: NCT01688011 . [Table: see text