A Phase II Trial of Geriatric Assessment-Guided Selection of Treatment Intensity in Older Adults With AML.

How to select the appropriate intensity of chemotherapy in older adults with acute myeloid leukemia (AML) remains an unanswered question. In a phase II trial of older adults ≥ 60 years with AML (n = 73), we used geriatric assessment (measures of comorbidity burden, physical and cognitive function) to determine fitness for intensive chemotherapy. We integrated the geriatric assessment and genetic test results to personalize the selection of chemotherapy intensity with a goal to reduce early mortality (NCT03226418). Broad eligibility criteria allowed enrolling patients representative of those treated in real-world practices: 45% of patients were ≥ 70 years, 57% had ≥ 2 comorbidities, 27% had a history of solid malignancies, and 74% had impairments in ≥ 2 geriatric assessment domains used to assign treatment intensity. Thirty-two percent of patients resided in rural areas, and 45% were comanaged with community oncologists. The median time from enrollment to therapy initiation was 1 day (range 0-13). Eight patients (11%) received intensive chemotherapy; others received low-intensity chemotherapy. Mortality at 30 days from diagnosis was 6.8% (95% confidence interval, CI 3.0%-15.1%) and at 90 days was 21.9% (95% CI 14.0%-32.7%). One-year survival was 45.9% (95% CI 35.6%-59.3%). Our study demonstrates that pre-treatment geriatric assessment in older adults with AML is feasible, can identify several functional impairments, and guide the selection of treatment intensity. A randomized trial is necessary to confirm the survival benefit of this approach over the traditional approach of treatment selection. Trial Registration: NCT03226418.