A phase 2 study of autologous stem cell transplantation as salvage therapy for older patients with aggressive B-cell lymphoma prospectively evaluated by comprehensive geriatric assessment: the FIL_RECANZ study.

Abstract

The FIL_RECANZ (ClinicalTrials.gov: NCT02371161) is a prospective study evaluating salvage with autologous stem cell transplantation (ASCT) in aggressive B-cell lymphoma patients aged 65 - 75, fit according to the FIL Geriatric Assessment (CGA). Seventy patients were analyzed who received salvage with three cycles of a platinum-based regimen. Response to salvage was 44% (21 complete, 10 partial remissions). Twenty-seven responding subjects underwent ASCT following BEAM/FEAM conditioning with a median of 5.6 × 10⁶ CD34+ cells/kg reinfused: 24 (89%) obtained complete remission, in 22 lasting > 12 months. After a median of 28 months from ASCT, 2-year event-free survival was 54%, with the most common grade 3-4 non-hematological toxicity consisting of gastrointestinal (10%) and infectious (8%). No treatment-related mortality was recorded within 100 days following ASCT. Our data indicate that CGA enables fit older patients to undergo ASCT with favorable tolerance and efficacy. These results may serve as a benchmark to assess more effective pre-ASCT therapies.