A Stratified Risk-Adapted Approach to Lymphoma Salvage in an Outpatient Setting.

Aims: Interim analysis of the safety and efficacy of a risk-adjusted approach to lymphoma salvage therapy. Methods: Patients were stratified - Group 1 (G1) (good risk - first relapse following durable CR1); Group 2 (G2) (poor risk - primary refractory, >1 relapse, or non-durable CR1); or Group 3 (G3) (relapse post-ASCT). Two regimens were evaluated: VGF (vinorelbine 25mg/sqm days 1 and 8, gemcitabine 1000mg/sqm days 1 and 8, pegfilgrastim 6mg SC day 9) (G1/3) and F-GIV (VGF plus ifosfamide 3000mg/sqm day 1) (G2). Following 2 cycles all patients were re-staged. Responsive patients (>50% reduction in disease and functional imaging negative) received 2 further cycles of the same therapy, the remainder ‘escalated’ therapy to F-GIV (G1/3) or IVAC (G2) (inpatient ifosfamide, VP-16 and Ara-C). Results: 45 of a planned 90 patients, median age 56 years, are evaluable (G1 = 16, G2 = 23, G3 = 6). Diagnoses were Hodgkin’s lymphoma n = 9 and NHL, n = 36 (DLC = 24, follicular = 6, others = 6). To date G1 and G2 have received 127 cycles of VGF or F-GIV, with grades 3/4 neutropenia or thrombocytopenia in 31% and 17% (VGF) and 74% and 78% (F-GIV) of patients, respectively. Febrile neutropenia, admission, treatment delay or dose-reductions occurred with 13%, 28%, 12%, 6% of cycles, respectively. Based on ITT the ORR is 59% (CR 33%). Conclusion: VGF and F-GIV can be safely administered on an outpatient basis and show significant activity against advanced lymphoma.