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

The American Society of Haematology (ASH) had its annual meeting earlier this month. Haematologists from around the world gathered at the San Diego Convention Centre to provide a forum for discussing critical issues in haematology. Nearly 20,000 clinicians, scientists, and others attended the four-day meeting, which consisted of an educational program and cutting-edge scientific sessions. The following was one of the presentations given at the meeting.

The aim of this study was to perform an interim analysis of the safety and efficacy of a risk-adjusted approach to lymphoma salvage therapy.Researchers stratified patients into 3 groups. 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).Out of a planned 90 patients, 45 (median age 56 years), were 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%).Researchers concluded that VGF and F-GIV can be safely administered on an outpatient basis and show significant activity against advanced lymphoma.(Source: American Society of Haematology (ASH): Blood, Volume 104, issue 11, November 16, 2004.)