Elderly patients with untreated advanced stage follicular lymphoma (FL) treated with brief chemoimmunotherapy Rituximab (R) FND+/-rituximab maintenance: Preliminary analysis of a prospective randomized study

Introduction: we investigated efficacy and safety of a brief chemo-immunotherapy RFND followed by randomization between R maintenance or observation in a study specifically devised for elderly. Material and methods: From January 2004 to December 2007, 235 pts (age 60-75) with untreated advanced stage FL were enrolled and treated with: 4 courses of RFND (Fludarabine, Mitoxantrone, Dexamethasone) followed by 4 weekly R consolidation; CR+CRu+PR pts were randomized between R maintenance (375 mg/m 2 every months for 4 doses) or observation. PCR analysis for IgH/Bcl-2 rearrangement was performed on bone marrow (BM) at diagnosis, after RFND, R consolidation and during maintenance/observation. Preliminary analysis was done after the first 80 randomized pts. This analysis included 95 pts recruited within this time frame. Results: Median age 65 (60-75); stage III/IV 16/70%; FLIPI low(L) 10%, intermediate(I) 30%, high(H) 60%. PCR analysis was done in 91 pts at diagnosis: 56% were Bcl-2+. N ORR CR PCR negativity associated with CR(46 pts Bcl2+ evaluable) Baseline 95 – – – R-FND x 4 95 86 (90%) 51 (54%) 18 (39%) R consolidation 88 80 (84%) 68 (72%) 31 (67%) Univariate analysis was performed: high CR rate was achieved also in poor prognosis pts (CR according to FLIPI: L 75%, I 88%, H 81%). The most frequent CTC grade 3-4 toxicity was neutropenia in 25% of the courses, with only 6 serious infections. No toxic deaths occurred. Any grade R related reactions were seen in 9% of the courses with R discontinuation in only 2 pts. So far 91 pts are alive and 4 died of lymphoma. Conclusions: A brief chemo-immunotherapy RFND + R consolidation is safe and effective with a high CR rate and PCR negativity in elderly pts with untreated FL with FLIPI H. R consolidation convirted in CR 56% of PR after RFND. The whole study will provide insights on the role of R maintenance after R-chemotherapy