Long-Term Results of First-Line Regimens in Advanced Symptomatic Follicular Lymphoma
Long-term results of the Italian phase III FOLL05 trial, reported by Luminari et al in the Journal of Clinical Oncology, indicate superior progression-free survival with R-CHOP (rituximab [Rituxan] plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) vs R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) in the initial treatment of advanced symptomatic follicular lymphoma, with no significant differences among regimens in 8-year overall survival.
Study Details
The FOLL05 trial compared R-CVP with R-CHOP and R-FM regimens without rituximab maintenance in 504 patients enrolled at 58 sites from March 2006 to September 2010. A prior report at a median follow-up of 34 months showed an improved time to treatment failure at 3 years, the primary study endpoint, for R-CHOP and R-FM vs R-CVP, with R-CHOP exhibiting a better risk-benefit ratio with regard to toxicity than R-FM. The current post hoc analysis provides findings after a median follow-up of 84 months (range = 1–119 months).
Long-Term Outcomes
Among all patients, 8-year rates were 44% for treatment failure and 48% for progression-free survival. In an analysis adjusting for Follicular Lymphoma International Prognostic Index 2 scores, the hazard ratios for progression-free survival vs R-CVP were 0.73 for R-CHOP (P = .037) and 0.67 for R-FM (P = .009). Among all patients, 8-year overall survival was 83%, with no significant difference observed among the R-CVP (85%), R-CHOP (83%), and R-FM (79%) groups (P = .243).
The risk of death from lymphoma was comparable among study groups (P = .900). The risk of death from causes unrelated to lymphoma at 8 years was higher in the R-FM group vs the R-CVP group (11.2% vs 1.8%, P = .005), with no significant difference observed between R-CVP and R-CHOP (6.4%, P = .157). More patients in the R-CVP group required second-line therapy than did those in the R-CHOP and R-FM groups (55% vs 38% and 32%; P < .001).
The investigators concluded: “With an 83% 8-year [overall survival] rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage [follicular lymphoma] treated with immunochemotherapy. The three study arms had similar [overall survival] but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.”
The study was supported by grants from the Associazione Angela Serra per la Ricerca sul Cancro, Modena.
Stefano Luminari, MD, of the University of Modena and Reggio Emilia, is the corresponding author of the Journal of Clinical Oncology article.
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