Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma
Stefano Luminari, Angela Ferrari, Martina Manni, Alessandra Dondi, Annalisa Chiarenza, Francesco Merli, Chiara Rusconi, Vittoria Tarantino, Alessandra Tucci, Umberto Vitolo, Sofia Kovalchuk, Emanuele Angelucci, Alessandro Pulsoni, Luca Arcaini, Francesco Angrilli, Gianluca Gaidano, Caterina Stelitano, Giovanni Bertoldero, Nicola Cascavilla, Flavia Salvi, Andrés J M Ferreri, Daniele Vallisa, Luigi Marcheselli, Massimo Federico, Stefano Luminari, Angela Ferrari, Martina Manni, Alessandra Dondi, Annalisa Chiarenza, Francesco Merli, Chiara Rusconi, Vittoria Tarantino, Alessandra Tucci, Umberto Vitolo, Sofia Kovalchuk, Emanuele Angelucci, Alessandro Pulsoni, Luca Arcaini, Francesco Angrilli, Gianluca Gaidano, Caterina Stelitano, Giovanni Bertoldero, Nicola Cascavilla, Flavia Salvi, Andrés J M Ferreri, Daniele Vallisa, Luigi Marcheselli, Massimo Federico
Abstract
Purpose The FOLL05 trial compared R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) regimens without rituximab maintenance as initial therapy for patients with advanced-stage follicular lymphoma (FL). A previous analysis with a median follow-up of 34 months showed a superior 3-year time to treatment failure, the primary study end point, with R-CHOP and R-FM versus R-CVP and showed R-CHOP to have a better risk-benefit ratio in terms of toxicity than R-FM. We report a post hoc analysis of this trial after a median follow-up of 7 years. Patients and Methods Of the 534 enrolled patients, 504 were evaluable. At the time of analysis, the median follow-up was 84 months (range, 1 to 119 months). Results The 8-year time to treatment failure and progression-free survival rates were 44% (95% CI, 39% to 49%) and 48% (95% CI, 43% to 53%), respectively. The hazard ratio for progression-free survival adjusted by FL International Prognostic Index 2 versus R-CVP was 0.73 for R-CHOP (95% CI, 0.54 to 0.98; P = .037) and 0.67 for R-FM (95% CI, 0.50 to 0.91; P = .009). The 8-year overall survival (OS) rate was 83% (95% CI, 79% to 87%), with no significant differences among study arms. Overall, we observed a higher risk of dying as a result of causes unrelated to lymphoma progression with R-FM versus R-CVP. Conclusion With an 83% 8-year OS rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage FL treated with immunochemotherapy. The three study arms had similar OS 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.
Trial registration: ClinicalTrials.gov NCT00774826.
Source: PubMed