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

S Luminari, A Ferrari, Martina Manni, Alessandra Dondi, A Chiarenza, F Merli, Chiara Rusconi, V Tarantino, Alessandra Tucci, Umberto Vitolo, S Kovalchuk, E Angelucci, A Pulsoni, L Arcaini, Francesco Angrilli, G. Gaidano, C Stelitano, G Bertoldero, N Cascavilla, F SalviAJM Ferreri, D Vallisa, L Marcheselli, M Federico

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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.
Original languageEnglish
Pages (from-to)689-696
Number of pages8
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume36
Issue number7
DOIs
Publication statusPublished - 2018

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Luminari, S., Ferrari, A., Manni, M., Dondi, A., Chiarenza, A., Merli, F., Rusconi, C., Tarantino, V., Tucci, A., Vitolo, U., Kovalchuk, S., Angelucci, E., Pulsoni, A., Arcaini, L., Angrilli, F., Gaidano, G., Stelitano, C., Bertoldero, G., Cascavilla, N., ... Federico, M. (2018). 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. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 36(7), 689-696. https://doi.org/10.1200/JCO.2017.74.1652