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J Clin Oncol. 2018 Mar 1;36(7):689-696. doi: 10.1200/JCO.2017.74.1652. Epub 2017 Nov 2.

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.

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1
Stefano Luminari, Angela Ferrari, and Francesco Merli, Azienda Ospedaliera Arcispedale Santa Maria Nuova-Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Reggio Emilia; Stefano Luminari, Martina Manni, Alessandra Dondi, Vittoria Tarantino, Luigi Marcheselli, and Massimo Federico, University of Modena and Reggio Emilia, Modena, Italy; Annalisa Chiarenza, Azienda Ospedaliera Universitaria Policlinico-Vittorio Emanuele, University of Catania, Catania; Chiara Rusconi, Azienda Socio Sanitaria Territoriale (ASST) -Grande Ospedale Metropolitano Niguarda; Andrés J.M. Ferreri, IRCCS San Raffaele Scientific Institute, Milano; Alessandra Tucci, ASST-Spedali Civili di Brescia, Brescia; Umberto Vitolo, Città della Salute e della Scienza University and Hospital, Torino; Sofia Kovalchuk, University of Florence, Florence; Emanuele Angelucci, Ospedale Policlinico San Martino, Genova; Alessandro Pulsoni, Sapienza University of Rome, Rome; Luca Arcaini, Fondazione IRCCS Policlinico San Matteo, Pavia; Francesco Angrilli, Spirito Santo Hospital, Pescara; Gianluca Gaidano, University of Eastern Piedmont, Novara; Caterina Stelitano, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria; Giovanni Bertoldero, Ospedale di Mirano, Mirano; Nicola Cascavilla, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo; Flavia Salvi, Ospedale SS Antonio e Biagio, Alessandria; and Daniele Vallisa, Guglielmo da Saliceto Hospital, Piacenza, Italy.

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.

PMID:
29095677
DOI:
10.1200/JCO.2017.74.1652

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