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

• Published in: Journal of clinical oncology Vol. 36; no. 7; pp. 689 - 696
• Main Authors: Luminari, Stefano, Ferrari, Angela, Manni, Martina, Dondi, Alessandra, Chiarenza, Annalisa, Merli, Francesco, Rusconi, Chiara, Tarantino, Vittoria, Tucci, Alessandra, Vitolo, Umberto, Kovalchuk, Sofia, Angelucci, Emanuele, Pulsoni, Alessandro, Arcaini, Luca, Angrilli, Francesco, Gaidano, Gianluca, Stelitano, Caterina, Bertoldero, Giovanni, Cascavilla, Nicola, Salvi, Flavia, Ferreri, Andrés J.M., Vallisa, Daniele, Marcheselli, Luigi, Federico, Massimo
• Format: Journal Article
• Language: English
• Published: United States 01.03.2018
• Subjects: Adult; Aged; Antibodies, Monoclonal, Murine-Derived - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cyclophosphamide - therapeutic use; Doxorubicin - therapeutic use; Follow-Up Studies; Humans; Lymphoma, Follicular - drug therapy; Lymphoma, Follicular - mortality; Lymphoma, Follicular - pathology; Middle Aged; Mitoxantrone - administration & dosage; Neoplasm Staging; Prednisone - therapeutic use; Rituximab - administration & dosage; Vidarabine - administration & dosage; Vidarabine - analogs & derivatives; Vincristine - therapeutic use
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.2017.74.1652

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.