TY - JOUR
T1 - 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
AU - Luminari, Stefano
AU - Ferrari, Angela
AU - Manni, Martina
AU - Dondi, Alessandra
AU - Chiarenza, Annalisa
AU - Merli, Francesco
AU - Rusconi, Chiara
AU - Tarantino, Vittoria
AU - Tucci, Alessandra
AU - Vitolo, Umberto
AU - Kovalchuk, Sofia
AU - Angelucci, Emanuele
AU - Pulsoni, Alessandro
AU - Arcaini, Luca
AU - Angrilli, Francesco
AU - Gaidano, Gianluca
AU - Stelitano, Caterina
AU - Bertoldero, Giovanni
AU - Cascavilla, Nicola
AU - Salvi, Flavia
AU - Ferreri, Andŕes J.M.
AU - Vallisa, Daniele
AU - Marcheselli, Luigi
AU - Federico, Massimo
N1 - Publisher Copyright:
© 2017 by American Society of Clinical Oncology.
PY - 2018/3/1
Y1 - 2018/3/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85042597378&partnerID=8YFLogxK
U2 - 10.1200/JCO.2017.74.1652
DO - 10.1200/JCO.2017.74.1652
M3 - Article
SN - 0732-183X
VL - 36
SP - 689
EP - 696
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 7
ER -
