FOLL05 试验的长期结果：比较 R-CVP、R-CHOP 和 R-FM 方案治疗初治晚期症状性滤泡性淋巴瘤患者的疗效。
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.
机构信息
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.
出版信息
J Clin Oncol. 2018 Mar 1;36(7):689-696. doi: 10.1200/JCO.2017.74.1652. Epub 2017 Nov 2.
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.
目的
FOLL05 试验比较了 R-CVP（利妥昔单抗+环磷酰胺、长春新碱和泼尼松）与 R-CHOP（利妥昔单抗+环磷酰胺、多柔比星、长春新碱和泼尼松）和 R-FM（利妥昔单抗+氟达拉滨和米托蒽醌）方案，这些方案均未进行利妥昔单抗维持治疗，作为晚期滤泡淋巴瘤（FL）患者的初始治疗。在中位随访 34 个月的一项先前分析中，R-CHOP 和 R-FM 组与 R-CVP 组相比，主要研究终点治疗失败时间（3 年）具有更高的优势，并且 R-CHOP 组在毒性方面的风险获益比优于 R-FM 组。我们报告了这项试验的事后分析，中位随访时间为 7 年。
患者和方法
534 名入组患者中，504 名患者可评估。在分析时，中位随访时间为 84 个月（范围，1 至 119 个月）。
结果
8 年时的治疗失败和无进展生存率分别为 44%（95%CI，39%至 49%）和 48%（95%CI，43%至 53%）。通过滤泡性淋巴瘤国际预后指数 2 调整的无进展生存的风险比，R-CHOP 组为 0.73（95%CI，0.54 至 0.98；P=0.037），R-FM 组为 0.67（95%CI，0.50 至 0.91；P=0.009）。8 年总生存率（OS）为 83%（95%CI，79%至 87%），各研究组之间无显著差异。总体而言，与 R-CVP 相比，R-FM 组因与淋巴瘤进展无关的原因而死亡的风险更高。
结论
FOLL05 试验的长期随访结果显示，接受免疫化疗治疗的晚期 FL 患者具有 83%的 8 年 OS 率，这证实了该治疗方案的良好预后。三个研究组的 OS 相似，但活性和毒性特征不同。与接受 R-CHOP 治疗的患者相比，接受 R-CVP 初始治疗的患者发生淋巴瘤进展的风险更高，并且需要额外治疗的风险更高。
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