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.

中文翻译：

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FOLL05 试验的长期结果比较 R-CVP 与 R-CHOP 与 R-FM 对晚期症状性滤泡性淋巴瘤患者的初始治疗

目的 FOLL05 试验比较了 R-CVP（利妥昔单抗加环磷酰胺、长春新碱和泼尼松）与 R-CHOP（利妥昔单抗加环磷酰胺、多柔比星、长春新碱和泼尼松）和 R-FM（利妥昔单抗加氟达拉滨和米托蒽醌）方案，但不加阿司匹林维持治疗晚期滤泡性淋巴瘤 (FL) 患者的初始治疗。之前的一项中位随访时间为 34 个月的分析显示，R-CHOP 和 R-FM 与 R-CVP 相比，治疗失败的 3 年时间更长，这是主要研究终点，并且显示 R-CHOP 具有更好的疗效。在毒性方面的风险收益比比 R-FM。我们报告了中位随访 7 年后对该试验的事后分析。患者和方法 在 534 名登记患者中，504 名是可评估的。在分析时，中位随访时间为 84 个月（范围为 1 至 119 个月）。结果 8 年治疗失败时间和无进展生存率分别为 44%（95% CI，39% 至 49%）和 48%（95% CI，43% 至 53%）。根据 FL 国际预后指数 2 与 R-CVP 调整后的无进展生存期风险比，R-CHOP 为 0.73（95% CI，0.54 至 0.98；P = .037），R-FM 为 0.67（95% CI， 0.50 到 0.91；P = .009)。8 年总生存 (OS) 率为 83%（95% CI，79% 至 87%），研究组之间没有显着差异。总体而言，我们观察到 R-FM 与 R-CVP 相比，由于与淋巴瘤进展无关的原因导致的死亡风险更高。结论 FOLL05 试验的长期随访 8 年 OS 率为 83%，证实了接受免疫化疗治疗的晚期 FL 患者的良好结果。三个研究组的 OS 相似，但活性和毒性特征不同。与接受 R-CHOP 的患者相比，最初接受 R-CVP 治疗的患者淋巴瘤进展的风险更高，需要额外治疗的风险也更高。