利妥昔单抗维持治疗滤泡性淋巴瘤患者的无进展生存获益持续存在：PRIMA 研究的长期结果。
Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study.
机构信息
Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.
Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.
出版信息
J Clin Oncol. 2019 Nov 1;37(31):2815-2824. doi: 10.1200/JCO.19.01073. Epub 2019 Jul 24.
PURPOSE
The PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety.
METHODS
Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m, once every 8 weeks), starting 8 weeks after the last induction treatment, or observation (no additional treatment). All patients in the extended follow-up provided their written informed consent (data cutoff: December 31, 2016).
RESULTS
In total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73; < .001). No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40; = .7948); 10-year OS estimates were approximately 80% in both study arms. No new safety signals were observed.
CONCLUSION
Rituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.
目的
PRIMA 研究（ClinicalTrials.gov 标识符：NCT00140582）证实，与观察相比，滤泡性淋巴瘤患者在一线免疫化疗后接受 2 年利妥昔单抗维持治疗可显著改善无进展生存期（PFS）。在此，我们报告 PRIMA 研究在 9 年随访后的最终 PFS 和总生存期（OS）结果，并提供安全性的最终概述。
方法
患有未经治疗的高肿瘤负荷滤泡性淋巴瘤的年龄＞18 岁患者被非随机分配接受三种免疫化疗诱导方案之一。有反应的患者在随机分配（按诱导方案、诱导治疗反应、治疗中心和地理区域分层）1：1接受 2 年利妥昔单抗维持治疗（375mg/m，每 8 周一次），起始于最后一次诱导治疗后 8 周，或观察（无额外治疗）。所有延长随访患者均提供了书面知情同意（数据截止日期：2016 年 12 月 31 日）。
结果
共 1018 例患者完成诱导治疗并被随机分配接受利妥昔单抗维持治疗（n=505）或观察（n=513）。在 1018 例患者中，有 607 例（59.6%）（利妥昔单抗维持治疗，n=309；观察，n=298）同意延长随访。数据截止后，利妥昔单抗维持治疗组的中位 PFS 为 10.5 年，而观察组为 4.1 年（风险比，0.61；95%CI，0.52 至 0.73；<0.001）。随机分配至利妥昔单抗维持治疗或观察的患者未见 OS 差异（风险比，1.04；95%CI，0.77 至 1.40；=0.7948）；两个研究组的 10 年 OS 估计值均约为 80%。未观察到新的安全性信号。
结论
诱导免疫化疗后利妥昔单抗维持治疗可显著改善 PFS，但不能改善 OS。
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