A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL).
A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL).
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复发性或难治性滤泡性淋巴瘤成人患者治疗结局的回顾性队列研究（ReCORD-FL）
DOI：
10.1097/hs9.0000000000000745
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发表时间：
2022-07
期刊：
影响因子：
6.6
通讯作者：
Link, Brian K.
中科院分区：
文献类型：
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作者：
Salles, Gilles;Schuster, Stephen J.;Fischer, Luca;Kuruvilla, John;Patten, Piers Em;von Tresckow, Bastian;Smith, Sonali M.;Ubieto, Ana Isabel Jiminez;Davis, Keith L.;Nagar, Saurabh P.;Zhang, Jie;Bollu, Vamsi;Jousseaume, Etienne;Ramos, Roberto;Wang, Yucai;Link, Brian K.
本研究（ReCORD-FL）旨在构建一个历史对照队列，以加强复发性/难治性滤泡性淋巴瘤（r/r FL）的单组试验。在北美和欧洲的10个中心进行了一项回顾性研究。要求1-3A级FL成人患者在接受≥2种治疗线（包括抗CD 20和烷化剂）后进行r/r。首次成为r/r后，要求患者开始≥1个额外治疗线，这定义了研究索引日期。观察从每一治疗线（包括指数线）开始至死亡、末次随访或2020年12月31日的终点。终点为完全缓解（CR）率、总缓解率（ORR）、至下次治疗或死亡的时间（TNT-D）、无事件生存期（EFS）和总生存期（OS）。确定了187名患者。大多数患者（80.2%）的首次治疗发生在三线（3L）（范围，3L-6L）。FL诊断后的中位随访时间为9年（范围：1-21年）。索引治疗的CR和ORR分别为39.0%和70.6%。索引的中位（95%置信区间）EFS为14.6（11.0-18.0）个月;索引的中位OS为10.6年。在连续治疗线之间以及在索引时双重难治性（抗CD 20单克隆抗体和烷化剂均为r/r）或POD 24（一线抗CD 20治疗后进展≤24个月）患者的结局恶化。研究结果表明，未满足的需求，FL患者多次复发，双重难治性，或POD 24疾病。基于收集的历史数据的稳健性和与先前研究（SCHOLAR-5）的可比性，ReCORD-FL为r/r FL的比较研究提供了有价值的对照数据来源。
This study (ReCORD-FL) sought to construct a historical control cohort to augment single-arm trials in relapsed/refractory follicular lymphoma (r/r FL). A retrospective study in 10 centers across North America and Europe was conducted. Adults with grade 1–3A FL were required to be r/r after ≥2 therapy lines including an anti-CD20 and an alkylator. After first becoming r/r, patients were required to initiate ≥1 additional therapy line, which defined the study index date. Endpoints were observed from start of each therapy line (including index line) until death, last follow-up, or December 31, 2020. Endpoints were complete response (CR) rate, overall response rate (ORR), time to next treatment or death (TNT-D), event-free survival (EFS), and overall survival (OS). One hundred eighty-seven patients were identified. Most patients’ (80.2%) index therapy occurred in third line (3L) (range, 3L–6L). Median follow-up from FL diagnosis was 9 years (range, 1–21 years). CR and ORR to the index therapy were 39.0% and 70.6%, respectively. Median (95% confidence interval) EFS from index was 14.6 (11.0-18.0) months; median OS from index was 10.6 years. Outcomes worsened across successive treatment lines and for patients who were double refractory (r/r to both an anti-CD20 monoclonal antibody and an alkylator) or POD24 (progressed ≤24 months after front-line anti-CD20) at index. Findings demonstrate the unmet need of FL patients with multiply relapsed, double refractory, or POD24 disease. Based on robustness of the historical data collected and comparability with a previous study (SCHOLAR-5), ReCORD-FL presents a valuable source of control data for comparative studies in r/r FL.