Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study.
Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study.
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DOI：
10.3324/haematol.2020.274803
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发表时间：
2022-02-01
期刊：
影响因子：
10.1
通讯作者：
Dreyling M
中科院分区：
文献类型：
--
作者：
Rule S;Barreto WG;Briones J;Carella AM;Casasnovas O;Pocock C;Wendtner CM;Zaja F;Robson S;MacGregor L;Tschopp RR;Nick S;Dreyling M
利妥昔单抗联合化疗诱导，随后进行长达 2 年的利妥昔单抗维持治疗，对于惰性非霍奇金淋巴瘤患者的无进展生存期具有长期益处。目前尚不清楚进一步延长利妥昔单抗维持治疗是否会带来额外的益处。 III 期 MabCute 研究招募了 692 名复发或难治性惰性非霍奇金淋巴瘤患者。对利妥昔单抗联合化疗诱导有反应且在皮下注射利妥昔单抗长达 2 年的初始维持后仍有反应的患者被随机分为皮下注射利妥昔单抗延长维持 (n=138) 或仅观察 (n=138)。由于事件数量不足，研究者评估的随机人群中无进展生存期的主要终点在研究结束时尚未得到解决（如果大约 330 名患者被随机分组，则需要 129 个事件才能达到 80% 功效、5% 显着性）。总共有 46 例无进展生存事件，利妥昔单抗组和观察组分别有 19 例和 27 例（分层对数秩检验 P=0.410；风险比 0.76 [95% 置信区间：0.37-1.53]）。任一随机组均未达到中位无进展生存期。没有新的安全信号；然而，利妥昔单抗组的不良事件发生率略高于长期维持期间观察组的不良事件发生率。因此，在初次诱导反应后用利妥昔单抗维持长达 2 年仍然是复发或难治性惰性非霍奇金淋巴瘤患者的标准治疗。 （ClinicalTrials.gov 标识符：NCT01461928）
Rituximab plus chemotherapy induction followed by rituximab maintenance for up to 2 years confers a long-term benefit in terms of progression-free survival in patients with indolent non-Hodgkin lymphoma. It is not known whether further prolonged maintenance with rituximab provides additional benefit. The phase III MabCute study enrolled 692 patients with relapsed or refractory indolent non-Hodgkin lymphoma. Patients who responded to induction with rituximab plus chemotherapy and were still responding after up to 2 years’ initial maintenance with subcutaneous rituximab were randomized to extended maintenance with subcutaneous rituximab (n=138) or observation only (n=138). The primary endpoint of investigator-assessed progression-free survival in the randomized population was un-addressed by the end of study because of an insufficient number of events (129 events were needed for 80% power at 5% significance if approximately 330 patients were randomized). In total, there were 46 progression-free survival events, 19 and 27 in the rituximab and observation arms, respectively (P=0.410 by stratified log-rank test; hazard ratio 0.76 [95% confidence interval: 0.37– 1.53]). The median progression-free survival was not reached in either randomized arm. There were no new safety signals; however, adverse events were seen slightly more frequently with rituximab than with observation during extended maintenance. Maintenance for up to 2 years with rituximab after response to initial induction therefore remains the standard of care in patients with relapsed or refractory indolent non- Hodgkin lymphoma. (Clinicaltrials.gov identifier: NCT01461928)
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