Ramsey Scott D, Nademanee Auayporn, Masszi Tamas, Holowiecki Jerzy, Abidi Muneer, Chen Andy, Stiff Patrick, Viviani Simonetta, Sweetenham John W, Radford John, Zhu Yanyan, Bonthapally Vijayveer, Thomas Elizabeth, Richhariya Akshara, Hunder Naomi N, Walewski Jan, Moskowitz Craig H
Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
City of Hope National Medical Center, Duarte, CA, USA.
Br J Haematol. 2016 Dec;175(5):860-867. doi: 10.1111/bjh.14316. Epub 2016 Sep 21.
Brentuximab vedotin (BV) significantly improved progression-free survival in a phase 3 study in patients with relapsed or refractory Hodgkin lymphoma (RR-HL) post-autologous-haematopoietic stem cell transplant (auto-HSCT); we report the impact of BV on quality of life (QOL) from this trial. The European Quality of Life five dimensions questionnaire was administered at the beginning of each cycle, end of treatment, and every 3 months during follow-up; index value scores were calculated using the time trade-off (TTO) method for UK-weighted value sets. Questionnaire adherence during the trial was 87·5% (N = 329). In an intent-to-treat analysis, compared with placebo, TTO scores in the BV arm did not exceed the minimally important difference (MID) of 0·08 except at month 15 (-0·084; 95% confidence interval, -0·143 to -0·025). On-treatment index scores were similar between arms and did not reach the MID at any time point; mixed-effect modelling showed that BV treatment effect was not significant (P = 0·2127). BV-associated peripheral neuropathy did not meaningfully impact QOL. Utility scores for patients who progressed declined compared with those who did not; TTO scores between these patients exceeded the MID beginning at month 15. In conclusion, QOL decreased modestly with BV consolidation treatment in patients with RR-HL at high risk of relapse after auto-HSCT.
在一项针对自体造血干细胞移植(auto-HSCT)后复发或难治性霍奇金淋巴瘤(RR-HL)患者的3期研究中,维布妥昔单抗(BV)显著改善了无进展生存期;我们报告了该试验中BV对生活质量(QOL)的影响。在每个周期开始、治疗结束时以及随访期间每3个月进行一次欧洲五维生活质量问卷的评估;使用时间权衡(TTO)方法针对英国加权值集计算指数值分数。试验期间问卷依从率为87.5%(N = 329)。在意向性分析中,与安慰剂相比,BV组的TTO分数除了在第15个月(-0.084;95%置信区间,-0.143至-0.025)外,均未超过0.08的最小重要差异(MID)。各治疗组的治疗期间指数分数相似,在任何时间点均未达到MID;混合效应模型显示BV治疗效果不显著(P = 0.2127)。BV相关的周围神经病变对生活质量没有显著影响。进展患者的效用分数与未进展患者相比有所下降;这些患者之间的TTO分数从第15个月开始超过MID。总之,对于auto-HSCT后复发风险高的RR-HL患者,BV巩固治疗会使生活质量略有下降。
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