文章：

ENDEAVOR研究中的健康相关生活质量：卡非佐米-地塞米松对比硼替佐米-地塞米松治疗复发/难治性多发性骨髓瘤

Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma

原文发布日期：2019-02-22

DOI: 10.1038/s41408-019-0181-0

类型: Article

开放获取: 是

英文摘要：

We examined effects of carfilzomib-dexamethasone (Kd56) versus bortezomib-dexamethasone (Vd) on health-related quality of life (HR-QoL) in relapsed/refractory multiple myeloma (MM) patients from the ENDEAVOR study. HR-QoL was assessed by the European Organisation for Research and Treatment of Cancer QoL Questionnaire (QLQ-C30), MM-specific module (QLQ-MY20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx) “Additional Concerns” neurotoxicity subscale. The QLQ-C30 Global Health Status (GHS)/QoL scale and seven prespecified subscales were compared between groups using mixed model for repeated measures. Of 929 randomized patients, 911 with ≥1 post-baseline assessment were included. Kd56 was associated with statistically significant improvements in GHS/QoL, fatigue, pain, side effects, and FACT/GOG-Ntx scores versus Vd, although mean differences did not meet thresholds for clinical significance. The Kd56 group had longer time to deterioration (TTD) in GHS/QoL (median 3.7 versus 2.8 months, p = 0.0046), physical function (5.6 versus 3.7 months, p = 0.0390), nausea/vomiting (17.6 versus 8.2 months, p = 0.0358), side effects (6.4 versus 3.7 months p < 0.0001), and FACT/GOG-Ntx (11.1 versus 5.5 months, p = 0.0004). Overall, Kd56 resulted in statistically but not clinically significant improvements in mean GHS/QoL scores versus Vd. Treatment with Kd56 versus Vd also significantly prolonged TTD in GHS/QoL, physical function, nausea/vomiting, side effects, and FACT/GOG-Ntx.

摘要翻译： 

我们研究了ENDEAVOR研究中卡非佐米-地塞米松（Kd56）与硼替佐米-地塞米松（Vd）对复发/难治性多发性骨髓瘤患者健康相关生活质量的影响。采用欧洲癌症研究与治疗组织生活质量核心问卷、多发性骨髓瘤专用模块以及癌症治疗功能性评估/妇科肿瘤协作组-神经毒性量表的“附加关注”神经毒性子量表进行评估。通过重复测量混合模型比较两组间QLQ-C30总体健康状况/生活质量量表及七个预设子量表。在929名随机分组患者中，纳入了911名至少有一次基线后评估数据的患者。与Vd组相比，Kd56在总体健康状况/生活质量、疲劳、疼痛、副作用及FACT/GOG-Ntx评分方面均实现统计学显著改善，但平均差异未达到临床显著性阈值。Kd56组在总体健康状况/生活质量（中位时间3.7个月 vs 2.8个月，p=0.0046）、躯体功能（5.6个月 vs 3.7个月，p=0.0390）、恶心呕吐（17.6个月 vs 8.2个月，p=0.0358）、副作用（6.4个月 vs 3.7个月，p<0.0001）及FACT/GOG-Ntx（11.1个月 vs 5.5个月，p=0.0004）方面均呈现更长的至恶化时间。总体而言，与Vd相比，Kd56在平均总体健康状况/生活质量评分上取得统计学显著但临床意义不显著的改善，同时显著延长了总体健康状况/生活质量、躯体功能、恶心呕吐、副作用及FACT/GOG-Ntx的至恶化时间。

原文链接：

Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma