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

被引:34
|
作者
Ludwig, Heinz [1 ]
Moreau, Philippe [2 ]
Dimopoulos, Meletios A. [3 ]
Mateos, Maria-Victoria [4 ]
Kaiser, Martin [5 ]
Hajek, Roman [6 ,7 ]
Feng, Shibao [8 ]
Cocks, Kim [9 ]
Buchanan, Jaqueline [8 ]
Weisel, Katja [10 ]
机构
[1] Wilhelminenhospital, Wilhelminen Canc Res Inst, Vienna, Austria
[2] Univ Nantes, Nantes, France
[3] Univ Athens, Sch Med, Athens, Greece
[4] Univ Hosp Salamanca, Salamanca, Spain
[5] Inst Canc Res, London, England
[6] Univ Hosp Ostrava, Ostrava, Czech Republic
[7] Univ Ostrava, Fac Med, Ostrava, Czech Republic
[8] Amgen Inc, Thousand Oaks, CA 91320 USA
[9] KCStats Consultancy, Leeds, W Yorkshire, England
[10] Univ Klinikum Tubingen, Tubingen, Germany
关键词
PATIENT-REPORTED OUTCOMES; FUNCTIONAL-ASSESSMENT; DOSE DEXAMETHASONE; OPEN-LABEL; QUESTIONNAIRE; LENALIDOMIDE; MODULE; EXPERIENCES; POPULATION; PREDNISONE;
D O I
10.1038/s41408-019-0181-0
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
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.
引用
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页数:13
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