随机 3 期研究中雷莫芦单抗联合多西他赛与安慰剂联合多西他赛治疗铂类耐药性晚期尿路上皮癌（RANGE）患者的健康相关生活质量。

Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE).

机构信息

Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, 20133, Milan, Italy.

University of Tsukuba, Tsukuba, Japan.

出版信息

BMC Urol. 2020 Nov 7;20(1):181. doi: 10.1186/s12894-020-00752-w.

BACKGROUND

To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC).

METHODS

RANGE-a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m) or placebo plus docetaxel were administered every 21 days until disease progression or unacceptable toxicity. Patients received maximum 10 cycles of docetaxel. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EuroQoL five-dimensions (EQ-5D-5L) were administered at baseline, start of each cycle, and 30-day follow-up visit. A ≥ 10-point change in QLQ-C30 scores was considered meaningful. Rates of improved/stable scores were compared between treatment arms using Fisher's exact test. Time to deterioration (TtD) was estimated and compared using Kaplan-Meier estimation and log-rank test.

RESULTS

Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQ-C30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit.

CONCLUSIONS

Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment.

CLINICAL TRAIL REGISTRATION

NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125 . Date of registration: April 24th 2015.

背景

评估雷莫芦单抗联合多西他赛治疗铂类耐药晚期尿路上皮癌（aUC）的患者报告结局。该方案改善了铂类耐药晚期尿路上皮癌的无进展生存期。

方法

RANGE 是一项在铂类耐药 aUC 患者中进行的随机、双盲、3 期试验。雷莫芦单抗（10mg/kg）联合多西他赛（75mg/m2）或安慰剂联合多西他赛每 21 天给药一次，直至疾病进展或不可接受的毒性。患者接受最多 10 个周期的多西他赛治疗。欧洲癌症研究与治疗组织生活质量问卷核心 30 项（EORTC QLQ-C30）和欧洲五维健康量表（EQ-5D-5L）在基线、每个周期开始和 30 天随访时进行评估。QLQ-C30 评分变化≥10 分被认为有意义。使用 Fisher 精确检验比较治疗组之间改善/稳定评分的发生率。使用 Kaplan-Meier 估计和对数秩检验比较 TtD。

结果

在 530 名患者中，每个治疗组约 97%的患者提供了基线 QLQ-C30 数据。在前 8 个周期中，治疗的依从性≥88%。治疗臂之间的平均基线 QLQ-C30 评分相似，总体生活质量（QoL）、疲劳、疼痛和失眠的评分最差。除了雷莫芦单抗治疗组疼痛评分改善更大外，治疗后 QLQ-C30 评分改善/稳定率在治疗组之间相似。QLQ-C30 量表的 TtD 有利于雷莫芦单抗组。基线 EQ-5D-5L 指数和视觉模拟评分在治疗组之间相似，随后治疗期间评分相对稳定。在停药后随访时，EQ-5D-5L 评分恶化。