雷莫芦单抗治疗日本晚期胃癌患者的生活质量：RAINBOW 三期试验的探索性分析。
Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial.
机构信息
Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Clinical Oncology, Kochi Health Sciences Center, Kochi, Japan.
出版信息
Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23.
BACKGROUND AND OBJECTIVE
Gastric cancer has been associated with notable geographic heterogeneity in previous multi-regional studies. In particular, patients from Japan have better outcomes compared with patients from other regions. Here, we assess patient-focused outcomes for the subgroup of Japanese patients in the global RAINBOW study.
METHODS
Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (QLQ-C30) at baseline and 6-week intervals. Investigators assessed performance status before each 4-week cycle. Time-to-deterioration in each QLQ-C30 scale was defined as randomization to first worsening of ≥ 10 points (on a 100-point scale). Time-to-deterioration in performance status was defined as first worsening to ≥ 2. Hazard ratios were estimated using Cox proportional hazards models.
RESULTS
The Japan subgroup contained 140 patients (ramucirumab plus paclitaxel, n = 68; placebo plus paclitaxel, n = 72); baseline QoL data were available for all patients. At baseline, QLQ-C30 scores were similar between study arms. Of the 15 QLQ-C30 scales, nine had a hazard ratio < 1, indicating similar or numerically longer time-to-deterioration in QoL for ramucirumab plus paclitaxel; all 95% confidence intervals included 1. Best mean change from baseline numerically favored ramucirumab plus paclitaxel in most QoL scales. The hazard ratios for time-to-deterioration of performance status to ≥ 2 were 0.64 in the Japan subgroup and 0.88 in the non-Asian subgroup. The Japan subgroup had better QoL at baseline compared with the non-Asian subgroup.
CONCLUSIONS
Treatment with ramucirumab plus paclitaxel maintained QoL and performance status over time compared with placebo plus paclitaxel in the Japan subgroup of the RAINBOW trial. These data suggest that the heterogeneity in gastric cancer between geographic regions includes multiple measures of QoL.
TRIAL REGISTRATION NUMBER
NCT01170663 (first submitted 21 July, 2010).
背景与目的
先前的多区域研究表明，胃癌存在显著的地域异质性。具体而言，与其他地区的患者相比，来自日本的患者具有更好的预后。在此，我们评估了 RAINBOW 研究中日本患者亚组的以患者为中心的结局。
方法
使用欧洲癌症研究与治疗组织生活质量问卷核心 30 项（QLQ-C30）在基线和 6 周间隔期评估生活质量（QoL）。在每 4 周周期前，研究者评估患者的体能状态。QLQ-C30 各量表的恶化时间定义为随机分组至首次恶化≥10 分（100 分制）。体能状态的恶化时间定义为首次恶化至≥2 分。使用 Cox 比例风险模型估计风险比。
结果
日本亚组包含 140 例患者（雷莫芦单抗联合紫杉醇，n=68；安慰剂联合紫杉醇，n=72）；所有患者均有基线 QoL 数据。基线时，研究组间 QLQ-C30 评分相似。在 15 个 QLQ-C30 量表中，有 9 个量表的风险比<1，表明雷莫芦单抗联合紫杉醇组的 QoL 恶化时间相似或数值上更长；所有 95%置信区间均包含 1。在大多数 QoL 量表中，雷莫芦单抗联合紫杉醇的最佳平均变化从基线开始呈现数值优势。日本亚组中，体能状态恶化至≥2 的风险比为 0.64，非亚洲亚组为 0.88。与非亚洲亚组相比，日本亚组的基线 QoL 更好。
结论
与安慰剂联合紫杉醇相比，雷莫芦单抗联合紫杉醇治疗在 RAINBOW 试验的日本亚组中随时间推移维持了 QoL 和体能状态。这些数据表明，胃癌在地域之间的异质性包括多种 QoL 指标。
试验注册号
NCT01170663（首次提交日期：2010 年 7 月 21 日）。
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