Chemotherapy vs supportive care alone for relapsed gastric, gastroesophageal junction, and oesophageal adenocarcinoma: a meta-analysis of patient-level data.
Chemotherapy vs supportive care alone for relapsed gastric, gastroesophageal junction, and oesophageal adenocarcinoma: a meta-analysis of patient-level data.
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DOI：
10.1038/bjc.2015.452
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发表时间：
2016-02-16
影响因子：
8.8
通讯作者：
Ford H
中科院分区：
文献类型：
--
作者：
Janowitz T;Thuss-Patience P;Marshall A;Kang JH;Connell C;Cook N;Dunn J;Park SH;Ford H
二线化疗治疗复发性胃癌和食管癌患者与单独支持性治疗（SC）相比已得到最近3期临床试验的支持，但缺乏患者水平数据的荟萃分析。我们检索了Medline、科克伦对照试验中心注册中心（CENTRAL）和Web of Science，寻找比较二线化疗与单独SC治疗胃癌和食管癌的3期临床试验。对三项确定的试验的综合患者水平数据进行荟萃分析。共确定了410例胃腺癌（n=301）、胃食管连接部腺癌（n=76）或食管腺癌（n=33）患者。总共有154例患者接受多西他赛单药治疗，84例患者接受伊立替康单药治疗，每例患者均接受SC治疗。172例患者仅接受SC治疗。化疗显著降低了死亡风险（风险比（HR）=0.63，95%可信区间（CI）=0.51-0.77，P<0.0001）。多西他赛（HR=0.71，95% CI=0.56-0.89，P=0.003）和伊立替康（HR=0.49，95% CI=0.36-0.67，P<0.001）治疗观察到了这种效应。一线化疗后3-6个月进展的患者总生存期（OS）获益最大（HR=0.39，95%CI =0.26-0.59，P<0.0001）。性能状态（PS）0-1与PS 2相比（HR=0.66，95% CI=0.46-0.94，P=0.02），局部晚期疾病与转移性疾病相比（HR=0.41，95% CI=0.25-0.67，P=0.0004）和老年（HR=0.94/5年，95% CI=0.90-0.99，P=0.01）是OS改善的重要预测因素。（HR=1.24，95% CI=0.96-1.59）或在完成一线治疗的前3个月内（HR=1.42，95% CI=1.09-1.83）是死亡风险增加的预测因素，与3 - 6个月之间的进展相比（P=0.03）。三项试验中只有一项报告了健康相关的生活质量结局，排除了对这些参数的荟萃分析。这项患者水平数据的荟萃分析证实，在铂类和氟尿嘧啶难治性胃和食管腺癌患者中，二线化疗治疗的OS显著优于SC单药治疗。健康相关的生活质量结果应纳入未来的试验中。
Second-line chemotherapy treatment of patients with relapsed gastric and oesophageal cancers in comparison with supportive care (SC) alone has been supported by recent phase 3 clinical trials, but a meta-analysis of patient-level data is lacking. We searched Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Web of Science for phase 3 clinical trials that compared second-line chemotherapy with SC alone for gastric and oesophageal cancers. A meta-analysis of the comprehensive patient-level data from the three identified trials was performed. A total of 410 patients with gastric (n=301), gastroesophageal junction (n=76), or oesophageal (n=33) adenocarcinoma were identified. In all, 154 patients received single-agent docetaxel and 84 patients received single-agent irinotecan, each with SC. SC alone was given to 172 patients. Chemotherapy significantly reduced the risk of death (hazard ratio (HR)=0.63, 95% confidence interval (CI)=0.51–0.77, P<0.0001). This effect was observed for treatment with docetaxel (HR=0.71, 95% CI=0.56–0.89, P=0.003) and irinotecan (HR=0.49, 95% CI=0.36–0.67, P<0.001). Overall survival (OS) benefit was greatest for patients who progressed 3–6 months following first-line chemotherapy (HR=0.39, 95% CI=0.26–0.59, P<0.0001). Performance status (PS) 0–1 compared with PS 2 (HR=0.66, 95% CI=0.46–0.94, P=0.02), locally advanced disease compared with metastatic disease (HR=0.41, 95% CI=0.25–0.67, P=0.0004) and older age (HR=0.94 per 5 years, 95% CI=0.90–0.99, P=0.01) were significant predictors of improved OS. Progression of disease during first-line treatment (HR=1.24, 95% CI=0.96–1.59) or within the first 3 months of completion of first-line treatment (HR=1.42, 95% CI=1.09–1.83) were predictors of an increased risk of death compared with progression between 3 and 6 months (P=0.03). Health-related quality of life outcomes were reported in only one of the three trials, precluding meta-analysis of these parameters. This meta-analysis of patient-level data confirms that second-line chemotherapy treatment results in significantly better OS compared with SC alone in patients with platinum and fluoropyrimidine refractory gastric and oesphageal adenocarcinoma. Health-related quality of life outcomes should be included in future trials in this setting.