Ter Veer Emil, Mohammad Nadia Haj, Lodder Paul, Ngai Lok Lam, Samaan Mary, van Oijen Martijn G H, van Laarhoven Hanneke W M
Department of Medical Oncology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, F4-224, 1105 AZ, Amsterdam, The Netherlands.
Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.
Gastric Cancer. 2016 Jul;19(3):696-712. doi: 10.1007/s10120-015-0587-8. Epub 2016 Jan 11.
S-1 is first-line therapy for advanced gastric cancer in Asia and is used with increased frequency in Western counties. We conducted a meta-analysis to investigate the efficacy and toxicity of S-1-based therapy compared with 5-fluorouracil (5-FU)/capecitabine-based therapy and S-1-based combination therapy compared with S-1 monotherapy.
MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, American Society of Clinical Oncology meeting abstracts, European Society for Medical Oncology meeting abstracts and ClinicalTrials.gov were searched for randomized clinical trials until May 2015. Data were extracted for overall survival (OS), progression-free-survival (PFS), objective response rate (ORR) and grade 1-2 and grade 3-4 adverse events. Stratified OS data for subgroups were extracted.
S-1 was not different from 5-FU (eight studies, n = 2788) in terms of OS [hazard ratio (HR) 0.93, 95 % confidence interval (CI) 0.85-1.01] and PFS (HR 0.87, 95 % CI 0.73-1.04), whereas ORR was higher (risk ratio 1.43, 95 % CI 1.05-1.96). There was no subgroup difference in efficacy among Asian and Western patients, but in Western patients S-1 was associated with a lower rate of febrile neutropenia, toxicity-related deaths and grade 3-4 stomatitis and mucositis compared with 5-FU. S-1 showed no difference in efficacy compared with capecitabine (three studies, n = 329), but was associated with a lower rate of grade 3-4 neutropenia and grade 1-2 hand-foot syndrome. S-1-combination therapy was superior to S-1 monotherapy (eight studies, n = 1808) in terms of OS (HR 0.76, 95 % CI 0.65-0.90), PFS (HR 0.68, 95 % CI 0.56-0.82) and ORR (risk ratio 1.20, 95 % CI 1.04-1.38) but was more toxic. Survival benefit of S-1 combination therapy over S-1 monotherapy was most pronounced in patients with non-measurable disease, diffuse-type histological features and peritoneal metastasis.
S-1 is effective and tolerable as first-line therapy for advanced gastric cancer in both Asian and Western countries.
S-1是亚洲晚期胃癌的一线治疗药物，在西方国家的使用频率也在增加。我们进行了一项荟萃分析，以研究S-1为基础的治疗与5-氟尿嘧啶（5-FU）/卡培他滨为基础的治疗相比的疗效和毒性，以及S-1联合治疗与S-1单药治疗相比的情况。
检索MEDLINE、Embase、Cochrane对照试验中央注册库、美国临床肿瘤学会会议摘要、欧洲医学肿瘤学会会议摘要和ClinicalTrials.gov，查找截至2015年5月的随机临床试验。提取总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）以及1-2级和3-4级不良事件的数据。提取亚组的分层OS数据。
在OS方面（风险比[HR] 0.93，95%置信区间[CI] 0.85-1.01）和PFS方面（HR 0.87，95% CI 0.73-1.04），S-1与5-FU（八项研究，n = 2788）无差异，而ORR更高（风险比1.43，95% CI 1.05-1.96）。亚洲和西方患者在疗效上无亚组差异，但在西方患者中，与5-FU相比，S-1导致发热性中性粒细胞减少、毒性相关死亡以及3-4级口腔炎和粘膜炎的发生率更低。与卡培他滨相比（三项研究，n = 329），S-1在疗效上无差异，但3-4级中性粒细胞减少和1-2级手足综合征的发生率更低。在OS（HR 0.76，95% CI 0.65-0.90）、PFS（HR 0.68，95% CI 0.56-0.82）和ORR（风险比1.20，95% CI 1.04-1.38）方面，S-1联合治疗优于S-1单药治疗（八项研究，n = 1808），但毒性更大。S-1联合治疗相对于S-1单药治疗的生存获益在不可测量疾病、弥漫型组织学特征和腹膜转移的患者中最为明显。
S-1作为亚洲和西方国家晚期胃癌的一线治疗药物，有效且耐受性良好。
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