Kitasato University School of Medicine, Sagamihara, Japan.
J Cancer Res Clin Oncol. 2014 Feb;140(2):319-28. doi: 10.1007/s00432-013-1563-5. Epub 2013 Dec 24.
Cisplatin plus 5-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer. However, cisplatin has several disadvantages, including renal toxicity and the need for admission. S-1 plus cisplatin has become a standard treatment for advanced gastric cancer in East Asia. This phase III study was designed to evaluate the potential benefits of adding docetaxel to S-1 without a platinum compound in patients with advanced gastric cancer.
Patients were randomly assigned to receive docetaxel plus S-1 or S-1 alone. The docetaxel plus S-1 group received docetaxel on day 1 and oral S-1 on days 1-14 of a 21-day cycle. The S-1 alone group received oral S-1 on days 1-28 of a 42-day cycle. The primary end point was overall survival.
Of the 639 patients enrolled, 635 were eligible for analysis. The median overall survival was 12.5 months in the docetaxel plus S-1 group and 10.8 months in the S-1 alone group (p = 0.032). The median progression-free survival was 5.3 months in the docetaxel plus S-1 group and 4.2 months in the S-1 alone group (p = 0.001). As for adverse events, neutropenia was more frequent in the docetaxel plus S-1 group, but remained manageable.
As first-line treatment for advanced gastric cancer, docetaxel plus S-1 significantly improves median overall and progression-free survival as compared with S-1 alone. (ClinicalTrials.gov number: NCT00287768).
顺铂联合 5-氟尿嘧啶已在全球范围内被接受为治疗晚期胃癌的标准方案。然而，顺铂具有多种缺点，包括肾毒性和需要住院治疗。S-1 联合顺铂已成为东亚地区治疗晚期胃癌的标准治疗方法。本 III 期研究旨在评估在晚期胃癌患者中，不使用铂类化合物而添加多西紫杉醇到 S-1 中可能带来的益处。
患者被随机分配接受多西紫杉醇联合 S-1 或 S-1 单药治疗。多西紫杉醇联合 S-1 组在第 1 天接受多西紫杉醇，第 1-14 天接受口服 S-1，每 21 天为一个周期。S-1 单药组在第 1-28 天接受口服 S-1，每 42 天为一个周期。主要终点为总生存期。
在纳入的 639 例患者中，有 635 例符合分析条件。多西紫杉醇联合 S-1 组的中位总生存期为 12.5 个月，S-1 单药组为 10.8 个月（p=0.032）。多西紫杉醇联合 S-1 组的中位无进展生存期为 5.3 个月，S-1 单药组为 4.2 个月（p=0.001）。在不良反应方面，多西紫杉醇联合 S-1 组更常见中性粒细胞减少，但仍可管理。
作为晚期胃癌的一线治疗，多西紫杉醇联合 S-1 与 S-1 单药相比，显著改善了中位总生存期和无进展生存期。（临床试验编号：NCT00287768）。
