Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START).
Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START).
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DOI：
10.1007/s00432-013-1563-5
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发表时间：
2014-02
影响因子：
3.6
通讯作者：
JACCRO and KCSG Study Group
中科院分区：
文献类型：
--
作者：
Koizumi W;Kim YH;Fujii M;Kim HK;Imamura H;Lee KH;Hara T;Chung HC;Satoh T;Cho JY;Hosaka H;Tsuji A;Takagane A;Inokuchi M;Tanabe K;Okuno T;Ogura M;Yoshida K;Takeuchi M;Nakajima T;JACCRO and KCSG Study Group
顺铂加5-氟尿嘧啶已被全球公认为治疗晚期胃癌的标准方案。然而，顺铂有几个缺点，包括肾毒性和需要入院。S-1 +顺铂已成为东亚地区晚期胃癌的标准治疗方案。这项III期研究旨在评估在S-1中添加多西他赛而不添加铂类化合物对晚期胃癌患者的潜在益处。患者被随机分配接受多西他赛加S-1或单独S-1治疗。多西紫杉醇+ S-1组在21天周期的第1天接受多西紫杉醇治疗，第1- 14天口服S-1。S-1组在42天周期的第1-28天口服S-1。主要终点为总生存期。在纳入的639例患者中，635例符合分析条件。多西他赛加S-1组的中位总生存期为12.5个月，单独S-1组的中位总生存期为10.8个月（p = 0.032）。多西他赛加S-1组的中位无进展生存期为5.3个月，单独S-1组的中位无进展生存期为4.2个月（p = 0.001）。至于不良事件，中性粒细胞减少症在多西紫杉醇加S-1组更频繁，但仍然可控。作为晚期胃癌的一线治疗，多西紫杉醇联合S-1与单独使用S-1相比，可显著提高中位总生存期和无进展生存期。（ClinicalTrials.gov编号：NCT00287768）。
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).
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影响因子：
45.3
作者：
O'Shaughnessy, J;Miles, D;Leonard, R
通讯作者：
Leonard, R
影响因子：
158.5
作者：
Martin, M;Pienkowski, T;Vogel, C
通讯作者：
Vogel, C
影响因子：
3.5
作者：
FILLASTRE, JP;RAGUENEZVIOTTE, G
通讯作者：
RAGUENEZVIOTTE, G
影响因子：
45.3
作者：
Fossella, F;Pereira, JR;Belani, CP
通讯作者：
Belani, CP
影响因子：
45.3
作者：
Al-Batran, Salah-Eddin;Hartmann, Joerg Thomas;Jaeger, Elke
通讯作者：
Jaeger, Elke