Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START)

Title
Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START)
Author(s)
이경희Koizumi W[Koizumi W]김열홍[김열홍]Fujii M[ Fujii M]김훈교[김훈교]Imamura H[ Imamura H]Hara T[ Hara T]정현철[정현철]조재용[조재용]Satoh T[Satoh T]
Keywords
PHASE-II TRIAL; ADVANCED ESOPHAGOGASTRIC CANCER; METASTATIC BREAST-CANCER; CELL LUNG-CANCER; PLUS CISPLATIN; GASTROESOPHAGEAL ADENOCARCINOMA; COMBINATION THERAPY; 1ST-LINE TREATMENT; FLUOROURACIL; EPIRUBICIN
Issue Date
201402
Publisher
SPRINGER
Citation
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY, v.140, no.2, pp.319 - 328
Abstract
Purpose 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. Methods 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. Results 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. Conclusion 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).
URI
http://hdl.handle.net/YU.REPOSITORY/33192http://dx.doi.org/10.1007/s00432-013-1563-5
ISSN
0171-5216
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의과대학 > 내과학교실 > Articles
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