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).
| Original language | English |
|---|---|
| Pages (from-to) | 319-328 |
| Number of pages | 10 |
| Journal | Journal of Cancer Research and Clinical Oncology |
| Volume | 140 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2014 Feb 1 |
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Keywords
- Advanced gastric cancer
- Chemotherapy
- Docetaxel
- S-1
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer : A randomized study (START). / Koizumi, Wasaburo; Kim, Yeul Hong; Fujii, Masashi; Kim, Hoon Kyo; Imamura, Hiroshi; Lee, Kyung Hee; Hara, Takuo; Chung, Hyun Cheol; Satoh, Taroh; Cho, Jae Yong; Hosaka, Hisashi; Tsuji, Akihito; Takagane, Akinori; Inokuchi, Mikito; Tanabe, Kazuaki; Okuno, Tatsuya; Ogura, Mariko; Yoshida, Kazuhiro; Takeuchi, Masahiro; Nakajima, Toshifusa.
In: Journal of Cancer Research and Clinical Oncology, Vol. 140, No. 2, 01.02.2014, p. 319-328.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer
T2 - A randomized study (START)
AU - Koizumi, Wasaburo
AU - Kim, Yeul Hong
AU - Fujii, Masashi
AU - Kim, Hoon Kyo
AU - Imamura, Hiroshi
AU - Lee, Kyung Hee
AU - Hara, Takuo
AU - Chung, Hyun Cheol
AU - Satoh, Taroh
AU - Cho, Jae Yong
AU - Hosaka, Hisashi
AU - Tsuji, Akihito
AU - Takagane, Akinori
AU - Inokuchi, Mikito
AU - Tanabe, Kazuaki
AU - Okuno, Tatsuya
AU - Ogura, Mariko
AU - Yoshida, Kazuhiro
AU - Takeuchi, Masahiro
AU - Nakajima, Toshifusa
PY - 2014/2/1
Y1 - 2014/2/1
N2 - 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).
AB - 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).
KW - Advanced gastric cancer
KW - Chemotherapy
KW - Docetaxel
KW - S-1
UR - http://www.scopus.com/inward/record.url?scp=84895077252&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84895077252&partnerID=8YFLogxK
U2 - 10.1007/s00432-013-1563-5
DO - 10.1007/s00432-013-1563-5
M3 - Article
C2 - 24366758
AN - SCOPUS:84895077252
VL - 140
SP - 319
EP - 328
JO - Journal of Cancer Research and Clinical Oncology
JF - Journal of Cancer Research and Clinical Oncology
SN - 0171-5216
IS - 2
ER -