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

Wasaburo Koizumi, Yeul Hong Kim, Masashi Fujii, Hoon Kyo Kim, Hiroshi Imamura, Kyung Hee Lee, Takuo Hara, Hyun Cheol Chung, Taroh Satoh, Jae Yong Cho, Hisashi Hosaka, Akihito Tsuji, Akinori Takagane, Mikito Inokuchi, Kazuaki Tanabe, Tatsuya Okuno, Mariko Ogura, Kazuhiro Yoshida, Masahiro Takeuchi, Toshifusa Nakajima

Research output: Contribution to journalArticle

98 Citations (Scopus)

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 languageEnglish
Pages (from-to)319-328
Number of pages10
JournalJournal of Cancer Research and Clinical Oncology
Volume140
Issue number2
DOIs
Publication statusPublished - 2014 Feb 1

Fingerprint

docetaxel
Platinum
Stomach Neoplasms
Survival
Cisplatin
Disease-Free Survival
Platinum Compounds
Far East
Neutropenia
Fluorouracil

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 journalArticle

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 2014, 'Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: A randomized study (START)', Journal of Cancer Research and Clinical Oncology, vol. 140, no. 2, pp. 319-328. https://doi.org/10.1007/s00432-013-1563-5
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. / Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer : A randomized study (START). In: Journal of Cancer Research and Clinical Oncology. 2014 ; Vol. 140, No. 2. pp. 319-328.
@article{6e53f60a56ea4bd39d1840773c3b4b91,
title = "Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: A randomized study (START)",
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).",
keywords = "Advanced gastric cancer, Chemotherapy, Docetaxel, S-1",
author = "Wasaburo Koizumi and Kim, {Yeul Hong} and Masashi Fujii and Kim, {Hoon Kyo} and Hiroshi Imamura and Lee, {Kyung Hee} and Takuo Hara and Chung, {Hyun Cheol} and Taroh Satoh and Cho, {Jae Yong} and Hisashi Hosaka and Akihito Tsuji and Akinori Takagane and Mikito Inokuchi and Kazuaki Tanabe and Tatsuya Okuno and Mariko Ogura and Kazuhiro Yoshida and Masahiro Takeuchi and Toshifusa Nakajima",
year = "2014",
month = "2",
day = "1",
doi = "10.1007/s00432-013-1563-5",
language = "English",
volume = "140",
pages = "319--328",
journal = "Journal of Cancer Research and Clinical Oncology",
issn = "0171-5216",
publisher = "Springer Verlag",
number = "2",

}

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 -