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

doi:10.1007/s00432-013-1563-5

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

Department of Biomedical Sciences

Research output: Contribution to journal › Article › peer-review

171 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 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	https://doi.org/10.1007/s00432-013-1563-5
Publication status	Published - 2014 Feb

Bibliographical note

Funding Information:
Acknowledgments This study was supported by the Japan Clinical Cancer Research Organization (JACCRO) and Korean Cancer Study Group (KCSG). We thank all of our patients and their families, as well as all of the site investigators. We are grateful to Dr. Y. Shimada of National Cancer Center Hospital and to Dr. T. Sasaki of Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital for their kind advice as members of the Independent Data Monitoring Committee. The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript.

Funding Information:
JACCRO and KCSG employees contributed to the study design and data collection and interpretation. This study was supported by an unconditioned grant from Sanofi K.K. Japan. Sanofi K.K. Japan had no role in the study design, data collection, analysis, or interpretation, or in writing

Keywords

Advanced gastric cancer
Chemotherapy
Docetaxel
S-1

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s00432-013-1563-5

Cite this

Koizumi, W., Kim, Y. H., Fujii, M., Kim, H. K., Imamura, H., Lee, K. H., Hara, T., Chung, H. C., Satoh, T., Cho, J. Y., 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, 140(2), 319-328. https://doi.org/10.1007/s00432-013-1563-5

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

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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",

note = "Funding Information: Acknowledgments This study was supported by the Japan Clinical Cancer Research Organization (JACCRO) and Korean Cancer Study Group (KCSG). We thank all of our patients and their families, as well as all of the site investigators. We are grateful to Dr. Y. Shimada of National Cancer Center Hospital and to Dr. T. Sasaki of Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital for their kind advice as members of the Independent Data Monitoring Committee. The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript. Funding Information: JACCRO and KCSG employees contributed to the study design and data collection and interpretation. This study was supported by an unconditioned grant from Sanofi K.K. Japan. Sanofi K.K. Japan had no role in the study design, data collection, analysis, or interpretation, or in writing",

year = "2014",

month = feb,

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",

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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

N1 - Funding Information: Acknowledgments This study was supported by the Japan Clinical Cancer Research Organization (JACCRO) and Korean Cancer Study Group (KCSG). We thank all of our patients and their families, as well as all of the site investigators. We are grateful to Dr. Y. Shimada of National Cancer Center Hospital and to Dr. T. Sasaki of Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital for their kind advice as members of the Independent Data Monitoring Committee. The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript. Funding Information: JACCRO and KCSG employees contributed to the study design and data collection and interpretation. This study was supported by an unconditioned grant from Sanofi K.K. Japan. Sanofi K.K. Japan had no role in the study design, data collection, analysis, or interpretation, or in writing

PY - 2014/2

Y1 - 2014/2

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

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JO - Journal of Cancer Research and Clinical Oncology

JF - Journal of Cancer Research and Clinical Oncology

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ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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