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Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial

PURPOSE: S-1 is a standard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia. Neoadjuvant or perioperative strategies dominate in Western countries, and docetaxel has recently shown significant survival benefits when combined with other standard regimens in...

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Autores principales: Yoshida, Kazuhiro, Kodera, Yasuhiro, Kochi, Mitsugu, Ichikawa, Wataru, Kakeji, Yoshihiro, Sano, Takeshi, Nagao, Narutoshi, Takahashi, Masazumi, Takagane, Akinori, Watanabe, Takuya, Kaji, Masahide, Okitsu, Hiroshi, Nomura, Takashi, Matsui, Takanori, Yoshikawa, Takaki, Matsuyama, Jin, Yamada, Makoto, Ito, Seiji, Takeuchi, Masahiro, Fujii, Masashi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Clinical Oncology 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524985/
https://www.ncbi.nlm.nih.gov/pubmed/30925125
http://dx.doi.org/10.1200/JCO.18.01138
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author Yoshida, Kazuhiro
Kodera, Yasuhiro
Kochi, Mitsugu
Ichikawa, Wataru
Kakeji, Yoshihiro
Sano, Takeshi
Nagao, Narutoshi
Takahashi, Masazumi
Takagane, Akinori
Watanabe, Takuya
Kaji, Masahide
Okitsu, Hiroshi
Nomura, Takashi
Matsui, Takanori
Yoshikawa, Takaki
Matsuyama, Jin
Yamada, Makoto
Ito, Seiji
Takeuchi, Masahiro
Fujii, Masashi
author_facet Yoshida, Kazuhiro
Kodera, Yasuhiro
Kochi, Mitsugu
Ichikawa, Wataru
Kakeji, Yoshihiro
Sano, Takeshi
Nagao, Narutoshi
Takahashi, Masazumi
Takagane, Akinori
Watanabe, Takuya
Kaji, Masahide
Okitsu, Hiroshi
Nomura, Takashi
Matsui, Takanori
Yoshikawa, Takaki
Matsuyama, Jin
Yamada, Makoto
Ito, Seiji
Takeuchi, Masahiro
Fujii, Masashi
author_sort Yoshida, Kazuhiro
collection PubMed
description PURPOSE: S-1 is a standard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia. Neoadjuvant or perioperative strategies dominate in Western countries, and docetaxel has recently shown significant survival benefits when combined with other standard regimens in advanced cancer and perioperative settings. PATIENTS AND METHODS: This randomized phase III study was designed to prove the superiority of postoperative S-1 plus docetaxel over S-1 alone for R0 resection of pathologic stage III gastric cancer. The sample size of 1,100 patients was necessary to detect a 7% increase in 3-year relapse-free survival as the primary end point (hazard ratio, 0.78; 2-sided α = .05; β = .2). RESULTS: The second interim analysis was conducted when the number of events reached 216 among 915 enrolled patients (median follow-up, 12.5 months). Analysis demonstrated the superiority of S-1 plus docetaxel (66%) to S-1 (50%) for 3-year relapse-free survival (hazard ratio, 0.632; 99.99% CI, 0.400 to 0.998; stratified log-rank test, P < .001), and enrollment was terminated as recommended by the independent data and safety monitoring committee. Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia, were higher in the S-1 plus docetaxel group, but all events were manageable. CONCLUSION: Addition of docetaxel to S-1 is effective with few safety concerns in patients with stage III gastric cancer. The present findings may also be applicable in countries in which perioperative adjuvant chemotherapy or chemoradiation is not standard.
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spelling pubmed-65249852020-05-20 Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial Yoshida, Kazuhiro Kodera, Yasuhiro Kochi, Mitsugu Ichikawa, Wataru Kakeji, Yoshihiro Sano, Takeshi Nagao, Narutoshi Takahashi, Masazumi Takagane, Akinori Watanabe, Takuya Kaji, Masahide Okitsu, Hiroshi Nomura, Takashi Matsui, Takanori Yoshikawa, Takaki Matsuyama, Jin Yamada, Makoto Ito, Seiji Takeuchi, Masahiro Fujii, Masashi J Clin Oncol ORIGINAL REPORTS PURPOSE: S-1 is a standard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia. Neoadjuvant or perioperative strategies dominate in Western countries, and docetaxel has recently shown significant survival benefits when combined with other standard regimens in advanced cancer and perioperative settings. PATIENTS AND METHODS: This randomized phase III study was designed to prove the superiority of postoperative S-1 plus docetaxel over S-1 alone for R0 resection of pathologic stage III gastric cancer. The sample size of 1,100 patients was necessary to detect a 7% increase in 3-year relapse-free survival as the primary end point (hazard ratio, 0.78; 2-sided α = .05; β = .2). RESULTS: The second interim analysis was conducted when the number of events reached 216 among 915 enrolled patients (median follow-up, 12.5 months). Analysis demonstrated the superiority of S-1 plus docetaxel (66%) to S-1 (50%) for 3-year relapse-free survival (hazard ratio, 0.632; 99.99% CI, 0.400 to 0.998; stratified log-rank test, P < .001), and enrollment was terminated as recommended by the independent data and safety monitoring committee. Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia, were higher in the S-1 plus docetaxel group, but all events were manageable. CONCLUSION: Addition of docetaxel to S-1 is effective with few safety concerns in patients with stage III gastric cancer. The present findings may also be applicable in countries in which perioperative adjuvant chemotherapy or chemoradiation is not standard. American Society of Clinical Oncology 2019-05-20 2019-03-29 /pmc/articles/PMC6524985/ /pubmed/30925125 http://dx.doi.org/10.1200/JCO.18.01138 Text en © 2019 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/ Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle ORIGINAL REPORTS
Yoshida, Kazuhiro
Kodera, Yasuhiro
Kochi, Mitsugu
Ichikawa, Wataru
Kakeji, Yoshihiro
Sano, Takeshi
Nagao, Narutoshi
Takahashi, Masazumi
Takagane, Akinori
Watanabe, Takuya
Kaji, Masahide
Okitsu, Hiroshi
Nomura, Takashi
Matsui, Takanori
Yoshikawa, Takaki
Matsuyama, Jin
Yamada, Makoto
Ito, Seiji
Takeuchi, Masahiro
Fujii, Masashi
Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
title Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
title_full Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
title_fullStr Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
title_full_unstemmed Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
title_short Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial
title_sort addition of docetaxel to oral fluoropyrimidine improves efficacy in patients with stage iii gastric cancer: interim analysis of jaccro gc-07, a randomized controlled trial
topic ORIGINAL REPORTS
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524985/
https://www.ncbi.nlm.nih.gov/pubmed/30925125
http://dx.doi.org/10.1200/JCO.18.01138
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