Phase II study of adjuvant chemotherapy of S-1 plus oxaliplatin for patients with stage III gastric cancer after D2 gastrectomy

Kohei Shitara, Keisho Chin, Takaki Yoshikawa, Hitoshi Katai, Masanori Terashima, Seiji Ito, Motohiro Hirao, Kazuhiro Yoshida, Eiji Oki, Mitsuru Sasako, Yasunori Emi, Toshimasa Tsujinaka

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Abstract

Background: The Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) demonstrated a survival benefit by adjuvant S-1 monotherapy in patients who had undergone curative resection of stage II/III gastric cancer, but there is still a need to improve the efficacy of treatment of stage III disease. We investigated the tolerability and safety of S-1 and oxaliplatin as adjuvant chemotherapy for stage III gastric cancer. Methods: Japanese patients with stage III gastric cancer who had undergone D2 or more extensive lymphadenectomy were enrolled. In the first cycle, S-1 (40–60 mg/m 2 twice daily) alone was given orally for 2 weeks of a 3-week cycle. From the second cycle, S-1 was administered as in the first cycle and oxaliplatin (100 mg/m 2 ) was infused intravenously on day 1. Treatment was continued for 8 cycles. The primary end point was the treatment completion rate for eight cycles. Results: Sixty-three patients were enrolled and 62 patients were included in analysis. The treatment completion rate was 74.2 %, which was higher than the expected completion rate of 72.0 %. The median relative dose intensities were 77.1 % for S-1 and 72.6 % for oxaliplatin, with 41.9 and 61.7 % patients requiring dose reduction of S-1 and oxaliplatin, respectively. Neutropenia was the only grade 3 or higher adverse event with an incidence 10 % or greater (32.3 %). There was no grade 3 or higher peripheral sensory neuropathy or treatment-related death. Conclusions: S-1 and oxaliplatin therapy is suggested to be manageable and safe with optimal dose reduction and delay in selected patients for stage III gastric cancer after D2 gastrectomy, and warrants further evaluation in larger studies.

Original languageEnglish
Pages (from-to)175-181
Number of pages7
JournalGastric Cancer
Volume20
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

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oxaliplatin
Gastrectomy
Adjuvant Chemotherapy
Stomach Neoplasms
Therapeutics
Peripheral Nervous System Diseases
Neutropenia
Lymph Node Excision

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology
  • Cancer Research

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Phase II study of adjuvant chemotherapy of S-1 plus oxaliplatin for patients with stage III gastric cancer after D2 gastrectomy. / Shitara, Kohei; Chin, Keisho; Yoshikawa, Takaki; Katai, Hitoshi; Terashima, Masanori; Ito, Seiji; Hirao, Motohiro; Yoshida, Kazuhiro; Oki, Eiji; Sasako, Mitsuru; Emi, Yasunori; Tsujinaka, Toshimasa.

In: Gastric Cancer, Vol. 20, No. 1, 01.01.2017, p. 175-181.

Research output: Contribution to journalArticle

Shitara, K, Chin, K, Yoshikawa, T, Katai, H, Terashima, M, Ito, S, Hirao, M, Yoshida, K, Oki, E, Sasako, M, Emi, Y & Tsujinaka, T 2017, 'Phase II study of adjuvant chemotherapy of S-1 plus oxaliplatin for patients with stage III gastric cancer after D2 gastrectomy', Gastric Cancer, vol. 20, no. 1, pp. 175-181. https://doi.org/10.1007/s10120-015-0581-1
Shitara, Kohei ; Chin, Keisho ; Yoshikawa, Takaki ; Katai, Hitoshi ; Terashima, Masanori ; Ito, Seiji ; Hirao, Motohiro ; Yoshida, Kazuhiro ; Oki, Eiji ; Sasako, Mitsuru ; Emi, Yasunori ; Tsujinaka, Toshimasa. / Phase II study of adjuvant chemotherapy of S-1 plus oxaliplatin for patients with stage III gastric cancer after D2 gastrectomy. In: Gastric Cancer. 2017 ; Vol. 20, No. 1. pp. 175-181.
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abstract = "Background: The Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) demonstrated a survival benefit by adjuvant S-1 monotherapy in patients who had undergone curative resection of stage II/III gastric cancer, but there is still a need to improve the efficacy of treatment of stage III disease. We investigated the tolerability and safety of S-1 and oxaliplatin as adjuvant chemotherapy for stage III gastric cancer. Methods: Japanese patients with stage III gastric cancer who had undergone D2 or more extensive lymphadenectomy were enrolled. In the first cycle, S-1 (40–60 mg/m 2 twice daily) alone was given orally for 2 weeks of a 3-week cycle. From the second cycle, S-1 was administered as in the first cycle and oxaliplatin (100 mg/m 2 ) was infused intravenously on day 1. Treatment was continued for 8 cycles. The primary end point was the treatment completion rate for eight cycles. Results: Sixty-three patients were enrolled and 62 patients were included in analysis. The treatment completion rate was 74.2 {\%}, which was higher than the expected completion rate of 72.0 {\%}. The median relative dose intensities were 77.1 {\%} for S-1 and 72.6 {\%} for oxaliplatin, with 41.9 and 61.7 {\%} patients requiring dose reduction of S-1 and oxaliplatin, respectively. Neutropenia was the only grade 3 or higher adverse event with an incidence 10 {\%} or greater (32.3 {\%}). There was no grade 3 or higher peripheral sensory neuropathy or treatment-related death. Conclusions: S-1 and oxaliplatin therapy is suggested to be manageable and safe with optimal dose reduction and delay in selected patients for stage III gastric cancer after D2 gastrectomy, and warrants further evaluation in larger studies.",
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T1 - Phase II study of adjuvant chemotherapy of S-1 plus oxaliplatin for patients with stage III gastric cancer after D2 gastrectomy

AU - Shitara, Kohei

AU - Chin, Keisho

AU - Yoshikawa, Takaki

AU - Katai, Hitoshi

AU - Terashima, Masanori

AU - Ito, Seiji

AU - Hirao, Motohiro

AU - Yoshida, Kazuhiro

AU - Oki, Eiji

AU - Sasako, Mitsuru

AU - Emi, Yasunori

AU - Tsujinaka, Toshimasa

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background: The Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) demonstrated a survival benefit by adjuvant S-1 monotherapy in patients who had undergone curative resection of stage II/III gastric cancer, but there is still a need to improve the efficacy of treatment of stage III disease. We investigated the tolerability and safety of S-1 and oxaliplatin as adjuvant chemotherapy for stage III gastric cancer. Methods: Japanese patients with stage III gastric cancer who had undergone D2 or more extensive lymphadenectomy were enrolled. In the first cycle, S-1 (40–60 mg/m 2 twice daily) alone was given orally for 2 weeks of a 3-week cycle. From the second cycle, S-1 was administered as in the first cycle and oxaliplatin (100 mg/m 2 ) was infused intravenously on day 1. Treatment was continued for 8 cycles. The primary end point was the treatment completion rate for eight cycles. Results: Sixty-three patients were enrolled and 62 patients were included in analysis. The treatment completion rate was 74.2 %, which was higher than the expected completion rate of 72.0 %. The median relative dose intensities were 77.1 % for S-1 and 72.6 % for oxaliplatin, with 41.9 and 61.7 % patients requiring dose reduction of S-1 and oxaliplatin, respectively. Neutropenia was the only grade 3 or higher adverse event with an incidence 10 % or greater (32.3 %). There was no grade 3 or higher peripheral sensory neuropathy or treatment-related death. Conclusions: S-1 and oxaliplatin therapy is suggested to be manageable and safe with optimal dose reduction and delay in selected patients for stage III gastric cancer after D2 gastrectomy, and warrants further evaluation in larger studies.

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