Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial

Takashi Yoshioka; Masanobu Takahashi; Yasuhiro Sakamoto; Akira Okita; Tadahisa Fukui; Yasuko Murakawa; Yoshiaki Shindo; Hiroo Imai; Hisatsugu Ohori; Hidekazu Shirota; Natsuko Chiba; Yuriko Sasahara; Takashi Nomura; Norimasa Fukushima; Takuhiro Yamaguchi; Hideki Shimodaira; Chikashi Ishioka

doi:10.21873/anticanres.15680

Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial

Takashi Yoshioka, Masanobu Takahashi, Yasuhiro Sakamoto, Akira Okita, Tadahisa Fukui, Yasuko Murakawa, Yoshiaki Shindo, Hiroo Imai, Hisatsugu Ohori, Hidekazu Shirota, Natsuko Chiba, Yuriko Sasahara, Takashi Nomura, Norimasa Fukushima, Takuhiro Yamaguchi, Hideki Shimodaira, Chikashi Ishioka

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Abstract

Background/Aim: This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. Patients and Methods: This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients aged ≥20 years with advanced HER2-negative gastric cancer that was refractory to S-1 were enrolled. Patients received 80 mg/m² cisplatin on day 1 intravenously and 1,000 mg/m² capecitabine twice daily from day 1 to day 14, in 3-week cycles. The primary endpoint was progression-free survival (PFS). The threshold overall response rate (ORR) was estimated to be 15%. The secondary endpoints were overall survival (OS), time to treatment failure, ORR, and toxicities. Results: In total, 21 patients were enrolled from seven hospitals. The median patient age was 63 years. Nineteen patients received the protocol treatment. Median PFS was 3.7 months [90% confidence interval (CI)=2.7-5.6 months], which did not reach the predefined threshold of 4.0 months. ORR was 5.9% (95%CI=0.0-17.1%). Median OS was 11.9 months (95% CI 6.3-19.4 months). Febrile neutropenia was observed in 5.3% of patients. The most frequently observed grade 3 non-hematologic toxicities were nausea (15.8%) and hyponatremia (15.8%). Conclusion: The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.

Original language	English
Pages (from-to)	2009-2015
Number of pages	7
Journal	Anticancer research
Volume	42
Issue number	4
DOIs	https://doi.org/10.21873/anticanres.15680
Publication status	Published - 2022 Apr

Keywords

Cisplatin
adjuvant chemotherapy
capecitabine
gastric cancer
metastasis

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

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

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10.21873/anticanres.15680

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Yoshioka, T., Takahashi, M., Sakamoto, Y., Okita, A., Fukui, T., Murakawa, Y., Shindo, Y., Imai, H., Ohori, H., Shirota, H., Chiba, N., Sasahara, Y., Nomura, T., Fukushima, N., Yamaguchi, T., Shimodaira, H., & Ishioka, C. (2022). Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial. Anticancer research, 42(4), 2009-2015. https://doi.org/10.21873/anticanres.15680

Yoshioka, T, Takahashi, M, Sakamoto, Y, Okita, A, Fukui, T, Murakawa, Y, Shindo, Y, Imai, H, Ohori, H, Shirota, H , Chiba, N, Sasahara, Y, Nomura, T, Fukushima, N, Yamaguchi, T, Shimodaira, H & Ishioka, C 2022, 'Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial', Anticancer research, vol. 42, no. 4, pp. 2009-2015. https://doi.org/10.21873/anticanres.15680

@article{33e28f80faa94f1983d5ed7998898cc0,

title = "Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial",

abstract = "Background/Aim: This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. Patients and Methods: This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients aged ≥20 years with advanced HER2-negative gastric cancer that was refractory to S-1 were enrolled. Patients received 80 mg/m2 cisplatin on day 1 intravenously and 1,000 mg/m2 capecitabine twice daily from day 1 to day 14, in 3-week cycles. The primary endpoint was progression-free survival (PFS). The threshold overall response rate (ORR) was estimated to be 15%. The secondary endpoints were overall survival (OS), time to treatment failure, ORR, and toxicities. Results: In total, 21 patients were enrolled from seven hospitals. The median patient age was 63 years. Nineteen patients received the protocol treatment. Median PFS was 3.7 months [90% confidence interval (CI)=2.7-5.6 months], which did not reach the predefined threshold of 4.0 months. ORR was 5.9% (95%CI=0.0-17.1%). Median OS was 11.9 months (95% CI 6.3-19.4 months). Febrile neutropenia was observed in 5.3% of patients. The most frequently observed grade 3 non-hematologic toxicities were nausea (15.8%) and hyponatremia (15.8%). Conclusion: The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.",

keywords = "Cisplatin, adjuvant chemotherapy, capecitabine, gastric cancer, metastasis",

author = "Takashi Yoshioka and Masanobu Takahashi and Yasuhiro Sakamoto and Akira Okita and Tadahisa Fukui and Yasuko Murakawa and Yoshiaki Shindo and Hiroo Imai and Hisatsugu Ohori and Hidekazu Shirota and Natsuko Chiba and Yuriko Sasahara and Takashi Nomura and Norimasa Fukushima and Takuhiro Yamaguchi and Hideki Shimodaira and Chikashi Ishioka",

note = "Funding Information: The Authors thank Toru Ishikawa and Noriko Takenaga at the Department of Clinical Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan for their technical assistance. The Authors thank Enago (www.enago.jp) for the English language review. This study was supported by research fundings from T-CORE, Sendai, Japan. Funding Information: Masanobu Takahashi reports receiving lecture fees from Daiichi-Sankyo and research funding from Ono Pharmaceutical Company. Chikashi Ishioka reports receiving lecture fees from Taiho, Chugai, Takeda, Bayer, Pfizer, Mochida, Asahi Kasei, Bristol-Myers Squibb, Daiichi-Sankyo, Merck Serono, and Novartis, and research funding from Chugai, Taiho, Bristol-Myers Squibb, Daiichi-Sankyo, Merck Serono, Yakult, Ono, and Novartis. The other Authors have no conflicts of interest. Publisher Copyright: {\textcopyright} 2022 International Institute of Anticancer Research. All rights reserved.",

year = "2022",

month = apr,

doi = "10.21873/anticanres.15680",

language = "English",

volume = "42",

pages = "2009--2015",

journal = "Anticancer Research",

issn = "0250-7005",

publisher = "International Institute of Anticancer Research",

number = "4",

}

TY - JOUR

T1 - Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer

T2 - A Phase II T-CORE1102 Trial

AU - Yoshioka, Takashi

AU - Takahashi, Masanobu

AU - Sakamoto, Yasuhiro

AU - Okita, Akira

AU - Fukui, Tadahisa

AU - Murakawa, Yasuko

AU - Shindo, Yoshiaki

AU - Imai, Hiroo

AU - Ohori, Hisatsugu

AU - Shirota, Hidekazu

AU - Chiba, Natsuko

AU - Sasahara, Yuriko

AU - Nomura, Takashi

AU - Fukushima, Norimasa

AU - Yamaguchi, Takuhiro

AU - Shimodaira, Hideki

AU - Ishioka, Chikashi

N1 - Funding Information: The Authors thank Toru Ishikawa and Noriko Takenaga at the Department of Clinical Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan for their technical assistance. The Authors thank Enago (www.enago.jp) for the English language review. This study was supported by research fundings from T-CORE, Sendai, Japan. Funding Information: Masanobu Takahashi reports receiving lecture fees from Daiichi-Sankyo and research funding from Ono Pharmaceutical Company. Chikashi Ishioka reports receiving lecture fees from Taiho, Chugai, Takeda, Bayer, Pfizer, Mochida, Asahi Kasei, Bristol-Myers Squibb, Daiichi-Sankyo, Merck Serono, and Novartis, and research funding from Chugai, Taiho, Bristol-Myers Squibb, Daiichi-Sankyo, Merck Serono, Yakult, Ono, and Novartis. The other Authors have no conflicts of interest. Publisher Copyright: © 2022 International Institute of Anticancer Research. All rights reserved.

PY - 2022/4

Y1 - 2022/4

N2 - Background/Aim: This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. Patients and Methods: This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients aged ≥20 years with advanced HER2-negative gastric cancer that was refractory to S-1 were enrolled. Patients received 80 mg/m2 cisplatin on day 1 intravenously and 1,000 mg/m2 capecitabine twice daily from day 1 to day 14, in 3-week cycles. The primary endpoint was progression-free survival (PFS). The threshold overall response rate (ORR) was estimated to be 15%. The secondary endpoints were overall survival (OS), time to treatment failure, ORR, and toxicities. Results: In total, 21 patients were enrolled from seven hospitals. The median patient age was 63 years. Nineteen patients received the protocol treatment. Median PFS was 3.7 months [90% confidence interval (CI)=2.7-5.6 months], which did not reach the predefined threshold of 4.0 months. ORR was 5.9% (95%CI=0.0-17.1%). Median OS was 11.9 months (95% CI 6.3-19.4 months). Febrile neutropenia was observed in 5.3% of patients. The most frequently observed grade 3 non-hematologic toxicities were nausea (15.8%) and hyponatremia (15.8%). Conclusion: The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.

AB - Background/Aim: This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. Patients and Methods: This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients aged ≥20 years with advanced HER2-negative gastric cancer that was refractory to S-1 were enrolled. Patients received 80 mg/m2 cisplatin on day 1 intravenously and 1,000 mg/m2 capecitabine twice daily from day 1 to day 14, in 3-week cycles. The primary endpoint was progression-free survival (PFS). The threshold overall response rate (ORR) was estimated to be 15%. The secondary endpoints were overall survival (OS), time to treatment failure, ORR, and toxicities. Results: In total, 21 patients were enrolled from seven hospitals. The median patient age was 63 years. Nineteen patients received the protocol treatment. Median PFS was 3.7 months [90% confidence interval (CI)=2.7-5.6 months], which did not reach the predefined threshold of 4.0 months. ORR was 5.9% (95%CI=0.0-17.1%). Median OS was 11.9 months (95% CI 6.3-19.4 months). Febrile neutropenia was observed in 5.3% of patients. The most frequently observed grade 3 non-hematologic toxicities were nausea (15.8%) and hyponatremia (15.8%). Conclusion: The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.

KW - Cisplatin

KW - adjuvant chemotherapy

KW - capecitabine

KW - gastric cancer

KW - metastasis

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U2 - 10.21873/anticanres.15680

DO - 10.21873/anticanres.15680

M3 - Article

C2 - 35347022

AN - SCOPUS:85127290775

SN - 0250-7005

VL - 42

SP - 2009

EP - 2015

JO - Anticancer Research

JF - Anticancer Research

IS - 4

ER -

Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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