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

This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients...

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Bibliographic Details
Published in:Anticancer research 2022-04, Vol.42 (4), p.2009-2015
Main Authors: Yoshioka, Takashi, Takahashi, Masanobu, Sakamoto, Yasuhiro, Okita, Akira, Fukui, Tadahisa, Murakawa, Yasuko, Shindo, Yoshiaki, Imai, Hiroo, Ohori, Hisatsugu, Shirota, Hidekazu, Chiba, Natsuko, Sasahara, Yuriko Ito, Nomura, Takashi, Fukushima, Norimasa, Yamaguchi, Takuhiro, Shimodaira, Hideki, Ishioka, Chikashi
Format: Article
Language:English
Subjects:
Cancer
Cisplatin
Confidence intervals
ErbB-2 protein
Gastric cancer
Health services
Hyponatremia
Metastases
Nausea
Neutropenia
Patients
Platinum
Reagents
Survival
Toxicity
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Summary:This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. 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/m cisplatin on day 1 intravenously and 1,000 mg/m 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. 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%). The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.
ISSN:0250-7005
1791-7530
DOI:10.21873/anticanres.15680