Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial.
Anticancer Res
; 42(4): 2009-2015, 2022 04.
Article
em En
| MEDLINE
| ID: mdl-35347022
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 ANDMETHODS:
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Esplênicas
/
Neoplasias Gástricas
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adult
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Humans
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Middle aged
Idioma:
En
Revista:
Anticancer Res
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Japão