RT Journal Article
SR Electronic
T1 Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 2009
OP 2015
DO 10.21873/anticanres.15680
VO 42
IS 4
A1 YOSHIOKA, TAKASHI
A1 TAKAHASHI, MASANOBU
A1 SAKAMOTO, YASUHIRO
A1 OKITA, AKIRA
A1 FUKUI, TADAHISA
A1 MURAKAWA, YASUKO
A1 SHINDO, YOSHIAKI
A1 IMAI, HIROO
A1 OHORI, HISATSUGU
A1 SHIROTA, HIDEKAZU
A1 CHIBA, NATSUKO
A1 SASAHARA, YURIKO (ITO)
A1 NOMURA, TAKASHI
A1 FUKUSHIMA, NORIMASA
A1 YAMAGUCHI, TAKUHIRO
A1 SHIMODAIRA, HIDEKI
A1 ISHIOKA, CHIKASHI
YR 2022
UL http://ar.iiarjournals.org/content/42/4/2009.abstract
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.