A Phase II Multi-Center Study of Triple Therapy with Paclitaxel, S-1 and Cisplatin in Patients with Advanced Gastric CancerIwase H.a · Shimada M.a · Tsuzuki T.a · Ina K.b · Sugihara M.c · Haruta J.d · Shinoda M.e · Kumada T.f · Goto H.g
aNagoya Medical Centre, bNagoya Memorial Hospital, cMeitetsu Hospital, dJapan Red Cross Nagoya First Hospital, Nagoya, eToyota Memorial Hospital, Toyota, fOgaki Municipal Hospital, Ogaki, and gNagoya University School of Medicine, Nagoya, Japan
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Objectives: To carry out a phase II multi-center study on the efficacy and safety of triple combination therapy with paclitaxel, S-1, and cisplatin in patients with unresectable/metastatic gastric cancer. Methods: A total of 63 patients from 8 institutions were included in this study. Paclitaxel (160 mg/m2) was administered by infusion for 3 h on the first day. S-1 (70 mg/m2/day) was administered orally for 14 consecutive days from the first day. Cisplatin (60 mg/m2) was administered intravenously over 24 h on day 14 of every 28-day cycle. Results: All 63 patients were assessed for clinical efficacy and safety. A total of 259 cycles of treatment were administered (median 4, range 1–10). Grade 3–4 toxicities included neutropenia in 30.2%, thrombocytopenia in 12.7%, and anemia in 11.1%. There was no grade 3–4 non-hematological toxicity or treatment-related death. Complete response was observed in 6 patients and partial response in 34 patients. The overall response rate was 63.5%. The median progression-free survival and response duration were 8.0 and 8.8 months, respectively, and median survival time was 15 months. Conclusions: Triple combination therapy with paclitaxel, S-1, and cisplatin showed promising safety and efficacy profiles with the potential to become a standard regimen for unresectable/metastatic gastric cancer.
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