A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer

• DOI: 10.1007/s00280-016-3013-y
• Publication Date: 2016-03-22T08:26:13Z
• Authors: Hiromi Kataoka; Yoshinori Mori; Takaya Shimura; Hirotada Nishie; Makoto Natsume; Hisato Mochizuki; Yoshikazu Hirata; Satoshi Sobue; Takashi Mizushima; Hitoshi Sano; Yusuke Mizuno; Makoto Nakamura; Atsuyuki Hirano; Kenji Tsuchida; Kazunori Adachi; Kyoji Seno; Mika Kitagawa; Takashi Kawai; Takashi Joh
• Keywords: Male; 0301 basic medicine; Receptor, ErbB-2; Kaplan-Meier Estimate; Middle Aged; Trastuzumab; Disease-Free Survival; 3. Good health; Drug Combinations; Oxonic Acid; 03 medical and health sciences; Stomach Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Humans; Female; Prospective Studies; Cisplatin; Response Evaluation Criteria in Solid Tumors; Aged; Tegafur

We evaluated the efficacy and safety of 5-weekly S-1 and cisplatin combined with trastuzumab, a monoclonal antibody against human epidermal growth factor receptor type 2 (HER2) for HER2-positive advanced gastric cancer (AGC).This phase II study treatment consisted of S-1 (80-120 mg per day) orally on day 1-21, cisplatin (60 mg/m(2)) intravenously on day 8, and trastuzumab (8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) intravenously. The primary end point was 1-year survival rate. The secondary end points included overall survival, progression-free survival (PFS), response rate (RR), and safety.A total 22 patients from seven centers were enrolled. In the 20 patients evaluable for analysis, the 1-year survival rate was 70 % (95 % confidence interval (CI) 49.9-90.1 %), and median survival time, PFS, and RR were 15.3, 7.5 months and 41.2 %, respectively. Major grade 3/4 adverse events were neutropenia (30 %), anorexia (30 %), leukopenia (25 %), fatigue (20 %), and anemia (15 %).Five-weekly S-1 and cisplatin combined with trastuzumab showed effective with favorable safety profile in patients with HER2-positive AGC.