779TiP - A randomized phase II trial of biweekly S-1 with paclitaxel (SPA) or oxaliplatin (SOX) as first-line chemotherapy in advanced gastric cancer patient...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer agents
Gastric Cancer
Biological Therapy
Presenter Mou Haibo
Authors M. Haibo, W. Fang, Y. Zheng, P. Zhao, C. Mao, X. Zhang, J. Qian, H. Jiang, Y. Zheng, N. Xu
  • Department Of Medical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, 310003 - Hangzhou/CN



Gastric cancer patients are commonly treated with S-1-based chemotherapy for three weeks or more to ensure two weeks of exposure at therapeutic doses. Severe side effects of S-1 such as mucositis, diarrhea and neutropenia often occur in the second week of treatment. We evaluated the activity and safety of every other week S-1 regimens with paclitaxel or oxaliplatin combinations as first-line chemotherapy in advanced gastric cancer patients. Patients and methods: Eligible patients with pathologically confirmed advanced gastric cancer patients were randomized into two arms. S-1 was administered orally (80 mg/m2/day) for 7 consecutive days in combination with paclitaxel 120 mg/m2 (SPA) or oxaliplatin 85 mg/m2 (SOX) on day 1 followed by a 7-day rest. Treatment continued in a biweekly manner until disease progressed, unacceptable toxicity was observed or the patient refused to continue. The primary endpoint was overall response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety.


Eighty-one gastric cancer patients were enrolled from June 2010 to March 2012. Patients were randomized to receive SPA (43) or SOX (38). Results are presented for 76 patients. The ORR for arm A was 43.6%, and that for arm B was 33.3% with no significant difference between the two arms (p = 0.35). The median PFS was 6.2 months for arm A vs. 5.1 months for arm B (p = 0.80); the median OS was 10.8 months for arm A and 10.0 months for arm B (p = 0.17). No treatment-related deaths occurred during the study. The most frequent toxicity was neutropenia (30.8% and 17.4% of grade 3/4 in arms A and B, respectively). The most common non-hematological toxicities were mucositis, diarrhea, and peripheral neuropathy, all in less than 5% of patients.


These preliminary findings suggest that biweekly S-1-based regimens have an acceptable ORR with tolerable side effects in advanced gastric cancer patients. The study will continue until 100 patients have been enrolled.


All authors have declared no conflicts of interest.