A Phase II Study of Irinotecan in Combination with Cisplatin as Second-line Chemotherapy in Patients with Metastatic or Locally Advanced Gastric Cancer

Background: Gastric cancer remains one of the leading causes of cancer death worldwide.Currently, no standard secondary-line chemotherapy for locally advanced ormetastatic gastric cancer is recommended. The aim of this study is to demonstrate and confirm the overall objective response rate to irinotecan plus cisplatin for previously treated patients with metastatic or locally advanced gastric cancer in Taiwan.Methods: Patients in this study had been diagnosed with gastric adenocarcinoma withevidence of advanced disease and had failure of first line chemotherapy ordocumented disease progression while receiving adjuvant chemotherapy.Patients had good Eastern Cooperative Oncology Group performance statusand adequate hematologic, renal and liver function. Patients received irinotecan 60 mg/m2followed by cisplatin 30 mg/m2on days 1 and 8, every 3weeks. Treatment was administered until disease progression, intolerabletoxicity or consent withdrawal. Evaluation was conducted every two cyclesusing the Response Evaluation Criteria in Solid Tumors. The toxicity wasrecorded by National Cancer Institute Common Terminology Criteria forAdverse Events version 3.0, year 2003.Results: From January 2007 to December 2008, 24 patients were enrolled. Theirmedian age was 54 years (range 30 to 77 years). Fifteen patients (63%) weremen. Five patients (21%) achieved partial response, while ten patients (42%)remained stable. The median progression-free survival was 109 days andmedian overall survival was 222 days. The major grade 3/4 toxicities wereneutropenia (20.9%) and diarrhea (8.3%).Conclusions: Second-line chemotherapy with irinotecan and cisplatin for advanced gastriccancer is effective and has acceptable toxicity.