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 or metastatic 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 with evidence of advanced disease and had failure of first line chemotherapy or documented disease progression while receiving adjuvant chemotherapy. Patients had good Eastern Cooperative Oncology Group performance status and adequate hematologic, renal and liver function. Patients received irinotecan 60 mg/m2 followed by cisplatin 30 mg/m2 on days 1 and 8, every 3 weeks. Treatment was administered until disease progression, intolerable toxicity or consent withdrawal. Evaluation was conducted every two cycles using the Response Evaluation Criteria in Solid Tumors. The toxicity was recorded by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0, year 2003. RESULTS From January 2007 to December 2008, 24 patients were enrolled. Their median age was 54 years (range 30 to 77 years). Fifteen patients (63%) were men. Five patients (21%) achieved partial response, while ten patients (42%) remained stable. The median progression-free survival was 109 days and median overall survival was 222 days. The major grade 3/4 toxicities were neutropenia (20.9%) and diarrhea (8.3%). CONCLUSIONS Second-line chemotherapy with irinotecan and cisplatin for advanced gastric cancer is effective and has acceptable toxicity.