Irinotecan plus cisplatin in advanced gastric or gastroesophageal junctioncarcinoma

A phase II study, was conducted to assess the response rate and toxicity pr ofile of the combination of irinotecan (CPT-II, Camptosar) and cisplatin (P latinol) administered weekly to patients whit untreated advanced adeno-carc inoma of the stomach or gastroesophageal junction. Patients with histologic proof of adenocarcinoma of the stomach or gastroesophageal junction and wi th adequate liver, kidney, and bone marrow functions were included. Patient s were treated,with 65 mg/m(2) of irinotecan plus 30 mg/m(2) of cisplatin, both administered intravenously 1 day per week for 4 consecutive weeks, fol lowed by a week recovery period Response rate, time to progression, surviva l, and toxic effects were analyzed. Thirty-six (95%) of 38 registered patie nts were assessable for toxicity and response. The median number of 6-week cycles per patient was 2.5 (range: 1 to 7 cycles). Four patients (11%) achi eved a complete response and 17 (47%) had a partial response for an overall response rate of 58%. Median time to progression of carcinoma was 24 weeks , and median survival was 9 months (range: 1 to 23+ months). There,uas one treatment-related death. Major toxic effects included diarrhea, neutropenia , and fatigue. The combination of irinotecan and cisplatin is active agains t gastric or gastroesophageal adenocarcinoma and should undergo further stu dy. The addition of other active drugs or radiation therapy to this regimen would be of interest.