Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer

Purpose: To evaluate the response, toxicity, survival, and quality of life in patients with unresectable or metastatic esophageal cancer treated with weekly irinotecan and cisplatin, Patients and Methods: Thirty-five patients with meta-static or unresectable esophageal adenocarcinoma (23 patients) or squamous cell carcinoma (12 pat ients) were treated. No prior chemotherapy was allowed, The majority of pat ients herd metastatic and bidimensionally measurable disease (34 patients e ach [97%]). patients were created with cisplatin 30 mg/m(2) and irinotecan 65 mg/m(2), repeated weekly for 4 weeks, followed by a 2-week rest period. Treatment was recycled every 6 weeks. Degree of dysphagia relief was monito red, and quality of life was measured prospectively using the European Orga nization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and Functional Assessment of Cancer Therapy General instruments. Results: Thirty-five patients were assessable for response and toxicity. Ma jor objective responses were observed in 20 patients (57%; 95% confidence i nterval, 41% to 73%), including two complete responses (6%), Similar respon se rates were observed for adenocarcinoma (12 of 23 patients; 52%) and squa mous carcinoma (eight of 12 patients; 66%). The median duration of response was 4.2 months (range, 1 to 8.8+ months). Median actuarial survival was 14 .6 months (range, 1 to 15.2+ months). In 20 patients with dysphagia assessa ble at baseline, 18 (90%) noted either improvement or resolution of dysphag ia on chemotherapy, Global quality of life improved in responding patients, primarily because of improvements in pain, emotional state, and relationsh ips with family and friends. Toxicity was relatively mild and included only three patients (9%) with grade 4 neutropenia and four (11%) with grade 3 d iarrhea. There were no treatment-related deaths. Conclusion: The combination of weekly cisplatin plus irinotecan had signifi cant activity in metastatic esophageal carcinoma, and resulted in significa nt relief of dysphagia, The regimen was well tolerated, with accept; able m yelosuppression and rare treatment-related diarrhea, Further evaluation of the combination of weekly irinotecan and cisplatin, including the addition of other agents to this regimen, is indicated, (C) 1999 by American Society of Clinical Oncology.