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


Authors: Ilson, D. H.; Saltz, L.; Enzinger, P.; Huang, Y.; Kornblith, A.; Gollub, M.; O'Reilly, E.; Schwartz, G.; DeGroff, J.; Gonzalez, G.; Kelsen, D. P.
Article Title: Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer
Abstract: 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 metastatic or unresectable esophageal adenocarcinoma (23 patients) or squamous cell carcinoma (12 patients) were treated. No prior chemotherapy was allowed. The majority of patients had metastatic and bidimensionally measurable disease (34 patients each [97%]). Patients were treated with cisplatin 30 mg/m2 and irinotecan 65 mg/m2, repeated weekly for 4 weeks, followed by a 2-week rest period. Treatment was recycled every 6 weeks. Degree of dysphagia relief was monitored, and quality of life was measured prospectively using the European Organization 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. Major objective responses were observed in 20 patients (57%; 95% confidence interval, 41% to 73%), including two complete responses (6%). Similar response rates were observed for adenocarcinoma (12 of 23 patients; 52%) and squamous 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 assessable at baseline, 18 (90%) noted either improvement or resolution of dysphagia on chemotherapy. Global quality of life improved in responding patients, primarily because of improvements in pain, emotional state, and relationships with family and friends. Toxicity was relatively mild and included only three patients (9%) with grade 4 neutropenia and four (11%) with grade 3 diarrhea. There were no treatment- related deaths. Conclusion: The combination of weekly cisplatin plus irinotecan had significant activity in metastatic esophageal carcinoma and resulted in significant relief of dysphagia. The regimen was well tolerated, with acceptable myelosuppression 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.
Keywords: adult; cancer survival; clinical article; treatment outcome; aged; middle aged; survival analysis; clinical trial; neutropenia; squamous cell carcinoma; carcinoma, squamous cell; cisplatin; diarrhea; adenocarcinoma; quality of life; computer assisted tomography; phase 2 clinical trial; bone marrow suppression; antineoplastic combined chemotherapy protocols; drug administration schedule; camptothecin; dexamethasone; irinotecan; questionnaire; dysphagia; granisetron; loperamide; recombinant granulocyte colony stimulating factor; esophagus cancer; deglutition disorders; esophageal neoplasms; intravenous drug administration; oral drug administration; barium; esophagography; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 17
Issue: 10
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1999-10-01
Start Page: 3270
End Page: 3275
Language: English
PUBMED: 10506629
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 16 August 2016 -- Source: Scopus