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Irinotecan in Combination With Fluorouracil in a 48-Hour Continuous Infusion As First-Line Chemotherapy for Elderly Patients With Metastatic Colorectal Cancer: A Spanish Cooperative Group for the Treatment of Digestive Tumors Study

From the Hospital Clínico San Carlos, Madrid; Hospital Santa Creu i San Pau; Hospital Duran i Reynals; Hospital Germans Trias i Pujol; Hospital Clinic i Provincial, Barcelona; Hospital General de Alicante, Alicante; Hospital Carlos Haya, Málaga; Hospital Miguel Servet, Zaragoza; Hospital Reina Sofía, Córdoba; Hospital Juan Canalejo, A Coruña; Hospital Virgen de los Lirios; Hospital General de Elche, Alicante; and Hospital General Universitario, Valencia, Spain

Address reprint requests to Javier Sastre, MD, Servicio de Oncología Médica, Hospital Clínico San Carlos, C/Profesor Martín Lagos, s/n, 28040 Madrid, Spain; e-mail: jsastre.hcsc{at}salud.madrid.org

PURPOSE: Elderly patients constitute a subpopulation with special characteristics that differ from those of the nonelderly and have been underrepresented in clinical trials. This study was performed to determine the efficacy and safety of irinotecan (CPT-11) in combination with fluorouracil (FU) administered as a 48-hour continuous infusion twice a month in elderly patients.

PATIENTS AND METHODS: Patients 72 years old with metastatic colorectal cancer, Eastern Cooperative Oncology Group performance status of 0 to 1, no geriatric syndromes, and no prior treatment were treated every 2 weeks with CPT-11 180 mg/m² plus FU 3,000 mg/m² in a 48-hour continuous infusion.

RESULTS: By intent-to-treat analysis, in 85 assessable patients, the objective response rate was 35% (95% CI, 25% to 46%), and stable disease was 33% (95% CI, 23% to 44%). Median time to progression was 8.0 months (95% CI, 6.0 to 10.0 months), and median overall survival time was 15.3 months (95% CI, 13.8 to 16.9 months). Toxicity was moderate. Grade 3 and 4 neutropenia, diarrhea, and asthenia were observed in 21%, 17%, and 13% of patients, respectively. Only one case of neutropenic fever occurred. There were two toxic deaths, one was a result of grade 4 diarrhea and acute kidney failure, and the other was a result of massive intestinal hemorrhage in the first cycle. The study of prognostic factors did not reveal any predictive factor of response. Response to treatment and baseline lactate dehydrogenase were the main factors conditioning progression-free and overall survival.

CONCLUSION: Twice a month continuous-infusion CPT-11 combined with FU is a valid therapeutic alternative for elderly patients in good general condition.

Presented previously as a poster at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004 (abstr 3597).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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