
Vol. 69, No. 5, 2005
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Clinical Study
Combination of Irinotecan (CPT-11) plus 5-Fluorouracil and Leucovorin (FOLFIRI Regimen) as First Line Treatment for Elderly Patients with Metastatic Colorectal Cancer: A Phase II Trial
J. Souglakos, A. Pallis, S. Kakolyris, D. Mavroudis, N. Androulakis, C. Kouroussis, S. Agelaki, N. Xenidis, G. Milaki, V. Georgoulias
Department of Medical Oncology, School of Medicine, University General Hospital of Heraklion, Heraklion, Crete, Greece
Address of Corresponding Author
Oncology 2005;69:384-390 (DOI: 10.1159/000089992)
Key Words
- Irinotecan
- Metastatic colorectal cancer
- Elderly patients
Abstract
Purpose: To evaluate the efficacy and tolerance of irinotecan (CPT-11) in combination with bolus and continuous infusion of 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFIRI regimen) as first-line treatment of elderly patients with metastatic colorectal cancer (MCC). Methods: Thirty consecutive, previously untreated patients with metastatic colorectal cancer, aged (median 76 years; range 70-84) were enrolled. The performance status (WHO) was 0 in 8, 1 in 16 and 2 in 6 patients; 19 (63%) patients had prior surgery and 8 (27%) adjuvant chemotherapy. CPT-11 (180 mg/m2 as a 90 min i.v. infusion) was administered on day 1, LV (200 mg/m2 as a 2-hour i.v. infusion), 5-FU (400 mg/m2/d i.v. bolus followed by 600 mg/m2/d as a 22-hour i.v. continuous infusion) were given on days 1 and 2 every 2 weeks. Results: Complete response was achieved in one (3.3%) patient and partial response in 10 (33.3%) (overall response rate: 36.6%; 95% C.I.: 26.6-48.4%); 11 (36.6%) patients had stable disease and, 8 (26.6%) disease progression. The median duration of response was 7.5 months and the median time to disease progression 7.0 months. After a median follow-up period of 17 months, the median overall survival was 14.5 months. Main toxicities were: grade 3-4 neutropenia (n = 6; 20%), grade 3 thrombocytopenia (n = 1; 3.3%), grade 2 anemia (n = 9; 30%), grade 3-4 diarrhea (n = 5; 17%) and grade 3 asthenia (n = 3; 10%). There was one treatment-related death due to neutropenic sepsis. Conclusions: The FOLFIRI combination is an active regimen with manageable toxicity as front-line treatment in patients above 70 years of age. Copyright © 2005 S. Karger AG, Basel
Author Contacts
Dr. Vassilis Georgoulias, MD, PhD Department of Medical Oncology University General Hospital of Heraklion, PO Box 1352 GR-71110 Heraklion, Crete (Greece) Tel. +30 2810 392747, Fax +30 2810 392802, E-Mail georgoul@med.uoc.gr
Article Information
Received: February 27, 2004
Accepted after revision: June 24, 2004
Published online: November 24, 2005
Number of Print Pages : 7
Number of Figures : 1, Number of Tables : 3, Number of References : 35 |
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