Weekly Irinotecan (CPT-11) in 5-FU Heavily Pretreated and Poor-Performance-Status Patients with Advanced Colorectal Cancer

Abstract

Irinotecan (CPT-11) is an effective drug in patients with advanced colorectal cancer (CRC). Little is known about its efficacy and safety in previously treated patients with poor performance status. We prospectively evaluated the antitumor efficacy and safety of CPT-11 monotherapy in this setting. Thirty-four patients with poor performance status (Karnofsky score between 60 and 80) and/or progressing on one or more previous 5-FU-based chemotherapy lines for advanced colorectal adenocarcinoma were enrolled in this study. Treatment consisted of irinotecan (CPT-11) at 100 mg/m(2) administered as a 60-min iv infusion every week for four consecutive weeks followed by a 2-wk rest period until disease progression or unacceptable toxicity. The overall objective response rate (WHO criteria) for the 34 patients included was 20.6% [95% confidence interval (CI): 6.3%-34.9%]. Stable disease was obtained in 13 patients (38.2%) and 14 patients (41.2%) progressed. The median time to disease progression was 5.5 mo (range: 0.9-17.5) and the median survival was 8.3 mo (95% CI: 1.7-16.9). Overall, weekly CPT-11 was well tolerated with grade 3/4 neutropenia as the main hematological toxicity (11 patients: 32.4%; 14 infusions: 3.3%), and delayed diarrhea (10 patients: 29.4%; 16 infusions: 3.8%) as the main grade 3/4 non-hematological toxicity. In conclusion, weekly CPT-11 at 100 mg/m(2) for four consecutive weeks followed by a 2-wk rest period showed antitumor efficacy and may be safely administered to heavily pretreated patients with advanced colorectal cancer and a poor performance status. Weekly CPT-11 monotherapy may be considered as a therapeutic option for this population of patients.

Disparities in the Use of Chemotherapy and Monoclonal Antibody Therapy for Elderly Advanced Colorectal Cancer Patients in the Community Oncology Setting

“…A poorer PS was an independent predictive factor for a lower likelihood of receiving initial doublet therapy and, coinciding with previous reports, a higher risk for mortality [25][26][27]. Few clinical trials explore treatment options for patients with a PS score of 2 or 3; further investigations regarding eligibility for treatment and the optimal treatment of these patients are needed [28]. Measures such as the Comprehensive Geriatric Assessment (CGA) may be used to evaluate eligibility for treatment in the elderly [29].…”

“…Few clinical trials explore treatment options for patients with a PS score of 2 or 3; further investigations regarding eligibility for treatment and the optimal treatment of these patients are needed [28]. Measures such as the Comprehensive Geriatric Assessment (CGA) may be used to evaluate eligibility for treatment in the elderly [29].…”

Treatment of patients with metastatic colorectal cancer and poor performance status: current evidence and challenges

“…Considering the 26 mCRC patients with ECOG PS ≥ 2 (76.5% of the sample), 20.6% (95% CI, 6.3-34.9%) experienced tumor response, and 38.2% of patients had stable disease. The median OS was 8.3 months (95% CI, 1.7-1.69), and the most frequent grade 3/4 toxicities were neutropenia in 11 patients (32.4%) and diarrhea in 10 patients (29.4%) 18 .…”