The impact of the irinotecan (IRI) schedule on quality of life in combination with capecitabine (CAP) in first-line treatment of metastatic colorectal cancer (MCC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research

Abstract

8120 Background: Combining infusional fluorouracil with oxaliplatin (OXA) or IRI is the new standard for first-line treatment of MCC in patients with good performance status. Oral CAP might be more convenient than infusional fluorouracil. Single agent IRI can be administered in a weekly or a 3-weekly schedule. Methods: We performed a randomized phase II trial investigating weekly IRI at a dose of 70 mg/m2 d1, 8, 15, 22, 29 (arm A) and 3-weekly IRI at a dose of 300/240 mg/m2 d1 and d22 (arm B) in combination with CAP 1000 mg/m2 twice daily d1–14 and d22–35 q42. Based on newly available phase I trial results (Cassata et al, Proc ASCO 2001; 20: 144a, Abstr 573), the IRI dose was reduced from 300 to 240 mg/m2 after one third of the treatment cycles has been administered. Quality of life (QL) was assessed with various self-report indicators and evaluated over the first 6 months of treatment in 75 patients with good performance status (0–1). Results: The two treatment arms were well balanced for relevant patient and disease characteristics. Patients in arm A and B indicated comparable physical well-being, mood, functional performance, effort to cope and overall treatment burden. Patients with 3-weekly schedule reported more severe diarrhea (p<0.05) and hair loss (p<0.01). Response rates after review were 18% for treatment A and 35% for B. Patients with an objective tumor response reported better physical well-being (p<0.001), mood (p<0.05), functional performance (p<0.05) and less effort to cope (p<0.01) and treatment burden (p<0.05) compared to the non-responders and stable disease patients. Conclusions: Considering quality of life, the 3-weekly CAPIRI schedule had an overall impact on QL comparable to the weekly schedule. The potentially detrimental impact of more severe diarrhea and hair loss of the 3-weekly CAPIRI was outweighed by the beneficial impact of better anti-tumor activity. This schedule will be used for further comparative trials. No significant financial relationships to disclose.