Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3577
© 2005 American Society of Clinical Oncology

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Abstract

Dose reduced first-line capecitabine monotherapy in older and less fit patients with advanced colorectal cancer (ACRC)

Ottawa Hosp Regional Cancer Ctr, Ottawa, ON, Canada; London Health Sciences Ctr, London, ON, Canada; British Columbia Cancer Agency, Kelowna, BC, Canada; Windsor Regional Cancer Ctr, Windsor, ON, Canada; Kingston Regional Cancer Ctr, Kingston, ON, Canada; Grand River Regional Cancer Ctr, Kitchener, ON, Canada; British Columbia Community Oncology Trialists, Burnaby, BC, Canada

3577

Background: Combination chemotherapy results in improved outcomes in trials of selected fit patients with ACRC. For older, less fit, more complicated patients, combination chemotherapy is associated with greater toxicity and less benefit. Sequential monotherapy is a reasonable option for these patients. Methods: A multicentre phase I/II trial of capecitabine (Xeloda) 2000mg/m² d1–14 q21d was conducted in 214 patients in one or more of the following subsets: age65 years (167 pts), ECOG performance status 1 (139 pts), elevated LDH (105 pts), prior pelvic radiation (54 pts), liver enzyme abnormalities (5 pts). Results: Median age was 72 years (range 38 to 90). At a median follow-up of 7.2 months, 131 patients are alive. A median 4 and mean 6.5 cycles were given (range 1 to 33). Prior pelvic radiation required dose reduction to 1500mg/m² for diarrhea in the 3^rd cycle. Of 192 patients evaluable for toxicity, there were no grade 3/4 hematologic toxicities. Grade 3/4 toxicity occurred in 22% of patients during the first 3 cycles (8.9% hand-foot syndrome, 6.3% diarrhea, 2.6% lethargy, 2.6% dehydration, 1% abdominal pain, 0.5% stomatitis). Dose reductions were required in 14% and dose delays in 21% for medical reasons. Of 151 evaluable, response is 13%, with 77% disease control (CR+PR+SD). Median PFS was 5.1 months. Of 128 pts progressing, 77 (60%) received further chemotherapy. Median overall survival for all patients is 16.3 months. Median survival for ECOG PS 0, 1, and 2 are 18.4, 15.2 and 8.3 months (p=0.013 for 3 way comparison). Good prognostic factors included ECOG PS=0, LDHULN, homocysteineULN and history of prior pelvic RT. Conclusions: Lower dose capecitabine is tolerable and active in less fit patients. In a capecitabine registration trial with fit pts at 2500mg/m², median survival was 12.8 months (Twelves, 2002). Although RR here was lower, survival was 16.3 months in this less fit population as part of a sequential monotherapy strategy. This study provides valuable information on outcomes in these under-studied patients for whom combination chemotherapy may not be preferred. Outcomes by subgroup will be reported at the meeting. Supported by research grant from Hoffmann-La Roche Ltd.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Hoffmann-La Roche Ltd. Hoffmann-La Roche Ltd.

Abstract presentation from the 2005 ASCO Annual Meeting