Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3683
© 2004 American Society of Clinical Oncology

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Abstract

A phase II trial of capecitabine (X) and irinotecan (I), in a biweekly schedule, for patients (Pts) with advanced/metastatic colorectal cancer (MCRC)

Hospital Gregorio Marañon, Madrid, Spain; Hospital de Mostoles, Mostoles, Spain; H. Universitario Virgen de las Nieves, Granada, Spain; Hospital General, Segovia, Spain

3683

Background: X and I are active in MCRC. The combination of these 2 agents has been shown to be synergistic. We conducted a phase II study of XI combination in a biweekly schedule in previously untreated pts with MCRC to evaluate the objective response rate (ORR), safety profile, time to progression (TTP) and overall survival (OS). Methods: Patients with histologically proven MCRC, measurable disease according to RECIST, ECOG PS 2 and adequate bone marrow, renal and hepatic functions were included. No prior chemotherapy (except adjuvant therapy) was allowed. Pts received I 175 mg/m2 iv D1 followed by oral X 1000 mg/m2 twice daily from D2–8. For patients >65 years, I and X were reduced to 140 mg/m2 and 750 mg/m2 twice daily, respectively. Cycles were repeated every 14 days. Toxicity was evaluated every cycle using NCI toxicity criteria. Results: 32 pts were enrolled to date: M/F, 22/10, median age was 68 years (49–80), 18 (56%) of pts were > 65 years, ECOG PS 0–1: 91%. Primary tumor sites were colon 47% (n=15), rectum 50% (n=16) or both 3% (n=1). Median number of metastatic lesions was 2 (19% with 2 sites) in liver (66%), lung (34%), lymph nodes (13%) and local recurrence (9%). To date, 280 cycles (median 10.5, range 2–12; 65/>65 142/138) were administered. Median relative dose intensity was 86% for X and 99% for I (89 and 99%, respectively, for pts >65years). All patients were evaluated for toxicity (see table) and 20 pts for response to date: 2 achieved CR, 8 PR, 3 SD and 7 PD resulting in an ORR of 50% (CI 95%: 27–73) and tumor growth control (RR + SD) in 65% of patients (CI 95%: 41–85). Median TTP and OS were not achieved yet. Conclusions: Capecitabine and Irinotecan, in a biweekly schedule, as 1st line treatment of MCRC is an active combination with a manageable toxicity profile, even in patients >65 years.

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