MADRID, SPAIN-Capecitabine (Xeloda) plus irinotecan(Drug information on irinotecan) (Camptosar), in a biweekly schedule as firstline treatment of locally advanced or metastatic colorectal cancer, is an active schedule with a manageable toxicity profile, even in patients older than 65 years. This conclusion and supporting results from a phase II trial were reported by Pilar Garcia-Alfonso, MD, of Hospital Gregorio Maranon in Madrid (abstract 3540). Dr. Garcia-Alfonso said that the biweekly schedule of capecitabine(Drug information on capecitabine)/ irinotecan (XELIRI) was less toxic than the standard 3-weekly XELIRI regimen. All 45 patients enrolled in the trial were evaluable for safety. Grade 3/4 toxicities were uncommon (Table 1). The most common grade 3/4 toxicity among patients ≤ 65 years was alopecia, occurring in 5 patients (3%) younger than age 65 but in no patients older than 65. The most common adverse events among these older patients were asthenia (nine patients [4%]) and diarrhea (seven patients [3%]). 50% Response Rate The overall response rate among the 38 patients evaluable for efficacy was 50% (95% confidence interval [CI]: 33%-67%). This total included 3 patients with complete responses and 16 patients with partial responses. The tumor-growth control rate (response rate plus stable disease rate) was 87% (CI 95%: 72%-96%). Dr. Garcia-Alfonso said that a total of 50 patients will be enrolled to evaluate time to progression. The 2-week treatment cycle consisted of 175 mg/m2 of irinotecan administered on day 1 as a 90-minute infusion and 1,000 mg/m2 of oral capecitabine twice daily on days 2 to 8. For patients older than age 65, the irinotecan dose was reduced to 140 mg/m2 and the capecitabine dose, to 750 mg/m2 twice daily. The median relative dose intensity was 94% for capecitabine and nearly 100% for irinotecan. The median age of the patients was 67 years (range, 42-80 years), with 25 patients (56%) older than age 65. Eastern Cooperative Oncology Group (ECOG) performance status was 0 to 1 in 93% of patients. Primary tumor sites were the colon (22 patients [51%]), rectum (21 patients [47%]), or both (1 patient [2%]). The median number of metastatic lesions was two, and the most common sites were the liver (56%) and the lungs (23%). Previous treatment, such as surgery (73%), adjuvant chemotherapy (44%), and radiotherapy (20%), was allowed if completed ≥ 6 months before enrollment.