3620 Background: XELOX is a highly active combination in 1st line MCRC, comparable to FOLFOX with less neutropenia and a convenient 3-weekly cycle length. As a well-tolerated, more home-based therapy, XELOX merits investigation in a more elderly pt population. Methods: Objectives of this phase II study were response rate (RR), safety profile, time to progression, overall survival and clinical benefit after XELOX chemotherapy as 1st line treatment in pts aged ≥ 70 years with histologically proven MCRC. Selection criteria included no prior chemotherapy (except adjuvant therapy), measurable disease according to RECIST, ECOG PS ≤ 2 and adequate bone marrow, renal and hepatic functions. Patients received oxaliplatin 130mg/m2 i.v. D1 followed by oral capecitabine 1000 mg/m2 twice daily for 14 days (750 mg/m2 if Cr Cl=30–50 ml/min) every 3 weeks. Toxicity was evaluated using WHO toxicity criteria. Results: 50 pts were evaluated for safety: M/F, 36/14, median age 75 years (70–82), ECOG PS 0/1: 54%/46%. 90.3% pts had no comorbidity, 90.2% had mild dependence on help (Barthel Index) and most (M/F 70.0%/63.6%) were autonomous (Lawton Index). Median number of metastatic sites was 1 (1 site 78.7%), in liver (68.1%), lung (34%) and nodes (12.8%). A total of 227 cycles have been administered: median 4.5 (1–8). Median relative dose intensity 92% for oxaliplatin and 98%/86% (Cr Cl ≤50/Cr Cl >50 ml/min, respectively) for capecitabine. Intent-to-treat efficacy analysis: 5 pts achieved CR, 13 PR, 12 SD, 14 PD and 6 NE (3 toxicity, 1 exitus, 1 lost of follow-up, 1 consent withdrawal) RR: 36% (95% CI: 22.7–49.3). With a median follow-up of 7.5 months, median TTP was 6.9 (95% CI: 4.8–9) months. There was 1 treatment-related death: diarrhea and asthenia. Conclusions: XELOX seems to be effective and well tolerated in 1st line treatment of elderly pts with MCRC. No significant financial relationships to disclose.