10556 Purpose: To determine the antitumor activity of vinorelbine (VNR) and capecitabine (Xeloda) when given together, as first-line treatment, in elderly metastatic breast cancer (MBC) patients. PATIENTS AND METHODS MBC patients, aged >65 years, with no prior chemotherapy for metastatic disease, received capecitabine 1,000-1,250 mg/m2 d 1→14 and VNR 20-25 mg/m2 d 1-8, q3wk for a maximum of 6 cycles. Doses of VNR and Xeloda were alternately escalated in each patient (VNR 20→25 on 2nd cycle, Xeloda 1,000→1,250 on 3rd cycle), in absence or relevant hematologic/nonhematologic toxicity. RESULTS Forty-seven MBC pts., median age 72 (range: 66-82) were enrolled. Metastatic sites: visceral/other = 30/17. Adjuvant chemotherapy: Yes/no = 21/27. The doses were escalated as planned in 24/47 pts. To date, 41/47 pts. are evaluable for response. Three CRs and 25 PRs have been recorded, giving a 68% ORR (Visceral/other = 59%/85%). At a median follow-up of 15.3 months, 19 pts. have progressed, and 18 died, median PFS and OS being 14.1, and 20.3 months, respectively. Toxicity has been in general mild or moderate. Grade 3-4 neutropenia has occurred in 29% of pts., with only 2 episodes of neutropenic sepsis. Severe gastrointestinal side effects have been observed in only 2 pts., while severe mucositis and hand-foot syndrome have never occurred. CONCLUSIONS VNR-Xeloda combination is highly active in elderly MBC patients. The adoption of an intrapatient dose escalation permits to minimize the risk of severe toxicity, without compromising efficacy. The accrual still continues until the planned sample size (60 pts.). No significant financial relationships to disclose.