NAPLES, ITALY-As firstline therapy in elderly patients with metastatic colorectal cancer, XELOX (capecitabine [Xeloda] and oxaliplatin(Drug information on oxaliplatin) (Eloxatin]) achieved an objective tumor response rate of 41% (abstract 3582). Final results of a phase II multicenter trial conducted by the Southern Italy Cooperative Oncology Group, National Tumour Institute in Naples, also showed progression-free survival of 8.5 months (95% confidence interval [CI]: 6.7-10.3) and overall survival of 14.4 months (95% CI: 11.9-16.9). "Ongoing phase III trials evaluating XELOX vs FOLFOX (fluorouracil [5-FU], leucovorin, oxaliplatin) with or without bevacizumab(Drug information on bevacizumab) (Avastin) are expected to confirm that capecitabine(Drug information on capecitabine) should replace 5-FU/leucovorin as the backbone of metastatic colorectal cancer therapy," the investigators concluded. Protocol Amended Safety and efficacy were assessed in 76 patients ≥ 70 years, with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and life expectancy ≤ 3 months. Two XELOX regimens were assessed. The 35 patients in series 1 received 1,000 mg/m2 of oral capecitabine twice daily on days 1 to 14 and 85 mg/m2 of oxaliplatin on day 1. In the absence of grade 2 or higher hematologic toxicity, the dose of oxaliplatin was increased to 100 mg/ m2 in cycle 2, and in the absence of grade 2 or higher nonhematologic toxicity in cycle 2, the dose of capecitabine was increased to 1,250 mg/m2 twice daily in the third and subsequent cycles. Once 35 patients were treated in that series, the protocol was amended for the next 45 patients: The dose of oxaliplatin was increased, first to 110 mg/m2 and then to 130 mg/m2. After 451 cycles of treatment, with a median of 6 cycles per patient, the overall response rate was 41% (95% CI, 30%-53%). No differences in activity were observed between the first and second series (Table 1). The disease control rate, which includes partial and complete responses plus stable disease, was 74%. Good Safety Profile The investigators reported that XELOX had a predictable and manageable safety profile in the elderly, with predominantly mild to moderate adverse events. The second series of XELOX administration, which had higher levels of oxaliplatin but kept capecitabine at 1,000 mg/m2, produced more hematologic adverse events. They included grade 3/4 neutropenia, thrombocytopenia, and anemia, which did not occur in the first series. There were no treatment-related deaths. "XELOX also offers benefit to the patient in terms of convenience, reduced discomfort, and avoidance of central venous access vs infusional 5-FU/leucovorin regimens," the investigators concluded. "These benefits are particularly important in elderly patients, who may have more difficulty in traveling to/from the oncology clinic."