Capecitabine (XEL) plus oxaliplatin (OX) tailored regimen for the first-line treatment of elderly patients (pts) with metastatic colorectal cancer (MCC). Final results of the Southern Italy Cooperative Oncology Group (SICOG) trial 0108

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3582 Background: In pts with MCC, XEL has shown greater response rate (RR), equivalent progression-free (PFS) and overall survival (OS), and better tolerability profile compared with 5-fluorouracil/leucovorin (5FU/LV). The addition of OX to 5FU/LV (FOLFOX4) has been shown to improve RR and PFS versus 5FU/LV, and RR, PFS and OS compared with irinotecan plus 5FU/LV. XEL may be an effective, well tolerated and more convenient alternative to 5-FU/LV in combination with these agents, namely in older pts. Methods: Elderly (≥ 70 years) pts with MCC were treated every 3 weeks with XEL 1,000 mg/m2 orally twice daily on days 1 to14, and OX 85 mg/m2 i.v. on day 1 (XELOX regimen). In the absence of grade (G) ≥ 2 hematologic toxicity, OX was increased to 100 mg/m2 in the 2nd cycle, and in the absence of G ≥ 2 non-hematologic toxicity during cycle 2, XEL was increased to 1,250 mg/m2 twice daily in 3rd and subsequent cycles. After treating 35 pts (1st series), protocol was amended so that only OX was planned to be raised to 100 mg/m2 and 130 mg/m2 in 2nd and 3rd cycle, respectively, in the following 45 pts (2nd series) Results: 76 pts, median age 75 (range 70–82) years entered into this study. In the 1st series, OX dose was increased in 2nd cycle in 18 (51%) pts, and XEL dose was increased in 3rd cycle in 4 (11%) pts. In the 2nd series, OX dose was increased to 110 mg/m2 in 2nd cycle in 26 (63%) pts, and to 130 mg/m2 in the 3rd cycle in 19 (46%) pts. In all, 2 complete and 29 partial responses were observed, for an overall RR of 41% (95% CI, 30–53%). After a median follow-up of 21 months (range, 6–36), median PFS was 8.5 months (95% CI, 6.7–10.3 months), and the median OS was 14.4 (95% CI, 11.9–16.9) months. On the whole series, 4 (5%) pts showed G ≥ 3 hematologic toxicity during their treatment, peripheral neuropathy reached G 3 in 6 (8%) pts, and G 3 hand-foot syndrome was seen in 10 (13%) pts. Conclusions: Fit elderly pts with MCC show a good RR to standard-dose XELOX with only mild toxicity observed in most pts. XELOX should therefore be considered as an important therapeutic option for elderly pts with MCC. No significant financial relationships to disclose.