Journal
EUROPEAN JOURNAL OF CANCER
Volume 42, Issue 18, Pages 3161-3168Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2006.08.034
Keywords
XELCX; Pvi-FU; advanced colorectal cancer; first-line treatment; capecitabine oxaliplatin
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This phase II randomised trial compares oxaliplatin plus protracted infusion of 5-fluorouracil (pviFOX) or oxaliplatin plus capecitabine (XELOX) in the first-line treatment of advanced colorectal cancer (ACRC). Methods: From December 2001 to March 2005, 118 patients were randomised to arm A ( pviFOX: pvi5-FU by a central venous catheter 250 mg/m2/daily d1-21 + oxaliplatin 130 mg/m2 d1 q3w) (56 pts) or arm B (XELOX: capecitabine 1000 mg/m2 po bid d1-14 + oxaliplatin at the same schedule) (62 pts). Results: Patient characteristics were well-balanced between the two arms. Median number of complete cycles was six. The objective responses were: CR 1 (1.7%) and 3 (4.8%), PR 26 (46.4%) and 24 (38.7%), SD 13 (23.2%) and 20 (32.3%), P 13(23.2%) and 10 (16.1%), not evaluable 3 (5.4%) and 5 (8.1%) in arms A and B, respectively; the CR + PR rate was 48.2% (95% confidence limits 34.6%61.9%) versus 43.5% (31.0%-56.7%). Median TTP was 7 versus 9 months, respectively. About 50% of the patients with symptoms or low performance status at baseline experienced improvement without major differences between the two arms. G3-4 diarrhoea was observed in 14.0% versus 8.2%, G3 stomatitis in 3.7% versus 0, and G3 neurotoxicity in 18.5% versus 24.6% in arms A and B, respectively. Eight patients in arm A (14.8%) had venous line problems that obliged the temporary suspension (six cases) or stopping (two cases) of the 5-FU infusion. Conclusion: Both pviFOX and XELOX are effective and safe first-line treatments for patients with ACRC. By avoiding intravenous (i.v.) administration by a central catheter, XELOX is favoured in clinical practice. (c) 2006 Elsevier Ltd. All rights reserved.
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