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Oral XELOX Regimen Comparable to FOX in Advanced Colorectal Ca, Preliminary Data Show

Oral XELOX Regimen Comparable to FOX in Advanced Colorectal Ca, Preliminary Data Show

BOLOGNA, ITALY-Preliminary results of a small phase II advanced colorectal cancer trial comparing a protracted fluorouracil (5-FU) infusion plus oxaliplatin (Eloxatin)(FOX) with capecitabine (Xeloda) plus oxaliplatin (XELOX) concluded that the capecitabine combination had similar efficacy and tolerability, Andrea Martoni, MD, of Orsola-Malpighi Hospital in Bologna, Italy reported (abstract 3617). Comparable Activity The median time to disease progression (TTP) was 6+ months with FOX vs 8.5+ months with XELOX. Dr. Martoni said that survival data are not mature, as 56% of patients are still alive. "These results suggest that XELOX has comparable activity to FOX in firstline treatment of advanced colorectal cancer. Toxicity is low and substantially similar in the two arms. Oral capecitabine combinations could be an acceptable alternative to protracted 5-FU infusion regimens," Dr. Martoni said. Dr. Martoni reported data for 111 patients randomized to the two treatment arms, 101 of whom were evaluable for response. The median number of cycles delivered was 6 (1-11) in arm A (FOX) and 6 (1-11) in arm B (XELOX). The objective responses were as follows: Arm A (FOX): complete response (CR) 2%, partial response (PR) 44.1%, stable disease (SD) 24.5%, progressive disease (PD) 14.3%. Arm B (XELOX): CR 5.8%, PR 34.6%, SD 36.6%, PD 17.3%; response rate 44.9% vs 40.3%. The median TTP was 8.5 months with FOX vs 9 months with XELOX. Surgical resection of liver metastases after chemotherapy was performed in 4.7% of patients in arm A vs 8.9% of patients in arm B. Only two patients showed grade 4 toxicity (diarrhea) in arm A (1) and in arm B (1). Toxicity Grade 3 treatment-related toxicities in arm A and B were neutropenia (2.4% vs 0), thrombocytopenia (2.4% vs 2.4%), stomatitis (3.8% vs 0), diarrhea (11.8% vs 7.1%), hypertransaminasemia (0 vs 1.8 %), hyperbilirubinemia (1.9% vs 1.8%), and neurotoxicity (15.4% vs 25.5%). "Our preliminary results suggest that FOX and XELOX, as administered in this trial, show high activity as first-line treatment," Dr. Martoni concluded. "Toxicity is low and substantially similar in the two arms," Dr. Martoni said.

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