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Capecitabine/Oxaliplatin Combination is Tolerable First-Line Treatment for Advanced Colorectal Cancer

Combinatorial capecitabine and oxaliplatin is a promising first-line treatment for advanced colorectal cancer that has similar efficacy and tolerability as does the standard fluorouracil/leucovorin treatment, with the added benefits of convenience and practicality, according to a recent Italian study.

5-fluorouracil is one of the most effective drugs used in the treatment of advanced colorectal cancer and is most commonly administered as a continuous infusion or an intravenous bolus injection. However, these methods of administration are costly and negatively impact the patient's quality of life.

Capecitabine is an oral tumour-selective drug that is converted to fluorouracil preferentially in tumour tissue and, in previous trials, has shown similar efficacy to intravenous bolus fluorouracil/leucovorin. In addition, oxaliplatin is a cisplatin analogue that has shown high anti-cancer activity in advanced colorectal cancer patients in combination with 5-fluorouracil. The use of this combinatorial therapy as an alternative to 5-fluorouracil is currently under investigation.

Dr M Zeuli and colleagues at the Regina Elena Cancer Institute, Roma, Italy, evaluated the tolerability and efficacy of combinatorial capecitabine and oxaliplatin in the treatment of advanced colorectal cancer in chemotherapy-naive patients.

The phase II study included 43 patients (32 men and 11 women, average age 63) with advanced colorectal cancer who had never been treated with chemotherapy. All participants were given 1 to 11 cycles of capecitabine (2500 mg/m²) daily for 2 weeks followed by 1 week of rest and oxaliplatin (120 mg/m² 2-hr infusion) once every 3 weeks. Patients were followed for an average of 6 months.

The primary toxicity was grade 3 or 4 diarrhoea, which was observed in 28% of patients and caused 3 patients to discontinue treatment and 4 patients to be hospitalised. Grade 3 or 4 nausea and vomiting occurred in 5% of patients and severe sensory neuropathy in 7%. It was noted that overall toxicity was highest in the first 3 cycles and steadily declined with dose adaptation in later cycles, though neurotoxicity was most prevalent after 3 treatment cycles.

In this study, haematological toxicity was moderate, with 12 patients having mild anaemia. However, grade 3 neutropenia resulted in 2 patients and life-threatening febrile neutropenia in 1 patient.

Overall, response rates were 44% in the intention-to-treat group and 48.7% in the per protocol analysis. Furthermore, the average overall survival was 20 months.

Dr Zeuli concludes that "combining capecitabine and oxaliplatin yields promising activity in advanced colorectal cancer." Dr. Zeuli further notes that "this combination may be preferable compared to a standard combination with infusional fluorouracil/leucovorin as it is more convenient and practical with similar efficacy."


Ann Oncol 2003 Sep;14:9:1378-82. "Phase II study of capecitabine and oxaliplatin as first-line treatment in advanced colorectal cancer"

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