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| |  ECCO11: Oral Xeloda (Capecitabine) Plus Intravenous Oxaliplatin Shows Good Efficacy and Tolerability in Advanced Colorectal Cancer By Ana Hidalgo-Simón LISBON, PORTUGAL -- October 25, 2001 -- The combination of oral Xeloda (capecitabine) and intravenous oxaliplatin provides effective treatment at a greatest convenience for the patient in advanced colorectal cancer. Capecitabine, a drug originally developed as a single agent, is a new anticancer therapy for oral administration. It is a fluoropyrimidine, which is converted into 5-fluorouracil (5-FU) once inside the tumour. The drug takes advantage of the higher thymidine phosphorylase activity in malignant tissue. Its activity and safety had already been tested in two large phase III trials, where it proved to be superior to 5-FU/leucovorin. Oxaliplatin is a recognized first-line therapy in combination with 5-FU/leucovorin, superior to 5-FU/leucovorin alone in phase III trials for advanced or metastatic colorectal cancer. Capecitabine and oxaliplatin have different mechanisms of action and no overlapping major toxicities. A large, multicentre, phase II trial was performed in Europe and Canada to explore the combination of capecitabine and oxaliplatin as first-line treatment for advanced colorectal cancer. The results were presented yesterday, at ECCO 11, the European Cancer Conference, in Lisbon, Portugal, by Dr. Chris Twelves, from the Beatson Oncology Centre, in Glasgow, Scotland. Investigators have recruited 96 patients so far. In this report they presented data from 37 patients for safety and 34 for efficacy. A total of 76 percent of patients had liver metastasis. Treatment consisted of oral capecitabine 1000 mg/mē twice daily on days 1-14, every three weeks, and intravenous oxaliplatin 130 mg/mē on day 1 every three weeks, as first line therapy. Median number of cycles per treatment was eight (1-10). The objective response rate was 50 percent, and that included two complete and 15 partial responses. Stabilisation of disease was observed in a further 10 patients. This high response rate was maintained across a wide population of patients. Overall, more than one third of patients have not progressed since beginning of treatment. Survival data was not ready to be presented but Dr. Twelves described it as "encouraging". The therapy was generally well tolerated. Most frequently reported grade 3/4 adverse reactions were: vomiting (14 percent), nausea (11 percent), diarrhoea (8 percent), neutropenia (8 percent) and thrombocytopenia (5 percent). Six patients withdrew from the study due to adverse events. Elevated bilirrubin, a known phenomenon with oral fluoropyrimidines was observed in 19 percent of patients, but was not associated with grade 3/4 elevated liver enzymes. "The toxicity we found is similar to that obtained with infusion of 5-FU/leucovorin and the efficacy of treatment is good. But effective therapy is achieved with far more convenience, because patients receive the oral treatment at home. This therapy may replace current treatments across a range of cancers, perhaps also in combination with radiotherapy," Dr. Twelves concluded. The study was sponsored by Roche.
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