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Capecitabine Effective with Either Irinotecan or Oxaliplatin for Advanced Colorectal Cancer: Presented at ECCO

By Cameron Johnston

COPENHAGEN, DENMARK -- October 2, 2003 -- Oral capecitabine is equally effective when combined with either irinotecan or oxaliplatin when used as a first-line treatment for advanced colorectal cancer. This may make a capecitabine-based combination approach a better option than 5-fluorouracil (5-FU)-based combination, which is more difficult to administer.

According to Axel Grothey, MD, professor of medicine and oncology at Martin Luther University, Halle, Germany, who led the study, oral capecitabine has been shown in other trials to be superior to 5-FU for treating colorectal tumours. With newer agents, however, such as oxaliplatin and irinotecan already being used to treat colorectal cancer, the question arose as to whether capecitabine would be as effective as 5-FU when combined with these agents.

Overall, 161 patients with colorectal cancer but a good performance status were enrolled in the trial. Approximately 60% had metastatic disease, and patients' average age was 62 years. Dr. Grothey presented the results of the trial here at ECCO 12: The European Cancer Conference, held September 21-25.

Patients were treated with capecitabine 1,000 mg twice daily for the first 14 days of a 21-day cycle. One group of 79 patients also received irinotecan 100-80 mg/m² on days 1 and 8, while the other group of 82 received oxaliplatin 70 mg/m² also on days 1 and 8 of the same 21-day cycle. Safety data were obtained from 160 patients, while 142 were evaluated for efficacy.

Overall survival was a median of 17 months in each group. Median progression-free survival was also similar between the groups: 7.1 months for those receiving irinotecan and 7.2 months for those receiving oxaliplatin.

The response rates in both arms were similar, too: 41% in the irinotecan group and 51% in the oxaliplatin group. A complete response was seen in 3 patients in the irinotecan group and 7 in the oxaliplatin group, while progressive disease was seen in 19 patients receiving irinotecan and 10 receiving oxaliplatin. These differences were not statistically significant.

Four of the first 40 patients in the irinotecan group died within the first 60 days of the study of septic diarrhoea, neutropaenia, pulmonary embolism, or an unknown cause, and the dose of the drug was reduced after that. However, patients receiving the lower dose of irinotecan did not show any difference in outcomes compared with those who received the higher dose.

Dr. Grothey said this study shows both drugs to be equally effective, and said they offer "substantial" efficacy in treating advanced colorectal cancer. Capecitabine is much easier to administer than 5-FU and is convenient for both physicians and patients and on that basis, be said, it should be used more widely in the treatment of advanced colorectal cancer.


[Study title: Capecitabine Effective with Irinotecan, or Oxaliplatin in Treating Colorectal Cancer. Abstract 295]

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