Bowel Cancer Patients Live Longer Taking Xeloda - Analysis Confirms That Oral Xeloda Is Superior To IV 5-FU
A pre-planned multivariate analysis of the five-year follow-up data shows that patients receiving chemotherapy after-surgery to treat colon cancer, are more likely to live longer when taking the chemotherapy pill Xeloda (capecitabine), compared to those receiving 5-FU/FA intravenous (IV) chemotherapy.
The study compared Xeloda to the previous gold-standard IV chemotherapy for colon cancer, 5-FU/FA*, also known as the Mayo Clinic regimen. The results showed that 5 years after beginning treatment, the percentage of patients who survived was higher in the group taking Xeloda than the group receiving IV 5-FU/FA (71.4% for Xeloda versus 68.4% in the 5 FU/FA group). Results from the study, known as the X-ACT trial, will be presented on Saturday 28 June at the World Congress on Gastrointestinal Cancer.
“These data leave no doubt that Xeloda is the better treatment option for patients,” said Professor Eduardo Diaz-Rubio, Chief of the Department of Medical Oncology, San Carlos Hospital Clinic, Madrid. “The Mayo Clinic regimen has been the standard, but now that we have long-term evidence supporting Xeloda’s superior efficacy it is time for that standard to change. When you combine these results with results from studies of Xeloda as an effective treatment for stomach and colorectal cancer, it is clear that Xeloda can replace IV 5-FU in all gastrointestinal cancer chemotherapy courses.”
The Mayo Clinic regimen requires that patients visit the hospital on five consecutive days to receive IV 5-FU/FA, whereas the chemotherapy pill Xeloda can be taken at home and offers patients increased flexibility.
“From my perspective, I really wanted to be at work,” said Andy Griffin, a colon cancer patient. “When taking Xeloda, I was able to drive myself to the hospital, have my checks and leave to go to work after only an hour. That was only once a month, which is very little time spent at the hospital and very little down time. To me that was really very good.”
Results previously presented on the X-ACT study show Xeloda’s superiority over IV 5-FU/FA in several other areas:
- Xeloda is more cost-effective than IV 5-FU/FA in the Mayo Clinic regimen.
- Xeloda causes less of the side-effects usually associated with chemotherapy.
- Patients taking oral Xeloda spend 85% less time visiting their doctor or hospital for treatment.
Based on the initial results of the X-ACT study, Xeloda was approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA) for adjuvant (post-surgery) treatment of colon cancer in 2005. As part of the study design, an additional analysis was planned to provide a more precise estimate of the effect of Xeloda on patient survival, known as a Cox analysis. This analysis showed that Xeloda was superior to IV 5-FU/FA. The Xeloda European label (SPC) for colon cancer was updated in April 2008 to reflect that Xeloda’s superiority against bolus 5-FU/FA has been demonstrated.
In January 2008, the EU approved Xeloda in combination with any chemotherapy in all lines of treatment with or without Avastin for advanced colorectal cancer.
This year will see 281,700 suffer with adjuvant colon cancer in the majority of the developed world (UK, Spain, Italy, France, Germany, Japan, Canada and the USA).(1)
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