A combination of Xeloda and Eloxatin (XELOX) was better than standard 5-FU and leucovorin chemotherapy in reducing recurrences of stage III colon cancer after surgery. Significantly more patients receiving XELOX were alive without cancer three years after treatment began.
Roche announced results of a Phase III clinical trial that compared XELOX chemotherapy to bolus 5-FU and leucovorin. The trial, nicknamed XELOXA (NO16968), enrolled almost 1,900 patients in 29 countries.
Its primary goal was to see if combining the oral drug Xeloda® (capecitabine) with Eloxatin® (oxaliplatin) could improve disease-free survival for stage III colon cancer patients.
In a press release, Roche said that full results of the trial will be presented at upcoming scientific meetings.
Patients were randomly assigned to one of two trial arms for a total of 24 weeks after their surgery:
- XELOX: 8 treatment cycles consisting of IV oxaliplatin on day 1, oral capecitabine on days 1-14, 7 days of rest.
- 5-FU/LV: Bolus IV injections of 5-FU modified by IV leucovorin in either the Mayo Clinic plan or Roswell Park plan depending on center.
Further analyses of the XELOXA trial are planned to determine:
- Whether XELOX improves overall survival.
- Whether patients find the XELOX treatment more convenient and are more satisfied with it.
- How much medical care is used with both treatments.
An analysis of XELOX safety and side effects was published in 2007 in the Journal of Clinical Oncology. That study found that overall treatment side effects were similar in both the XELOX and 5-FU/LV groups, but the type of side effects differed.
- Overall, patients on XELOX experienced less diarrhea and hair loss, but they had more neuropathy, vomiting, and hand-foot syndrome than those who got FU/LV.
- Compared to the Mayo Clinic 5-FU treatment, patients on XELOX had more serious (grade 3-4) GI side effects and fewer changes in blood counts.
- Compared to the Roswell Park regimen, XELOX patients had fewer serious GI problems and more changes in blood counts.
- Treatment-related deaths (6 per 1000) were the same in both groups.
William M. Burns, CEO of Roche’s Pharmaceuticals Division, said,
While Xeloda is already approved for the treatment of early-stage colon cancer as monotherapy, the results of this study mean that physicians will now be able to offer their patients Xeloda as a combination chemotherapy. This is an important development for patients as colon cancer, if caught early enough, can be cured, so physicians need a wide range of treatment options.
Roche is planning to ask health authorities to extend the current Xeloda labeling to include use with oxaliplatin for stage III colon cancer.