The Food and Drug Administration (FDA) will conduct a priority review of the supplemental New Drug Application submitted by Roche for twice-daily oral chemotherapy with the combination of capecitabine(Drug information on capecitabine) (Xeloda) and intravenous docetaxel(Drug information on docetaxel) (Taxotere) in patients with locally advanced and/or metastatic breast cancer previously treated with anthracycline therapy. The FDA notified Roche that the review of the application (submitted on March 7, 2001) will be completed in 6 months.
"The FDA’s urgency on this matter is good news for women who fail anthracycline therapy and need additional therapy options," said Georges Gemayel, vice president, National Specialty Care Business Operations, at Roche.
Phase III Study Results
Data submitted in March for the FDA’s review included the results of a large phase III study that compared the combination of capecitabine and docetaxel in women previously treated with docetaxel alone and looked at survival, time to disease progression, and tumor response rate.
Median survival among women treated with the combination compared to docetaxel alone was 13.7 vs 11.1 months (P = .0119); time to disease progression was 6.1 vs 4.2 months (P = .0001); and tumor response rate was 42% vs 30% (P = .006).
The capecitabine/docetaxel study involved 511 women and was conducted in the United States, Canada, Australia, and countries in Europe, Asia, and Latin America. Women were randomized to either combination therapy (oral capecitabine, 1,250 mg/m2 twice daily, days 1 to 14 with 1 week of rest, plus IV docetaxel, 75 mg/m2, day 1 of each 21-day treatment cycle) or monotherapy (IV docetaxel, 100 mg/m2, day 1 of each 21-day treatment cycle).
The combination of capecitabine and docetaxel was associated with more adverse events than docetaxel alone, including more diarrhea, stomatitis, hand-foot syndrome, and nausea/vomiting. These symptoms were manageable with appropriate medical intervention and by dose interruptions and/or reductions when needed. Patients receiving docetaxel alone experienced a higher incidence of neutropenic fever, myalgia, and arthralgia. The health-related quality of life, as assessed by a standardized questionnaire (the European Organization for Research and Treatment of Cancer Quality of Life C30 questionnaire), and the number of hospitalizations for treatment-related adverse events were similar in both groups.