The results of a phase III trial of capecitabine(Drug information on capecitabine) (Xeloda) in combination with docetaxel(Drug information on docetaxel) (Taxotere) for the treatment of metastatic breast cancer were published in a recent issue of the Journal of Clinical Oncology (20:2812-2823, 2002). Based on data from this trial, the US Food and Drug Administration approved the use of the capecitabine/docetaxel combination for this indication.
The investigation demonstrated that the combination of docetaxel and capecitabine decreased the risk of death by 23% compared to docetaxel alone (median survival: 14.5 vs 11.5 months, P = .0126). In addition, patients in the combination arm achieved a statistically significant superior objective tumor response of 42% (30%, P = .006) and a significantly longer time to disease progression compared to patients in the docetaxel monotherapy arm (median: 6.1 vs 4.2 months, P = .0001).
"We believe that the survival advantage of the combination of Xeloda plus Taxotere may benefit many patients with metastatic breast cancer," said Georges Gemayel, vice president, National Specialty Care Business Operation, at Roche.
A total of 511 patients with locally advanced or metastatic breast cancer who had failed anthracycline treatment were randomized to either the combination (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 cycle) or monotherapy (IV docetaxel: 100 mg/m2, day 1 of each 21-day cycle). Study end points included overall survival, time to disease progression, and tumor response rate.
"The combination of Xeloda and Taxotere is a major advancement in treating women with metastatic breast cancer, due in large part to the significant survival advantage observed with the combination," said Joyce O’Shaughnessy, md, codirector of breast cancer research at Baylor-Sammons Cancer Center and US Oncology. "This represents a crucial development, as improvements in patient survival are the bottom line, and the data from this study show early and consistent benefits for women treated with Xeloda and Taxotere, including survival, overall response rates, and time to disease progression."
The most common side effects of the combination therapy included gastrointestinal disturbances and hand-foot syndrome (painful swelling, rash, or ulceration of hands and feet) and for docetaxel alone, included pain in the joints and muscles and low white blood cell counts.