The results of a phase III trial of capecitabine (Xeloda) in combination with 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
The results of a phase III trial of capecitabine (Xeloda) in combination withdocetaxel (Taxotere) for the treatment of metastatic breast cancer werepublished 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 Administrationapproved the use of the capecitabine/docetaxel combination for this indication.
The investigation demonstrated that the combination of docetaxel andcapecitabine 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 thecombination arm achieved a statistically significant superior objective tumorresponse of 42% (30%, P = .006) and a significantly longer time to diseaseprogression compared to patients in the docetaxel monotherapy arm (median: 6.1vs 4.2 months, P = .0001).
"We believe that the survival advantage of the combination of Xelodaplus Taxotere may benefit many patients with metastatic breast cancer,"said Georges Gemayel, vice president, National Specialty Care BusinessOperation, at Roche.
A total of 511 patients with locally advanced or metastatic breast cancer whohad 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 (IVdocetaxel: 100 mg/m2, day 1 of each 21-day cycle). Study end points includedoverall survival, time to disease progression, and tumor response rate.
"The combination of Xeloda and Taxotere is a major advancement intreating women with metastatic breast cancer, due in large part to thesignificant survival advantage observed with the combination," said Joyce O’Shaughnessy,md, codirector of breast cancer research at Baylor-Sammons Cancer Center and USOncology. "This represents a crucial development, as improvements inpatient survival are the bottom line, and the data from this study show earlyand consistent benefits for women treated with Xeloda and Taxotere, includingsurvival, overall response rates, and time to disease progression."
The most common side effects of the combination therapy includedgastrointestinal disturbances and hand-foot syndrome (painful swelling, rash, orulceration of hands and feet) and for docetaxel alone, included pain in thejoints and muscles and low white blood cell counts.