SAN ANTONIOUpdated results from a major phase III study of docetaxel
(Taxotere) plus capecitabine (Xeloda) in metastatic breast cancer confirmed
the value of this new combination.
Joyce O’Shaughnessy, MD, co-director of breast cancer research at
Baylor-Sammons Cancer Center and US Oncology, Dallas, presented the initial
results at the 2000 San Antonio Breast Cancer symposium. Updated results
were provided at the 2001 meeting by Sasha Vukelja, MD, of the Tyler Cancer
Center, Tyler, Texas (abstract 352).
The study continues to show that docetaxel plus capecitabine yields a
significant survival benefit, compared with docetaxel alone: Median survival
of 14.5 months vs 11.5 months (P < .01), for a 22.5% reduced risk of
death. Patients on the combination also had a significant difference in
tumor response (32% vs 23%, P = .025) and longer median time to progression
(6.1 months vs 4.2 months, P = .001).
The phase III study was a large international trial of 511 patients
previously exposed to anthracyclines. Patients received either the
combination of capecitabine 1,250 mg/m² twice daily on days 1 to 14 plus
docetaxel 75 mg/m² on day 1 or monotherapy with docetaxel 100 mg/m² on day 1 of a 21-day cycle.
Based on these data, Dr. Vukelja said, "we believe an estimated
additional 10% of patients with metastatic disease will be alive at the end
of 12 months when on Xeloda/Taxotere combination chemotherapy, compared with
In addition, other investigators who conducted a poststudy analysis of
the data (abstract 442) suggested that the survival advantage with the
combination may be underestimated due to poststudy crossover in the
single-agent arm. Twenty-eight percent of the 166 patients receiving
poststudy chemotherapy received capecitabine, which was associated with
improved outcomes, compared with other poststudy agents.
The choice of poststudy therapy was not defined in the protocol and was
selected at the discretion of the investigator. After a minimum follow-up of
23 months, 218 patients (85%) in the combination arm and 198 patients (77%)
in the docetaxel arm have received at least one poststudy treatment.