ASCOA multicenter, open-label, phase II study has
confirmed results of the pivotal study of capecitabine (Xeloda) for
treatment of taxane-refractory metastatic breast cancer. In this
study, 25% of patients with measurable disease treated with
capecitabine responded, with a median duration of response of 8.3
months, median time to progression of 3.2 months, and median survival
of 12.3 months.
This study is encouraging in that it supports previous findings
that even patients with tough-to-treat tumors who have failed
first-line chemotherapy may experience a positive response with
Xe-loda, Joanne Blum, MD, PhD, of the Physician Reliance
Network (PRN) Research, Inc., said at an ASCO poster session. The
study was conducted under the auspices of PRN Research and Baylor
University Medical Center-Charles A. Sammons Cancer Center, Dallas.
Five centers in the US and France enrolled 75 patients with
bidimensionally measurable disease (69 patients) or evaluable disease
(5 patients). All patients had failed at least two previous
chemotherapy regimens for advanced/metastatic disease, one of which
included paclitaxel (Taxol) or docetaxel (Taxotere).
Patients received twice-daily oral capecitabine at 2,510
mg/m²/day for 14 days, followed by a 1-week rest period and
repeated in 3-week cycles.
Of the 69 patients with measurable disease, 17 (25%) responded, all
with a partial response; 30% had stable disease. Similar
response rates were seen in both subpopulations of paclitaxel- and
docetaxol-refractory patients, she said.
The objective response rate in paclitaxel failing or resistant tumors
was 27%, thereby confirming the results of the pivotal study that led
to FDA approval of the agent. In that study, 20% of
paclitaxel-refractory patients responded. The 20% response rate in
docetaxel-refractory patients showed that the agent also has activity
in these patients.
Of 40 patients with symptoms at baseline, 8 (20%) had a clinical
benefit. Of 27 patients with baseline pain of more than 20 mm on a
visual analog scale, 7 (26%) had a significant improvement in pain.
Adverse effects associated with capecitabine were predictable
and manageable, Dr. Blum said. Hand-foot syndrome, diarrhea,
stomatitis, and nausea were the only grade 3-4 treatment-related
adverse events that occurred in more than 10% of patients. Only 4.1%
of patients had a grade 4 treatment-related event, he said, and there
were no treatment-related deaths.