SEOUL, KoreaUse of capecitabine (Xeloda) plus vinorelbine (Navelbine)
is effective in metastatic breast cancer patients previously treated with
anthracycline and taxane drugs, according to preliminary data from a phase
II study. The study involved 24 patients enrolled at the Asan Medical
Center, University of Ulsan College of Medicine, Seoul. Jin-Hee Ahn, Sr.,
MD, clinical instructor, and colleagues reported the results in the ASCO
proceedings (abstract 2030).
All of the patients had metastatic breast cancer and an ECOG performance
status of 2 or less. The median age was 45 years (range, 29 to 75).
Capecitabine at 1,250 mg/m² bid was given orally on days 1 to 14 and
vinorelbine at 25 mg/m² was given IV on days 1 and 8, every 3 weeks until
progression or unacceptable toxicities. The median number of cycles was 4.
At a median follow-up of 126 days, 19 patients with measurable disease
could be evaluated for response. The overall response rate was 52.6%,
including one complete response and nine partial responses. Median response
duration was 119 days. Median time to progression was 168 days (range, 28 to
Although there were no treatment-related deaths, the dosage of
capecitabine had to be reduced in 11.1% of cycles. Vinorelbine could not be
given in 25.4% of cycles on day 8 due to grade 3-4 neutropenia, and the dose
of day 8 vinorelbine was reduced in 24.6% of cycles due to grade 2
neutropenia, as called for in the protocol. Only one patient had febrile
The overall toxicity spectrum was: grade 3-4 neutropenia, 22.2%;
hand-foot syndrome grade 1 (20.6%) and grade 2 (7.1%); grade 2 stomatitis,
8.7%; grade 2 neuropathy, 2.4%.
Woo K. Kim, MD, professor of medicine, University of Ulsan, and a
hematologist/oncologist at Asan Medical Center, advised ONI that updated
results would be presented at the Korean Cancer Association meeting.