SEOUL, KoreaUse of capecitabine(Drug information on 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 462+).
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 neutropenia.
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.