Capecitabine Monotherapy in Taxane-Refractory Metastatic Breast Cancer (MBC) Patients

ABSTRACT

PURPOSE: The therapeutic options for MBC patients who have been previously treated with taxane and anthracycline are limited. Capecitabine (Xeloda(R)) is a novel tumor- selective oral fluoropyrimidine, and it provides effective and well tolerated therapy for patients with MBC who are resistant to or are failing with anthracycline and taxane therapy. We present our experiences with oral capecitabine that was given as monotherapy for taxane and anthracycline pre-treated MBC patients from CNU hospital. METHODS: The study subjects were 32 female patients having MBC that progressed after anthracycline and taxane treatment, and they were then treated with oral capecitabine monotherapy from 1999 to 2002. The median disease free survival period was 26 months. All the patients had good ECOG perfomance status (>2) and normal renal function. The primary end points were the response rate, time to progression (TTP) and overall survival. The response rate was assessed with standard UICC criteria, and toxicity was assessed with NCI toxicity criteria. RESULTS: The sites of first metastasis were bone in 17 cases (53.1%); cervical LN 5 (15.6%); liver 3 (9.4%); lung 3 (9.4%); chest wall 2 (6.3%); brain 1 (3.1%); and contralateral axillary LN 1 (3.1%). The clinical response rates to therapy were 1 case of CR (3.1%); 13 cases of PR (40.6%); 11 cases of stable disease (34.4%); 6 cases of progressive disease (18.8%). The median TTP was 6.0 months (95% CI 5.53~8.47). The median overall survival was 15.0 months (95% CI 11.90~16.10). Toxicities related to therapy were 5 cases of hand-foot skin reaction (15.6%); 3 cases of diarrhea (9.4%); and 1 case of stomatitis (3.1%). There was no bone marrow depression or alopecia. All treatment related toxicities were improved by a short period of drug interruption or dose reduction (2, 500 mg/m2/day to 2, 000 mg/m2/day). CONCLUSION: Taxane resistant MBC has a poor prognosis. Oral capecitabine monotherapy provided activity in this subgroup of patients with an overall response rate of 43.7% and a stable disease rate of 34.4%. Oral capecitabine is well tolerated with an acceptable toxicity profile in this population.