PURPOSE
To evaluate the efficacy and safety of paclitaxel for metastatic breast cancer patients who had received previous chemotherapy, we have performed phase II multicenter trial between December 1997 and December 1998.
MATERIALS AND METHOD
Thirty patients were accrued to this study and paclitaxel was administered at 175 mg/m2 as a 3-hour intravenous infusion every 3 weeks until the progression of the disease.
RESULTS
Objective response were observed in 13 of 30 patients (43.3%). There were 1 complete response (3.3%) and 12 partial responses (40%). Especially, 50% (11/22) of patients who had received prior anthracycline-containing regimens for adjuvant or metastatic disease responded to paclitaxel. Responses were observed in all sites of metastatic disease. One hundred forty-nine cycles of treatment were administered, with a median of six cycles per patient. Grade III and IV toxicities included neutropenia (24%), elevated liver enzyme (10%), peripheral neuropathy (10%), arthralgia/myalgia (23%), and alopecia (87%). No significant hypersensitivity type reaction or cardiac arrhythmia were seen. Median duration of response was 7.2 months.
CONCLUSIONS
These results suggested that paclitaxel is active therapeutic agent in metastatic breast cancer patients and it can be safely administered by 3-hour intravenous infusion with premedication.