Toxicity profile and objective response of paclitaxel in metastatic breast cancer.

OBJECTIVE: To evaluate the efficacy and toxicity of 1-hour weekly Paclitaxel in metastatic breast cancer along with evaluation of overall survival. DESIGN: A phase II interventional trial. PLACE AND DURATION OF STUDY: Oncology Department, Combined Military Hospital, Rawalpindi, between August 2001 to July 2003. PATIENTS AND METHODS: Thirty-six patients were enrolled in the study. All patients with histologically confirmed and bi-dimensionally measurable metastatic breast cancer who had received previously either chemotherapy or hormone therapy were included in the study. Paclitaxel was administered in 1-hour weekly infusion in a dose of 100 mg/m2 for 12 doses. RESULTS: All patients had received previous chemotherapy with either CAF or CMF. Twenty-five patients had also received hormone therapy, 61% had two or more metastatic sites involved, and lung was the common site of involvement. Complete response was observed in 4 (11.1%) patients, partial response in 14 (38.8%) patients, with an overall response rate of 50.0%. Clinical benefit was 94.4% and median overall survival was 11 months. Treatment was well-tolerated with no grade 3 or 4 toxicity. Common side effects were arthralgias, myalgias and neutropenia. CONCLUSION: Treatment with 1-hour weekly infusion of Paclitaxel is a well-tolerated chemotherapy with a substantial degree of efficacy in patients with metastatic breast cancer.