A PILOT-STUDY TO EVALUATE PACLITAXEL (TAXOL(TM)) AS PRIMARY MEDICAL-TREATMENT FOR PATIENTS WITH INOPERABLE STAGE-III AND STAGE-IV BREAST-CARCINOMA

The activity of paclitaxel has been extensively investigated in previo usly treated patients with metastatic breast carcinoma. We evaluated t he activity of paclitaxel as primary medical therapy in patients with stage III and IV breast carcinoma. 6 female patients were recruited wi th no previous history of surgery, radiotherapy or chemotherapy. Pacli taxel was administered as a 3-h infusion at a dose of 225 mg/m(2) repe ated every 3 weeks weekly to a maximum of 10 cycles. 2 patients achiev ed a complete response, one of whom had a normal trucut biopsy of the affected breast 6 months after discontinuation of chemotherapy and rad iotherapy and a normal mammogram at 17 months. 3 patients achieved a p artial response and one stabilised. The patients received between four and ten cycles of chemotherapy. Paclitaxel at this dose was associate d with toxicity including alopecia, stomatitis, nausea and diarrhoea. Moderately severe neutropenia occurred in 4 patients, 2 requiring anti biotics but was of short duration and did not necessitate a dose reduc tion for subsequent courses. Paclitaxel has shown activity as primary medical therapy in patients with inoperable breast carcinoma at presen tation at this dosage and schedule. One patient achieved a complete re sponse and avoided surgery altogether and all 6 patients had their pri mary tumour downgraded. It may be indicated as a single agent in this context or in combination with other drugs with proven activity in bre ast carcinoma. Copyright (C) 1996 Elsevier Science Ltd