A phase II study of single agent paclitaxel in patients at first relapse following initial chemotherapy for breast...

This study was initiated to evaluate the safety and efficacy of 3-weekly paclitaxel given at 225 mg/m2 over 3 hours without colony stimulating factor support in patients at their first relapse following adjuvant therapy for breast cancer. Thirty patients were entered into the study; all were assessable for response and toxicity. All patients had received adjuvant/neo-adjuvant chemotherapy; 22 patients had had prior hormonal therapy and 26 previous adjuvant radiotherapy. The group was characterized by a short time to first relapse (median 7.5 months (range 2-43)) and widespread disease, with 22 patients having multiple disease sites including: nodes (43%), skin and soft tissue (43%), liver (40%), lung (37%) and bone (50%). A total of 219 cycles of paclitaxel were given, with a median of eight per patient. The major non-haematological toxicities were: grade 3 alopecia (82% cycles), grade 2/3 arthralgia/myalgia (26%), grade 2/3 fatigue (16%) and grade 2/3 peripheral nervous system toxicity (12%). Haematological toxicity was mainly neutropenia of short duration, with grade 4 counts documented in 16% of cycles. Thrombocytopenia was minimal and there were no significant hypersensitivity reactions. The objective response rate was 60% (95% CI 42.5-77.5) with one complete response and 17 partial responses. The median duration of overall response was 30 weeks (range 15-75+ (95% CI 25-33)) with a median survival time for all patients of 42 weeks (range 1-124+). This study demonstrates that paclitaxel 225 mg/m2 is well tolerated as a 3-hour infusion and can be given safely in an outpatient setting without routine use of granulocyte colony stimulating factor. The response rate is encouraging and shows that this regimen is effective in this poor prognosis patient population.