Weekly TP Regimen as a Postoperative Adjuvant Chemotherapy for Completely Resected Breast Cancer in China: Final Result of a Phase II Trial

Objectives: To investigate the safety and long-term survival with weekly paclitaxel combined with cisplatin (wTP) as a postoperative adjuvant chemotherapy regimen for breast cancer.
Methods: Patients with breast cancer were treated postoperatively with paclitaxel 40 mg/m2 intravenously on days 1, 8 and 15, cisplatin 25 mg/m2 also intravenously on days 1,8 and 15, repeated every 21-28 days as a cycle. Toxicity and survival rate were evaluated after chemotherapy.
Results: Between September 1993 and August 2001, 20 patients were enrolled. Median age was 52 years (range, 35–71 years). According to the TNM stage system, all patients were staged Ⅱ or Ⅲ. Median number of chemotherapy cycles was 3 (range, 1–6), and 10 patients received 4 to 6 cycles of wTP. After a median follow-up of 83 months, 2 deaths and 6 relapses were documented. The five year overall survival rate was 90%. All patients could be evaluated with regard to toxicity. No treatment related deaths were recorded. Neutropenia occurred in 75% of patients during treatment, all recovering after G-CSF injection. Other symptoms included nausea/vomiting, elevation of transaminase, urea nitrogen/creatinine and alopecia.
Conclusions: wTP is safe and effective at the doses tested. However, a randomized clinical trial is needed to compare wTP with other conventional adjuvant regimens of breast cancer postoperatively.