Improvements in survival in patients receiving primary chemotherapy with docetaxel for breast cancer: A randomised controlled trial

Primary chemotherapy is used in the treatment of breast cancer with the intention of reducing the size of the primary tumour and thus increasing breast conservation rates. A variety of chemotherapeutic regimens have been used with clinical response rates of approximately 80%, but complete pathological response rates of more than 15% are rare. Previous studies have demonstrated that a complete pathological response is predictive of longer survival. Improved clinical response (94%) and impressive complete pathological response rates (34%) have been documented recently in patients receiving primary chemotherapy using a docetaxel-containing regimen. The aim of this study was to determine whether primary chemotherapy with a docetaxel-conlaining regimen results in an improvement in overall survival benefit in patients with large and locally advanced breast cancers. Methods: Patients with large and locally advanced breast cancer (T2>4cm, T3 or T4) received 4 cycles of CVAP (cyclophosphamide, vincristine, doxorubicin, prednisolone) chemotherapy. Clinical response was then assessed. Those with a partial response (PR) or complete clinical response (CR) were randomised to receive either another 4 cycles of CVAP or 4 cycles of docetaxel. All patients whose tumours failed to respond received a further 4 cycles of docetaxel. Results: 167 patients have been enrolled into the study, with 102 suitable for randomisation. Median follow-up was 38 months (24 to 56 months). A significantly higher clinical response (94% vs 66%) and complete pathological response (34% vs 18%) was seen in patients randomised to receive docetaxel. In patients randomised to receive further CVAP, 3-year survival was 84%, while in those randomised to receive docetaxel, 3-year survival was 97% (p=0.02; log-rank test). In patients randomised to receive further CVAP, the 3-year disease-free interval was 77%, while in those randomised to receive docetaxel, the 3-year disease free interval was 90% (p=0.03; log-rank test). Conclusion: Primary treatment with docetaxel following an anthracycline-based treatment regimen resulted in significantly increased rates of survival and disease-free interval compared with continued anthracycline-based treatment.