ABSTRACT
This large adjuvant trial in node-positive breast cancer explored two questions: first, whether increasing the dose intensity and total dose of anthracyclines in classic AC (doxorubicin and cyclophosphamide) CT improved DFS and OS; and second, whether these outcomes were improved by the addition of 4 cycles of paclitaxel (T) following 4 cycles of AC. Patients were randomized to three different doses of doxorubicin, 60, 75, or 90 mg/m2, in combination with cyclophosphamide 600 mg/m2, followed by either 4 cycles of paclitaxel 175 mg/m2 or no further CT. At the interim analysis, with 18 months median follow-up, significantly superior DFS and OS was observed for the patients randomized to receive paclitaxel. DFS was 86% and 90% (p 0.008) in the AC and AC T arms, respectively, while OS was 95% and 97% (p 0.04), respectively. In contrast, increasing the dose intensity and cumulative dose of anthracyclines had not, during that follow-up period, improved the DFS or OS. The prolongation of CT with paclitaxel had some associated side-effects; however, these were modest in incidence and severity.
