Addition of weekly paclitaxel (P) after dose intensified epirubicin/cyclophosphamide (EC) (NECTA-protocol) as primary systemic chemotherapy (PST) in locally advanced breast cancer (LABC) improves pathologic response rate (pCR) in comparison to peoperative dose intensified EC

Abstract

10712 Background: Green M et al. (Proc Am Soc Clin Oncol 2002, abstract 135) demonstrated an improvement of pCR up to 28,8% by changing the preoperative application of 3 weekly P 225 mg/m2 (q21) to weekly P 80 mg or 150mg/m2 (q7) completed by 4 cycles FAC. Our study-group observed a pCR of 6% after 3 preoperative cycles of dose-intensified EC (120 mg/600 mg/m2 q14 or q21) in LABC. Dose-density (q14) did not improve pCR (Euler U et al. Proc Am Soc Clin Oncol 2002, abstract 126). As a consequence we studied the preoperative effect of 12 cycles P 80 mg/m2 (q7) after 3 cycles EC (120 mg/600 mg/m2 q21) . Methods: Between 2002 and 2005 61 patients (pts) with LABC (T2–4/N0–2/M0) were operated after PST with the NECTA-protocol. Irradiation after breast conserving therapy (BCT) was obligate. Immunohistochemical analysis were performed in tumor tissues from core biopsy before PST and from surgery. Results: The medium age was 49,2 yrs, 29,2% had negative ER-status, 48,1% negative PR-status and 22% HER2 overexpression. 76,2% had a cT2-tumor, 18,6% a cT3-tumor and 5,1% a cT4-tumor, 48,3% clinically showed positive lymph nodes. The medium follow up was 27 months (2–41 months). The clinical and pathological response rate was 94,8%. pCR was diagnosed in 8,6%. BCT was feasible in 94,8%. The documented recurrence rate was 14,7% (9 pts: 4 with local relapse, 3 with metastases and 2 with simultaneous local and distant recurrence), 8 pts with recurrence had a cT2-tumor. In the meantime 3 pts died. Conclusions: The additional treatment with weekly paclitaxel after EC induced a high rate of clinical and pathological response. The rate of conservative surgery was very high (94,8%). In the retrospective analysis NECTA-regime improved pCR. In comparison to other taxane-based PST-protocols pCR-rate (8,6%) was low. A phase III study will compare the NECTA-regime with the classical EC-regime in PST. No significant financial relationships to disclose.