Sequential FEC 100-Docetaxel (T) Neoadjuvant Chemotherapy (NCT) in Stage II-III Operable Breast Cancer.

Abstract Background: NCT is increasingly used for operable breast cancer to allow breast conservation. Our objective was to evaluate clinical and pathological response after sequential NCT of 3 cycles of FEC 100- 3 cycles of T. This chemotherapy is currently the reference in the adjuvant setting in France.In PACS 01 trial (Roche et al. J Clin Oncol, 2006) FEC followed by T significantly improved 5 years overall survival rates (90.7%) compared to 6 FEC 100 in node-positive breast cancer. However this active combination has not yet been evaluated in NCT.Methods: 101 patients (pts) from February 2005 to September 2008 with pathologically confirmed stage II-III untreated operable breast cancer received 3 cycles (c) of FEC 100 (epirubicin 100 mg/m² + 5-fluorouracil and cyclophosphamide 500mg/m²) followed by 3 c of T (100mg/m²) every 3 weeks. pCR was defined according to Chevallier's (Am J Clin Oncol, 1993) as level 1 and 2 and to Sataloff's classification (J Am Coll Surg, 1995) as grade A. A clinical, mammography and ultrasound breast evaluation was performed at baseline, after 3 c and before surgery.Results: Median age was 52.3 years [28-72]. Median diameter of the tumor was 42 mm [14-100]. 83 pts had a ductal, 14 a lobular, 3 ductal and lobular, 1 another carcinoma. 8.9% were grade I SBR, 58.4% grade II SBR, 28.7% grade III SBR and 4% unspecified. 74 (73.3%) tumors were HR+, 9(8.9%) Her-2 + and 18(17.8%) triple negative. 55 pts (54.4%) were premenopausal.After 3 cycles of FEC 100, ultrasound objective response rate (ORR) was 15%: 13 pts had a partial response and 2 pts had a complete response.After 6 cycles of NCT, ultrasound ORR was 62.5%: 53 pts had a partial response and 7 pts had a complete response.Most frequent grade (G) 3-4 adverse events were neutropenia which occured in 16 pts (15.8%) with G 3 febrile neutropenia in 11 pts (10.9%) (G-CSF optional). Most frequent G 1-2 averse events were nausea which occured in 43 pts(42.6%), myalgia in 27 pts(26.7%) and stomatitis in 23 pts(22.8%).After the completion of NCT, 76 pts (75.2%) underwent breast-conserving surgery. 12(11.9%) achieved pCR using Chevallier's classification and 15(14.8%) using Sataloff's classification.Conclusion: Sequential NCT with FEC followed by T was active and relatively well tolerated. Breast-conserving rate appeared satisfactory. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1105.