[P1-11-03] Pathological Complete Response after Neoadjuvant Chemotherapy + Trastuzumab Treatment Predicts Survival and Detects a Patient Subgroup at High Need for Improvement of Anti-HER2 Therapy. Three Year Median Follow-Up Data of the TECHNO Trial.
Untch M, Fasching PA, Konecny GE, Hasmueller S, Lebeau A, Kreienberg R, Camara O, Müller V, du Bois A, Kühn T, Stickeler E, Harbeck N, Höss C, Kahlert S, Beck T, Fett W, Mehta K, von Minckwitz G, Loibl S. Helios Kliniken Berlin Buch; Frauenklinik, Universitätsfrauenklinikum Erlangen; UCLA, Division of Hematology/Oncology; LMU München; UKE Hamburg-Eppendorf; Universitätsfrauenklinik Ulm; UFK Jena; UKE Klinik und Poliklinik Gynäkologie Hamburg; HSK Wiesbaden; Kreiskrankenhaus Gifhorn; Universitätsfrauenklinik Freiburg; TU München, UFK Köln; Krankenhaus Ebersberg; Krankenhaus Rosenheim; Hämato-Onkologische Praxis, Wuppertal; German Breast Group, Neu-Isenburg, Germany
Purpose: To evaluate the efficacy and safety of epirubicin/cyclophosphamide followed by paclitaxel/trastuzumab as neoadjuvant treatment in patients with HER2-overexpressing primary breast cancer (BC).
Patients and Methods: Patients with HER2-overexpressing primary BC (≥2cm or inflammatory BC) received preoperative 4 cycles epirubicin/cyclophosphamide (90/600 mg/m2), q3w) followed by 4 cycles paclitaxel 175 mg/m2 q3w with trastuzumab 6 mg/kg body weight q3w (8 mg/kg as loading dose) followed by surgery. Trastuzumab was continued after surgery until completion of 12 months treatment. The primary endpoint was pathological complete response (pCR) defined as no invasive tumor in the breast and axillary lymph nodes.
Results: Two hundred seventeen patients were enrolled. 39% achieved a pCR. Breast conserving surgery was possible in 138/217 (64%) of the patients. Median follow-up was 41 months and 3-year disease-free survival (DFS) was 88% in patients with pCR compared to 73% in patients without pCR (p=0.01). Three year overall survival (OS) was 96% in patients with pCR compared to 86% without pCR (p=0.025). In multivariate analysis pCR remained a significant prognostic factor for DFS and OS (DFS hazard ratio (HR) 2.5 [95% CI 1.2-5.1] p=0.013; OS HR 4.9 [95% CI 1.4-17.4] p=0.012). A cardiac event was reported in 8/217 (3.7%) patients; 6 had an LVEF decrease and two developed 2 (0.9%) clinical congestive heart failure.
Conclusion: The neoadjuvant combination of trastuzumab and chemotherapy results in a high chance for a pCR. However, those patients without a pCR have an increased risk for relapse and death and are therefore candidates for further improvement of anti-HER2 directed therapy.
Thursday, December 9, 2010 5:30 PM
Poster Session 1: Treatment - Therapeutic Strategies: Neoadjuvant Chemotherapy (5:30 PM-7:30 PM)