Abstract P1-12-03: Short term quality of life with epirubicin-fluorouracil-cyclophosphamid (FEC) and sequential epirubicin/cyclophosphamid-docetaxel (EC-DOC) chemotherapy in patients with primary breast cancer – Results from the prospective multi-center randomized Adebar trial

Background: The grade of recommendation for adjuvant dose-dense chemotherapy in patients with high risk primary breast cancer is heterogeneous among international guidelines. Understanding the impact on quality of life (QOL) by adjuvant dose dense chemotherapy in comparison to standard adjuvant chemotherapy is thereby a crucial factor, especially if the benefit is potentially low. This study aims to assess the impact on QOL by adjuvant dose dense chemotherapy in the prospective randomized multi-center ADEBAR trial. Methods: QOL was assessed at baseline (t1), before cycle 4 FEC (Epirubicin 60mg/m2 i.v. d 1 + 8, 5-Fluoruracil 500mg/m2 i.v. d 1 + 8, Cyclophosphamide 75mg/m2 p.o. d 1–14, q4w x 6) and cycle 5 EC-DOC (Epirubicin 90mg/m2 plus Cyclophosphamide 600mg/m2 q3w x 4, sequentially followed by Docetaxel 100mg/m2 q3w x 4) (t2), 4 weeks after chemotherapy (t3), 6 weeks after radiation (t4) and 1 year after baseline (t5) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23). A multivariate mixed model was fitted to test for differences between the two treatment arms. Primary endpoint was global QOL, secondary endpoints physical functioning, nausea&vomiting, fatigue and systemic therapy side effects. A minimum clinically meaningful difference was considered to be 10 points. Results: 1306 patients were recruited between 3/2002 and 5/2005 675 were assigned to the FEC and 688 to the EC-DOC arm. Compliance to QOL assessment was 74% at baseline and 58% four weeks after therapy, but dropped to 11% after one year follow up. After the beginning of treatment global QOL dropped in both arm by 3 to 4 points. In the EC-DOC arm QOL dropped further at t3 by 7 points and stayed stable in the FEC arm. 6 weeks after radiation QOL exceeded baseline in both arms by 6 to 8 points. The differences between treatment arms were strongest at t3 (54.1 vs. 49.7) but did not reach clinical relevance at any point in time. Physical functioning, nausea vomiting, fatigue and systemic therapy side effects followed with some minor exceptions similar patterns, but showed higher amplitudes. Conclusion: In conclusion we could not detect a statistically significant difference between the two treatment arms in QOL parameters, indicating that dose dense adjuvant chemotherapy did not impact QOL at a clinically relevant level compared to standard adjuvant chemotherapy. Citation Format: Schwentner L, Harbeck N, Singer S, Eichler M, Rack B, Forstbauer H, Wischnik A, Scholz C, Fink V, Huober J, Friedl T, Weissenbacher T, Härtl K, Kiechle M, Janni W. Short term quality of life with epirubicin-fluorouracil-cyclophosphamid (FEC) and sequential epirubicin/cyclophosphamid-docetaxel (EC-DOC) chemotherapy in patients with primary breast cancer – Results from the prospective multi-center randomized Adebar trial. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-12-03.