PMID- 30267987 OWN - NLM STAT- MEDLINE DCOM- 20190520 LR - 20190520 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 103 DP - 2018 Nov TI - UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer. PG - 184-194 LID - S0959-8049(18)30939-0 [pii] LID - 10.1016/j.ejca.2018.06.025 [doi] AB - PURPOSE: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS). PATIENTS AND METHODS: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)-/HER2- BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m(2)) or ixabepilone (40 mg/m(2)). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy. RESULTS: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58-1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66-1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53-1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II-III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29-1.05; p = 0.063). All patients experienced >/=1 adverse events (AEs): 75% reported grade III-IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone). CONCLUSION: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II-III lymphocytic infiltration) requires further evaluation. CI - Copyright (c) 2018 Elsevier Ltd. All rights reserved. FAU - Campone, Mario AU - Campone M AD - ICO Rene Gauducheau, Saint-Herblain, France. Electronic address: Mario.campone@ico.unicancer.fr. FAU - Lacroix-Triki, Magali AU - Lacroix-Triki M AD - Gustave Roussy, Villejuif, France. FAU - Roca, Lise AU - Roca L AD - Centre Val D'Aurelle, Montpellier, France. FAU - Spielmann, Marc AU - Spielmann M AD - Gustave Roussy, Villejuif, France. FAU - Wildiers, Hans AU - Wildiers H AD - University Hospitals Leuven and KULeuven, Leuven, Belgium. FAU - Cottu, Paul AU - Cottu P AD - Institut Curie, Paris, France. FAU - Kerbrat, Pierre AU - Kerbrat P AD - Centre Eugene Marquis, Rennes, France. FAU - Levy, Christelle AU - Levy C AD - Centre Francois Baclesse, Caen, France. FAU - Desmoulins, Isabelle AU - Desmoulins I AD - Centre Georges-Francois Leclerc, Dijon, France. FAU - Bachelot, Thomas AU - Bachelot T AD - Centre Leon Berard, Lyon, France. FAU - Winston, Tan AU - Winston T AD - Mayo Clinic, Jacksonville, FL, USA. FAU - Eymard, Jean-Christophe AU - Eymard JC AD - Institut Jean Godinot, Reims, France. FAU - Uwer, Lionel AU - Uwer L AD - Centre Alexis Vautrin, Nancy, France. FAU - Duhoux, Francois P AU - Duhoux FP AD - Cliniques Universitaires Saint-Luc, Universite Catholique de Louvain, Brussels, Belgium. FAU - Verhoeven, Didier AU - Verhoeven D AD - University of AntwerpAZ, Belgium. FAU - Jaubert, Dominique AU - Jaubert D AD - Clinique Tivoli, Bordeaux, France. FAU - Coeffic, David AU - Coeffic D AD - Polyclinique de Courlancy, Reims, France. FAU - Orfeuvre, Hubert AU - Orfeuvre H AD - CH de Fleyriat, Bourg en Bresse, France. FAU - Canon, Jean Luc AU - Canon JL AD - Grand Hopital de Charleroi, Charleroi, Belgium. FAU - Asselain, Bernard AU - Asselain B AD - Institut Curie, Paris, France. FAU - Martin, Anne-Laure AU - Martin AL AD - R&D UNICANCER, UCBG, Paris, France. FAU - Lemonnier, Jerome AU - Lemonnier J AD - R&D UNICANCER, UCBG, Paris, France. FAU - Roche, Henri AU - Roche H AD - Institut Claudius Regaud, IUCT Oncopole, Toulouse, France. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180926 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Epothilones) RN - 15H5577CQD (Docetaxel) RN - 3Z8479ZZ5X (Epirubicin) RN - 8N3DW7272P (Cyclophosphamide) RN - K27005NP0A (ixabepilone) RN - U3P01618RT (Fluorouracil) SB - IM MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use MH - Breast Neoplasms/*drug therapy/pathology MH - Chemotherapy, Adjuvant/*methods MH - Cyclophosphamide/pharmacology/*therapeutic use MH - Docetaxel/pharmacology/*therapeutic use MH - Epirubicin/pharmacology/*therapeutic use MH - Epothilones/pharmacology/*therapeutic use MH - Female MH - Fluorouracil/pharmacology/*therapeutic use MH - Humans MH - Middle Aged MH - Neoplasm Staging MH - Survival Analysis MH - Young Adult OTO - NOTNLM OT - Adjuvant chemotherapy OT - Docetaxel OT - Early breast cancer OT - Ixabepilone OT - Poor prognosis breast cancer OT - Triple-negative breast cancer EDAT- 2018/09/30 06:00 MHDA- 2019/05/21 06:00 CRDT- 2018/09/30 06:00 PHST- 2018/04/13 00:00 [received] PHST- 2018/06/18 00:00 [revised] PHST- 2018/06/19 00:00 [accepted] PHST- 2018/09/30 06:00 [pubmed] PHST- 2019/05/21 06:00 [medline] PHST- 2018/09/30 06:00 [entrez] AID - S0959-8049(18)30939-0 [pii] AID - 10.1016/j.ejca.2018.06.025 [doi] PST - ppublish SO - Eur J Cancer. 2018 Nov;103:184-194. doi: 10.1016/j.ejca.2018.06.025. Epub 2018 Sep 26.