Myotax: A phase II trial of docetaxel plus non-pegylated liposomal doxorubicin as first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines E. Curtit a,b,c,d , P. Nouyrigat e , N. Dohollou f , E. Levy g , A. Lortholary h , J. Gligorov i , T. Facchini j , D. Jaubert k , N. Maille e , X. Pivot a,c,d , V. Grange ´ l , L. Cals a, * a Department of Medical Oncology, University Hospital Jean Minjoz, Besanc ¸on 25030, France b CIC in Biotherapies 506, University Hospital Jean Minjoz, Besanc ¸on 25030, France c INSERM UMR 645, Besanc ¸on 25020, France d University of Franche Comte ´, IFR 133, Besanc ¸on 25000, France e Oncology Unit, Centre Hospitalier Intercommunal de Toulon la Seyne sur Mer, Toulon, France f Oncology Unit, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France g Oncology Unit, Ho ˆpital Europe ´en Georges Pompidou, Paris, France h Department of Medical Oncology, Centre Catherine de Sienne, Nantes, France i Department of Medical Oncology, APREC APHP Tenon, Paris, France j Cancer Institute, Courlancy, Reims, France k Oncology Unit, Clinique Tivoli, Bordeaux, France l Medical Affairs Department, Cephalon France, 20 rue Charles Martigny, Maisons Alfort, France ARTICLE INFO Article history: Available online 13 September 2011 Keywords: Cardiotoxicity Docetaxel Non-pegylated liposomal doxorubicin Metastatic breast cancer ABSTRACT Aim: Non-pegylated liposomal doxorubicin (NPLD) has demonstrated equivalent antitu- mour activity to conventional doxorubicin and a significantly lower risk of cardiotoxicity when given as a single agent or in combination with cyclophosphamide. This phase II trial was performed to evaluate the efficacy and the safety of NPLD and docetaxel combination in patients with metastatic breast cancer previously exposed to adjuvant anthracyclines. Patients and methods: Thirty-four patients received NPLD 60 mg/m 2 and docetaxel 75 mg/m 2 in a 21-day cycle as first-line therapy of metastatic breast cancer. Treatment was planned for six cycles and was continued until progression or toxicity. Results: Objective response rate among response-assessable patients was 79% (95% CI (con- fidence interval), 64–94%) and 27% (95% CI, 11–43%) presented a complete response. Median progression free survival was 11.3 months (95% CI, 6.2–13.3 months) and median overall survival was 28.2 months (95% CI, 16–36.4 months). Symptomatic grade 3 cardiotoxicity occurred in 15% of cases and febrile neutropenia in 47% of the patients. Conclusions: The combination of NPLD and docetaxel demonstrated high antitumour activ- ity in a population of metastatic breast cancer patients exposed to adjuvant anthracyclines and showed an unexpected and unexplained 15% symptomatic left ventricular systolic dysfunction rate. Ó 2011 Elsevier Ltd. All rights reserved. 0959-8049/$ - see front matter Ó 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.ejca.2011.08.004 * Corresponding author: Address: Department of Medical Oncology, University Hospital Jean Minjoz, 1 boulevard Fleming, Besanc ¸ on 25 030 Cedex, France. Tel.: +33 (0) 3 81 66 93 21; fax: +33 (0) 3 81 66 88 58. E-mail address: lcals@chu-besancon.fr (L. Cals). EUROPEAN JOURNAL OF CANCER 47 (2011) 2396 – 2402 Available at www.sciencedirect.com journal homepage: www.ejconline.com