Neoadjuvant Sequential Docetaxel Followed by High-Dose Epirubicin in Combination With Cyclophosphamide Administered Concurrently With Trastuzumab. The DECT Trial

Laura Pizzuti, Maddalena Barba, Diana Giannarelli, Domenico Sergi, C. Botti, Paolo Marchetti, Michele Anzà, Marcello Maugeri-Saccà, C. Natoli, Simona Di Filippo, Teresa Catenaro, Federica Tomao, A. Amodio, S. Carpano, Letizia Perracchio, Marcella Mottolese, Luigi Di Lauro, Giuseppe Sanguineti, A. Di Benedetto, Antonio GiordanoPatrizia Vici

Research output: Contribution to journalArticle

Abstract

To report the results of the DECT trial, a phase II study of locally advanced or operable HER2-positive breast cancer (BC) treated with taxanes and concurrent anthracyclines and trastuzumab. Eligible patients (stage IIA-IIIB HER2-positive BC, 18–75 years, normal organ functions, ECOG ≤1, and left ventricular ejection fraction (LVEF) ≥55%) received four cycles of neoadjuvant docetaxel, 100 mg/m2 intravenously, plus trastuzumab 6 mg/kg (loading dose 8 mg/kg) every 3 weeks, followed by four 3-weekly cycles of epirubicin 120 mg/m2 and cyclophosphamide, 600 mg/m2, plus trastuzumab. Primary objective was pathologic complete response (pCR) rate, defined as ypT0/is ypN0 at definitive surgery. We enrolled 45 consecutive patients. All but six patients (13.3%) completed chemotherapy and all underwent surgery. pCR was observed in 28 patients (62.2%) overall and in 6 (66.7%) from the inflammatory subgroup. The classification and regression tree analysis showed a 100% pCR rate in patients with BMI ≥25 and with hormone negative disease. The median follow up was 46 months (8–78). Four-year recurrence-free survival was 74.7% (95%CI, 58.2–91.2). Seven patients (15.6%) recurred and one died. Treatment was well tolerated, with limiting toxicity being neutropenia. No clinical cardiotoxicity was observed. Six patients (13.4%) showed a transient LVEF decrease (

Original languageEnglish
Pages (from-to)2541-2547
Number of pages7
JournalJournal of Cellular Physiology
Volume231
Issue number11
DOIs
Publication statusPublished - Nov 1 2016

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Cell Biology
  • Physiology

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    Pizzuti, L., Barba, M., Giannarelli, D., Sergi, D., Botti, C., Marchetti, P., Anzà, M., Maugeri-Saccà, M., Natoli, C., Di Filippo, S., Catenaro, T., Tomao, F., Amodio, A., Carpano, S., Perracchio, L., Mottolese, M., Di Lauro, L., Sanguineti, G., Di Benedetto, A., ... Vici, P. (2016). Neoadjuvant Sequential Docetaxel Followed by High-Dose Epirubicin in Combination With Cyclophosphamide Administered Concurrently With Trastuzumab. The DECT Trial. Journal of Cellular Physiology, 231(11), 2541-2547. https://doi.org/10.1002/jcp.25432