Neoadjuvant Sequential Docetaxel Followed by High‐Dose Epirubicin in Combination With Cyclophosphamide Administered Concurrently With Trastuzumab. The DECT Trial |
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| Authors: | Laura Pizzuti Maddalena Barba Diana Giannarelli Domenico Sergi Claudio Botti Paolo Marchetti Michele Anzà Marcello Maugeri‐Saccà Clara Natoli Simona Di Filippo Teresa Catenaro Federica Tomao Antonella Amodio Silvia Carpano Letizia Perracchio Marcella Mottolese Luigi Di Lauro Giuseppe Sanguineti Anna Di Benedetto Antonio Giordano Patrizia Vici |
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| Affiliation: | 1. Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy;2. Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy;3. Biostatistics Unit, Regina Elena National Cancer Institute, Rome, Italy;4. Department of Surgery, Regina Elena National Cancer Institute, Rome, Italy;5. Oncology Unit, Sant'Andrea Hospital, La Sapienza University of Rome, Rome, Italy;6. Department of Medical, Oral and Biotechnological Sciences and CeSI‐MeT, G. d'Annunzio University, Chieti, Italy;7. Santa Maria Goretti, Hospital of Latina, Latina, Italy;8. Department of Gynecologic Oncology, University “Sapienza”, Rome, Italy;9. Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy;10. Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy;11. Sbarro Institute for Cancer Research and Molecular Medicine and Center for Biotechnology, College of Science and Technology, Temple University, Philadelphia, Pennsylvania |
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| 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 (<10%). In one patient we observed a ≥10% asymptomatic LVEF decrease persisting after surgery. Notwithstanding their limited applicability due to the current guidelines, our findings support the efficacy of the regimen of interest in the neoadjuvant setting along with a fairly acceptable toxicity profile, including cardiotoxicity. Results on BMI may invite further assessment in future studies. J. Cell. Physiol. 231: 2541–2547, 2016. © 2016 The Authors. Journal of Cellular Physiology Published by Wiley Periodicals, Inc. |
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