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

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 ve...

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Bibliographic Details
Published in:Journal of cellular physiology 2016-11, Vol.231 (11), p.2541-2547
Main Authors: Pizzuti, Laura, Barba, Maddalena, Giannarelli, Diana, Sergi, Domenico, Botti, Claudio, Marchetti, Paolo, Anzà, Michele, Maugeri-Saccà, Marcello, Natoli, Clara, Di Filippo, Simona, Catenaro, Teresa, Tomao, Federica, Amodio, Antonella, Carpano, Silvia, Perracchio, Letizia, Mottolese, Marcella, Di Lauro, Luigi, Sanguineti, Giuseppe, Di Benedetto, Anna, Giordano, Antonio, Vici, Patrizia
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Body Mass Index
Breast Neoplasms - drug therapy
Breast Neoplasms - pathology
Breast Neoplasms - surgery
Cyclophosphamide - administration & dosage
Cyclophosphamide - adverse effects
Cyclophosphamide - therapeutic use
Dose-Response Relationship, Drug
Epirubicin - adverse effects
Epirubicin - therapeutic use
Female
Humans
Middle Aged
Neoadjuvant Therapy - adverse effects
Neoplasm Staging
Original
Original s
Surgery
Taxoids - adverse effects
Taxoids - therapeutic use
Trastuzumab - administration & dosage
Trastuzumab - adverse effects
Trastuzumab - therapeutic use
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Summary: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 (
ISSN:0021-9541
1097-4652
DOI:10.1002/jcp.25432