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, 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 & 1 others Patrizia Vici

Research output: Contribution to journalArticle

4 Citations (Scopus)

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

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docetaxel
Cordless telephones
Epirubicin
Cyclophosphamide
Surgery
Taxoids
Chemotherapy
Anthracyclines
Toxicity
Stroke Volume
Hormones
Breast Neoplasms
Trastuzumab
Neutropenia

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Cell Biology
  • Physiology

Cite this

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

In: Journal of Cellular Physiology, Vol. 231, No. 11, 01.11.2016, p. 2541-2547.

Research output: Contribution to journalArticle

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, Giordano, 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, vol. 231, no. 11, pp. 2541-2547. https://doi.org/10.1002/jcp.25432
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. / Neoadjuvant Sequential Docetaxel Followed by High-Dose Epirubicin in Combination With Cyclophosphamide Administered Concurrently With Trastuzumab. The DECT Trial. In: Journal of Cellular Physiology. 2016 ; Vol. 231, No. 11. pp. 2541-2547.
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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 (",
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AU - Giannarelli, Diana

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AU - Botti, Claudio

AU - Marchetti, Paolo

AU - Anzà, Michele

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