Phase II trial of combination of pegylated liposomal doxorubicin, cisplatin, and infusional 5-fluorouracil (CCF) plus trastuzumab as preoperative treatment for locally advanced and inflammatory breast cancer

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Abstract

Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.

Original languageEnglish
Pages (from-to)483-488
Number of pages6
JournalClinical Breast Cancer
Volume10
Issue number6
DOIs
Publication statusPublished - 2010

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Inflammatory Breast Neoplasms
Fluorouracil
Cisplatin
Estrogen Receptors
Therapeutics
Breast Neoplasms
letrozole
Trastuzumab
liposomal doxorubicin
Triptorelin Pamoate
Neoplasms
Poisons
Progesterone Receptors
Doxorubicin

Keywords

  • HER2 positivity
  • Left ventricular ejection fraction

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{c6299edc2f184472bda1dc1725921b53,
title = "Phase II trial of combination of pegylated liposomal doxorubicin, cisplatin, and infusional 5-fluorouracil (CCF) plus trastuzumab as preoperative treatment for locally advanced and inflammatory breast cancer",
abstract = "Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10{\%} tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47{\%}) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41{\%}) had inflammatory breast cancer (IBC) and 84{\%} of patients had clinically positive nodes. A clinical response rate of 94{\%} (95{\%} CI, 79{\%}-99{\%}) and a pCR rate of 41{\%} (95{\%} CI, 24{\%}-59{\%}) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.",
keywords = "HER2 positivity, Left ventricular ejection fraction",
author = "Rosalba Torrisi and Anna Cardillo and Giuseppe Cancello and Silvia Dellapasqua and Alessandra Balduzzi and Raffaella Ghisini and Alberto Luini and Paolo Veronesi and Giuseppe Viale and Aron Goldhirsch and Marco Colleoni",
year = "2010",
doi = "10.3816/CBC.2010.n.064",
language = "English",
volume = "10",
pages = "483--488",
journal = "Clinical Breast Cancer",
issn = "1526-8209",
publisher = "Elsevier",
number = "6",

}

TY - JOUR

T1 - Phase II trial of combination of pegylated liposomal doxorubicin, cisplatin, and infusional 5-fluorouracil (CCF) plus trastuzumab as preoperative treatment for locally advanced and inflammatory breast cancer

AU - Torrisi, Rosalba

AU - Cardillo, Anna

AU - Cancello, Giuseppe

AU - Dellapasqua, Silvia

AU - Balduzzi, Alessandra

AU - Ghisini, Raffaella

AU - Luini, Alberto

AU - Veronesi, Paolo

AU - Viale, Giuseppe

AU - Goldhirsch, Aron

AU - Colleoni, Marco

PY - 2010

Y1 - 2010

N2 - Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.

AB - Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.

KW - HER2 positivity

KW - Left ventricular ejection fraction

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U2 - 10.3816/CBC.2010.n.064

DO - 10.3816/CBC.2010.n.064

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SN - 1526-8209

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