A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer

M. Venturini, C. Bighin, F. Puglisi, N. Olmeo, E. Aitini, G. Colucci, O. Garrone, A. Paccagnella, G. Marini, L. Crinò, M. Mansutti, B. Baconnet, A. Barbato, L. Del Mastro

Research output: Contribution to journalArticle

Abstract

To evaluate the cardiotoxicity, general toxicity, and activity of non-pegylated liposomal doxorubicin, in combination with docetaxel and trastuzumab, as first-line therapy in metastatic breast cancer.Thirty-one patients with metastatic human epidermal growth factor receptor 2-overexpressing breast cancer, who had not previously received chemotherapy for metastatic disease, received non-pegylated liposomal doxorubicin (50mg/m2), docetaxel (75mg/m2) and trastuzumab (2mg/kg/week) for up to eight cycles, followed by trastuzumab alone for up to 52 weeks. Cardiotoxicity was defined as a decrease in left ventricular ejection fraction (LVEF) to below 45%, or a decrease in LVEF of at least 20% from baseline.Mean LVEF was maintained at baseline level also in the subset of patients who had received anthracycline previously. Cardiotoxicity developed in three patients during the treatment cycles, and in two further patients after the end of the study. The most common adverse events were haematological toxicity, alopecia, asthenia and fever. The best overall response rate was 65.5%. Median time to progression was 13.0 months.The combination of non-pegylated liposomal doxorubicin, docetaxel and trastuzumab combines acceptable cardiac and general toxicity and promising activity as first-line therapy in metastatic breast cancer.

Original languageEnglish
Pages (from-to)333-338
Number of pages6
JournalBreast
Volume19
Issue number5
DOIs
Publication statusPublished - Oct 2010

Fingerprint

docetaxel
Stroke Volume
Breast Neoplasms
Asthenia
Anthracyclines
Alopecia
Therapeutics
Fever
Drug Therapy
liposomal doxorubicin
Cardiotoxicity
Trastuzumab

Keywords

  • Cardiotoxicity
  • Docetaxel
  • Metastatic breast cancer
  • Non-pegylated liposomal doxorubicin
  • Phase II trial
  • Trastuzumab

ASJC Scopus subject areas

  • Surgery

Cite this

A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer. / Venturini, M.; Bighin, C.; Puglisi, F.; Olmeo, N.; Aitini, E.; Colucci, G.; Garrone, O.; Paccagnella, A.; Marini, G.; Crinò, L.; Mansutti, M.; Baconnet, B.; Barbato, A.; Del Mastro, L.

In: Breast, Vol. 19, No. 5, 10.2010, p. 333-338.

Research output: Contribution to journalArticle

Venturini, M, Bighin, C, Puglisi, F, Olmeo, N, Aitini, E, Colucci, G, Garrone, O, Paccagnella, A, Marini, G, Crinò, L, Mansutti, M, Baconnet, B, Barbato, A & Del Mastro, L 2010, 'A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer', Breast, vol. 19, no. 5, pp. 333-338. https://doi.org/10.1016/j.breast.2010.01.018
Venturini, M. ; Bighin, C. ; Puglisi, F. ; Olmeo, N. ; Aitini, E. ; Colucci, G. ; Garrone, O. ; Paccagnella, A. ; Marini, G. ; Crinò, L. ; Mansutti, M. ; Baconnet, B. ; Barbato, A. ; Del Mastro, L. / A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer. In: Breast. 2010 ; Vol. 19, No. 5. pp. 333-338.
@article{7def6829417a4474913d9f2fce2b3a8f,
title = "A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer",
abstract = "To evaluate the cardiotoxicity, general toxicity, and activity of non-pegylated liposomal doxorubicin, in combination with docetaxel and trastuzumab, as first-line therapy in metastatic breast cancer.Thirty-one patients with metastatic human epidermal growth factor receptor 2-overexpressing breast cancer, who had not previously received chemotherapy for metastatic disease, received non-pegylated liposomal doxorubicin (50mg/m2), docetaxel (75mg/m2) and trastuzumab (2mg/kg/week) for up to eight cycles, followed by trastuzumab alone for up to 52 weeks. Cardiotoxicity was defined as a decrease in left ventricular ejection fraction (LVEF) to below 45{\%}, or a decrease in LVEF of at least 20{\%} from baseline.Mean LVEF was maintained at baseline level also in the subset of patients who had received anthracycline previously. Cardiotoxicity developed in three patients during the treatment cycles, and in two further patients after the end of the study. The most common adverse events were haematological toxicity, alopecia, asthenia and fever. The best overall response rate was 65.5{\%}. Median time to progression was 13.0 months.The combination of non-pegylated liposomal doxorubicin, docetaxel and trastuzumab combines acceptable cardiac and general toxicity and promising activity as first-line therapy in metastatic breast cancer.",
keywords = "Cardiotoxicity, Docetaxel, Metastatic breast cancer, Non-pegylated liposomal doxorubicin, Phase II trial, Trastuzumab",
author = "M. Venturini and C. Bighin and F. Puglisi and N. Olmeo and E. Aitini and G. Colucci and O. Garrone and A. Paccagnella and G. Marini and L. Crin{\`o} and M. Mansutti and B. Baconnet and A. Barbato and {Del Mastro}, L.",
year = "2010",
month = "10",
doi = "10.1016/j.breast.2010.01.018",
language = "English",
volume = "19",
pages = "333--338",
journal = "Breast",
issn = "0960-9776",
publisher = "Churchill Livingstone",
number = "5",

}

TY - JOUR

T1 - A multicentre Phase II study of non-pegylated liposomal doxorubicin in combination with trastuzumab and docetaxel as first-line therapy in metastatic breast cancer

AU - Venturini, M.

AU - Bighin, C.

AU - Puglisi, F.

AU - Olmeo, N.

AU - Aitini, E.

AU - Colucci, G.

AU - Garrone, O.

AU - Paccagnella, A.

AU - Marini, G.

AU - Crinò, L.

AU - Mansutti, M.

AU - Baconnet, B.

AU - Barbato, A.

AU - Del Mastro, L.

PY - 2010/10

Y1 - 2010/10

N2 - To evaluate the cardiotoxicity, general toxicity, and activity of non-pegylated liposomal doxorubicin, in combination with docetaxel and trastuzumab, as first-line therapy in metastatic breast cancer.Thirty-one patients with metastatic human epidermal growth factor receptor 2-overexpressing breast cancer, who had not previously received chemotherapy for metastatic disease, received non-pegylated liposomal doxorubicin (50mg/m2), docetaxel (75mg/m2) and trastuzumab (2mg/kg/week) for up to eight cycles, followed by trastuzumab alone for up to 52 weeks. Cardiotoxicity was defined as a decrease in left ventricular ejection fraction (LVEF) to below 45%, or a decrease in LVEF of at least 20% from baseline.Mean LVEF was maintained at baseline level also in the subset of patients who had received anthracycline previously. Cardiotoxicity developed in three patients during the treatment cycles, and in two further patients after the end of the study. The most common adverse events were haematological toxicity, alopecia, asthenia and fever. The best overall response rate was 65.5%. Median time to progression was 13.0 months.The combination of non-pegylated liposomal doxorubicin, docetaxel and trastuzumab combines acceptable cardiac and general toxicity and promising activity as first-line therapy in metastatic breast cancer.

AB - To evaluate the cardiotoxicity, general toxicity, and activity of non-pegylated liposomal doxorubicin, in combination with docetaxel and trastuzumab, as first-line therapy in metastatic breast cancer.Thirty-one patients with metastatic human epidermal growth factor receptor 2-overexpressing breast cancer, who had not previously received chemotherapy for metastatic disease, received non-pegylated liposomal doxorubicin (50mg/m2), docetaxel (75mg/m2) and trastuzumab (2mg/kg/week) for up to eight cycles, followed by trastuzumab alone for up to 52 weeks. Cardiotoxicity was defined as a decrease in left ventricular ejection fraction (LVEF) to below 45%, or a decrease in LVEF of at least 20% from baseline.Mean LVEF was maintained at baseline level also in the subset of patients who had received anthracycline previously. Cardiotoxicity developed in three patients during the treatment cycles, and in two further patients after the end of the study. The most common adverse events were haematological toxicity, alopecia, asthenia and fever. The best overall response rate was 65.5%. Median time to progression was 13.0 months.The combination of non-pegylated liposomal doxorubicin, docetaxel and trastuzumab combines acceptable cardiac and general toxicity and promising activity as first-line therapy in metastatic breast cancer.

KW - Cardiotoxicity

KW - Docetaxel

KW - Metastatic breast cancer

KW - Non-pegylated liposomal doxorubicin

KW - Phase II trial

KW - Trastuzumab

UR - http://www.scopus.com/inward/record.url?scp=77957155047&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77957155047&partnerID=8YFLogxK

U2 - 10.1016/j.breast.2010.01.018

DO - 10.1016/j.breast.2010.01.018

M3 - Article

C2 - 20185313

AN - SCOPUS:77957155047

VL - 19

SP - 333

EP - 338

JO - Breast

JF - Breast

SN - 0960-9776

IS - 5

ER -