← Back to Search
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
Published 2010 · Medicine
Download PDFAnalyze on Scholarcy
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 (50 mg/m(2)), docetaxel (75 mg/m(2)) and trastuzumab (2 mg/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.
This paper references
Liposome‐encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first‐line therapy of metastatic breast carcinoma
L. Harris (2002)
Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193).
G. Sledge (2003)
erbB-2 and response to doxorubicin in patients with axillary lymph node-positive, hormone receptor-negative breast cancer.
S. Paik (1998)
Improved anti-tumor response rate with decreased cardiotoxicity of non-pegylated liposomal doxorubicin compared with conventional doxorubicin in first-line treatment of metastatic breast cancer in patients who had received prior adjuvant doxorubicin: results of a retrospective analysis
G. Batist (2006)
Cardiac safety of trastuzumab in combination with epirubicin and cyclophosphamide in women with metastatic breast cancer: results of a phase I trial.
M. Untch (2004)
USE OF CHEMOTHERAPY PLUS A MONOCLONAL ANTIBODY AGAINST HER 2 FOR METASTATIC BREAST CANCER THAT OVEREXPRESSES HER 2
Tamoxifen and toremifene lower serum cholesterol by inhibition of delta 8-cholesterol conversion to lathosterol in women with breast cancer.
H. Gylling (1995)
Multicenter phase II study of trastuzumab in combination with epirubicin and docetaxel as first-line treatment for HER2-overexpressing metastatic breast cancer
M. Venturini (2005)
Improving the therapeutic index of anthracycline chemotherapy: focus on liposomal doxorubicin (Myocet).
R. Leonard (2009)
WHO Handbook for Reporting Results of Cancer Treatment
R. Hunter (1980)
Congestive heart failure in patients treated with doxorubicin
S. Swain (2003)
Cardiotoxicity of epirubicin/paclitaxel-containing regimens: role of cardiac risk factors.
A. Gennari (1999)
A systematic overview of chemotherapy effects in breast cancer.
J. Bergh (2001)
Nonpegylated Liposomal Doxorubicin (TLC-D99), Paclitaxel, and Trastuzumab in HER-2-Overexpressing Breast Cancer: A Multicenter Phase I/II Study
J. Cortés (2009)
Daunomycin-induced cardiotoxicity in children and adults. A review of 110 cases.
D. V. Von Hoff (1977)
Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over.
R. Paridaens (2000)
Editorial [Hot Topic: Anti-Cancer Drugs Executive Editor: Elke Bergmann-Leitner]
E. S. Bergmann-Leitner (2005)
Toni M. Dando (2005)
Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31.
E. Tan-chiu (2005)
Chemotherapy: what progress in the last 5 years?
A. Hamilton (2005)
Risk factors for doxorubicin-induced congestive heart failure.
D. V. Von Hoff (1979)
Optimal two-stage designs for phase II clinical trials.
R. Simon (1989)
New developments and treatment in multiple myeloma: new drugs in the treatment of multiple myeloma.
M. Boccadoro (2002)
Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer.
S. Chan (1999)
Cardiac dysfunction in the trastuzumab clinical trials experience.
A. Seidman (2002)
Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer.
G. Batist (2001)
Type II chemotherapy-related cardiac dysfunction: time to recognize a new entity.
M. Ewer (2005)
Antitumour antibiotic containing regimens for metastatic breast cancer.
S. Lord (2004)
This paper is referenced by
Substituting Doxorubicin with Nonpegylated Liposomal Doxorubicin for the Treatment of Early Breast Cancer: Results of a Retrospective Study
N. Davidson (2014)
— miejsce niepegylowanej doksorubicyny liposomalnej The role of anthracyclines in the treatment of advanced breast cancer — the place of nonpegylated liposomal doxorubicin
A. Skrzypczyk (2010)
Non-pegylated liposomal doxorubicin in metastatic breast cancer patients: a valuable therapeutic option requiring caution.
D. Bernardi (2010)
The Role of Liposomal Anthracyclines in Metastatic Breast Cancer
A. Gennari (2013)
“Short Course” of Nonpegylated Liposomal Doxorubicin Plus Paclitaxel and Trastuzumb as Primary Systemic Therapy for Operable and Locally-Advanced Breast Cancer: A Phase II Study (PacLiDox 07)
David G Rossi (2011)
Liposomal Doxorubicin in the Treatment of Breast Cancer Patients: A Review
J. Lao (2013)
A nem pegilált liposzomális doxorubicin (Myocet®), mint a szabad doxorubicin kevésbé kardiotoxikus alternatívája
T. Nagykálnai (2010)
First-Line Chemotherapy with Liposomal Doxorubicin Plus Cyclofosfamide in Metastatic Breast Cancer: A Case Report of Early and Prolonged Response
F. Riccardi (2013)
Emerging nanotherapeutic strategies in breast cancer.
E. Blanco (2014)
Neoadjuvant chemotherapy and concomitant trastuzumab in breast cancer: a pooled analysis of two randomized trials
F. Petrelli (2011)
Bioactives: PEGylated Delivery
Anthracyclines in the management of metastatic breast cancer: state of the art
A. Gennari (2011)
Nonpeghylated liposomal doxorubicin combination regimen (R‐COMP) for the treatment of lymphoma patients with advanced age or cardiac comorbidity
L. Rigacci (2020)
Case histories: breast cancer
A. Gennari (2011)
Pegylated liposomal doxorubicin plus carboplatin in patients with metastatic breast cancer: a phase II study.
R. Collea (2012)
A phase I/II trial of non-pegylated liposomal doxorubicin, docetaxel and trastuzumab as first-line treatment in HER-2-positive locally advanced or metastatic breast cancer.
D. Amadori (2011)
Topoisomerase Inhibitors in Metastatic Breast Cancer: Overview of Current Practice and Future Development
Marie-Catherine Vanderbeeken (2013)
Trastuzumab as first-line therapy in HER2-positive metastatic breast cancer patients
L. Mastro (2012)
Role of trastuzumab in the management of HER2-positive metastatic breast cancer.
A. Milani (2010)
What is the best choice of partner chemotherapy with trastuzumab for metastatic breast cancer?
C. Gourmelon (2012)
Current status of nanomedicine in the chemotherapy of breast cancer
A. I. Fraguas-Sánchez (2019)
Myotax: a phase II trial of docetaxel plus non-pegylated liposomal doxorubicin as first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines.
E. Curtit (2011)
A recommended practical approach to the management of anthracycline-based chemotherapy cardiotoxicity: an opinion paper of the working group on drug cardiotoxicity and cardioprotection, Italian Society of Cardiology
P. Spallarossa (2016)
[Non-pegylated doxorubicin (Myocet®) as the less cardiotoxic alternative of free doxorubicin].
T. Nagykálnai (2010)
Trastuzumab cardiotoxicity: from clinical trials to experimental studies
B. Németh (2017)
Anti-HER2 et cancers du sein métastatiques: Résultats cliniques des anti-HER2 actuels et futurs
S. Guiu (2012)
Molecular‐targeted nanotherapies in cancer: Enabling treatment specificity
E. Blanco (2011)