Please confirm you are human (Sign Up for free to never see this)
← Back to Search
Docetaxel Plus Epirubicin Is A Highly Active, Well-tolerated, First-line Chemotherapy For Metastatic Breast Cancer: Results Of A Large, Multicentre Phase II Study
S. Morales, Antonio Lorenzo, M. Ramos, P. Ballesteros, M. Méndez, C. Almanza, J. Castellanos, J. A. Moreno-Nogueira, J. Casal, J. Lizón, A. Oltra, A. Frau, I. Machengs, A. Galán, J. Belón, C. Llorca
Published 2003 · Medicine
Save to my Library
Download PDFAnalyze on Scholarcy
PurposeIn this multicentre phase II study, the efficacy and safety profile of the combination of docetaxel and epirubicin as first-line chemotherapy for metastatic breast cancer (MBC) were evaluated.MethodsEpirubicin (75 mg/m2) and docetaxel (75 mg/m2) were given intravenously once every 3 weeks for six cycles to 133 patients with MBC.ResultsThe overall clinical response rate was 67% (complete and partial responses were 23% and 44%, respectively). The median time to progression was 10.8 months (95% CI 9.7–12.6) and the median overall survival was 19.5 months. Granulocyte colony-stimulating factor support was administered to 32% of patients and in 22% of cycles. Grade 3/4 neutropenia occurred in 35% of patients and febrile neutropenia in 19%. The most frequent grade 3/4 non-haematological toxicities (as percent of patients) were asthenia (6%), vomiting (5%) and nausea (5%). No patients developed congestive heart failure.ConclusionsThe combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.
This paper references
Chemotherapy of breast cancer. In: Perry MC (ed) The chemotherapy source book
GG Kardinal (1996)
Taxane/anthracycline combinations: setting a new standard in breast cancer?
J. Nabholtz (2001)
Escalating doses of docetaxel and epirubicin as first-line ther- apy for metastatic breast cancer. A phase I/II study of the National Cancer Institute of Canada—Clinical Trials Group (abstract 687)
ME Trudeau (1999)
Prospective Randomized Trial of Docetaxel Versus Mitomycin Plus Vinblastine in Patients With Metastatic Breast Cancer Progressing Despite Previous Anthracycline-Containing Chemotherapy
J. M. Nabholtz (1999)
Epirubicin/docetaxel regimen in progressive breast cancer—a phase II study
E. Salminen (2002)
Phase I study of docetaxel (D) in combination with epirubicin (E) as first-line chemotherapy (CT) in metastatic breast cancer (abstract 644)
G Raab (1998)
Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer.
S. Chan (1999)
Phase II trial of doxorubicin and docetaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: Eastern Cooperative Oncology Group Study E1196.
J. Sparano (2000)
Evolution in the treatment of advanced breast cancer.
J. Crown (1998)
Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study.
L. Gianni (1995)
Identification of the highest dose of docetaxel associable with active doses of epirubicin. Results from a dose-finding study in advanced breast cancer patients.
M. Venturini (2001)
Docetaxel: overview of an active drug for breast cancer.
J. Crown (2001)
Front-line treatment of advanced breast cancer with docetaxel and epirubicin: a multicenter phase II study.
D. Mavroudis (2000)
High-Dose Epirubicin Plus Docetaxel at Standard Dose With Lenograstim Support as First-line Therapy in Advanced Breast Cancer
A. Milla-Santos (2001)
Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer . The 303 Study Group
S Chan (1999)
First line epirubicin (EPI) and Taxotere (TXT) in advanced breast cancer: a phase I study (abstract 690)
M Venturini (1998)
Taxotere does not change the pharmacokinetic profile of doxorubicin (Dox) and doxorubicinol (Dx-ol) (abstract 853)
R Bellot (1998)
Docetaxel in patients with metastatic breast cancer: a phase II study of the National Cancer Institute of Canada-Clinical Trials Group.
M. Trudeau (1996)
Phase II trial of doxorubicin and paclitaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: an Eastern Cooperative Oncology Group Study.
J. Sparano (1999)
Docetaxel and anthracycline polychemotherapy in the treatment of breast cancer.
J. Nabholtz (1999)
Dose-finding study of docetaxel and doxorubicin in first-line treatment of patients with metastatic breast cancer.
J. L. Misset (1999)
Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group.
L. Bastholt (1996)
Combination of taxanes and anthracyclines in first-line chemotherapy of metastatic breast cancer: an interim report.
K. Friedrichs (2002)
Doubling epirubicin dose intensity (100 mg/m2 versus 50 mg/m2) in the FEC regimen significantly increases response rates. An international randomised phase III study in metastatic breast cancer. The Epirubicin High Dose (HEPI 010) Study Group.
G. Brufman (1997)
Front-line treatment of metastatic breast cancer with docetaxel and epirubicin: a multicenter dose-escalation study. The Greek Breast Cancer Cooperative Group (GBCCG).
C. Kouroussis (1999)
Epirubicin‐Docetaxel Combination in First‐Line Chemotherapy for Patients With Metastatic Breast Cancer: Final Results of a Dose‐Finding and Efficacy Study
P. Viens (2001)
Dose-finding study of epidoxorubicin and docetaxel as first-line chemotherapy in patients with advanced breast cancer.
O. Pagani (1999)
Docetaxel (Taxotere) in combination with anthracyclines in the treatment of breast cancer.
J. Nabholtz (2000)
One-sample multiple testing procedure for phase II clinical trials.
T. Fleming (1982)
Combined analysis of two phase II trials in patients with primary and advanced breast cancer with epidoxorubicin and docetaxel+granulocyte colony stimulating factor
C. Wenzel (2002)
Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group.
J. Nabholtz (1999)
Cancer statistics, 1999
S. Landis (1999)
Paclitaxel and anthracycline combination chemotherapy for metastatic breast cancer.
P. Kaufman (1999)
Epidoxorubicin and docetaxel as first-line chemotherapy in patients with advanced breast cancer: a multicentric phase I-II study.
O. Pagani (2000)
Chemotherapy of breast cancer
L. Perlow (1984)
Chemotherapy of breast cancer: are the taxanes going to change the natural history of breast cancer?
J. Nabholtz (2000)
Doxorubicin (DOX) and Taxotere (TXT): a pharmacokinetic study of the combination in advanced breast cancer (abstract 790)
J Schuller (1998)
Review of docetaxel and doxorubicin-based combinations in the management of breast cancer: from metastatic to adjuvant setting.
J. Nabholtz (1999)
Chemotherapy of breast cancer in the elderly.
A. Rossi (2005)
Clinical and pharmacokinetic data of a docetaxel-epirubicin combination in metastatic breast cancer
M. Airoldi (2004)
Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women.
R. Fossati (1998)
The Status of Breast Cancer Management: Challenges and Opportunities
G. Hortobagyi (2004)
This paper is referenced by
Dose Escalation Study of Epirubicin and Docetaxel in Patients with Advanced or Recurrent Breast Cancer
Ichiro Ichinose (2008)
Le cancer du sein non métastatique
J. Saglier (2005)
Prospective Multicenter Randomized Phase III Study of Weekly versus Standard Docetaxel plus Doxorubicin (D4) for First-Line Treatment of Metastatic Breast Cancer
H. Stemmler (2010)
Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial.
H. Roché (2006)
Docetaxel and epirubicin salvage regimen in relapsed anthracycline-sensitive metastatic breast cancer patients after anthracycline-containing adjuvant therapy
J. H. Seo (2008)
Revisiting Dosing Regimen Using Pharmacokinetic/Pharmacodynamic Mathematical Modeling: Densification and Intensification of Combination Cancer Therapy
C. Meille (2016)
Significant alterations in the expression pattern of kallikrein-related peptidase genes KLK4, KLK5 and KLK14 after treatment of breast cancer cells with the chemotherapeutic agents epirubicin, docetaxel and methotrexate
Georgia Papachristopoulou (2012)
Sequential docetaxel as adjuvant chemotherapy for node-positive or/and T3 or T4 breast cancer: clinical outcome (Mansoura University)
H. Sakr (2013)
Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer.
D. Mavroudis (2010)
Revisiting dosing regimen using PK/PD modeling: the MODEL1 phase I/II trial of docetaxel plus epirubicin in metastatic breast cancer patients
E. Hénin (2016)
Advanced Breast Cancer: Treatment with Docetaxel/Epirubicin
A. Pallis (2008)
A multicenter phase I-II study of docetaxel plus epirubicin plus bevacizumab as first-line treatment in women with HER2-negative metastatic breast cancer.
K. Tryfonidis (2013)
Prospective Multicenter Randomized Phase III Study of Weekly versus Standard Docetaxel (D2) for First-Line Treatment of Metastatic Breast Cancer
H. Stemmler (2010)
Docetaxel/anthracycline combinations for breast cancer treatment.
G. Minckwitz (2007)
First-Line Chemotherapy with Anthracycline and Taxane Combination in Metastatic Breast Cancer. Detection of bone metastases with TRACP 5b
J. Korpela (2011)
Computational oncology — mathematical modelling of drug regimens for precision medicine
D. Barbolosi (2016)
Dose-Dense Epirubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Chemotherapy in Node-Positive Breast Cancer
H. Mirzaei (2013)