Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : the M77001 study group

Marty, Michael, Cognetti, Francesco, Maraninchi, Dominique, Snyder, Ray, Mauriac, Louis, Tubiana-Hulin, Michele, Chan, Stephen, Grimes, David, Antón, Antonio, Lluch, Anna, Kennedy, John, O'Byrne, Kenneth J., Conte, PierFranco, Green, Michael, Ward, Carol, Mayne, Karen, & Extra, Jean-Marc (2005) Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : the M77001 study group. Journal of Clinical Oncology, 23(19), pp. 4265-4274.

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Abstract

Purpose: This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Patients and Methods: Patients were randomly assigned to six cycles of docetaxel 100 mg/m 2 every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression.

Results: A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen more commonly with the combination (32%) than with docetaxel alone (22%), and there was a slightly higher incidence of febrile neutropenia in the combination arm (23% v 17%). One patient in the combination arm experienced symptomatic heart failure (1%). Another patient experienced symptomatic heart failure 5 months after discontinuation of trastuzumab because of disease progression, while being treated with an investigational anthracycline for 4 months.

Conclusion: Trastuzumab combined with docetaxel is superior to docetaxel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity. © 2005 by American Society of Clinical Oncology.

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ID Code: 65226
Item Type: Journal Article
Refereed: Yes
Additional URLs:
Keywords: anthracycline, antibiotic agent, docetaxel, doxorubicin, epidermal growth factor receptor 2, granulocyte colony stimulating factor, trastuzumab, antineoplastic agent, monoclonal antibody, taxoid, adjuvant therapy, adult, aged, alopecia, anemia, anorexia, arthralgia, article, asthenia, breast cancer, cancer combination chemotherapy, cancer patient, cancer survival, clinical trial, combination chemotherapy, constipation, controlled clinical trial, controlled study, diarrhea, disease course, drug dose reduction, drug efficacy, drug fatality, drug safety, drug withdrawal, dyspnea, epistaxis, erythema, fatigue, febrile neutropenia, female, fever, headache, heart failure, heart left ventricle ejection fraction, human, injection site reaction, lacrimation, leukopenia, loading drug dose, major clinical study, metastasis, monotherapy, mucosa inflammation, multicenter study, multiple cycle treatment, myalgia, nausea, neutropenia, overall survival, paresthesia, peripheral edema, phase 2 clinical trial, priority journal, randomized controlled trial, rash, septicemia, side effect, stomatitis, treatment failure, treatment response, vomiting, adolescent, breast tumor, chemically induced disorder, comparative study, drug screening, metabolism, middle aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Drug Evaluation, Humans, Neoplasm Metastasis, Receptor, erbB-2, Taxoids
DOI: 10.1200/JCO.2005.04.173
ISSN: 0732-183X
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: © 2005 by American Society of Clinical Oncology
Deposited On: 09 Dec 2013 04:49
Last Modified: 14 Jan 2014 01:19

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