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Originally published as JCO Early Release 10.1200/JCO.2005.04.173 on May 23 2005

Journal of Clinical Oncology, Vol 23, No 19 (July 1), 2005: pp. 4265-4274
© 2005 American Society of Clinical Oncology.
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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

Michel Marty, Francesco Cognetti, Dominique Maraninchi, Ray Snyder, Louis Mauriac, Michèle Tubiana-Hulin, Stephen Chan, David Grimes, Antonio Antón, Ana Lluch, John Kennedy, Kenneth O’Byrne, PierFranco Conte, Michael Green, Carol Ward, Karen Mayne, Jean-Marc Extra

From the Institut Gustave-Roussy, Villejuif; Institut Paoli Calmettes, Marseille; Institut Bergonié, Bordeaux; Centre Rene Huguenin, Saint-Cloud; Institut Curie, Paris, France; Regina Elena Cancer Institute, Rome; University Hospital, Modena, Italy; St Vincent’s Hospital, Fitzroy; Wesley Medical Centre, Auchenflour; Royal Melbourne Hospital, Melbourne, Australia; Nottingham City Hospital, Nottingham; Department of Oncology, Leicester Royal Infirmary, Leicester; Roche Products Limited, Welwyn Garden City, United Kingdom; Hospital Miguel Servet, Zaragoza, Spain; Hospital Clinico Universitaire, Valencia, Spain; St James Hospital, Dublin, Ireland; and F. Hoffmann-La Roche Ltd, Basel, Switzerland

Address reprint requests to Michel Marty, MD, PhD, Innovative Therapeutics, Hôpital Saint Louis, 1 avenue Claude Vellefaux, 75010 Paris, France; e-mail: memarty{at}free.fr

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/m2 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.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.


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