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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/11710

Title: Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeutic Regimens
Authors: Valero, Vicente
Forbes, John
Pegram, Mark D.
Pienkowski, Tadeusz
Eiermann, Wolfgang
von Minckwitz, Gunter
Roche, Henri
Martin, Miguel
Crown, John
Mackey, John R.
Fumoleau, Pierre
Rolski, Janusz
Mrsic-Krmpotic, Zrinka
Jagiello-Gruszfeld, Agnieszka
Riva, Alessandro
BUYSE, Marc
Taupin, Henry
Sauter, Guido
Press, Michael F.
Slamon, Dennis J.
Issue Date: 2011
Publisher: AMER SOC CLINICAL ONCOLOGY
Citation: JOURNAL OF CLINICAL ONCOLOGY, 29(2). p. 149-156
Abstract: Purpose Docetaxel-trastuzumab (TH) is effective therapy for HER2-amplified metastatic breast cancer (MBC). Preclinical findings of synergy between docetaxel, carboplatin, and trastuzumab (TCH) prompted a phase III randomized trial comparing TCH with TH in patients with HER2-amplified MBC. Patients and Methods Two hundred sixty-three patients were randomly assigned to receive eight 3-week cycles of TH (trastuzumab plus docetaxel 100 mg/m(2)) or TCH (trastuzumab plus carboplatin at area under the serum concentration-time curve 6 and docetaxel 75 mg/m(2)). Trastuzumab was given at 4 mg/kg loading dose followed by a 2 mg/kg dose once per week during chemotherapy, and then 6 mg/kg once every 3 weeks until progression. Results Patient characteristics were balanced between groups. There was no significant difference between TH and TCH in terms of the primary end point, time to progression (medians of 11.1 and 10.4 months, respectively; hazard ratio, 0.914; 95% CI, 0.694 to 1.203; P = .57), response rate (72% for both groups), or overall survival (medians of 37.1 and 37.4 months, respectively; P = .99). Rates of grades 3 or 4 adverse effects for TH and TCH, respectively, were neutropenic-related complications, 29% and 23%; thrombocytopenia, 2% and 15%; anemia, 5% and 11%; sensory neuropathy, 3% and 0.8%; fatigue, 5% and 12%; peripheral edema, 3.8% and 1.5%; and diarrhea, 2% and 10%. Two patients given TCH died of sepsis, and one patient given TH experienced sudden cardiac death. Absolute left ventricular ejection fraction decline > 15% was seen in 5.5% of patients on the TH arm and 6.7% of patients on the TCH arm. Conclusion Adding carboplatin did not enhance TH antitumor activity. TH (docetaxel, 100 mg/m(2)) and TCH (docetaxel, 75 mg/m(2)) demonstrated efficacy with acceptable toxicity in women with HER2-amplified MBC. J Clin Oncol 29:149-156. (C) 2010 by American Society of Clinical Oncology
Notes: [Valero, Vicente] Univ Texas MD Anderson Canc Ctr, Dept Breast Med Oncol, Unit 1354, Houston, TX 77030 USA. Univ Newcastle, Australia New Zealand Breast Canc Trials Grp, Calvary Mater Hosp, Newcastle, NSW 2308, Australia. Univ Calif Los Angeles, Los Angeles, CA USA. Univ So Calif, Los Angeles, CA USA. Marie Sklodowska Curie Mem Canc Ctr, Warsaw, Poland. Marie Sklodowska Curie Mem Canc Ctr, Krakow, Poland. Niepubl Zaklad Opieki Zdrowotnej Onkomed, Olsztyn, Poland. Red Cross Womens Hosp, Munich, Germany. Univ Womens Hosp, Frankfurt, Germany. Inst Claudius Regaud, Toulouse, France. Canc Int Res Grp, Paris, France. Ctr Georges Francois Leclerc, Dijon, France. Hosp Gregorio Maranon, Madrid, Spain. Grp Espanol Invest Canc Mama, Madrid, Spain. St Vincents Univ Hosp, Irish Clin Oncol Res Grp, Dublin 4, Ireland. Univ Alberta, Cross Canc Inst, Edmonton, AB, Canada. Univ Hosp Tumors, Zagreb, Croatia. Int Inst Drug Dev, Louvain, Belgium. Hasselt Univ, I BioStat Ctr Stat, Hasselt, Belgium. Univ Basel, Inst Pathol, Basel, Switzerland. vvalero@mdanderson.org
URI: http://hdl.handle.net/1942/11710
DOI: 10.1200/JCO.2010.28.6450
ISI #: 000285965400018
ISSN: 0732-183X
Category: A1
Type: Journal Contribution
Validation: ecoom, 2012
Appears in Collections: Research publications

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