Abstract | BACKGROUND: METHODS: RESULTS: By March 15, 2005, 394 events (recurrent, second primary cancer, or death before recurrence) had been reported, triggering the first scheduled interim analysis. Of these, 133 were in the trastuzumab group and 261 in the control group (hazard ratio, 0.48; P<0.0001). This result crossed the early stopping boundary. The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years. Trastuzumab therapy was associated with a 33 percent reduction in the risk of death (P=0.015). The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831. CONCLUSIONS:
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Authors | Edward H Romond, Edith A Perez, John Bryant, Vera J Suman, Charles E Geyer Jr, Nancy E Davidson, Elizabeth Tan-Chiu, Silvana Martino, Soonmyung Paik, Peter A Kaufman, Sandra M Swain, Thomas M Pisansky, Louis Fehrenbacher, Leila A Kutteh, Victor G Vogel, Daniel W Visscher, Greg Yothers, Robert B Jenkins, Ann M Brown, Shaker R Dakhil, Eleftherios P Mamounas, Wilma L Lingle, Pamela M Klein, James N Ingle, Norman Wolmark |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 353
Issue 16
Pg. 1673-84
(Oct 20 2005)
ISSN: 1533-4406 [Electronic] United States |
PMID | 16236738
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Copyright | Copyright 2005 Massachusetts Medical Society. |
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Doxorubicin
- Cyclophosphamide
- Receptor, ErbB-2
- adriamycinol
- Trastuzumab
- Paclitaxel
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Topics |
- Adult
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, mortality, radiotherapy, surgery)
- Chemotherapy, Adjuvant
- Cyclophosphamide
(administration & dosage)
- Disease-Free Survival
- Doxorubicin
(administration & dosage, analogs & derivatives)
- Female
- Heart Diseases
(chemically induced)
- Humans
- Mastectomy
- Middle Aged
- Paclitaxel
(administration & dosage)
- Proportional Hazards Models
- Receptor, ErbB-2
(analysis)
- Recurrence
- Survival Analysis
- Trastuzumab
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