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Source

New England Journal of Medicine 2005;353(16):1673-84. Abstract


Purpose

Combine the results of two trials comparing adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab

Patients and methods

  • National Surgical Adjuvant Breast and Bowel Project trial B-31
    – AC paclitaxel (n = 872)
    – AC paclitaxel + trastuzumab (n = 864)
  • North Central Cancer Treatment Group trial N9831
    – AC paclitaxel (n = 807)
    – AC paclitaxel + trastuzumab (n = 808)
    – AC/paclitaxel trastuzumab (excluded from analysis)
  • Eligibility
    – NSABP-B-31: HER2-positive (IHC 3+ or FISH-positive), node-positive
    disease in patients with LVEF ≥ low normal limit
    – N9831: HER2-positive (IHC 3+ or FISH-positive), node-positive
    or high-risk node-negative disease (tumor >2 cm if ER/PR-positive
    or >1 cm if ER/PR-negative) in patients with LVEF ≥ low normal limit
  • Patients with protocol-defined history of cardiac disease excluded
  • Endpoints
    – Primary: Disease-free survival
    – Secondary: Overall survival, time to distant recurrence, death from breast cancer, contralateral breast cancer and others

Results

SELECT PUBLICATIONS

Bartlett JM. Pharmacodiagnostic testing in breast cancer: Focus on HER2 and trastuzumab therapy. Am J Pharmacogenomics 2005;5(5):303-15. Abstract

Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med 2005;353(16):1652-4. No abstract available

Dent R, Clemons M. Adjuvant trastuzumab for breast cancer. BMJ 2005;331(7524):1035-6. No abstract available

Dybdal N et al. Determination of HER2 gene amplification by f luorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat 2005;93(1):3-11. Abstract

Ewer MS et al. Reversibility of trastuzumab-related cardiotoxicity: New insights based on clinical course and response to medical treatment. J Clin Oncol 2005;23(31):7820-6. Abstract

Hortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med 2005;353(16):1734-6. No abstract available

Mamounas EP. Can we approach zero relapse in breast cancer? Oncologist 2005;10(Suppl 2):9-17. Abstract

Perez EA et al. NCCTG N9831: May 2005 update. Presentation. ASCO 2005. No abstract available

Press MF et al. Diagnostic evaluation of HER-2 as a molecular target: An assessment of accuracy and reproducibility of laboratory testing in large, prospective, randomized clinical trials. Clin Cancer Res 2005;11(18):6598-607. Abstract

Romond EH et al. Doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab as adjuvant therapy for patients with HER-2 positive operable breast cancer — Combined analysis of NSABP-B31/NCCTG-N9831. Presentation. ASCO 2005. No abstract available

Romond EH et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353(16):1673-84. Abstract

Tan-Chiu E et al. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol 2005;23(31):7811-9. Abstract

 

 
 
 
     
 
 


 
Editor’s Note:
Cheetos and raisins for dinner: The curse of Wilma and why a public sector that can’t figure out a way to get electricity to gas stations seems unlikely to
be victorious in the “war on cancer”
 
Harold J Burstein, MD, PhD
- Select publications
 
Charles L Vogel, MD
- Select publications
 
Eleftherios P Mamounas, MD, MPH
- Select publications
 
Journal Club

Breast Cancer Journal Club Notes

Trastuzumab Plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer

Trastuzumab After Adjuvant Chemotherapy in HER2-Positive Breast Cancer

E2100: A Randomized Phase III Trial of Paclitaxel versus Paclitaxel Plus Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Safety and Efficacy of Two Different Doses of Capecitabine in the
Treatment of Advanced Breast Cancer (ABC) in Older Women

Fulvestrant versus Anastrozole for the Treatment of Advanced
Breast Carcinoma: A Prospectively Planned Combined Survival
Analysis of Two Multicenter Trials

Patterns of Care in Medical Oncology: A Case Survey Comparing Practices of Breast Cancer Investigators and General Oncologists
— Section A: Adjuvant Endocrine Therapy

 
CME Information
Faculty Disclosures
Editor's Office