hot off the press: four year results for the 2 No. American herceptin adjuvant trials

[Lani]

J Clin Oncol. 2011 Jul 18. [Epub ahead of print]
Four-Year Follow-Up of Trastuzumab Plus Adjuvant Chemotherapy for Operable Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Joint Analysis of Data From NCCTG N9831 and NSABP B-31.
Perez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, Martino S, Mamounas EP, Kaufman PA, Wolmark N.
Source
Edith A. Perez, Mayo Clinic, Jacksonville, FL; Edward H. Romond. University of Kentucky, Lexington, KY; Vera J. Suman, Mayo Clinic, Rochester, MN; Jong-Hyeon Jeong, University of Pittsburgh; Nancy E. Davidson, University of Pittsburgh Cancer Institute; Charles E. Geyer Jr and Norman Wolmark, Allegheny General Hospital, Pittsburgh, PA; Silvana Martino, The Angeles Clinic and Research Institute, Santa Monica, CA; Eleftherios P. Mamounas, Aultman Cancer Center, Canton, OH; and Peter A. Kaufman, Dartmouth Hitchcock Medical Center, Lebanon, NH.
Abstract
PURPOSE Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited. PATIENTS AND METHODS Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis. Results At 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39% reduction in death rate in favor of the trastuzumab-containing arm (P < .001). CONCLUSION These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects.

PMID: 21768458

[Jackie07]

I'd question the ethics of the parties responsible for these studies.

I remember when Herceptin was first approved, many trials began to offer all participants Herceptin because of its proven effectiveness for Her2 positive breast cancer. The effectiveness of Herceptin has been known for many years. The researchers of these studies should have offered participants Herceptin once it's approved by the FDA (in 2005? 2007?)

[Becky]

They did offer and about 25% of the control (non Herceptin) arm took it (primarily alone and not with chemo obviously). They are called the observational group