Although some of the more prominent trials first come to mind such as such as ACOSOG Z0011, NSABP B-32, and AMAROS, published articles from around the world describe 46 different randomized trials related to sentinel nodes and breast cancer.
This presentation will describe selected aspects of what we have learned from these randomized trials. The most important thing is that the surgical community has not sufficiently come to grips with conducting clinical trials. It is easy to critique the shortcomings of individual trials. The more important question is why there are shortcomings in the first place. The worldwide community should come together to make sure that the important questions are asked and definitively answered. The results from an effective clinical trial are not controversial.
The methods to conduct clinical trials are remarkably simple. This starts with an important clinical question that if answered will lead to better care. The parameters related to answering the clinical question involve basic statistics. The statistics should be sufficiently sophisticated but should also be intuitively clear to all participants. Then there needs to be a commitment by participants to conduct the trial. Our surgical societies need to be much more prominent in setting the standards that inspire the membership to enter patients in clinical trials. Effective tools that describe methods for training and quality control of surgical trials exist and are not that complicated nor expensive. Dissemination of the results should be so clear and transparent that it is understandable after reading the article once. The results from an effective clinical trial are not ambiguous.
The published articles that report randomized clinical trials for sentinel nodes and breast cancer can be found at www.TreeofMedicine.com . If you do not already have access to the database go to the Tree of Medicine website and click on “Topics” located in the top right of the home page. Then click on Sentinel Node and Breast cancer and navigate to and click on “Sign up for free”. Once in the data base look under the first level heading “Randomized trials”.