Sentinel Nodes: Clinical Trial Data Needed
Authors: David Krag, Taka Ashikaga, Jeff Abrams, Armando E. Giuliano
Journal: Journal of Clinical Oncology (2000)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2000.18.22.3873 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11078501 Sentinel Nodes: Clinical Trial Data Needed David KragxDavid KragSearch for articles by this author , Taka AshikagaxTaka AshikagaSearch for articles by this author , Jeff AbramsxJeff AbramsSearch for articles by this author Armando E. GiulianoxArmando E. GiulianoSearch for articles by this author Show More University of Vermont Burlington, VTNational Cancer Institute Bethesda, MDJohn Wayne Cancer Institute Santa Monica, CA https://doi.org/10.1200/JCO.2000.18.22.3873 First Page Full Text PDF Figures and Tables © 2000 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse15112000In Reply:I agree with some of the comments of Drs Krag, Abrams, and Ashikaga regarding our article “Prospective Observational Study of Sentinel Lymphadenectomy Without Further Axillary Dissection.”1 Their points concerning the rationale for removing regional nodes in patients with breast cancer are similarly stated in the Discussion of our article. I also recognize that physical examination, which was a detection method in our study, is an inaccurate method for assessing breast cancer regional recurrence. However, this method is, in fact, the most widely used assessment, has been used in nearly all studies to date, and continues to be the detection method in most ongoing studies. That there are unknown technical and biologic factors regarding sentinel lymphadenectomy (SLND) we acknowledged in the text. The impact of axillary dissection on survival is controversial, and the impact of SLND is unknown. Our article states, “this series is too small to detect slight differences in survival. Currently, there are no other survival data for patients who do not undergo axillary lymphadenectomy (ALND). …”While I agree with the above comments, I take strong issue with the contention that our study “may discourage efforts to conduct further critical evaluation through ongoing clinical trials.” First, that was not our intent. Our intent was quite the contrary. Further, we have actually treated patients who have been discouraged from entering sentinel node trials because they were told by their physicians “it is unsafe” to remove just the sentinel node. Our prospective observational study demonstrates for the first time the safety and feasibility of sentinel node biopsy alone in selected cases of breast cancer and therefore supports ongoing trials as safe and worthwhile. Our findings should, in fact, encourage clinicians to enter patients onto such trials. Clinical medicine is often advanced by initial observations at single institutions that are later expanded and confirmed at multiple centers. We have now provided such an initial observation that should serve as the basis for the larger, ongoing, multicenter trials.I cannot reconcile why Krag, Abrams, and Ashikaga believe we concluded that “routine ALND can be eliminated for patients with histopathologically negative sentinel nodes.” I am particularly troubled by their omission of the actual word used in our article, namely, “suggests.” This omission alters the tone, meaning, and significance of our study. We were more cautious. The article states several times, including in the conclusion of the abstract, that this study “supports” SLND as a staging alternative for breast cancer and then later that this study “suggests” that routine ALND can be eliminated. On page 2558, the article states that “we cannot exclude the possibility that these patients have subclinical nonsentinel metastases not detected by immunohistochemistry that might become clinically significant in time.” The article further acknowledges, “Large multicenter trials are required to answer these issues.” The three National Cancer Institute–sponsored ongoing breast cancer sentinel node trials are described in some detail. Such a description of ongoing trials is quite unusual for a scientific communication in a peer-reviewed publication. The article further remarks that we hope the ongoing trials will “definitively answer whether SLND can replace ALND … .”Therefore, I cannot agree with Krag, Abrams, and Ashikaga that our article may discourage participation in clinical trials. Although no author can control how a reader “may” react to a given publication, we made every effort to be cautious in our conclusion and encouraged participation in the National Cancer Institute–sponsored ongoing trials with no bias to any one trial. Many of us will continue to work hard to complete these important clinical studies. Regardless, I remain convinced that the results of our prospective observational study suggest that SLND may be an alternative to routine axillary lymph node dissection in some patients with breast cancer. In addition, I think most readers will agree that our study reflects the safety of SLND while promoting the rationale and need for further clinical trials. REFERENCE1. Giuliano AE, Haigh PI, Brennan MB, et al: Prospective observational study of sentinel lymphadenectomy without further axillary dissection in patients with sentinel node–negative breast cancer. J Clin Oncol 18:: 2553,2000-2559, Link, Google Scholar