Author Contributions: Dr Giuliano had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Giuliano, Reintgen, Morrow, Hunt, Cote.
Acquisition of data: Giuliano, Hawes, Whitworth, Morrow, Leitch, Hunt, Abati, Cote.
Analysis and interpretation of data: Giuliano, Hawes, Ballman, Whitworth, Blumencranz, Morrow, Leitch, Hunt, McCall, Abati, Cote.
Drafting of the manuscript: Giuliano, Hawes, Ballman, Morrow, Hunt, Cote.
Critical revision of the manuscript for important intellectual content: Giuliano, Hawes, Ballman, Whitworth, Blumencranz, Morrow, Leitch, Hunt, McCall, Abati, Cote.
Statistical analysis: Ballman, McCall, Cote.
Obtained funding: Giuliano, Cote.
Administrative, technical, or material support: Giuliano, Hawes, Whitworth, Reintgen, Morrow, Leitch, Hunt, Cote.
Study supervision: Giuliano, Cote.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Giuliano reported that he has received support from ACOSOG for travel to ACOSOG meetings. Dr Hawes reported receiving grant support from the NIH and travel support from ACOSOG and has personal and institutional grants pending from the NIH, the US Department of Defense, California Breast Cancer Research, Whittier Foundation, and V-Force. Dr Ballman reported institutional support from the National Institute of Cancer and other support from AstraZeneca, Lilly, and Novartis. Dr Whitworth reported travel support from ACOSOG. Dr Blumencranz reported institutional support from Morton Plant Hospital, serving on the Florida Society of General Surgeons board of directors; and institutional payment for lectures from Hologic. Dr Morrow reported grant support from ACOSOG. Dr Leitch reported travel support from ACOSOG and institutional support from ACOSOG for capitation payments for patients enrolled in a study.
Funding/Support: This study was supported by funds from the National Institutes of Health, under the grants entitled “Bone Marrow and Sentinel Node Micrometastases in Breast Cancer” (NCI R01 CA 85840; R. Cote, principal investigator) and American College of Surgeons Oncology Group (NCI U10 CA076001).
Role of the Sponsor: The sponsors had no role in the design and conduct of the study; the collection, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official view of the National Institutes of Health.
Previous Presentation: Presented in part at the annual meeting of the American Society of Clinical Oncology, June 4-8, 2010, Chicago, Illinois.
Additional Contributions: We thank the ACOSOG staff, in particular the leadership of Heidi Nelson, MD (ACOSOG Group Co-Chair, Mayo Clinic, Rochester, Minnesota), David Ota, MD (ACOSOG Group Co-Chair, Duke University, Durham, North Carolina), and Samuel A. Wells Jr, MD (senior clinician, National Cancer Institute, Bethesda, Maryland). All 3 of these physicians contributed to study design and/or manuscript review; none received compensation. We thank Gwen Berry, MHA, of the John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, California, for her editorial assistance, for which she received no compensation beyond her regular salary. We also thank the investigators and their site research teams. Finally, we wish to thank the brave patients with breast cancer who participated in this study and their caregivers.