A substantial proportion of patients enrolled on ACOSOG Z0011 received protocol-deviant radiation treatment. It is currently unknown whether these deviations involved the use of more extensive fields in patients at higher nomogram-predicted risk.
We used the M.D. Anderson (MDA) and Memorial Sloan-Kettering (MSK) nomograms to estimate risk of additional positive axillary nodes using surgical pathology information. In the control arm, we compared axillary dissection (AD) findings to nomogram-predicted estimates for validation. We used logistic regression to evaluate whether nomogram-estimated higher risk of nodal involvement was associated with high tangent (HT) or supraclavicular (SCV) radiation fields for patients with known radiation field design.
552/856 (64.5%) had complete details for the MDA nomogram. Mean MDA risk estimate in both treatment arms was 23.8%. Estimated risk for patients on the AD arm with positive nodes was 25.9%. Higher risk estimate was associated with additional positive nodes in the AD arm (OR 1.04, 95% CI 1.02–1.06, p < 0.0001). We observed significant association with higher MDA nomogram-estimated risk and SCV radiation (OR 1.07, 95% CI 1.04–1.10, p < 0.0001) but not HT (OR 0.99, 95% CI 0.96–1.02, p = 0.52) The MSK nomogram had similar associations.
MDA and MSK nomogram risk estimates were associated with lymph node risk in ACOSOG Z0011. Radiation oncologists’ use of differing radiation fields were associated with treating higher risk patients.
ClinicalTrials.gov id: NCT00003854.
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Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology).The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. https://acknowledgments.alliancefound.org.
Conflict of interest
Dr. Katz owns common stock in Dr. Reddy's Laboratories, Healthcare Services Group, Mazor Robotics, and U.S. Physical Therapy. Dr. Ballman reports grants from National Cancer Institute, during the conduct of the study; personal fees from Eli Lilly, personal fees from Janssen Pharmaceuticals, personal fees from Janssen/Johnson and Johnson, personal fees from Medtronic, personal fees from Takeda, outside the submitted work; In addition, Dr. Ballman has a patent Genomic signature of recurrence in prostate cancer with royalties paid to Mayo Clinic, and a patent Genomic signature of benefit from trastuzumab issued to Mayo Clinic. Dr. Jagsi reports stock options as compensation for her advisory board role in Equity Quotient, a company that evaluates culture in health care companies; she has received personal fees from Amgen and Vizient and grants for unrelated work from the National Institutes of Health, the Doris Duke Foundation, the Greenwall Foundation, the Komen Foundation, and Blue Cross Blue Shield of Michigan for the Michigan Radiation Oncology Quality Consortium, outside the submitted work. Dr. Giuliano reports grants and other from ACOSOG, other from Alliance, during the conduct of the study.
All procedures performed in ACOSOG Z0011 were in accordance with the ethical standards of the ACOSOG (Alliance) study group and with the 1964 Helsinki Declaration and its subsequent amendments.
Informed consent was obtained from all individual participants included in this study.
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Katz, M.S., McCall, L., Ballman, K. et al. Nomogram-based estimate of axillary nodal involvement in ACOSOG Z0011 (Alliance): validation and association with radiation protocol variations. Breast Cancer Res Treat (2020). https://doi.org/10.1007/s10549-020-05555-z
- Breast cancer
- Axillary lymph node
- Sentinel lymph node
- Radiation therapy