Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint
| Autor: | Judy C. Boughey, Michael D. Alvarado, Rachael B. Lancaster, W. Fraser Symmans, Rita Mukhtar, Jasmine M. Wong, Cheryl A. Ewing, David A. Potter, Todd M. Tuttle, Tina J. Hieken, Jodi M. Carter, James W. Jakub, Henry G. Kaplan, Claire L. Buchanan, Nora T. Jaskowiak, Husain A. Sattar, Jeffrey Mueller, Rita Nanda, Claudine J. Isaacs, Paula R. Pohlmann, Filipa Lynce, Eleni A. Tousimis, Jay C. Zeck, M. Catherine Lee, Julie E. Lang, Paulette Mhawech-Fauceglia, Roshni Rao, Bret Taback, Constantine Godellas, Margaret Chen, Kevin M. Kalinsky, Hanina Hibshoosh, Brigid Killelea, Tara Sanft, Gillian L. Hirst, Smita Asare, Jeffrey B. Matthews, Jane Perlmutter, Laura J. Esserman, and I-SPY 2 Investigators |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Clinical Trials and Supportive Activities Disease lcsh:RC254-282 and I-SPY 2 Investigators 03 medical and health sciences 0302 clinical medicine Breast cancer Pharmacotherapy Surgical oncology Clinical Research medicine Clinical endpoint Pharmacology (medical) Radiology Nuclear Medicine and imaging 030212 general & internal medicine Author Correction Cancer business.industry General surgery Axillary Lymph Node Dissection lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease Clinical trial Axilla medicine.anatomical_structure Oncology 030220 oncology & carcinogenesis Patient Safety business |
| Zdroj: | NPJ breast cancer, vol 4, iss 1 npj Breast Cancer, Vol 4, Iss 1, Pp 1-5 (2018) NPJ Breast Cancer |
| Popis: | Advances in the surgical management of the axilla in patients treated with neoadjuvant chemotherapy, especially those with node positive disease at diagnosis, have led to changes in practice and more judicious use of axillary lymph node dissection that may minimize morbidity from surgery. However, there is still significant confusion about how to optimally manage the axilla, resulting in variation among practices. From the viewpoint of drug development, assessment of response to neoadjuvant chemotherapy remains paramount and appropriate assessment of residual disease—the primary endpoint of many drug therapy trials in the neoadjuvant setting—is critical. Therefore decreasing the variability, especially in a multicenter clinical trial setting, and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node dissection, for all patients is necessary. The key elements which include proper staging and identification of nodal involvement at diagnosis, and appropriately targeted management of the axilla at the time of surgical resection are presented. The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with node positive disease, and present a framework for prospective clinical trials and practice. |
| Databáze: | OpenAIRE |
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