Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials

Autor: Linda K. Han, Mark B. Faries, Charles E. Cox, Kenneth B. Deck, Anne M. Wallace, David R. Vera, Dennis King, Eli Avisar, Helen Krontiras, Lori Christman, Schlomo Schneebaum, Carl K. Hoh, Nathan Hall, Thomas G. Frazier, Stephen P. Povoski, Karl K. Limmer
Jazyk: angličtina
Předmět:
Zdroj: Annals of surgical oncology, vol 20, iss 8
Annals of Surgical Oncology
ISSN: 1068-9265
DOI: 10.1245/s10434-013-2887-8
Popis: BackgroundSentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [(99m)Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance.MethodsA total of 13 centers contributed 148 patients with breast cancer. Each patient received [(99m)Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [(99m)Tc]tilmanocept.ResultsA total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [(99m)Tc]tilmanocept for a concordance rate of 99.04 % (p
Databáze: OpenAIRE