학술논문

Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials
Document Type
article
Source
Annals of Surgical Oncology. 20(8)
Subject
Biomedical and Clinical Sciences
Oncology and Carcinogenesis
Cancer
Patient Safety
Clinical Research
Clinical Trials and Supportive Activities
Breast Cancer
Adult
Aged
Aged
80 and over
Axilla
Breast Neoplasms
Coloring Agents
Dextrans
Female
Humans
Lymph Nodes
Lymphatic Metastasis
Mannans
Middle Aged
Radionuclide Imaging
Radiopharmaceuticals
Sentinel Lymph Node Biopsy
Technetium Tc 99m Pentetate
Oncology & Carcinogenesis
Oncology and carcinogenesis
Language
Abstract
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