Combined Analysis of Phase III Trials Evaluating [99mTc]Tilmanocept and Vital Blue Dye for Identification of Sentinel Lymph Nodes in Clinically Node-Negative Cutaneous Melanoma
| Autor: | Jonathan S. Zager, Christopher A. Puleo, Anne M. Wallace, Julian A. Kim, Vernon K. Sondak, Schlomo Schneebaum, Dennis King, Lori Christman, Steve R. Martinez, Mark B. Faries, Jane L. Messina, Stanley P. L. Leong, Bruce J. Averbook |
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| Rok vydání: | 2012 |
| Předmět: |
Melanomas
Adult Male Pathology medicine.medical_specialty Skin Neoplasms Phase iii trials Sentinel lymph node 99mTc-tilmanocept Mannans Young Adult Rosaniline Dyes medicine Humans Prospective Studies Coloring Agents Radionuclide Imaging Melanoma Aged Neoplasm Staging Aged 80 and over Intraoperative Care Blue dye Sentinel Lymph Node Biopsy business.industry Dextrans Middle Aged Prognosis medicine.disease Node negative Oncology Lymphatic Metastasis Cutaneous melanoma Technetium Tc 99m Pentetate Female Surgery Lymph Nodes Lymph Radiology Radiopharmaceuticals business Follow-Up Studies |
| Zdroj: | Annals of Surgical Oncology |
| ISSN: | 1534-4681 1068-9265 |
| Popis: | Background [99mTc]Tilmanocept is a CD206 receptor-targeted radiopharmaceutical designed for sentinel lymph node (SLN) identification. Two nearly identical nonrandomized phase III trials compared [99mTc]tilmanocept to vital blue dye. Methods Patients received [99mTc]tilmanocept and blue dye. SLNs identified intraoperatively as radioactive and/or blue were excised and histologically examined. The primary end point, concordance, was the proportion of blue nodes detected by [99mTc]tilmanocept; 90 % concordance was the prespecified minimum concordance level. Reverse concordance, the proportion of radioactive nodes detected by blue dye, was also calculated. The prospective statistical plan combined the data from both trials. Results Fifteen centers contributed 154 melanoma patients who were injected with both agents and were intraoperatively evaluated. Intraoperatively, 232 of 235 blue nodes were detected by [99mTc]tilmanocept, for 98.7 % concordance (p |
| Databáze: | OpenAIRE |
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