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The efficacy of Tilmanocept in sentinel lymph mode mapping and identification in breast cancer patients: a comparative review and meta-analysis of the 99mTc-labeled nanocolloid human serum albumin standard of care

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Abstract

Sentinel lymph node (SLN) mapping is common, however question remains as to what the ideal imaging agent is and how such an agent might provide reliable and stable localization of SLNs. 99mTc-labeled nanocolloid human serum albumin (Nanocoll®) is the most commonly used radio-labeled colloid in Europe and remains the standard of care (SOC). It is used in conjunction with vital blue dyes (VBDs) which relies on simple lymphatic drainage for localization. Although the exact mechanism of Nanocoll SLN localization is unknown, there is general agreement that Nanocoll exhibits the optimal size distribution and radiolabeling properties of the commercially available radiolabel colloids. [99mTc]Tilmanocept is a novel radiopharmaceutical designed to address these deficiencies. Our aim was to compare [99mTc]Tilmanocept to Nanocoll for SLN mapping in breast cancer. Data from the Phase III clinical trials of [99mTc]Tilmanocept’s concordance with VBD was compared to a meta-analysis of a review of the literature to identify a 99mTc albumin colloid SOC. The primary endpoints were SLN localization rate and degree of localization. Six studies were used for a meta-analysis to identify the colloid-based SOC. Five studies (6,134 patients) were used to calculate the SOC localization rate of 95.91 % (CI 0.9428–0.9754) and three studies (1,380 patients) were used for the SOC SLN degree of localization of 1.6683 (CI 1.5136–1.8230). The lower bound of the confidence interval was used for comparison to Tilmanocept. Tilmanocept data included 148 patients, and pooled analysis revealed a 99.99 % (CI 0.9977–1.0000) localization rate and degree of localization of 2.16 (CI 1.964–2.3600). Tilmanocept was superior to the Nanocoll SOC for both endpoints (P < 0.0001).

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Acknowledgments

We would like to acknowledge the technical assistance of Ms. Stephanie Dietz and Ms. Amy Bulgrin in the compilation of the data sets. This analysis supported by funds from Navidea Biopharmaceuticals.

Conflict of interest

FOC is an employee and officer of Navidea Biopharmaceuticals. WLM is an employee of Navidea Biopharmaceuticals. MSB is an employee of Navidea Biopharmaceuticals. BCA is an employee of Navidea Biopharmaceuticals. DRV is the inventor of Tilmanocept. The remaining authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Division of General Surgery, Department of Surgery, UCSD Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, CA, 92093, USA

    Christopher A. Tokin & Anne M. Wallace

  2. Division of Nuclear Medicine, Department of Radiology, UCSD Moores Cancer Center, UCSD In Vivo Cancer and Molecular Imaging Program, University of California, San Diego, La Jolla, CA, USA

    David R. Vera

  3. Navidea Biopharmaceuticals, Dublin, OH, USA

    Frederick O. Cope, Wendy L. Metz, Michael S. Blue, Beth M. Potter & Bonnie C. Abbruzzese

  4. College of Pharmacy, The Ohio State University, Columbus, OH, USA

    Richard D. Hartman & Marcus T. Joy

  5. STATKING Clinical Services, Cincinnati, OH, USA

    Dennis W. King & Lori A. Christman

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  1. Christopher A. Tokin
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  2. Frederick O. Cope
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  3. Wendy L. Metz
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  4. Michael S. Blue
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  7. Richard D. Hartman
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  11. David R. Vera
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  12. Anne M. Wallace
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Correspondence to Anne M. Wallace.

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Tokin, C.A., Cope, F.O., Metz, W.L. et al. The efficacy of Tilmanocept in sentinel lymph mode mapping and identification in breast cancer patients: a comparative review and meta-analysis of the 99mTc-labeled nanocolloid human serum albumin standard of care. Clin Exp Metastasis 29, 681–686 (2012). https://doi.org/10.1007/s10585-012-9497-x

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  • DOI: https://doi.org/10.1007/s10585-012-9497-x

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