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NEW APPROACHES TO THE TREATMENT OF HEPATIC MALIGNANCIES |
From the Departments of Surgery (AMW) and Anesthesiology (GS), University of California, San Diego Comprehensive Cancer Center (AMW, CKH, DRV, DDD), and the Division of Nuclear Medicine (CKH, DRV), University of California, San Diego, La Jolla, California.
Correspondence: Address correspondence and reprint requests to: Anne M. Wallace, MD, Theodore Gildred Cancer Facility, 200 West Arbor Drive, San Diego, CA 92103-8421; Fax: 619-543-6644; E-mail: amwallace{at}ucsd.edu
ABSTRACT
Background: Lymphoseek is a new radiopharmaceutical that accumulates in lymphatic tissue by binding to a receptor that resides on the surface of macrophage cells. We conducted a phase I clinical trial in which Lymphoseek was compared with filtered [99mTc]sulfur colloid (fTcSC) for sentinel node detection in patients with breast cancer.
Methods: Twelve women (42–71 years) with breast cancer were randomly assigned to a 3-hour imaging protocol with peritumoral/subdermal injections (.5 mCi) of either Lymphoseek (1 nmol; molecular weight, 28 kDa; diameter, .007 µm) or .2 µm of fTcSC. Serial images were acquired for 180 minutes. Sentinel nodes, excised within 4.2 to 7.3 hours of administration, were assayed in a dose calibrator.
Results: The receptor-binding agent, Lymphoseek, exhibited a significantly (P = .0025) faster injection site clearance (rate, .255 ± .147/hour; fTcSC rate, .014 ± .018/hour); the mean Lymphoseek clearance half-time was 2.72 ± 1.57 hours compared with 49.5 ± 38.5 hours for fTcSC. The primary sentinel node uptake of Lymphoseek (range, .02%–1.12%; mean, .55% ± .43%) and fTcSC (range, .00%–1.93%; mean, .65% ± .63%) did not differ (P = .75). Lymphoseek exhibited a lower mean number of sentinel nodes per study (n = 1.3) than fTcSC (n = 1.7) and a higher concordance with Lymphazurin.
Conclusions: The molecular receptor-binding agent Lymphoseek demonstrated faster injection site clearance and equivalent primary sentinel node uptake when compared with fTcSC.
Key Words: Sentinel lymph node biopsy • Radiopharmaceutical • [99mTc]DTPA-mannosyl-dextran • Lymphoseek
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