August 20, 2015 — Navidea Biopharmaceuticals announced publication of the results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc 99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site pain in patients with breast cancer undergoing lymphoscintigraphy.
The paper titled, “Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy,” was published online in the Annals of Surgical Oncology and indicated, with patient-reported data, a statistically significant reduction in the level of post-injection associated pain using Lymphoseek compared with use of an fTcSC tracer.
“As surgeons who perform sentinel lymph node (SLN) biopsy procedures in breast cancer patients, one of our key focuses is optimizing a patient’s overall experience,” said Anne Wallace, M.D., professor of surgery, UC San Diego School of Medicine, director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center and the study’s lead investigator. “We designed this study to understand if Lymphoseek injection is less painful and could improve the patient experience. The results demonstrated that Lymphoseek, in fact, minimizes patient discomfort while allowing for effective SLN mapping.”
The publication included results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicated baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.
Lymphoseek is a U.S. Food and Drug Administration (FDA)-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients.
For more information: www.navidea.com