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Lymphoscintigram after peritumoral injection of tilmanocept in a patient with floor of mouth carcinoma. The sentinel node (small spot) close to the injection site (large spot) is clearly visible. (Image: Prof. Remco de Bree, VU University Medical Center Amsterdam)
0 Comments Feb 27, 2015 | News Americas

New tracer helps avoid neck dissection in head and neck cancer patients

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HOUSTON/COLUMBUS, Ohio/MIAMI, USA: A team of researchers has been able to accurately identify the sentinel node—the first lymph node to which a cancer spreads—in head and neck squamous cell carcinoma (HNSCC) using a novel radiotracer. This finding represents a significant step forward in reducing the complications caused by neck dissection in patients with head and neck tumors.

The radioactive diagnostic imaging agent used, 99mTc-tilmanocept, was approved by the Food and Drug Administration in 2013 under the product name Lymphoseek. Up to now, it has been used to locate lymph nodes in patients with breast cancer, melanoma or squamous cell carcinoma of the oral cavity who are undergoing surgery to remove tumor-draining lymph nodes, such as selective neck dissection.

New application possibilities of tilmanocept

Researchers from the U.S. have now found that tilmanocept can accurately identify the sentinel node in HNSCC, a difficult process, as there are up to 150 different lymph nodes in the neck. Thus, with the novel tracer, the number of HNSCC patients who currently undergo selective neck dissection can be reduced significantly.

"Until recently, surgeons had little choice but to carry out en-bloc surgery of all the soft tissue in a lymph node region, with all the after-effects that this entailed for the patient," explained Prof. Remco de Bree, head and neck surgeon at the VU University Medical Center Amsterdam and study adviser. "Our current multi-center pivotal study has shown that in many patients, by using a radiotracer with a novel receptor-based mechanism, the sentinel node can be reliably identified and removed for biopsy without having to undertake more extensive surgery," he stated.

Avoiding unnecessary neck dissection is important, given that the surgery can have significant negative side effects. These include decreased shoulder mobility with associated pain, difficulties with talking or swallowing, permanent nerve damage and numbness on the side where the surgery has been carried out.

Study design and results

In order to test the effectiveness of tilmanocept regarding head and neck cancer, the researchers performed a trial with early-stage HNSCC patients in 12 different medical centers in the U.S. A total of 83 patients who were all scheduled to undergo neck dissection were injected with the tracer. The researchers were able to identify and remove at least one sentinel node in 81 patients.

Compared with studies that use standard radio-colloid tracers, the sentinel node biopsy using tilmanocept provided a high identification rate and low false negative rate for sentinel nodes at all oral cavity sites, thus facilitating an accurate prediction of the spread of the cancer.

"Where other tracers have problems in identifying and harvesting of sentinel nodes when there is a close spatial relation between injection site and sentinel node—which is pronounced in the floor of mouth tumors—tilmanocept facilitated accurate prediction of the spread of the cancer in all oral cavity sites. We believe that we have made an important step forward in minimizing post-operative morbidity for patients with early HNSCC, enabling a more accurate identification of the stage of their disease, and reducing the cost to health care systems at the same time," stated de Bree.

Follow-up study

The researchers now plan to start a study in the European Union in which patients will undergo sentinel node mapping (lymphoscintigraphy) after the injection of both types of radiotracers. "If we find that lymphoscintigrams using tilmanocept are at least as good as the conventional radio-colloid tracers in identification and visualization of sentinel nodes, we would like to see a randomized clinical trial involving large numbers of patients," said De Bree.

The study report, titled "Pivotal Trial Results and EU Comparison of 99mTc-Tilmanocept in Sentinel Node Biopsy in Head and Neck Cancer Patients," was presented at the fifth International Conference on Innovative Approaches in Head and Neck Oncology in Nice, France, on Feb. 13.

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