Sentinel node biopsy makes case in oral cavity cancer

Source: www.medpagetoday.com Author: Charles Bankhead Patients with early-stage oral cavity cancers had similar survival with less neck disability with a less invasive approach to lymph node assessment, a multicenter randomized study showed. The 3-year overall survival (OS) rate was 87.9% with sentinel lymph node biopsy (SLNB) and 86.6% with elective node dissection (ND). The 3-year disease-free survival (DFS) rate was 78.7% versus 81.3% in the SLNB and ND groups. Both outcomes met statistical criteria for noninferiority of the two approaches to lymph node assessment. The SLNB group had significantly better scores on a test of neck function, reported Yasuhisa Hasegawa, MD, PhD, of Asahi University Hospital in Gifu, Japan, and co-authors. "SLNB-navigated ND is noninferior and less invasive than elective ND," the authors wrote in the paper online in the Journal of Clinical Oncology. "The results of this study may promote a widespread use of SLNB (for early-stage OCSCC [oral-cavity squamous cell carcinoma]) worldwide." The results added to a growing volume of evidence suggesting similar outcomes between SLNB and the more-invasive ND. Last year a randomized study from France showed a 2-year relapse-free survival rate of 89-91% with the two approaches to lymph node assessment in oral and oropharyngeal cancer. A large retrospective cohort study resulted in similar OS and a shorter hospital stay as compared with ND. Multiple studies have demonstrated improved functional outcomes and lower complication rates with SLNB, the authors noted. Optimal management of clinically node-negative early-stage OCSCC remains controversial. Advantages have been reported for observation, ND, [...]

Lymphoseek designated fast track status in head and neck cancer

Source: www.empr.com Author: press release Navidea announced that the FDA has granted Fast Track designation to Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymposeek Injection was evaluated in a prospective, open-label, multicenter, within-patient study (NEO3-06). It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection. A minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease was required. Thirty nine subjects out of over 80 subjects enrolled were determined to have pathology-positive lymph nodes. Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before the end of 2013. Lymphoseek is already approved for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

2013-12-11T04:54:14-07:00December, 2013|Oral Cancer News|
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