Sentinel Lymph Node Biopsy in Early Stage Oral Cavity Disease (NRG-HN006)

April 15 2020

Article by Jennifer Hsing Choe, MD, of Duke University’s Duke Cancer Institute

Treatment for early stage oral cavity cancers typically entail elective node dissection (END) due to the risk of occult metastasis. END is a typical approach for management of early stage oral cancers. However, 70-80% of these cases will have uninvolved nodal disease which resulted in a much more extensive surgery than may have been necessary for locoregional control. The resulting long-term effects of elective node dissections can result in significant morbidity, such as muscle weakness due to spinal accessory nerve damage that impairs patient quality of life. While heavily used in melanoma and breast cancer, sentinel lymph node biopsy for guidance on the necessity of elective node dissection in oral cavity cancers has yet to be prospectively evaluated in a randomized study.

Expected to be open for accrual in late Spring, NRG-HN006 is a phase II/III trial that evaluates the role of sentinel lymph node biopsy compared to a full elective neck dissection in patients with early stage oral cavity cancer (T1-T2 N0, AJCC 8th edition). Patients with negative baseline PET/CTs will be randomly assigned to either receive a sentinel lymph node biopsy versus an elective node dissection. A sentinel node biopsy approach capitalizes on the draining patterns of oral cavity tumors to isolate the most likely involved LNs without subjecting the patients to the potential complications of a neck dissection.

Quality of life measures will serve as the phase II primary endpoint while the phase III component will include quality of life in addition to disease-free survival as co-primary endpoints. Results of this study will provide prospective evidence as to whether sentinel lymph node biopsies provide an informed decision-making tool for sparing early stage oral cavity patients from the potential surgical complications of an elective node dissection.

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