In a French phase III trial (Senti-MERORL) reported in the Journal of Clinical Oncology, Garrel et al found that sentinel node biopsy demonstrated oncologic equivalance to neck lymph node dissection in 2-year neck node recurrence–free survival in patients with operable cT1–T2N0 oral/oropharyngeal cancer.
In the multicenter equivalence trial, 279 eligible patients were randomly assigned to undergo neck lymph node dissection (n = 139) or sentinel node biopsy (n = 140), with biopsy alone performed if negative or followed by neck lymph node dissection if positive during primary tumor surgery. The primary outcome was neck node recurrence–free survival at 2 years.
Neck Node Recurrence–Free Survival
Mean follow-up was 4.95 years in the neck lymph node dissection group and 4.74 years in the sentinel node biopsy group. Neck node recurrence–free survival at 2 years was 89.6% in the neck lymph node dissection group vs 90.7% in the sentinel node biopsy group; the difference between groups was 1.1%, which was lower than the 10% hypothesis, confirming equivalence (P for equivalence < .01).
Neck node recurrence–free survival at 5 years was 88.6% vs 93.0%. Disease-specific survival was 95.5% vs 93.0% at 2 years and 88.6% vs 87.1% at 5 years. Overall survival was 92.6% vs 88.7% at 2 years and 81.8% vs 82.2% at 5 years. No significant differences between groups were observed for neck node recurrence–free survival (P = .92), disease-specific survival (P = .68), or overall survival (P = .42).
Median hospital stay was 8 days in the neck lymph node dissection group vs 7 days in the sentinel node biopsy group (P < .01).
Functional outcomes were significantly worse in the neck lymph node dissection group until 6 months after surgery, including elements of self-reported neck-shoulder impairment (eg, shoulder stiffness), arm abduction test results, and physiotherapy prescription rates.
The investigators concluded: “This study demonstrated the oncologic equivalence of the sentinel node biopsy and neck lymph node dissection approaches, with lower morbidity in the sentinel node biopsy arm during the first 6 months after surgery, thus establishing sentinel node biopsy as the standard of care in oral/oropharyngeal cancer.”
Renaud Garrel, MD, PhD, of the Head Neck Cancer & Laryngology Department, University Hospital Center of Montpellier, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the French National Institute of Cancer. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.