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.

Study Details

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.