Study title

Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer

journal

New England Journal of Medicine

study year

2015

QUESTION

Is there a survival difference between elective neck dissection (END) and therapeutic neck dissection (TND)?

Does ultrasonography have a role in early detection of nodal metastases during follow-up?

Study DESIGN

Prospective randomized controlled trial

STUDY GROUPS

END (ipsilateral neck dissection at the time of primary surgery) (n=245) vs TND (watchful waiting followed by neck dissection for nodal relapse) (n=255)

Population

Patients with lateralized stage T1-T2 oral squamous cell carcinoma (OCSCC)

Inclusion criteria

18-75 years old

Histopathologically proven invasive T1-T2 SCC of the oral cavity lateralized to one side of the midline

No previous treatment Amenable to undergoing oral excision

No history of head and neck cancer

Exclusion criteria

Previous surgery in head and neck

Upper alveolar/palatal lesions

Large heterogeneous leukoplakias

Diffuse oral submucous fibrosis

Follow-up

39 months

Primary endpoint(s)

Overall survival: END 80% (95% CI 74.1 – 85.8) vs TND 67.5% (95%CI 61.0 – 73.9). Hazard ratio = 0.64 in END group (p=0.01)

Secondary endpoint(s)

Disease-free survival: END 69.5% vs TND 45.9% (p<0.001)> Hazard ratio = 0.45 in END group (p<0.001)

Adverse events: END 6.6% vs TND 3.6%

Weblink

[https://www.nejm.org/doi/full/10.1056/nejmoa1506007]()

Brief summary

In early OCSCC, END resulted in higher overall and disease-free survival than TND

Authors

D’Cruz et al

Head and Neck Disease management Group, Mumbai, India