title: Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer.
abstract: BACKGROUND
  Whether patients with early-stage oral cancers should be treated with elective neck dissection at the time of the primary surgery or with therapeutic neck dissection after nodal relapse has been a matter of debate.
  
  
  METHODS
  In this prospective, randomized, controlled trial, we evaluated the effect on survival of elective node dissection (ipsilateral neck dissection at the time of the primary surgery) versus therapeutic node dissection (watchful waiting followed by neck dissection for nodal relapse) in patients with lateralized stage T1 or T2 oral squamous-cell carcinomas. Primary and secondary end points were overall survival and disease-free survival, respectively.
  
  
  RESULTS
  Between 2004 and 2014, a total of 596 patients were enrolled. As prespecified by the data and safety monitoring committee, this report summarizes results for the first 500 patients (245 in the elective-surgery group and 255 in the therapeutic-surgery group), with a median follow-up of 39 months. There were 81 recurrences and 50 deaths in the elective-surgery group and 146 recurrences and 79 deaths in the therapeutic-surgery group. At 3 years, elective node dissection resulted in an improved rate of overall survival (80.0%; 95% confidence interval [CI], 74.1 to 85.8), as compared with therapeutic dissection (67.5%; 95% CI, 61.0 to 73.9), for a hazard ratio for death of 0.64 in the elective-surgery group (95% CI, 0.45 to 0.92; P=0.01 by the log-rank test). At that time, patients in the elective-surgery group also had a higher rate of disease-free survival than those in the therapeutic-surgery group (69.5% vs. 45.9%, P<0.001). Elective node dissection was superior in most subgroups without significant interactions. Rates of adverse events were 6.6% and 3.6% in the elective-surgery group and the therapeutic-surgery group, respectively.
  
  
  CONCLUSIONS
  Among patients with early-stage oral squamous-cell cancer, elective neck dissection resulted in higher rates of overall and disease-free survival than did therapeutic neck dissection. (Funded by the Tata Memorial Centre; ClinicalTrials.gov number, NCT00193765.).
authors.affiliation: From Head Neck Services (A.K.D., R.V., N.K., M.D., G.P., D.C., A.D., P.C., P.P., S.N., D.N.), Department of Medical Oncology, Advanced Center for Treatment, Research and Education in Cancer (S.G.), Clinical Research Secretariat (R.H.), and the Departments of Radiation Oncology (J.P.A., S.G.-L.), Head Cytology (S.K.), Radio-diagnosis (S.A.), and Surgical Oncology (R.B.) - all at the Tata Memorial Centre, Mumbai, India.
authors.forename: Anil K
authors.initials: AK
authors.lastname: D'Cruz
authors.forename: Richa
authors.initials: R
authors.lastname: Vaish
authors.forename: Neeti
authors.initials: N
authors.lastname: Kapre
authors.forename: Mitali
authors.initials: M
authors.lastname: Dandekar
authors.forename: Sudeep
authors.initials: S
authors.lastname: Gupta
authors.forename: Rohini
authors.initials: R
authors.lastname: Hawaldar
authors.forename: Jai Prakash
authors.initials: JP
authors.lastname: Agarwal
authors.forename: Gouri
authors.initials: G
authors.lastname: Pantvaidya
authors.forename: Devendra
authors.initials: D
authors.lastname: Chaukar
authors.forename: Anuja
authors.initials: A
authors.lastname: Deshmukh
authors.forename: Shubhada
authors.initials: S
authors.lastname: Kane
authors.forename: Supreeta
authors.initials: S
authors.lastname: Arya
authors.forename: Sarbani
authors.initials: S
authors.lastname: Ghosh-Laskar
authors.forename: Pankaj
authors.initials: P
authors.lastname: Chaturvedi
authors.forename: Prathamesh
authors.initials: P
authors.lastname: Pai
authors.forename: Sudhir
authors.initials: S
authors.lastname: Nair
authors.forename: Deepa
authors.initials: D
authors.lastname: Nair
authors.forename: Rajendra
authors.initials: R
authors.lastname: Badwe
mesh_terms: D000328:Adult; D000368:Aged; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000401:mortality / Q000601:surgery*; D037981:Neck Dissection; D009367:Neoplasm Staging; D018307:Neoplasms, Squamous Cell / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D016019:Survival Analysis; D057832:Watchful Waiting