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Bending the Curve Trial by Trial
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Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer

N = 596NCT00193765

Population
Lateralised stage T1 or T2 oral squamous-cell carcinoma, node negative
Design
Prospective randomised controlled trial (Tata Memorial Centre), 2004 to 2014, in lateralised stage T1 or T2 oral squamous-cell carcinoma: elective node dissection (ipsilateral neck dissection at the time of primary surgery) versus therapeutic node dissection (watchful waiting followed by neck dissection for nodal relapse). 596 patients enrolled; as prespecified by the data and safety monitoring committee, the report summarises the first 500 patients (245 elective, 255 therapeutic), median follow-up 39 months. Primary end point OS; secondary DFS.
Primary endpoint
OS
Arms
  • Therapeutic neck dissection (control, n = 255): Watchful waiting followed by neck dissection for nodal relapse
  • Elective neck dissection (experimental, n = 245): Ipsilateral neck dissection at the time of primary surgery
People
D'Cruz AK, Head and Neck Disease Management Group, Tata Memorial Centre
OSHR 0.64 (95% CI 0.45–0.92)Δ 36-month OS+12.5 pointsΔ 36-month DFS+23.6 points
Show the numbers
Results reported for Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer
EndpointAnalysisElective neck dissectionTherapeutic neck dissectionEffect
OSFirst 500 patients (245 elective, 255 therapeutic), as prespecified by the data and safety monitoring committeeinterimmedian follow-up 39 monthsD'Cruz 201580% at 3 y (74.1–85.8%)67.5% at 3 y (61.0–73.9%)HR 0.64 (95% CI 0.45–0.92)P=0.0181 recurrences and 50 deaths in the elective group; 146 recurrences and 79 deaths in the therapeutic group.
DFSFirst 500 patients (245 elective, 255 therapeutic)interimmedian follow-up 39 monthsD'Cruz 201569.5% at 3 y45.9% at 3 yP<0.001
Results reported for Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer
EndpointAnalysisElective neck dissectionTherapeutic neck dissectionEffect
OSFirst 500 patients (245 elective, 255 therapeutic), as prespecified by the data and safety monitoring committeeinterimmedian follow-up 39 monthsD'Cruz 201580% at 3 y (74.1–85.8%)67.5% at 3 y (61.0–73.9%)HR 0.64 (95% CI 0.45–0.92)P=0.0181 recurrences and 50 deaths in the elective group; 146 recurrences and 79 deaths in the therapeutic group.
DFSFirst 500 patients (245 elective, 255 therapeutic)interimmedian follow-up 39 monthsD'Cruz 201569.5% at 3 y45.9% at 3 yP<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.640.45–0.92
Primary publication: D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, et al. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015;373(6):521-9. PubMedDOI

Appears in

Sources

  1. D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, et al. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015;373(6):521-9.

    PubMedDOI