Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial

Abstract

PURPOSE This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points. METHODS Sixteen institutions in Japan participated in the study (trial registration number: UMIN000006510). Patients of age ≥ 18 years with histologically confirmed, previously untreated OCSCC (Union for International Cancer Control TNM Classification of Malignant Tumors 7th edition T1-2, node-negative no distant metastasis), with ≥ 4 mm (T1) depth of invasion, were randomly assigned to undergo standard selective ND (ND group; n = 137) or SLNB-navigated ND (SLNB group; n = 134). The primary end point was the 3-year overall survival rate, with a 12% noninferiority margin; secondary end points included postoperative neck functionality and complications and 3-year disease-free survival. Sentinel lymph nodes underwent intraoperative multislice frozen section analyses for the diagnosis. Patients with positive sentinel lymph nodes underwent either one-stage or second-look ND. RESULTS Pathologic metastasis-positive nodes were observed in 24.8% (34 of 137) and 33.6% (46 of 134) of patients in the ND and SLNB groups, respectively ( P = .190). The 3-year overall survival in the SLNB group (87.9%; lower limit of one-sided 95% CI, 82.4) was noninferior to that in the ND group (86.6%; lower limit 95% CI, 80.9; P for noninferiority < .001). The 3-year disease-free survival rate was 78.7% (lower limit 95% CI, 72.1) and 81.3% (75.0) in the SLNB and ND groups, respectively ( P for noninferiority < .001). The scores of neck functionality in the SLNB group were significantly better than those in the ND group. CONCLUSION SLNB-navigated ND may replace elective ND without a survival disadvantage and reduce postoperative neck disability in patients with early-stage OCSCC.

Sentinel Lymph Node Biopsy Versus Elective Node Dissection in Stage cT1‐2N0 Oral Cavity Cancer

“…47 Patient-reported outcomes will also be explored using the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). While two robust RCTs were included in our analysis that also looked extensively into shoulder morbidity and quality of life, 17,18 more studies such as the aforementioned clinical trial with larger sample sizes are needed to provide stronger evidence for SNB to be considered as a viable alternative to END for OCSCC.…”

“…14 Despite proven diagnostic capabilities and improved morbidity compared with END, there is limited data on survival outcomes between SNB and END. [14][15][16][17][18][19][20][21][22][23] Recently published randomized controlled trials (RCTs) by Hasegawa et al 18 and Garrel et al 17 found no survival differences between SNB and END arms. However, concerns have been raised about the a priori sample size requirements in these noninferiority trials, 24,25 and if these trials were adequately powered.…”

Centralised pathology service for sentinel node biopsy in oral cavity cancer: The Southeast England Consortium experience

“…Recent years have seen a growing body of evidence to indicate that SNLB, with completion neck dissection where necessary, has similar patient survival outcomes as END for the management of the N0 neck in early stage OSCC. [8][9][10][11]20 Furthermore, cost and quality of life analyses appear to favour SNLB over END in these patients. 12,21,22 Given these observations, several authorities recommend SLNB as the standard of care in cT1-2 N0 OSCC, while some professional bodies recommend that all patients with this disease should have access to the procedure.…”

“…Recent reports indicate similar survival outcomes between SLNB and END, [8][9][10][11] while emerging evidence suggests reduced morbidity in the former. 10,12 These findings have led several authorities to recommend SLNB over END in the management of T1-2 N0 OSCC.…”

Sentinel Node Biopsy or Neck Dissection for Early-Stage Oral Cancer For Long Term Follow-Up: Matched-Pair Analysis for pN0 Necks

“…Only one study compared a large retrospective cohort of patients of a database from the National Cancer Data Base without pairing both groups of patients 35 . Other two multicenter prospective trials observed a non-inferiority of SLNB over END regarding recurrence free, disease speci c and overall survival, but not all patients had a longer follow-up [36][37] . Our study was the rst to evaluate the recurrence rate between SNB and END groups with a longer follow-up, with a proposal of pairing patients statistically.…”