一项关于 IIb 级保留颈部清扫术在临床淋巴结阴性口腔鳞癌中应用的随机对照试验结果。
Results of a randomized controlled trial of level IIb preserving neck dissection in clinically node-negative squamous carcinoma of the oral cavity.
机构信息
Department of Surgical Oncology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221 005, India.
Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221 005, India.
出版信息
World J Surg Oncol. 2018 Nov 8;16(1):219. doi: 10.1186/s12957-018-1518-z.
BACKGROUND
The lymphatic spread from the cancers of the oral cavity follows an orderly progression and involvement of lower nodes without involvement of upper nodes and skip metastasis is rare. Selective neck dissections are increasingly being performed for node-positive patients; however, in node-negative patients the options of wait and watch, prophylactic radiotherapy, and prophylactic elective node dissections are debated. Quality of life and shoulder functions are important to choose the appropriate therapeutic modality.
PATIENTS AND METHODS
Patients with oral squamous carcinoma with clinically and radiologically negative neck were randomized to IIb preserving superselective neck dissection or conventional supraomohyoid neck dissection. The primary end point of the study was recurrence of disease (clinical or radiological) and shoulder function as demonstrated by the clinical examination and electromyography. The secondary end point was quality of life as measured by the FACT-HN version 4 questionnaire at the end of 1 year follow-up.
RESULTS
The mean number of lymph node harvested per patient was 25.6 (range 8-85). Of the 32 patients, 3 had histologically positive node in level Ib, one of these patients had single positive node while the remaining two had three positive nodes in level Ib. At median follow-up of 36 months disease-free survival in IIb, sparing group was 83% compared to 91% in control arm, the difference in survival between two groups was statistically not significant (p = 0.694). EMG of the shoulder showed denervation pattern in 45% patients undergoing IIb preserving surgery at 1 month follow-up compared to 95% in conventional surgery group, this recovered in all patients but one at 3 months and 100% recovery was seen at 6 months.
CONCLUSIONS
The results of the present study indicate that superselective IIb preserving neck dissections are technically feasible and appear to be oncologically safe procedures when performed as elective prophylactic procedures in highly select group of patients. A significant number of occult metastasis seen in the present study suggests prophylactic dissection to be better than wait and watch policy. Results also show initial higher shoulder morbidity at 1 month in patients undergoing IIb preserving dissections; however, at the end of 1 year recovery is complete and both procedures are comparable.
TRIAL REGISTRATION
The trial is registered at clinicaltrials.gov with registration no NCT00847717 ; registered on February 19, 2009.
背景
口腔癌的淋巴转移遵循有序的进展，先累及下部淋巴结，而不先累及上部淋巴结，跳跃性转移很少见。对于阳性淋巴结患者，越来越多地进行选择性颈部清扫术；然而，对于阴性淋巴结患者，观察等待、预防性放疗和预防性选择性淋巴结清扫术的选择存在争议。选择适当的治疗方式时，生活质量和肩部功能很重要。
患者和方法
临床和影像学检查均为阴性的口腔鳞状细胞癌患者被随机分为 IIb 保留型超选择性颈部清扫术或常规 supraomohyoid 颈部清扫术。该研究的主要终点是疾病（临床或影像学）复发和肩部功能（通过临床检查和肌电图显示）。次要终点是通过 FACT-HN 第 4 版问卷在 1 年随访结束时测量的生活质量。
结果
每位患者平均采集的淋巴结数为 25.6 个（范围 8-85 个）。在 32 名患者中，3 名患者的 Ib 水平有组织学阳性淋巴结，其中 1 名患者有单个阳性淋巴结，其余 2 名患者有 3 个 Ib 水平的阳性淋巴结。在中位随访 36 个月时，IIb 保留组的无疾病生存率为 83%，对照组为 91%，两组间生存率差异无统计学意义（p=0.694）。在 1 个月随访时，接受 IIb 保留手术的患者中有 45%的肩部肌电图显示失神经模式，而常规手术组有 95%，所有患者除 1 例外，在 3 个月时均恢复，6 个月时完全恢复。
结论
本研究结果表明，超选择性 IIb 保留颈部清扫术在高度选择的患者群体中作为选择性预防性手术是可行的，并且在肿瘤学上是安全的。本研究中发现的大量隐匿性转移表明预防性清扫术优于观察等待策略。结果还显示，在接受 IIb 保留性清扫术的患者中，术后 1 个月肩部发病率较高，但在 1 年后完全恢复，两种手术效果相当。
试验注册
该试验在 clinicaltrials.gov 上注册，注册号为 NCT00847717；于 2009 年 2 月 19 日注册。
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