择期性与治疗性颈清扫术在淋巴结阴性口腔癌中的应用。

Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer.

机构信息

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.

出版信息

N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.

DOI:10.1056/NEJMoa1506007

PMID:26027881

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.).

摘要

背景

对于早期口腔癌患者，应在原发手术时行选择性颈清扫术（ipsilateral neck dissection at the time of the primary surgery），还是在淋巴结复发后行治疗性颈清扫术（therapeutic node dissection），一直存在争议。

方法

本前瞻性、随机、对照试验评估了原发手术时行选择性颈清扫术（ipsilateral neck dissection at the time of the primary surgery）（同侧颈部清扫术）与淋巴结复发后行治疗性颈清扫术（watchful waiting followed by neck dissection for nodal relapse）（观察等待后行颈清扫术）对侧位 T1 或 T2 口腔鳞癌患者的生存影响。主要和次要终点分别为总生存和无病生存。

结果

2004 年至 2014 年，共纳入 596 例患者。根据数据和安全监测委员会的规定，本报告总结了前 500 例患者（选择性手术组 245 例，治疗性手术组 255 例）的结果，中位随访 39 个月。选择性手术组发生 81 例复发和 50 例死亡，治疗性手术组发生 146 例复发和 79 例死亡。3 年时，选择性颈清扫术组总生存率（80.0%；95%置信区间 [CI]，74.1 至 85.8）高于治疗性颈清扫术组（67.5%；95%CI，61.0 至 73.9），死亡风险比为 0.64（95%CI，0.45 至 0.92；log-rank 检验 P=0.01）。此时，选择性颈清扫术组无病生存率（69.5% vs. 45.9%，P<0.001）也高于治疗性颈清扫术组。在大多数亚组中，选择性颈清扫术均优于治疗性颈清扫术，无显著交互作用。选择性颈清扫术组和治疗性颈清扫术组的不良事件发生率分别为 6.6%和 3.6%。