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在芝加哥当地时间5月31日下午的ASCO全体会议上，印度孟买Tata纪念中心的Anil D’Cruz教授带来的一项研究发现，预防性颈部淋巴结手术改善早期口腔癌患者生存（LBA3）。医脉通对此进行了报道。

Anil D’Cruz教授

ASCO专家Jyoti D. Patel评论说：“这项研究回答了长期困惑全世界医生的一个问题。我们不想要做过多的手术，除非是必要的，对于早期口腔癌患者，我们现在知道更广泛的手术可以延长生命。”

早期口腔癌颈部的处理一直是人们争论的问题，选择性颈部淋巴结切除（END）与治疗性颈清术（TND）的选择存在争议。 该研究是一项前瞻性的III期随机临床试验（NCT00193765），研究分析了单侧T1或T2期口腔鳞癌的患者初次手术时行经口END术较TND术（淋巴结复发时颈清）的优势。基于肿瘤大小、部位、性别及术前颈部超声对患者进行分层。主要终点为总生存期（OS），次要终点为无病生存期（DFS）。该试验计划END比TND在OS上有10％的优势（单侧 α=0.05，β=0.2），假设TND组的5年OS为60％，计划样本为710例。

2004年1月至2014年6月试验最终随机入组596例。一项500例患者（TND 255例，END 245例），最短随访时间9个月的中期意向性治疗分析，由数据安全监测委员会依据每组观察到的死亡数执行。两组间的肿瘤部位与分期无差异。其中427例舌癌，68例颊粘膜癌，5例口底癌；T1期221例，T2例279例。中位随访时间为39个月，TND组与END组的复发例数分别为146例与81例。END组的3年OS及DFS显著高于TND组，OS(80.0% vs.67.5%, HR=0.63, 95%CI 0.44-0.89, p=0.01) ，DFS(69.5% vs.45.9%, HR=0.44, 95%CI 0.34-0.58, p<0.001)。使用Cox回归对分层因子进行校正后，END组在OS和DFS上仍较TND组有明显优势。

在TND组复发病例每增加15例，死亡病例将增加8例。早期口腔癌患者行选择性颈部淋巴清扫术可以减少37％的死亡率，应考虑将此方案最为标准治疗方案。

会议专题》》》2015年ASCO年会专题报道

摘要原文

Background: Management of the neck in early oral cancers has been a matter of debate with clinical equipoise between elective (END) or therapeutic neck dissection (TND).

Methods: This is a prospective phase III RCT (NCT00193765) to test the superiority of END at the time of primary surgery over TND (neck dissection at the time of nodal relapse) in patients with lateralized T1 or T2 squamous carcinoma of oral cavity, amenable to peroral excision. Patients were stratified based on size, site, sex and preoperative neck ultrasound. The primary end point was overall survival (OS) and secondary end point was disease-free survival (DFS). The trial was planned to demonstrate a 10% superiority (1-sided α = 0.05 and β = 0.2) in OS for END vs. TND, assuming 60% 5-year OS in TND arm, with a planned sample size of 710. 

Results: This trial was terminated after 596 patients were randomized between January 2004 and June 2014. An interim intent-to-treat analysis of initial 500 patients (255 in TND, 245 END) with a minimum follow-up of 9 months was performed as mandated by Data and Safety Monitoring Committee based on the number of observed deaths in each arm. Both arms were balanced for site and stage. There were 427 tongue, 68 buccal mucosa and 5 floor of mouth tumors; 221 were TI and 279 T2. At a median follow-up of 39 months there were 146 recurrences in TND and 81 in END arms respectively. The 3-year OS was significantly higher in END compared to TND arm (80.0% vs. 67.5%, HR = 0.63, 95%CI 0.44-0.89, p = 0.01) as was 3-year DFS (69.5% vs. 45.9%, HR = 0.44, 95%CI 0.34-0.58, p < 0.001). After adjusting for stratification factors in Cox regression, END continued to be significantly superior to TND for both OS and DFS. 

Conclusions: There were 8 excess deaths for every 15 excess recurrences in the TND arm. Elective neck dissection in patients with early oral SCC results in 37% reduction in mortality and should be considered the standard of care.