NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, New South Wales 2050, Australia.
Br J Cancer. 2012 Mar 13;106(6):1045-52. doi: 10.1038/bjc.2012.62.
Sentinel lymph node biopsy (SLNB) is less invasive than axillary lymph node dissection (ALND) for staging early breast cancer, and has a lower risk of arm lymphoedema and similar rates of locoregional recurrence up to 8 years. This study estimates the longer-term effectiveness and cost-effectiveness of SLNB.
A Markov decision model was developed to estimate the incremental quality-adjusted life years (QALYs) and costs of an SLNB-based staging and management strategy compared with ALND over 20 years' follow-up. The probability and quality-of-life weighting (utility) of outcomes were estimated from published data and population statistics. Costs were estimated from the perspective of the Australian health care system. The model was used to identify key factors affecting treatment decisions.
The SLNB was more effective and less costly than the ALND over 20 years, with 8 QALYs gained and $883,000 saved per 1000 patients. The SLNB was less effective when: SLNB false negative (FN) rate >13%; 5-year incidence of axillary recurrence after an SLNB FN>19%; risk of an SLNB-positive result >48%; lymphoedema prevalence after ALND <14%; or lymphoedema utility decrement <0.012.
The long-term advantage of SLNB over ALND was modest and sensitive to variations in key assumptions, indicating a need for reliable information on lymphoedema incidence and disutility following SLNB. In addition to awaiting longer-term trial data, risk models to better identify patients at high risk of axillary metastasis will be valuable to inform decision-making.
前哨淋巴结活检（SLNB）在分期早期乳腺癌方面比腋窝淋巴结清扫术（ALND）具有更小的侵袭性，并且发生手臂淋巴水肿的风险较低，局部区域复发率在 8 年内相似。本研究评估了 SLNB 的长期有效性和成本效益。
开发了一个马尔可夫决策模型，以估计与 ALND 相比，在 20 年的随访中，基于 SLNB 的分期和管理策略的增量质量调整生命年（QALY）和成本。结局的概率和生命质量加权（效用）值是根据已发表的数据和人口统计数据进行估计的。成本是从澳大利亚医疗保健系统的角度进行估计的。该模型用于确定影响治疗决策的关键因素。
在 20 年的时间里，SLNB 比 ALND 更有效且成本更低，每 1000 名患者可获得 8 个 QALY 并节省 883,000 美元。当以下情况发生时，SLNB 的效果较差：SLNB 假阴性（FN）率>13%；SLNB FN 后 5 年腋窝复发率>19%；SLNB 阳性结果的风险>48%；ALND 后淋巴水肿的流行率<14%；或淋巴水肿效用减少<0.012。
SLNB 优于 ALND 的长期优势是适度的，并且对关键假设的变化敏感，这表明需要有关 SLNB 后淋巴水肿发生率和不便利性的可靠信息。除了等待更长时间的试验数据外，更好地识别具有高腋窝转移风险的患者的风险模型将有助于为决策提供信息。
