Real-world snapshot of lung nodule management raises concerns

芝加哥——南加州医科大学的Nichole Tanner医生在美国胸科医师协会(ACCP)年会上报告了一项纳入385例患者的回顾性分析结果：因可疑肺结节而被社区呼吸科医生实施手术的患者，每3例中就有1例并无癌症。而且，半数良性疾病患者接受了侵入性操作。


Nichole Tanner医生

医生的判断在新近更新的ACCP肺癌指南中占有重要地位(Chest 2013;143:e93S-e120S)。指南建议临床医生根据自己的临床判断进行定性和/或采用经过验证的风险模型进行定量，在检查前估计直径＞8 mm的不确定结节的恶性概率。

这项研究在全美16个地点进行，受试者有直径8~20 mm的结节，大多是既往(45%)或目前(27.5%)吸烟者、白人(86%)，并有私人保险(55.3%)或Medicare保险(38.2%)，平均年龄为64.5岁。

侵入性操作包括除单纯影像学监测以外的任何操作。计算机断层扫描(CT)和纤支镜引导下穿刺活检被认为是微创侵入性操作，而明显有创性操作包括任何外科操作，如纵隔镜检查、胸廓切开和电视辅助胸腔镜手术(VATS)。

结果显示，仅有184例患者接受了监测，而且检查次数跨度很大，2年内从1次到“令人震惊的7次”CT或正电子发射断层扫描(PET)扫描不等。而这些结节没有1个是恶性的。

在接受了活检的124个结节中，35%为恶性，56%被诊断为良性，8%根据稳定性被判断为良性。在77个手术切除的的结节中，64%为恶性，36%为良性。

该研究结果令人欣慰的方面是社区呼吸医生遇到的肺结节76%是良性的，令人担忧的一面是随着肺癌筛查的广泛开展，对此类患者的处理方式趋于多样化。

在报告结束后的例行讨论中，一些与会者表达了对“36%的患者因良性疾病接受手术”这一现状的担忧，并强调胸廓切开术伴随着3%的死亡率，而且手术后肺功能有可能下降。包括胸外科医生在内的其他与会者则反驳，切除可疑的结节可以在早期解决肺部疾病，从而不必再重复进行CT/PET成像，而且也顺应了一些患者的要求(以消除担忧甚至是为了通过入职前体检)。

会议共同主持人、麦克吉尔大学的介入呼吸病学专家Anne Gonzalez医生在接受采访时表示：“我对于如此多的患者直接接受手术也感到震惊，但另一方面，指南确实推荐，如果怀疑肺癌的概率足够高——达到65%，患者就应当接受手术。”Gonzalez医生还呼应了与会者的讨论，指出这项研究没有详细记录患者的结节是偶然发现的还是因出现症状而接受筛查是发现的。

在多变量分析中，吸烟(OR，3.28)和结节较大(12~15 mm：OR，3.30；16~20 mm：OR，4.97)对侵入性操作的对象选择有影响。研究者还发现地理位置不是预测因素。在16~20 mm的结节和12~15 mm的结节中，分别有39%和31%为癌症，而在8~11 mm的结节中仅有12%为癌症。

一名与会者表示，他所在的医院建立了一个由45人组成的多学科肿瘤委员会以评估肺结节患者的处置，因良性疾病接受手术的患者数量随之大幅减少。Tanner医生在接受采访时表示，这种方法在患者不会失访的情况下是有帮助的，而且可获得多个科室的医生的支持，但“我不认为这种方法对所有肺结节都适用”。“在肺癌筛查程序方面，我们退伍军人事务部医院很快就将开始根据Fleischner肺结节影像学随访标准和ACCP指南作出诊断和治疗决策，以及ACCP指南。”

Tanner医生报告称为Integrated诊断公司(该研究的资助方)提供了咨询服务。


By: PATRICE WENDLING, Oncology Practice

CHICAGO – One in three patients sent to surgery for a suspicious lung nodule by their community pulmonologist did not have cancer in a retrospective analysis of 385 patients.

In addition, half of patients with benign disease underwent an invasive procedure, Dr. Nichole Tanner said at the annual meeting of the American College of Chest Physicians (ACCP).

In addition, half of patients with benign disease underwent an invasive procedure, Dr. Nichole Tanner said at the annual meeting of the American College of Chest Physicians (ACCP).

Physician judgment plays a key role in the newly updated ACCP lung cancer guidelines (Chest 2013;143:e93S-e120S). They recommend that clinicians estimate the pretest probability of malignancy for indeterminate nodules larger than 8 mm either qualitatively by using their clinical judgment and/or quantitatively with a validated risk model.

Patients in the study, conducted at 16 sites across the country, had 8- to 20-mm nodules, and were mostly former (45%) or current smokers (27.5%), white (86%), and covered by private insurance (55.3%) or Medicare (38.2%). Their average age was 64.5 years.

Invasive procedures included anything outside of simple imaging for monitoring. Computed tomography (CT)- and bronchoscopic-guided biopsy were considered minor invasive procedures, while major invasive procedures included any surgical procedure such as mediastinoscopy, thoracotomy, and video-assisted thorascopic surgery (VATS).

Monitoring only was used for 184 patients, and ran the gamut from one to a "shocking seven" CT or positron-emission tomography (PET) scans in 2 years, said Dr. Tanner, with the Medical University of South Carolina, Charleston. None of these nodules were malignant.

Of the 124 nodules biopsied, 35% were malignant, 56% were diagnosed as benign, and 8% were benign based on stability.

Of the 77 nodules surgically removed, 64% were malignant and 36% were benign, she said.

While a reassuring 76% of nodules seen by community pulmonologists were benign, the results highlight the complexity involved in managing a patient population that is surely on the rise as lung cancer screening spreads nationally.

During a rousing debate that followed the presentation, audience members expressed concern over the 36% of patients taken to surgery for benign disease, highlighting a 3% death rate associated with thoracotomy and the potential for reduced lung function after surgery.

Others, including a thoracic surgeon, countered that removal of a suspicious nodule can catch lung disease at an earlier stage, eliminates the need for repeat CT/PET imaging exposure, and is requested by some patients for their peace of mind or even to pass a pre-employment physical.

Session comoderator and interventional respirologist Dr. Anne Gonzalez, with McGill University Health Center, Montreal, said in an interview, "I was perhaps shocked there were so many [patients] that went directly to surgery, but on the other hand, the guidelines do recommend that if the suspicion of lung cancer is high enough – 65% – patients should go to surgery."

Dr. Gonzalez also echoed comments from the floor that, importantly, the study failed to detail whether patients’ nodules were identified as incidental findings or were the result of symptom-driven screening.

In a multivariate analysis, current smoking (odds ratio, 3.28) and larger nodule size (12-15 mm: OR, 3.30; 16-20 mm: OR, 4.97) influenced who underwent invasive procedures, Dr. Tanner said. Geographic region of the country did not pan out as a predictor.

Cancer was present in 39% of 16- to 20-mm nodules and 31% of 12- to 15-mm nodules, compared with 12% of 8- to 11-mm nodules.

One attendee commented that the number of patients undergoing surgery for benign disease at his institution has dramatically declined with the establishment of a 45-member multidisciplinary tumor board to review and manage patients with lung nodules.

This approach is helpful in that patients won’t be lost to follow-up and can be presented with a plan that has the support of multiple physicians, but "I don’t see this as a feasible way with which to manage every pulmonary nodule," Dr. Tanner said in an interview. "In the lung cancer screening program we’re implementing at our Veterans Affairs hospital in the very near future, we will have a nodule tracking system to ensure that no patients are lost to follow-up and will make treatment and diagnostic decisions based on the Fleischner criteria for radiographic follow-up of lung nodules, as well as the ACCP guidelines."

Dr. Tanner reported consulting for the study sponsor, Integrated Diagnostics.