Why is the current state of lung nodule management worrisome?

  Physician judgment has an important place in the newly updated ACCP guidelines for lung cancer. The guidelines recommend that clinicians estimate the probability of malignancy in indeterminate nodules >8 mm in diameter prior to screening, based on their own clinical judgment for characterization and/or quantification using validated risk models.  The study was conducted at 16 sites across the United States, and subjects had nodules 8 to 20 mm in diameter, were mostly former (45%) or current (27.5%) smokers, white (86%), and had private insurance (55.3%) or Medicare coverage (38.2%), and had a mean age of 64.5 years.  Invasive operations included any operation other than imaging monitoring alone. Computed tomography (CT) and fibrinoscopy-guided puncture biopsy were considered minimally invasive operations, while apparently invasive operations included any surgical operation such as mediastinoscopy, thoracotomy, and television-assisted thoracoscopic surgery (VATS).  The results showed that only 184 patients were monitored, and the number of examinations ranged from 1 to an “alarming 7” CT or PET scans over a 2-year period. None of the nodules were malignant.  Of the 124 nodules that underwent biopsy, 35% were malignant, 56% were diagnosed as benign, and 8% were judged to be benign based on stability. Of the 77 surgically resected nodules, 64% were malignant and 36% were benign.  The reassuring aspect of the study’s results is that 76% of the pulmonary nodules encountered by community respiratory physicians were benign, and the worrisome aspect is that the management of such patients tends to diversify as lung cancer screening becomes more widely available.  During the regular discussion following the presentation, several participants expressed concern that “36% of patients undergo surgery for benign disease” and emphasized that thoracotomy is associated with a 3% mortality rate and the possibility of decreased lung function after surgery. Other participants, including thoracic surgeons, countered that removal of suspicious nodules could resolve lung disease at an early stage, thus eliminating the need for repeat CT/PET imaging, and also responding to requests from some patients (to allay concerns or even to pass a pre-employment physical exam).  In an interview, conference co-moderator Anne Gonzalez, MD, an interventional respiratory pathologist at McGill University, said, “I am also shocked that so many patients are undergoing the procedure directly, but on the other hand, the guidelines do recommend that if the probability of suspicion of lung cancer is high enough – -to 65%, the patient should undergo surgery.” Dr. Gonzalez also echoed the participants’ discussion, noting that the study did not document in detail whether patients’ nodules were found incidentally or whether they were found by undergoing screening for the onset of symptoms.  In multivariate analysis, smoking (OR, 3.28) and larger nodules (12-15 mm: OR, 3.30; 16-20 mm: OR, 4.97) had an impact on subject selection for invasive procedures. The investigators also found that geographic location was not a predictive factor. Cancer was found in 39% of 16-20 mm nodes and 31% of 12-15 mm nodes, respectively, while only 12% of 8-11 mm nodes were cancerous.  One participant said his hospital established a 45-member multidisciplinary oncology committee to evaluate the disposition of patients with pulmonary nodules, and the number of patients undergoing surgery for benign disease has subsequently decreased dramatically. in an interview, Dr. Tanner said this approach is helpful in cases where patients are not lost to follow-up and can be supported by physicians from multiple departments, but “I don’t think this approach works for all lung nodules.” “In terms of lung cancer screening procedures, we at the VA hospital will soon begin to make diagnostic and treatment decisions based on the Fleischner Lung Nodule Imaging Follow-up and ACCP guidelines, as well as the ACCP guidelines.”