Investigating extrathoracic metastatic disease in patients with apparently operable lung cancer

Background. The optimal approach to the investigation of possible distant metastases in patients with apparently operable non-small cell lung cancer who do not have symptoms suggesting metastatic disease is controversial. Methods. We conducted a randomized, controlled trial in thoracic surgery services at mainly academic tertiary- and secondary-care general hospitals. We recruited 634 patients with apparently operable, suspected or proven non-small cell carcinoma of the lung without findings on history, physical examination, laboratory testing, or imaging suggesting extrathoracic metastases. Patients were randomly allocated to receive either mediastinoscopy and computed tomography of the chest and then, depending on the results, immediate thoracotomy or bone scintigraphy and computed tomographic scanning of the head, liver, and adrenal glands. Results. The relative risk of thoracotomy without cure (the combination of open and closed thoracotomy, incomplete resection, and thoracotomy with subsequent recurrence) in the full investigation group versus the limited investigation group was 0.80 (95% confidence interval [CI], 0.56 to 1.13; p = 0.20). Forty-three patients in the full investigation group and 61 patients in the limited investigation group underwent a thoracotomy but subsequently had recurrence (relative risk, 0.70; 95% CI, 0.47 to 1.03; p = 0.07). Patients in the full investigation group were more likely to have avoided thoracotomy because of extrathoracic metastatic disease than those in the limited investigation group (22 patients versus 10 patients, respectively; relative risk, 2.19; 95% CI, 1.04 to 4.59; p value = 0.04). The total number of negative invasive tests was six in the full investigation group and one in the limited investigation group (relative risk, 6.1; 95% CI, 0.72 to 51.0; p = 0.10) and the total number of invasive tests, 11 versus six, respectively (relative risk, 1.84; 95% CI, 0.68 to 4.98; p = 0.23). The full investigation strategy cost $823 less per patient (95% CIs 2,482 to -725). Conclusions. Full investigation for metastatic disease in patients with non-small cell lung cancer without symptoms or signs of metastatic disease may reduce the number of thoracotomies without cure. The higher the threshold for considering symptoms to suggest metastatic disease, the more likely it is that investigation will spare patients futile thoracotomy. (C) 2001 by The Society of Thoracic Surgeons.