Investigating extrathoracic metastatic disease in patients with apparentlyoperable lung cancer

Background. The optimal approach to the investigation of possible distant m etastases in patients with apparently operable non-small cell lung cancer w ho do not have symptoms suggesting metastatic disease is controversial. Methods. We conducted a randomized, controlled trial in thoracic surgery se rvices at mainly academic tertiary- and secondary-care general hospitals. W e recruited 634 patients with apparently operable, suspected or proven non- small cell carcinoma of the lung without findings on history, physical exam ination, laboratory testing, or imaging suggesting extrathoracic metastases . Patients were randomly allocated to receive either mediastinoscopy and co mputed tomography of the chest and then, depending on the results, immediat e 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 sub sequent recurrence) in the full investigation group versus the limited inve stigation 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). Pati ents in the full investigation group were more likely to have avoided thora cotomy because of extrathoracic metastatic disease than those in the limite d investigation group (22 patients versus 10 patients, respectively; relati ve risk, 2.19; 95% CI, 1.04 to 4.59; p value = 0.04). The total number of n egative invasive tests was six in the full investigation group and one in t he 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, respectivel y (relative risk, 1.84; 95% CI, 0.68 to 4.98; p = 0.23). The full investiga tion 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 T he Society of Thoracic Surgeons.