Abstract
Objective. Stereotactic body radiotherapy (SBRT) has recently been investigated as an alternative treatment in place of surgery in clinical trials, especially in medically inoperable (MI) patients. However, no clear rationale for the criteria used to determine whether or not a patient is MI has yet been demonstrated. Methods. Between January 2004 and October 2012, 740 patients underwent surgical resection of clinical stage IA non-small cell lung cancer (NSCLC). In the present study, MI was defined as an FEV1.0 of ≤0.8 l, %DLCO of <40%, PaO2 of ≤70 mmHg, PaCO2 of >50 mmHg or three or more severe comorbidities, based on the criteria of MI frequently used in clinical trials of SBRT for NSCLC patients. The clinicopathological characteristics and surgical outcomes were compared between the MI patients (n=91) and operable patients (n=649). Results. The proportion of males (P=0.002), elderly subjects (P<0.001) and smokers (P<0.001) were higher among the MI patients than the operable patients. Limited surgery (wedge lung resection or segmentectomy) was performed in 37 (40.7%) MI patients and 227 (35.0%) operable patients (P=0.289). Mediastinal lymph node dissection was performed in 48 (52.7%) MI patients and 413 (63.6%) operable patients (P=0.045). The rate of overall morbidity was higher in the MI patients (38.5% in the MI patients vs 23.4% in the operable patients, P=0.002). The 30-day and 90-day mortality rates among the MI patients were 1.1% and 3.3%, respectively. Although overall survival was significantly worse in the MI patients (P=0.002), there were no significant differences in cancer-specific survival between the groups (P=0.293). Conclusions. Surgical resection can be performed safely in MI patients, with an equivalent cancer-specific survival to that observed in operable patients. Therefore, the current criteria used to determine whether a patient is MI for clinical trials of SBRT for NSCLC are not appropriate for evaluating the true degree of operability.
