Standard therapy for inoperable stage III NSCLC is concurrent chemoradiotherapy (CCRT). The value of consolidation chemotherapy with docetaxel (D) plus cisplatin (C) following definitive CCRT was reported from a multinational, phase 3, randomized trial (Park K, et al. ASCO 2014. Abstract 7500). In this trial, 437 patients with inoperable stage III NSCLC were randomized to receive either CCRT alone (D + C + 66 Gy of thoracic radiation given as 33 fractions) or CCRT followed by consolidation chemotherapy with 3 additional cycles of D + C. The primary endpoint of the study was progression-free survival (PFS), with secondary endpoints of overall survival (OS), overall response rate, and safety. Median PFS was 8.0 months in the CCRT-alone arm versus 9.1 months in the consolidation arm (P = .38). Similarly, median OS was not significantly different among the 2 arms: 20.6 months and 21.2 months in the CCRT-alone and consolidation arms, respectively (P = .48). Negative studies such as this add value to the management of patients with NSCLC because they provide evidence that will prevent unnecessary patient exposure to potentially toxic therapy and lower the cost burden of treatment. Nevertheless, exploratory biomarker studies are under way with tissue samples from this study to evaluate the possibility that a biomarker-specific patient subset may benefit from consolidation therapy in this setting.
