Dichotomous ALK-IHC is a better predictor for ALK inhibition outcome than traditional ALK-FISH in advanced non–small cell lung cancer

摘要: Purpose: ALK rearrangement detection using FISH is the standard test to identify patients with non-small cell lung carcinoma (NSCLC) eligible for treatment inhibitors. Recently, protein expression in resectable NSCLC showed predictive value. We evaluated tumor response rate and survival after crizotinib of advanced activation both dichotomous immunohistochemical (IHC) staining FISH.Experimental Design: Patients stage IV treated were selected. Tumor was assessed. rearrangements detected by (Vysis ALK-break-apart FISH-Probe KIT) IHC [Ventana (D5F3) CDx assay]. Cohorts ALK-FISH-positive from four other hospitals used validation.Results: Twenty-nine consecutive ALK-positive diagnosed and/or on small biopsies or fine-needle aspirations (FNA) All ALK-IHC-positive responded except three primary resistance. No observed 13 but ALK-IHC-negative patients. This confirmed an external cohort 16 Receiver operator characteristic (ROC) curves ALK-IHC ALK-FISH compared outcome that outperforms [tumor area under curve: (AUC), 0.86 vs. 0.64, P = 0.03; progression-free (PFS): AUC 0.36, 0.005; overall (OS): AUC, 0.78 0.41, 0.01, respectively].Conclusions: Dichotomous superior FNA predict NSCLC. Our data strongly suggest adapting guidelines as companion diagnostic select who benefit ALK-targeting therapy. Clin Cancer Res; 23(15); 4251-8. ©2017 AACR.