• Chest · Dec 2015

    Randomized Controlled Trial

    RANDOMIZED TRIAL OF ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION WITH AND WITHOUT RAPID ON-SITE EVALUATION FOR LUNG CANCER GENOTYPING.

    • Rocco Trisolini, Alessandra Cancellieri, Carmine Tinelli, Dario de Biase, Ilaria Valentini, Gianpiero Casadei, Daniela Paioli, Franco Ferrari, Giovanni Gordini, Marco Patelli, and Giovanni Tallini.
    • Chest. 2015 Dec 1; 148 (6): 1430-7.

    BackgroundExperts and scientific society guidelines recommend that rapid on-site evaluation (ROSE) be used with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) to optimize lung cancer genotyping, but no comparative trial has been carried out to confirm and quantify its usefulness.MethodsTo assess the influence of ROSE on the yield of EBUS-TBNA for a multigene molecular analysis of lung cancer samples, consecutive patients with suspected or known advanced lung cancer were randomized to undergo EBUS-TBNA without ROSE (EBUS arm) or with ROSE (ROSE arm). The primary end point was the rate of the successful accomplishment of the institution's clinical protocol for molecular profiling of nonsquamous non-small cell lung cancer (EGFR and KRAS testing, followed by ALK testing for tumors with EGFR and KRAS wild-type status).ResultsComplete genotyping was achieved in 108 of 126 patients (85.7%) (90.8% in the ROSE arm vs 80.3% in the EBUS arm, P = .09). The patients in the ROSE arm were less likely to have samples that could be used only for pathologic diagnosis because of minimal tumor burden (0 vs 6, P = .05), and were more likely to have the bronchoscopy terminated after a single biopsy site (58.9% vs 44.1%, P = .01).ConclusionsROSE prevents the need for a repeat invasive diagnostic procedure aimed at molecular profiling in at least one out of 10 patients with advanced lung cancer and significantly reduces the risk of retrieving samples that can be used only for pathologic subtyping because of minimal tumor burden.Trial RegistryClinicalTrials.gov; No.: NCT01799382; URL: www.clinicaltrials.gov.

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