title: Randomized Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration With and Without Rapid On-site Evaluation for Lung Cancer Genotyping.
abstract: BACKGROUND
  Experts 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.
  
  
  METHODS
  To 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).
  
  
  RESULTS
  Complete 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).
  
  
  CONCLUSIONS
  ROSE 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.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT01799382; URL: www.clinicaltrials.gov.
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna; Interventional Pulmonology Unit, Policlinico Sant'Orsola-Malpighi, Bologna. Electronic address: rocco.trisolini@aosp.bo.it.
authors.forename: Rocco
authors.initials: R
authors.lastname: Trisolini
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Cancellieri
authors.affiliation: Clinical Epidemiology and Biometry Service, IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: Tinelli
authors.affiliation: Pathology Unit, Bellaria Hospital, Bologna.
authors.forename: Dario
authors.initials: D
authors.lastname: de Biase
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Valentini
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Casadei
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Daniela
authors.initials: D
authors.lastname: Paioli
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Franco
authors.initials: F
authors.lastname: Ferrari
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gordini
authors.affiliation: Thoracic Endoscopy and Pulmonology Unit, the Pathology Unit, and the Intensive Care Unit/118 EMS, Maggiore Hospital, Bologna.
authors.forename: Marco
authors.initials: M
authors.lastname: Patelli
authors.affiliation: Pathology Unit, Bellaria Hospital, Bologna.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Tallini
mesh_terms: D000368:Aged; D001999:Bronchoscopy / Q000379:methods*; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics / Q000473:pathology; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000379:methods*; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D005838:Genotype; D060005:Genotyping Techniques; D006801:Humans; D008175:Lung Neoplasms / Q000235:genetics / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D047368:Tumor Burden
chemical_list: C117307:KRAS protein, human; C512478:EGFR protein, human; D066246:ErbB Receptors; D016283:Proto-Oncogene Proteins p21(ras)