title: Prospective phase II trial of preresection thoracoscopic mediastinal restaging after neoadjuvant therapy for IIIA (N2) non-small cell lung cancer: results of CALGB Protocol 39803.
abstract: OBJECTIVE
  Accurate pathologic restaging of N2 stations after neoadjuvant therapy in stage IIIA (N2) non-small cell lung cancer is needed.
  
  
  METHODS
  A prospective multi-institutional trial was designed to judge the feasibility of videothoracoscopy to restage the ipsilateral nodes in mediastinoscopy-proven stage IIIA (N2) non-small cell lung cancer after 2 cycles of platinum-based chemotherapy and/or 40 Gy or more of radiotherapy. The goals included biopsy of 3 negative N2 node stations or to identify 1 positive N2 node or pleural carcinomatosis.
  
  
  RESULTS
  Ten institutions accrued 68 subjects. Of the 68 subjects, 46 (68%) underwent radiotherapy and 66 (97%) underwent chemotherapy. Videothoracoscopy successfully met the prestudy feasibility in 27 patients (40%): 3 negative stations confirmed at thoracotomy in 7, persistent stage N2 disease in 16, and pleural carcinomatosis in 4. In 20 procedures (29%), no N2 disease was found, 3 stations were not biopsied because of unanticipated nodal obliteration. Thus, 47 videothoracoscopy procedures (69%, 95% confidence interval, 57%-80%) restaged the mediastinum. Videothoracoscopy was unsuccessful in 21 patients (31%) because the procedure had to be aborted (n = 11) or because of false-negative stations (n = 10). Of the 21 failures, 15 were right-sided, and 10 had a positive 4R node. The sensitivity of videothoracoscopy was 67% (95% confidence interval, 47%-83%), and the negative predictive value was 73% (95% confidence interval, 56%-86%) if patients with obliterated nodal tissue were included. The sensitivity was 83% (95% confidence interval, 63%-95%) and the negative predictive value was 64% (95% confidence interval, 31%-89%) if those patients were excluded. The specificity was 100%. One death occurred after thoracotomy.
  
  
  CONCLUSIONS
  Videothoracoscopy restaging was "feasible" in this prospective multi-institutional trial and provided pathologic specimens of the ipsilateral nodes. Videothoracoscopy restaging was limited by radiation and the 4R nodal station.
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Mass 02115, USA. mjaklitsch@partners.org
authors.forename: Michael T
authors.initials: MT
authors.lastname: Jaklitsch
authors.forename: Lin
authors.initials: L
authors.lastname: Gu
authors.forename: Todd
authors.initials: T
authors.lastname: Demmy
authors.forename: David H
authors.initials: DH
authors.lastname: Harpole
authors.forename: Thomas A
authors.initials: TA
authors.lastname: D'Amico
authors.forename: Robert J
authors.initials: RJ
authors.lastname: McKenna
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Krasna
authors.forename: Leslie J
authors.initials: LJ
authors.lastname: Kohman
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Swanson
authors.forename: Malcolm M
authors.initials: MM
authors.lastname: DeCamp
authors.forename: Xiaofei
authors.initials: X
authors.lastname: Wang
authors.forename: Susan
authors.initials: S
authors.lastname: Barry
authors.forename: David J
authors.initials: DJ
authors.lastname: Sugarbaker
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology* / Q000601:surgery / Q000628:therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology* / Q000601:surgery / Q000628:therapy; D008297:Male; D008482:Mediastinum; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011446:Prospective Studies; D020775:Thoracic Surgery, Video-Assisted; D013906:Thoracoscopy / Q000379:methods