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

Michael T. Jaklitsch*, Lin Gu, Todd Demmy, David H. Harpole, Thomas A. D'Amico, Robert J. McKenna, Mark J. Krasna, Leslie J. Kohman, Scott J. Swanson, Malcolm M. Decamp, Xiaofei Wang, Susan Barry, David J. Sugarbaker

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)9-16
Number of pages8
JournalJournal of Thoracic and Cardiovascular Surgery
Volume146
Issue number1
DOIs
StatePublished - Jul 2013

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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