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
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.
CTSNet classification
10
28
Abbreviations and Acronyms
CALGB
Cancer and Leukemia Group B
EBUS
endobronchial ultrasound
EUS
endoesophageal ultrasound
NPV
negative predictive value
NSCLC
non–small cell lung cancer
PET
positron emission tomography
VATS
videothoracoscopy
Cited by (0)
The research for CALGB 39803 was supported, in part, by grants from the National Cancer Institute (CA31946) to the Cancer and Leukemia Group B (Monica M. Bertagnolli, MD, Chair) and to the CALGB Statistical Center (Daniel J. Sargent, PhD, CA33601).
The content of this report is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.
Disclosures: Authors have nothing to disclose with regard to commercial support.
A complete list of the institutions participating in this study can be found in the Appendix.