Prospective phase II trial of pre-resection thoracoscopic (VATS) restaging following neoadjuvant therapy for IIIA(N2) non-small cell lung cancer (NSCLC): Results of CALGB 39803

Abstract

7065 Background: N2 nodal downstaging following neoadjuvant therapy for Stage IIIA(N2) NSCLC correlates with improved survival after lung resection. Pathologic assessment of nodes following neoadjuvant therapy may avoid unnecessary thoracotomy. Repeat mediastinoscopy has increased risk and limited efficacy. VATS may provide a safe alternative for restaging. Methods: The primary objective of this prospective multi-institutional study was to determine the feasibility of VATS restaging of ipsilateral nodes in mediastinoscopy proven stage IIIA(N2) NSCLC following 2 cycles neoadjuvant platinum-based chemotherapy (chemo) and/or ≥ 40 Gy radiotherapy (XRT) prior to thoracotomy. The goal of VATS re-staging was to biopsy 3 (-) lymph node stations, 1 (+) N2 node, or pleural carcinomatosis. Results: 70 evaluable patients (pts) were accrued from 10 institutions, 47% male, 97% white, and 71% aged between 50 and 69 years. 60% had performance status (PS) = 0, 40% PS = 1. 47 pts (67%) had XRT, 68 (97%) had chemo. Number of VATS incisions ranged from 1 to 4, median 3. Median time of VATS was 63 minutes, range from 27 to 313. VATS restaging met criteria in 40 pts (57%) and revealed: 4 pleural carcinomatosis, 17 persistent N2 disease, 19 had 3 (-) nodal stations. An additional 13 VATS (18.6%) found no evidence of persistent N2 disease, but had inadequate nodal sampling due to unanticipated obliteration of nodal tissue. Thus, 53 VATS (76%, 95% CI: 64 - 85%) were able to restage the mediastinum. VATS was unsuccessful in 17 (24%): 11 due to adhesions/fibrosis, 4 from tumor bulk preventing nodal access, 1 VATS was aborted due to airway injury, and 1 had inadequate lung deflation. Of the 53 completed VATS, 21 provided cancer tissue, and 31 had histologic tissue obtained during thoracotomy. N2 downstaging occurred in 32 pts (46%). Sensitivity of VATS was 75%, specificity was 100%, and negative predictive value was 75.8%. No deaths, but 1 airway injury was directly attributed to VATS. Conclusions: VATS restaging was feasible and provided pathologic assessment of ipsilateral nodes in treated IIIA(N2) NSCLC. New treatment paradigms can be built on pathologic restaging. No significant financial relationships to disclose.