The Lung ART adjuvant radiotherapy phase 3 randomized trial: Impact of quality of resection in stage IIIAN2 patients.

Abstract

8522 Background: Lung ART is an international phase 3 trial whose main objective was to evaluate the impact of post-operative conformal radiotherapy (PORT) on disease-free survival (DFS) in patients with completely resected pathologically proven N2 non-small cell lung cancer (NSCLC), with or without neo- or adjuvant chemotherapy. Previously communicated results showed no impact of PORT on DFS. However, as quality of surgical resection and extent of lymph node dissection were expected to be critically important in the interpretation of results, surgical and pathological reports were centrally reviewed by a surgical committee. Methods: A surgical advisory committee composed of 4 expert thoracic surgeons reviewed anonymized surgical and pathological reports of all included patients. Pre-defined classification rules were defined using published guidelines from the International Association for the Study of Lung Cancer and the European Society of Thoracic Surgeons. Tumor resection was defined as complete (no residual tumor and adequate lymph node assessment), uncertain (highest mediastinal nodal station involved, incomplete nodal exploration, involved N2 removed in fragments) or incomplete (presence of residual tumor). Nodal exploration was classified as sampling, selective dissection or extensive dissection. Results: 501 patients were included in the Lung ART trial. Before surgical committee review intervention, all patients except 2 had complete resection. 496 patients’ reports were analyzed by the surgical advisory committee. The basic characteristics are specified in the following table: Conclusions: Monitoring of the quality of nodal exploration and of resection should be implemented in randomized studies evaluating peri-operative strategies in NSCLC in order to provide reliable and generalizable results. Clinical trial information: NCT00410683. [Table: see text]