title: Current readings: Window-of-opportunity trials for thoracic malignancies.
abstract: Recent major advances in metastatic non-small cell lung cancer have occurred with the identification of molecular biomarker targets and administration of novel agents with resulting improvement in clinical outcomes. In the early-stage setting, personalized therapy with novel agents and molecular profiling are being incorporated into neoadjuvant "window-of-opportunity" trials. These important studies enable biomarker research and an expedited analysis of the efficacy of the targeted agent. However, there are significant limitations to window-of-opportunity trials. The aim of this article is to review the current window-of-opportunity trials of neoadjuvant targeted agents for thoracic malignancies, discuss the benefits and limitations of these trials, and propose more optimal alternative trial end points. Neoadjuvant trials of resectable non-small cell lung cancer and mesothelioma that are ongoing or under development and relevant to thoracic surgeons are also discussed. The success of these trials will depend on a collaborative multidisciplinary effort, especially from the field of thoracic surgery.
authors.affiliation: Department of Thoracic & Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: astsao@mdanderson.org.
authors.forename: Anne S
authors.initials: AS
authors.lastname: Tsao
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic; D020022:Genetic Predisposition to Disease; D006801:Humans; D008175:Lung Neoplasms / Q000235:genetics / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D025202:Molecular Diagnostic Techniques; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D018579:Patient Selection; D010641:Phenotype; D057285:Precision Medicine; D011237:Predictive Value of Tests; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor
keywords: NSCLC; neoadjuvant; targeted agents; thoracic malignancies; window-of-opportunity trials