Randomized Controlled Trial of the Role of Positron Emission Tomography in the Management of Stage I and II Non–Small-Cell Lung Cancer Rosalie C. Viney, Michael J. Boyer, Madeleine T. King, Patricia M. Kenny, Christine A. Pollicino, Jocelyn M. McLean, Brian C. McCaughan, and Michael J. Fulham A B S T R A C T Purpose Positron emission tomography (PET) is a costly new technology with potential to improve preoperative evaluation for patients with non–small-cell lung cancer (NSCLC). There is increasing pressure for PET to be included in standard diagnostic work-up before decisions about surgical management of NSCLC. The resource implications of its widespread use in staging NSCLC are significant. Methods A randomized controlled trial was conducted to investigate the impact of PET on clinical management and surgical outcomes for patients with stage I-II NSCLC. The primary hypothesis was that PET would reduce the proportion of patients with stage I-II NSCLC who underwent thoracotomy by at least 10% through identification of patients with inoperable disease. Results One hundred eighty-four patients with stage I-II NSCLC were recruited and randomly assigned; 92% had stage I disease. Following exclusion of one ineligible patient, 92 patients were assigned to no PET and 91 to PET. Compared with conventional staging, PET upstaged 22 patients, confirmed staging in 61 and staged two patients as benign. Stage IV disease was rarely detected (two patients). PET led to further investigation or a change in clinical management in 13% of patients and provided information that could have affected management in a further 13% of patients. There was no significant difference between the trial arms in the number of thoracotomies avoided (P = .2). Conclusion For patients who are carefully and appropriately staged as having stage I-II disease, PET provides potential for more appropriate stage-specific therapy but may not lead to a significant reduction in the number of thoracotomies avoided. J Clin Oncol 22:2357-2362. © 2004 by American Society of Clinical Oncology INTRODUCTION Non–small-cell lung cancer (NSCLC) ac- counts for approximately 80% of all lung can- cer. At presentation, approximately 25% of patients have disease suitable for surgical re- section. 1 Following surgical resection, up to 40% of patients with clinical stage I disease and 60% of patients with clinical stage II disease ultimately experience relapse, implying that they had occult metastatic disease at the time of presentation. Such patients do not benefit from surgery, and the ability to identify them could save an unnecessary thoracotomy. Positron emission tomography (PET) is a relatively new imaging technology with potential to improve preoperative staging. Many malignant tumors show increased glucose utilization when compared with normal tissues. 2 Whole body PET with [ 18 F]fluorodeoxyglucose (FDG) can iden- tify regions of increased glucose metabolism in nonenlarged structures, allowing detec- tion of tumor metastases earlier than with anatomic imaging methods. Data suggest PET may improve the accuracy of preoper- ative staging of NSCLC, but, in general, these are from small, retrospective, uncon- From the Centre for Health Economics Research and Evaluation, University of Technology, Sydney; Medical Oncology Unit, Sydney Cancer Centre; Cardiotho- racic Surgical Unit, PET Unit, and De- partment of PET and Nuclear Medicine, Royal Prince Alfred Hospital; and Fac- ulty of Medicine, University of Sydney, Sydney, Australia. Submitted April 17, 2003; accepted March 27, 2004. Supported by a National Health and Medical Research Council Project Grant. Authors’ disclosures of potential con- flicts of interest are found at the end of this article. Address reprint requests to Rosalie Viney, Centre for Health Economics Research and Evaluation, University of Technology, Sydney, PO Box 123, Broadway, Sydney, NSW 2007, Australia; e-mail: rosalie.viney@chere.uts.edu.au. © 2004 by American Society of Clinical Oncology 0732-183X/04/2212-2357/$20.00 DOI: 10.1200/JCO.2004.04.126 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 22  NUMBER 12  JUNE 15 2004 2357 Downloaded from ascopubs.org by 3.236.216.222 on June 14, 2022 from 003.236.216.222 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.