JCO Early Release, published online ahead of print Mar 27 2006
Journal of Clinical Oncology, 10.1200/JCO.2005.02.4695
Received April 24, 2005
Accepted October 26, 2005
Traditional Versus Up-Front [18F] Fluorodeoxyglucose-Positron Emission Tomography Staging of Non-Small-Cell Lung Cancer: A Dutch Cooperative Randomized Study
Gerarda J.M. Herder , Henk Kramer , Otto S. Hoekstra , Egbert F. Smit *, Jan Pruim , Harm van Tinteren , Emile F. Comans , Paul Verboom , Carin A. Uyl-de Groot , Alle Welling , Marinus A. Paul , Maarten Boers , Pieter E. Postmus , Gerrit J. Teule , and Harry J.M. Groen
From the Departments of Pulmonology, Nuclear Medicine and PET Research, Surgery, and Clinical Epidemiology and Biostatistics, VU University Medical Center; the Comprehensive Cancer Center, Amsterdam; Departments of Pulmonology, and Nuclear Medicine and PET-Center, University Medical Center, Groningen; Institute for Medical Technology Assessment, Erasmus MC, University Medical Center, Rotterdam: Department of Pulmonology, Medical Center-Alkmaar, Alkmaar, the Netherlands; and the POORT Study Group.
* To whom correspondence should be addressed. E-mail: ef.smit{at}vumc.nl
Purpose: We investigated whether application of positron emission tomography (PET) immediately after first presentation might simplify staging while maintaining accuracy, as compared with traditional strategy in routine clinical setting.
Methods: At first presentation, patients with a provisional diagnosis of lung cancer without overt dissemination were randomly assigned to traditional work-up (TWU) according to international guidelines or early PET followed by histologic/cytologic verification of lesions, or imaging and follow-up. Patients with [18F] fluorodeoxyglucose (18FDG) -avid, noncentral tumors without suspicion of mediastinal or distant metastases on PET proceeded directly to thoracotomy. Follow-up in presumed benign lesions was at least 12 months. In patients treated with surgery or neoadjuvant therapy, the quality of staging was measured by comparing the clinical stage to the final stage (combination of peroperative staging and 6 months of follow-up). To investigate test substitution, we analyzed the number of (non)invasive tests to achieve clinical TNM staging, and its associated costs.
Results: Between 1999 and 2001, 465 patients (233 TWU, 232 PET) were enrolled at 22 hospitals. The mean (standard deviation) number of procedures to finalize staging was equal in the TWU arm and the PET arm: 7.9 (2.0) v 7.9 (1.9), P = .90, respectively. Mediastinoscopies occurred significantly less often in the PET arm. Agreement between clinical and final stage was good in both arms ( = .85 v .78; P = .07). Costs did not differ significantly.
Conclusion: Up-front 18FDG-PET in patients with (suspected) lung cancer does not reduce the overall number of diagnostic test, but it maintains quality of TNM staging with the use of less invasive surgery.

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