A tabulated summary of the FDG PET literature.

This special supplement to The Journal of Nuclear Medicine is a detailed tabulation of literature on FDG PET in oncology (1993–June 2000), cardiology (1986–June 2000), and neurology (1980–June 2000). This document is a subset of the original document formally submitted to the Health Care Financing Administration (HCFA) in July 2000 to request expanded Medicare reimbursement for FDG PET. It has been improved by eliminating any errors in tabulation and further clarified as the result of comments from an independent review of the original HCFA submission. This document also differs from the original HCFA submission in that it does not include some background sections and lacks references that were identified but not used because of specific inclusion and exclusion criteria. The goal of this document is to provide a summary of all FDG PET literature for the specified periods, with tabulated values of sensitivity, specificity, percentage in management changes, etc. This document is not intended to be a formal meta-analysis or cost-effectiveness analysis of the available literature. Instead, it is meant to provide an overview of the available literature, so that future detailed studies can use this document as a starting point. Because of the difficulty of searching all FDG PET literature, this document inevitably does not include some research articles and abstracts that may be useful. The authors have tried to make the search as comprehensive as possible, but some literature may have been overlooked. Details of the literature search strategy are provided in Appendix A. Although a formal meta-analysis is not performed, a simple weighted averaging of data using various strategies is presented (Appendix B). This weighted averaging is meant to give only a general indication of the overall accuracy values and, therefore, should be interpreted with care. A data pooling analysis is also included. The document is organized to show, first, how the tabulated data should be interpreted. This is followed by oncologic, cardiac, and neurologic application sections that provide, for each disease process, a disease background section, a case example illustrating the clinical implementation of FDG PET, an explanation of why FDG PET helped, a key management issues section (see also Maisey et al. ( 285)), and a summary of evidence for FDG PET with management change data for the disease and references to the relevant full literature search (in tabulated form) for the accuracy of FDG PET in specific applications. The numbers of patient studies utilized in calculating summary management changes are displayed in Tables 20 and 24 along with management figures and are embedded (without display) within the individual spreadsheets as selected from the data lines that report management change information. In addition, a summary of results from the literature search on FDG PET in all cancers is provided, as well as a summary of FDG PET literature searched for the oncologic, cardiac, and neurologic applications. A full reference list is also provided at the end. Appendix A gives details on the way in which literature was searched and analyzed, and Appendix B reports some alternate approaches to summarizing the data. The average FDG PET sensitivity and specificity across all oncology applications are estimated at 84% (based on 18,402 patient studies) and 88% (based on 14,264 patient studies), respectively. The average management change across all applications is estimated to be 30% (based on 5,062 patients). These data were obtained combining 419 total articles and abstracts on studies in which FDG PET was used. Various methods of analysis were applied to these data (Table 25), which revealed only a small amount of variation in the ratio values. Specifically, the sensitivity of PET ranged from 84%–87%, the specificity ranged from 88%–93%, and the accuracy ranged from 87%–90%. At the time of submission of this work, HCFA had just announced expanded coverage for FDG PET to include imaging for various aspects of lung, colorectal, esophageal, Received Dec. 27, 2000; accepted Dec. 27, 2000. For correspondence or reprints contact: Sanjiv S. Gambhir, MD, PhD, UCLA School of Medicine, 700 Westwood Plaza, B3-399A BRI, Box 951770, Los Angeles, CA 90095-1770.