Summary of the Standards, Options and Recommendations for the use of positron emission tomography with 2-[18F]fluoro-2-deoxy-D-glucose (FDP-PET scanning) in oncology (2002)

Abstract

The objective was to review the available scientific data and to develop the Standards, Options, and Recommendations (SORs) for the role of and indications for FDG-PET scanning in oncology. The main steps in patient care that were studied were diagnosis of the primary disease, initial and secondary metastatic assessment, evaluation of treatment response, and detection of recurrent disease. The recommendations made relate to the primary cancer sites defined as priorities on the basis of the available scientific data: cancers of lung and pleural, melanoma, gynaecological cancers, gastrointestinal cancers, head-and-neck cancers, urological cancers, lymphomas, soft-tissue and bone sarcomas, and cancers of the thyroid, and also carcinomas of unknown primary site. For some cancer sites, the working group considered that an evaluation was either not timely or that the available data were inadequate. These topics, in particular cerebral tumours and childhood cancers, will be addressed when these recommendations are updated. The details of the methodology have been published previously ( Fervers et al, 2001 ). For this particular SOR, a multidisciplinary group of experts was set up by the French National Federation of Cancer Centres (FNCLCC) and the French Society for Biophysics and Nuclear Medicine (Société Française de Biophysique et Médecine Nuclear, SFBMN) to critically appraise the available evidence on the role of and indications for FDG-PET scanning in oncology. Literature searches were performed for each cancer site in Medline , from January 1996 to November 2001, and in the Cochrane Library, Issue 3, 1999. The Cancerlit database and the proceedings from American Society of Clinical Oncology conferences were also searched. The search excluded articles in languages other than English and French, as well as in vitro and animal studies. Studies in which tracers other than FDG were used were not specifically sought, although studies comparing FDG with other tracers were included for certain cancer sites, when they provided data for the relevant outcomes. The review met with a recurrent difficulty: multiple publication in different journals of the same study, with an increasing number of patients, and sometimes with the authors in a different order. In this situation, only the last publication, including the largest number of patients, was retained for this report. The literature search was complemented with personal references supplied by the experts. In certain chapters, references published after November 2001 were added when the working group considered it necessary, especially when the new references had an impact on the definition of a standard or an option. The data analysis also included three reports of evaluations and recommendations for FDG-PET scanning ( Adams et al, 1999 ; Robert and Milne, 1999 ; AETMIS, Agence d'évaluation des technologies et des modes d'intervention en santé, 2001 ) and the report of a German consensus conference ( Reske and Kotzerke, 2001 ). The working group selected and critically appraised pertinent references and then proposed the ‘Standards’, ‘Options’, and ‘Recommendations’ for the role of and indications for FDG-PET scanning in oncology, based on either the best available evidence or expert agreement. ‘Standards’ identify clinical situations for which there exist strong indications or contraindications for a particular FDG-PET application and ‘Options’ identify situations for which there are several alternatives, none of which have shown clear superiority over the others ( Table 1 ). In any SOR, there can be several ‘Options’ for a given clinical situation. ‘Recommendations’ enable the ‘Options’ to be weighted according to the available evidence. Several FDG-PET applications can be recommended for the same clinical situation, so that clinicians can make a choice according to specific clinical parameters, for example, local circumstances, skills, equipment, resources, and patient preferences. Adapting the SORs to a local situation is possible if the reason for the choice is sufficiently transparent and this is crucial for successful implementation. Inclusion of patients in clinical trials is an appropriate form of patient management in oncology and is recommended frequently within the SORs, particularly in situations where evidence is too weak to support a particular FDG-PET application. The type of evidence underlying any ‘Standard’, ‘Option’, or ‘Recommendation’ is indicated using a classification developed by the FNCLCC based on previously published models. The level of evidence depends not only on the type and quality of the studies reviewed, but also on the concordance of the results ( Table 2 ). When no clear scientific evidence exists, judgment is made according to professional experience and consensus of the working group (‘expert agreement’). In this particular situation, that is, a diagnostic test, it is sometimes difficult to classify levels of evidence. In addition, PET scanning is an emerging technique, for which many indications are still being evaluated. The working group, therefore, decided to identify not only standards and options for protocols being evaluated but also indications that require confirmation. The standards are based on levels of evidence A or B and represent indications for which the working group considered that PET scanning is essential for the care of patients. The options are usually based on a high level of evidence (B2), whereas the indications that require confirmation are those for which published data are scarce or insufficient (levels of evidence C, D, and expert agreement). For certain indications, despite a low level of evidence, the clinical usefulness of PET scanning was considered by the working group to be high, thus the indication is classified as an option (expert agreement). The document containing the SORs was then reviewed by a group of independent experts (see the Appendix ) and after taking into consideration their comments, the guidelines were validated by the working group. This English-language version is based on the summary version, which was itself based on the French full text version ( Bourguet et al, 2003 ). The French full text and summary versions are available on the FNCLCC web site ( http://www.fnclcc.fr/sci/sor/bonnes_pratiques/tep_fdg.htm ). A working group has been set up to monitor new scientific data on FDG-PET systematically. These clinical practice guidelines will be updated when new evidence becomes available or if there is a new consensus among the experts. In addition, patient-targeted information is being developed by the SOR SAVOIR PATIENT project, based on the specialist information (available late 2003). The SORs for use of FDG-PET scanning in oncology are summarised in Table 3 .