PET with ¹⁸F-fluorodeoxyglucose for staging of non-small cell lung cancer

Summary:

Aims: To evaluate studies on the use of positron emission tomography with the glucose analog ¹⁸F-fluorodeoxyglucose (FDG-PET) for the preoperative staging of patients with non-small cell lung cancer (NSCLC) according to the criteria of evidence based medicine and to discuss the cost-effectiveness of the technique. Methods: Clinical studies published between 1995 and 2002 on the preoperative staging of non-small cell lung cancer were used for this analysis. Studies that did not meet the criteria published by the European Agency for the Evaluation of Medicinal Products (EMEA) were excluded. The validity of the studies was evaluated by a standardized rating system developed by the Agency for Health Care Policy and Research (AHCPR). Results: For the detection of mediastinal lymph node metastases the mean sensitivity and specificity of FDG-PET on a patient basis is 85% and 87% (16 studies, 1355 patients). In studies that compared FDG-PET and computed tomography (CT) the mean sensitivity of CT was 66% at a specificity of 71%. In the detection of distant metastases FDG-PET correctly changed the tumor stage in 18% of the patients when compared to CT based staging (10 studies, 1073 patients). Five cost effectiveness analyses from the USA, Japan, and Germany concluded that FDG-PET improves the outcome of treatment at reduced or only slightly increased overall costs. Improvement of patient outcome was also demonstrated in a randomized trial, which found that the risk of a futile thoracotomy was reduced by 51% (p = 0.003) when FDG-PET was added to the preoperative staging. Conclusion: According to the criteria of the AHCPR the use of FDG-PET for detection of mediastinal lymph node and distant metastases is documented at a level of evidence Ia and Ib, respectively. Since systematic analyses also indicate a favorable cost-effectiveness ratio FDG-PET has to be considered as ”strictly indicated“ for the preoperative staging of non-small cell lung cancer.

Zusammenfassung:

Ziele: In dieser Arbeit wurde die Positronenemissionstomographie mit ¹⁸F-Fluordeoxyglukose (FDG-PET) zum präoperativen Staging des nicht kleinzelligen Bronchial-karzinoms (NSCLC) nach Kriterien der evidenzbasierten Medizin bewertet und Analysen zur Kosteneffektivität des Verfahrens diskutiert. Methodik: Von 1995 bis 2002 veröffentlichte Studien zur präoperativen NSCLCDiagnostik mittels FDG-PET wurden nach den Kriterien der European Agency for the Evaluation of Medicinal Products (EMEA) ausgewählt und nach einem standardisierten Rating-System der Agency for Health Care Policy and Research (AHCPR) bzgl. Validität ihrer Aussagen beurteilt. Ergebnisse: Die mittlere Sensitivität und Spezifität der FDG-PET beträgt auf Patientenbasis 85% bzw. 87% (16 Studien, 1355 Patienten). Für den direkten Vergleich mit der Computertomographie (CT) ergibt sich eine mittlere Sensitivität und Spezifität von 66% bzw. 71%. Beim Nachweis von Fernmetastasen führt die FDG-PET bei 18% der Patienten zu einer korrekten Veränderung des Tumorstadiums im Vergleich zur CT-basierten Diagnostik (10 Studien, 1073 Patienten). Fünf Kosten/Nutzenanalysen aus den USA, Japan und Deutschland kamen zu dem Schluss, dass FDG-PET das Behandlungsergebnis verbessern kann und zu reduzierten oder nur geringfügig erhöhten Gesamtkosten für Diagnostik und Therapie führt. Die Verbesserung des Behandlungsergebnisses wurde auch in einer randomisierten Studie belegt, in der das Risiko einer nicht kurativen Thorakotomie durch die FDG-PET um 51% verringert wurde (p = 0,003). Schlussfolgerung: Nach den AHCPR-Kriterien ist die Diagnostik von NSCLCLymphknoten- bzw. -Fernmetastasen auf Evidenzstufe Ia bzw. Ib belegt. Da außerdem eine günstige Kosten/ Nutzenrelation besteht, ist nach medizinischen und gesundheitsökonomischen Kriterien die FDG-PET zum präoperativen Staging des Bronchialkarzinoms als »streng empfohlen« anzusehen.

Key words:

EBM - NSCLC - staging - ¹⁸F-FDG-PET - cost-effectiveness analysis

Schlüsselwörter:

EbM - nicht kleinzelliges Bronchialkarzinom - Staging - ¹⁸F-FDG-PET - Kosten/Nutzenanalyse

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