Ontario oncology trials to evaluate the clinical and economic impact of 18-FDG PET

Abstract

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Objectives: In 2002 Ontario determined that there was insufficient evidence on the utility of FDG PET to proceed to widespread implementation; five trials were designed to inform decision making. We report the results of 1 of the 2 completed trials.

Methods: ELPET is a randomized control trial (RCT) of patients with Stage I to IIIA non small cell lung cancer (NSCLC) comparing conventional imaging (C) [CT abdomen including liver and adrenals, bone scan and cranial imaging] to PET/CT (P) plus cranial imaging.

Results: 337 patients were enrolled from 8 centres between July 2004 and August 2007; 167 in the C-arm and 170 in the P-arm. 17 patients (10 on C and 7 on P) were excluded from the analysis for protocol violations. The mean age was 66 years and 50% were male. Twenty-three (14%) of 163 patients in the P-arm were correctly upstaged and avoided inappropriate surgery compared to 11 (7%) of 157 in the C-arm, p=0.046 Fisher’s exact, 95% CI for the 7% risk difference, 0.03% to14%.

Conclusions: In NSCLC, staging with PET/CT better identifies those patients with mediastinal and extrathoracic disease, sparing some from stage-inappropriate surgery. The 3 previously published RCTs tested the addition of P to C, whereas we compared P with C. Our study shows that P can replace C in early stage NSCLC. This strategy has an economic impact by avoiding costs related to unnecessary surgery and those for staging abdominal CT and bone scan (about $1100/case in Ontario) and impacts on patient safety by avoiding CT-associated radiation exposure and nephrotoxicity. PET/CT imaging for the preoperative assessment of potentially resectable NSCLC is now being used widely in Ontario.

Research Support: Ontario Ministry of Health and Long Term Care