PET imaging of zirconium-89 labelled cetuximab: A phase I trial in patients with head and neck and lung cancer.

BACKGROUND AND PURPOSE: PET imaging of cetuximab uptake may help selecting cancer patients with the highest chance of benefit. The aim of this phase I trial was to determine the safety of the tracer89 Zr-cetuximab and to assess tumour uptake.

METHODS: Two dose schedules were used; two consecutive doses of 60MBq89 Zr-cetuximab or a single dose of 120MBq, both preceded by 400mg/m2 of unlabelled cetuximab. Toxicity (CTCAE 3.0) was scored twice weekly. PET-CT scans were acquired on days 4, 5 and 6 (step 1) or 5, 6, 7 (step 2). Because tumour uptake could not be assessed satisfactorily, a third step was added including EGFR overexpressing tumours.

RESULTS: Nine patients were included (6 NSCLC; 3 HNC). No additional toxicity was associated with administration of89 Zr-cetuximab compared to standard cetuximab. A tumour to blood ratio (TBR)>1 was observed in all but one patient, with a maximum of 4.56. TBR was not different between dose schedules. There was a trend for higher TBR at intervals>5days after injection.

CONCLUSIONS: Both presented89 Zr-cetuximab administration schedules are safe. The recommended dose for future trials is 60MBq, with a minimum time interval for scanning of 6days.