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

Abstract

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 tracer ⁸⁹Zr-cetuximab and to assess tumour uptake. Two dose schedules were used; two consecutive doses of 60MBq ⁸⁹Zr-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. Nine patients were included (6 NSCLC; 3 HNC). No additional toxicity was associated with administration of ⁸⁹Zr-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. Both presented ⁸⁹Zr-cetuximab administration schedules are safe. The recommended dose for future trials is 60MBq, with a minimum time interval for scanning of 6days.