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 tracer (89)zr-cetuximab and to assess tumour uptake.
Methods: Two dose schedules were used; two consecutive doses of 60 MBq Zr-89-cetuximab or a single dose of 120 MBq, both preceded by 400 mg/m(2) 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 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 > 5 days after injection.
Conclusions: Both presented 89Zr-cetuximab administration schedules are safe. The recommended dose for future trials is 60 MBq, with a minimum time interval for scanning of 6 days. (C) 2016 Elsevier Ireland Ltd. All rights reserved.
- Phase I trial
- GROWTH-FACTOR RECEPTOR
- PLUS CETUXIMAB
- 1ST-LINE CHEMOTHERAPY