Overview
This study aims to evaluate the role of early response assessment by 18F-FDG PET/CT in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma with PD-L1 CPS \>1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.
Description
Eligible patients will receive two administrations of Pembrolizumab as monotherapy.
An 18F-FDG PET/CT scan will be performed at baseline (T0; no more than 30 days before the first drug administration) and after two cycles (T1, at 6 weeks).
Patients will be considered responders if they achieve a complete response (defined as complete resolution of FDG uptake within the target lesions) or a partial response (i.e., \>=30% decrease in the target tumor FDG SULpeak).
After the first two administrations of Pembrolizumab, as well as in case of progressive disease (i.e., \>=30% increase in the target tumor FDG SULpeak or advent of new 18FDG-avid lesions), any treatment modification will be determined by the physician according to routine clinical practice
Eligibility
Inclusion Criteria:
- Histological diagnosis of recurrent and/or metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment
- CPS PD-L1 \>=1
Exclusion Criteria:
- Any controindication to immune checkpoint inhibitors
