This study aims to evaluate the role of early response assessment by 18F-FDG PET/CT inpatients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinomawith PD-L1 CPS >1 treated with pembrolizumab monotherapy, in accordance with routineclinical practice.
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
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
Tor Vergata University Hospital
Rome, Italy, Italy
Investigator: Vincenzo Formica, Professor
Contact: +390620908190
vincenzo.formica@uniroma2.it
Vincenzo Formica, Professor
+390620908190
vincenzo.formica@uniroma2.it
Not Provided