This protocol covers first-line palliative management of oral cavity carcinoma that is incurable, recurrent, or metastatic, where pathological evaluation confirms the absence of PD-L1-expressing tumour or immune cells — a combined positive score (CPS) below 1 — in a patient with good general condition who is no longer eligible for local therapy.
Oral cavity carcinoma is incurable, recurrent, or metastatic. Pathological assessment has confirmed that neither tumour cells nor immune cells express PD-L1 at a meaningful level (CPS <1). The patient retains good performance status and local therapeutic options are no longer appropriate.
First-line palliative treatment in this population involves an EGFR-targeting antibody given as part of a combination regimen, followed by a maintenance phase that continues until disease progression. The complete regimen, cycle count, eligibility criteria, and continuation rules are detailed in the full structured protocol.
In patients pathologically lacking PD-L1 expressing tumor or immune cells (CPS<1), the EGFR receptor targeting antibody cetuximab should be used as first line therapy in combination with platinum (preferably cisplatin) and 5-fluorouracil (EXTREME regimen) in the palliative setting in patients in good general condition who no longer qualify for local therapy.
After 4-6 cycles of this combination, PD-L1 positive patients shall receive maintenance therapy until progression with pembrolizumab or PD-L1 negative patients with cetuximab.
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