This protocol addresses first-line systemic treatment for patients with advanced or metastatic oesophageal squamous-cell carcinoma (SCC) whose tumours have a PD-L1 tumour proportion score (TPS) of 1% or more — a biomarker-selected population for whom specific evidence-based regimens apply.
PD-L1 expression with a TPS ≥1% on tumour cells is the defining criterion for this subpopulation. Meeting this threshold qualifies patients for combination immunotherapy-based strategies supported at the highest level of evidence (Level I, A; ESMO-MCBS v1.1 score: 4).
Evidence-based first-line options for this group involve immune checkpoint inhibitor-based combinations — including both an immunotherapy-with-chemotherapy strategy and a dual immunotherapy strategy. Each carries distinct considerations regarding response and early progression risk. The complete regimen details, eligibility criteria, and decision algorithm are in the full protocol.
DOI: 10.1016/j.annonc.2022.07.003
NivolumabeChT is recommended in patients with tumours expressing PD-L1 with a TPS 1% [I, A; ESMO-MCBS v1.1 score: 4]. Nivolumabeipilimumab can be given, but a lower radiological response rate and increased risk of early progression and death in patients treated without ChT needs to be considered [I, B; ESMO-MCBS v1.1 score: 4].
The phase III CheckMate 648 study randomised patients with treatment-naive advanced oesophageal SCC to (i) cisplatine5-FU; (ii) nivolumabecisplatine5-FU or (iii) nivolumab plus the anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody ipilimumab.
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