Performance status 2 or higher in EMA labels for advanced non-small-cell lung cancer: a cross-sectional SmPC analysis

Abstract

BACKGROUND: Advanced NSCLC patients with ECOG PS ?2 are common, under-represented in pivotal trials, and have inferior outcomes with immune checkpoint inhibitors. EU label coverage for ECOG PS ?2 and PS-based dosing guidance is unknown. MATERIALS AND METHODS: We reviewed EU SmPCs for systemic anticancer medicines with ?1 NSCLC indication authorised by 16 February 2026. ECOG PS language was extracted from Sections 4.1/4.2 and 5.1. Products were classified as explicit (Section 4.1/4.2 allows ECOG PS ?2), label-anchored (Section 5.1 defines a population including ECOG PS ?2), or trial-anchored (Section 5.1 reports ECOG PS ?2 enrolment without PS wording). PS-linked dosing in Sections 4.2/4.4 was coded as ECOG-explicit (formal ECOG/WHO/Zubrod or Karnofsky thresholds) or qualitative (poor-PS language without a formal scale). RESULTS: We identified 41 NSCLC medicines/regimens. Gemcitabine explicitly allowed monotherapy in ECOG PS 2 (1/41, 2.4%). Atezolizumab monotherapy for platinum-ineligible NSCLC was label-anchored via IPSOS (population enriched for ECOG PS 2-3), yielding 2/41 (4.9%) products with any label-level ECOG PS ?2 signal. Six targeted agents were trial-anchored only (6/41, 14.6%), with PS ?2 representation generally small or inconsistently reported when available. PS was rarely a dosing variable: carboplatin included ECOG-explicit initial dose-reduction guidance, and oral vinorelbine included qualitative PS-linked starting-dose/escalation language (2/41, 4.9% any PS-linked dose guidance). CONCLUSION: EU NSCLC labels seldom address ECOG PS ?2 and rarely use PS for dose selection. Poor-PS treatment extrapolates from ECOG PS 0-1 evidence, supporting PS-inclusive trials and more standardised PS reporting in future SmPCs.