Uso de gefitinibe como primeira linha no câncer de pulmão não pequenas células com mutação de EGFR no sistema público de saúde brasileiro: revisão de literatura

Abstract

Non-small cell lung cancer (NSCLC) remains one of the greatest challenges in modern oncology, particularly within public healthcare systems. Gefitinib, a first-generation tyrosine kinase inhibitor (TKI), was incorporated into the Brazilian Unified Health System (SUS) in 2013 for patients harboring EGFR mutations. However, more than a decade later, effective access to this therapy remains limited. Objective: To review the scientific evidence on the use of gefitinib as first-line treatment for patients with EGFR-mutated NSCLC within the context of the SUS, discussing clinical outcomes and the main barriers to its implementation. Method: A narrative literature review was conducted through searches in the PubMed, SciELO, and LILACS databases, covering publications from 2010 to 2024. Included studies comprised clinical trials, systematic reviews, observational studies, and official documents from the Brazilian Ministry of Health and CONITEC. Results: The literature demonstrates that gefitinib provides significant improvement in progression-free survival (PFS) and presents a more favorable toxicity profile compared with conventional chemotherapy. Nevertheless, the benefit in overall survival (OS) was not consistently observed in pivotal trials, mainly due to the high rate of treatment crossover. Pharmacoeconomic analyses suggest that gefitinib is a cost-effective option in Brazil; however, the SUS reimbursement model, with payments considerably lower than the actual treatment cost, along with the limited availability of molecular testing for EGFR mutations, largely restrict its real-world use. Conclusions: Although gefitinib represents a meaningful advance in personalized oncology, its incorporation into the SUS has not yet translated into equitable access for most patients. This scenario highlights a persistent gap between public health policy and clinical practice, underscoring the need for strategies that ensure the effective implementation of targeted therapies within the Brazilian public healthcare system.