Date de tip real world privind utilizarea nivolumabului în cancerul pulmonar nonmicrocelular avansat – dincolo de linia a doua. Experienţa noastră în România imediat după rambursarea imunoterapiei prin sistemul naţional de sănătate

Abstract

Background. Lung cancer represents the main cause of can­cer-related mortality at a worldwide level and ranks se­cond in global incidence statistics. The therapeutic ma­nage­ment of non-small cell lung cancer (NSCLC) has been substantially mo­di­fied by the development of im­mu­ne checkpoint in­hi­bi­tors (ICI), nivolumab, pem­bro­li­zu­mab, durvalumab and ate­zo­li­zu­mab. In Romania, the reimbursement of healthcare costs for im­mune check­point inhibitors has started since late 2017. Aim of the study. The assessment of efficacy, safety profile, over­all sur­vi­val (OS) and progression-free survival (PFS) from real-world data for nivolumab as second-line therapy for advanced and metastatic NSCLC. Our real-world stu­dy was conducted between 1.01.2018 and 31.12.2020, right after the approval of ni­vo­lu­mab in Europe for me­ta­static NSCLC. Methodology. For data analysis, we used R programming language, version 3.6.2, the Excel ap­pli­ca­tion in Microsoft 365 for Enterprise pack. Results. We studied 34 participants from our lot. Nivolumab was administered from second line and beyond. The ave­rage age was 65.5 years old. The majority of patients had mul­tiple co­mor­bi­di­ties. The histopathology was re­pre­sen­ted by 56% non-squamous NSCLC, and 44% squamous NSCLC. The overall sur­vi­val for nivolumab therapy was 72.3 weeks (18.07 months). The overall survival for non-smokers was 32.5 weeks (8.12 months) versus 93 weeks for smokers (23.25 months). The over­all survival for women was 15.3 weeks (3.8 months) and for men this value could not be reached. The overall survival for squamous carcinoma was 72.3 weeks (18.1 months), and for non-squamous carcinoma, it was 93 weeks (23.25 months). Median PFS was 17.3 weeks (4.3 months). Conclusions. ICI with nivo­lu­mab administered from second line and beyond had a favorable safety profile and manageable adverse events, si­mi­lar to those described in pivotal studies, making them a reasonable choice in pretreated, frail and elderly pa­tients. Dis­tinc­tively, our real-world data regarding OS and PFS did not show the same advantage magnitude as seen in CheckMate 017 and CheckMate 057 studies.