Real-world data on patients with metastatic non-small-cell lung cancer treated with checkpoint inhibitors in an Italian Teaching Hospital in 2015–2018

Abstract

Background Non-small-cell lung carcinoma (NSCLC) accounts for 85–90% of all forms of lung cancer. Immuno-oncology represents a valid new approach but the high cost requires a specific evaluation of the health outcomes. This study describes the real-world efficacy, safety and cost profiles of the new anti-PD-1 immune-checkpoint inhibitors nivolumab and pembrolizumab on a cohort of 56 selected patients with advanced NSCLC. Methods A retrospective, observational analysis was conducted on patients treated with immune checkpoint inhibitors from September 2015 to September 2018 at Azienda Ospedaliera Universitaria “Mater Domini” in Catanzaro, Italy. Data sources were medical records, internal prescription cards and reports of adverse reactions. Results Fifty-six patients were diagnosed with advanced NSCLC, 64.3% characterized by a non-squamous histology, 30.3% squamous and 5.4% not specified. First-line treatment with pembrolizumab was administered to 11 patients for an average of 4.4 months, while 45 patients were treated with nivolumab for an average of 8.6 months. Data showed a survival rate of 95% after 6 months and 88% after 12 months. Most patients received immunotherapy as a second-line or subsequent treatment. In terms of prior therapy among all the patients, 43 had received platinum-based treatments. Indirect comparison with other real-world data studies showed variability in methodologies and an alignment in terms of results. Conclusion This study, based on real-world data, was a first step in the assessment of the impact of the introduction of a significant new class of treatments, i.e. immunotherapy, and covers patients, treatments and outcomes, as well as organizational and economic variables.

How many Italian cancer patients are eligible for, and may respond to, Italian Medicines Agency-approved immune checkpoint inhibitors?

“…In the meantime, the necessary evidence is being collected on the cost-effectiveness of the various ICI treatments also in real world Italy. [44][45][46][47][48] However, it still only covers some indications. Therefore, even if some specific indications appear economically advantageous, [44][45][46][47][48] these therapies must be guaranteed to all patients who can benefit from them.…”

“…[44][45][46][47][48] However, it still only covers some indications. Therefore, even if some specific indications appear economically advantageous, [44][45][46][47][48] these therapies must be guaranteed to all patients who can benefit from them. In this challenge, the estimates provided in the present research can contribute to the evaluation of the sustainability of these therapies for all cancer patients.…”

First-Line Pembrolizumab Plus Chemotherapy for Advanced Squamous NSCLC: Real-World Outcomes at U.S. Oncology Practices

“… 24 Other recent observational studies included too few patients with advanced squamous NSCLC receiving ICI-chemotherapy to warrant discussion in the context of the present study. 25 , 26 , 27 , 28 , 29 …”