Background
In light of results of pivotal phase III randomized controlled trials (RCTs) concerning the effect of first-line tyrosine kinase inhibitor (TKIs) in first-line for advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR)-mutations, it might be interesting to examine the magnitude of the clinical benefit from TKIs in this setting of patients.
Methods
European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) was applied to pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations, to derive a relative ranking (from grade 1 to grade 5) of the magnitude of clinically meaningful benefit that can be expected from TKIs (erlotinib, gefitinib and afatinib) in this subset of patients.
Results
Our study evaluated 8 phase III RCTs (including 1710 patients). The main reported outcomes of the considered pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations and the corresponding ESMO-MCBS score are reported in Table 1.
Main outcomes of the considered pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations and the corresponding ESMO-MCBS score
Conclusions
The ESMO-MCBS reached high grade (grade 4) for all TKIs treatments with at least a phase III RCT. Combining pharmacological costs of drugs with the measure of efficacy represented by the PFS, it is evident that afatinib is the most cost-effective, with the lowest difference in costs per month-PFS gained (1682.3 €, data derived from literature) and a comparable high grade of magnitude of clinical benefit.
Clinical trial identification
Not required. This is a review article.
Legal entity responsible for the study
N/A
Funding
N/A
Disclosure
All authors have declared no conflicts of interest.