1511P - TKIs in first-line for advanced NSCLC with activating EGFR-mutations: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Presenter Jacopo Giuliani
Citation Annals of Oncology (2016) 27 (6): 522-525. 10.1093/annonc/mdw391
Authors J. Giuliani, A. Bonetti
  • Dept. Oncology, Ospedale di Legnago, 37045 - Legnago/IT

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.

Abstract

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

Authors/Trial Comparative Regimens N° of patients Primary endpoint OS (months) PFS (months) p-Value* PFS/OS gain (months)** PFS/OS HR (95% C.I.)** ESMO-MCBS
Zhou et al, 2011 OPTIMAL carboplatin + gemcitabine erlotinib 7282 PFS NRNR 4.613.1  

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.