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TKIs in first-line for advanced NSCLC with activating EGFR-mutations: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) applied to pivotal phase III randomized controlled trials

Date

08 Oct 2016

Session

Poster Display

Presenters

Jacopo Giuliani

Citation

Annals of Oncology (2016) 27 (6): 522-525. 10.1093/annonc/mdw391

Authors

J. Giuliani, A. Bonetti

Author affiliations

  • Dept. Oncology, Ospedale di Legnago, 37045 - Legnago/IT
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Resources

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.

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