Abstract
BackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain.MethodsPost-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. One hundred-fifty five patients were enrolled (August 2016–December 2018) from 30 sites. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.Results70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most patients had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8 months. One hundred-fifty five patients were evaluable for response, 1.3% complete response, 40.6% partial response, 31% stable disease and 11.6% disease progression. Objective response rate was 42%. Median progression-free survival was 9.4 months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which were grade 1 or 2. The resource cost study indicates early use is warranted.ConclusionThis study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events.Trial registrationClinical trial registration number:NCT03790397.
Highlights
AURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer
The identification of oncogenic driver alterations that can be targeted by EGFR tyrosine kinase inhibitors (EGFR-Tyrosine kinase inhibitors (TKI): erlotinib, gefitinib, afatinib, dacotinib) for EGFR mutated tumors has improved median progressionfree survival (PFS), overall response rates and quality of life in metastatic non-small cell lung cancer (NSCLC) patients, making EGFR TKIs the first-line treatment of choice in patients with EGFR mutation (EGFRm) advanced NSCLC [3]
Based on the lack of real-world results in this setting, and the experience with osimertinib in Spain since 2015, we proposed a retrospective study to describe the experience in terms of efficacy and safety in EGFR/T790M+ NSCLC
Summary
AURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. The identification of oncogenic driver alterations that can be targeted by EGFR tyrosine kinase inhibitors (EGFR-TKI: erlotinib, gefitinib, afatinib, dacotinib) for EGFR mutated tumors has improved median progressionfree survival (PFS), overall response rates and quality of life in metastatic NSCLC patients, making EGFR TKIs the first-line treatment of choice in patients with EGFR mutation (EGFRm) advanced NSCLC [3]. EGFR T790M mutations have been detected in 48–62% of patients that develop resistance to EGFR-TKIs [4, 5]
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