Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group.
Acrylamides
/ administration & dosage
Adult
Aged
Aged, 80 and over
Aniline Compounds
/ administration & dosage
Carcinoma, Non-Small-Cell Lung
/ diagnosis
ErbB Receptors
/ antagonists & inhibitors
Female
Follow-Up Studies
Humans
Lung
/ pathology
Lung Neoplasms
/ diagnosis
Male
Middle Aged
Mutation
Neoplasm Staging
Progression-Free Survival
Protein Kinase Inhibitors
/ administration & dosage
Retrospective Studies
Spain
/ epidemiology
EGFR-activating mutations
Non-small cell lung cancer
Osimertinib
Real-world data
Second line
T790M EGFR mutation
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
06 Mar 2021
06 Mar 2021
Historique:
received:
20
09
2020
accepted:
17
02
2021
entrez:
7
3
2021
pubmed:
8
3
2021
medline:
4
5
2021
Statut:
epublish
Résumé
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. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain. Post-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. progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources. 70% 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. This 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. Clinical trial registration number: NCT03790397 .
Sections du résumé
BACKGROUND
BACKGROUND
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. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain.
METHODS
METHODS
Post-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
OBJECTIVE
progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.
RESULTS
RESULTS
70% 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.
CONCLUSION
CONCLUSIONS
This 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 REGISTRATION
BACKGROUND
Clinical trial registration number: NCT03790397 .
Identifiants
pubmed: 33676426
doi: 10.1186/s12885-021-07922-5
pii: 10.1186/s12885-021-07922-5
pmc: PMC7937205
doi:
Substances chimiques
Acrylamides
0
Aniline Compounds
0
Protein Kinase Inhibitors
0
osimertinib
3C06JJ0Z2O
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
Banques de données
ClinicalTrials.gov
['NCT03790397']
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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