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
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Published:2021-03-06
Issue:1
Volume:21
Page:
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ISSN:1471-2407
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Container-title:BMC Cancer
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language:en
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Short-container-title:BMC Cancer
Author:
Provencio MarianoORCID, Terrasa Josefa, Garrido Pilar, Campelo Rosario García, Aparisi Francisco, Diz Pilar, Aguiar David, García-Giron Carlos, Hidalgo Julia, Aguado Carlos, González Jorge García, Esteban Emilio, Gómez-Aldavarí Lorenzo, Moran Teresa, Juan Oscar, Chara Luís Enrique, Marti Juan L., Castro Rafael López, Ortega Ana Laura, Moreno Elia Martínez, Coves Juan, Sánchez Peña Ana M., Bosch-Barrera Joaquim, Gastaldo Amparo Sánchez, Núñez Natalia Fernández, del Barco Edel, Cobo Manuel, Isla Dolores, Majem Margarita, Navarro Fátima, Calvo VirginiaORCID
Abstract
Abstract
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
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: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.
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
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
Clinical trial registration number:NCT03790397.
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
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