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

Mariano Provencio, Josefa Terrasa, Pilar Garrido, Rosario García Campelo, Francisco Aparisi, Pilar Diz, David Aguiar, Carlos García-Giron, Julia Hidalgo, Carlos Aguado, Jorge García González, Emilio Esteban, Lorenzo Gómez-Aldavarí, Teresa Moran, Oscar Juan, Luís Enrique Chara, Juan L Marti, Rafael López Castro, Ana Laura Ortega, Elia Martínez Moreno, Juan Coves, Ana M Sánchez Peña, Joaquim Bosch-Barrera, Amparo Sánchez Gastaldo, Natalia Fernández Núñez, Edel Del Barco, Manuel Cobo, Dolores Isla, Margarita Majem, Fátima Navarro, Virginia Calvo, Mariano Provencio, Josefa Terrasa, Pilar Garrido, Rosario García Campelo, Francisco Aparisi, Pilar Diz, David Aguiar, Carlos García-Giron, Julia Hidalgo, Carlos Aguado, Jorge García González, Emilio Esteban, Lorenzo Gómez-Aldavarí, Teresa Moran, Oscar Juan, Luís Enrique Chara, Juan L Marti, Rafael López Castro, Ana Laura Ortega, Elia Martínez Moreno, Juan Coves, Ana M Sánchez Peña, Joaquim Bosch-Barrera, Amparo Sánchez Gastaldo, Natalia Fernández Núñez, Edel Del Barco, Manuel Cobo, Dolores Isla, Margarita Majem, Fátima Navarro, Virginia Calvo

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 .

Keywords: EGFR-activating mutations; Non-small cell lung cancer; Osimertinib; Real-world data; Second line; T790M EGFR mutation.

Conflict of interest statement

A summary conflict of interest statement in a separate document.

Figures

Fig. 1
Fig. 1
Estimated median OS of patients treated with osimertinib
Fig. 2
Fig. 2
Estimated median PFS of patients treated with osimertinib

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