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

• Main Authors: 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
• Format: Article
• Language: English
• Published: BMC 2021-03-01
• Series: BMC Cancer
• Subjects: Osimertinib; Real-world data; EGFR-activating mutations; T790M EGFR mutation; Second line; Non-small cell lung cancer
• Online Access: https://doi.org/10.1186/s12885-021-07922-5

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 .