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

• Published in: BMC cancer Vol. 21; no. 1; p. 230
• Main Authors: Provencio, Mariano, 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, Virginia
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 06.03.2021; BioMed Central; BMC
• Subjects: Acrylamides - administration & dosage; Acrylamides - adverse effects; Adenocarcinoma; Adult; Adverse events; Aged; Aged, 80 and over; Aniline Compounds - administration & dosage; Aniline Compounds - adverse effects; Carcinoma, Non-Small-Cell Lung - diagnosis; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - genetics; Carcinoma, Non-Small-Cell Lung - mortality; Chemotherapy; Clinical medicine; Data collection; Development and progression; Drug therapy; EGFR-activating mutations; Epidermal growth factor receptors; ErbB Receptors - antagonists & inhibitors; ErbB Receptors - genetics; Ethics; Female; Follow-Up Studies; Gene mutations; Genetic aspects; Health aspects; Humans; Lung - pathology; Lung cancer; Lung cancer, Non-small cell; Lung Neoplasms - diagnosis; Lung Neoplasms - drug therapy; Lung Neoplasms - genetics; Lung Neoplasms - mortality; Male; Middle Aged; Mutation; Neoplasm Staging; Non-small cell lung cancer; Non-small cell lung carcinoma; Osimertinib; Patients; Primary care; Progression-Free Survival; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein-tyrosine kinase; Radiation therapy; Real-world data; Response rates; Retrospective Studies; Second line; Small cell lung carcinoma; Spain - epidemiology; Statistical analysis; T790M EGFR mutation; Targeted cancer therapy; Toxicity; Spain; Second line; T790M EGFR mutation; Osimertinib; Non-small cell lung cancer; Real-world data; EGFR-activating mutations
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-021-07922-5

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 .