ASTRIS, a large real-world study to evaluate the efficacy of osimertinib in epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer patients: Clinical characteristics and genotyping methods in a Spanish cohort.
Por:
Vicente-Baz D, Paredes A, Morán T, Massuti B, Reguart N, Álvarez R, Insa A, Juan-Vidal O, Artal Á, Esteban E, García-Campelo R, Ortega-Granados AL, Diz P, González-Larriba JL, Terrasa J, de Las Peñas R, Rodríguez-Abreu D, Callejo Á, Márquez G and Provencio M
Publicada:
1 jul 2020
Ahead of Print:
13 ene 2020
Resumen:
PURPOSE: Osimertinib has proven efficacy in EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) patients; however, its benefits have not been evaluated in a real-world setting. METHODS: ASTRIS is a single-arm, open-label, multinational study to evaluate the efficacy and safety of osimertinib for the treatment of EGFR T790M mutation-positive NSCLC. We present the study design and preliminary cut-off analysis results (as of October 2017) describing the baseline characteristics and methodology for T790M mutation detection in the Spanish cohort. RESULTS: The Spanish cohort included 131 patients from a total 3014 patients. Forty patients (28.1%) were still undergoing therapy at the time of cut-off; 68.7% were women and 97.7% were Caucasian, with a mean age of 64.8 (SD 11.7) years. The most common type of sample for evaluating T790M mutations was tissue (55.0%), and samples were obtained from the primary tumor in 61.1% of cases. Mutation analysis was performed by the local laboratory in 60.3% of cases and using the Roche Cobas® EGFR assay in 43.5% of cases. CONCLUSIONS: ASTRIS is expected to confirm the benefits of osimertinib in a real-world setting. Data on real-world practices for the detection of the EGFR T790M mutation may provide additional information for the designing of guidelines for best practices.
Filiaciones:
Vicente-Baz D:
Hospital Universitario Virgen Macarena, Sevilla, Spain
Paredes A:
Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain
Morán T:
ICO - Badalona Hospital Universitari Germans Trias I Pujol, Universitat Autònoma de Barcelona (UAB), IGTP, B-ARGOS, Badalona, Spain
:
Alicante University Hospital, Alicante, Spain
Reguart N:
Hospital Clínic de Barcelona, Barcelona, Spain
Álvarez R:
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Insa A:
Hospital Clínico Universitario de Valencia, Valencia, Spain
Juan-Vidal O:
Hospital Universitario y Politecnic La Fe, Valencia, Spain
Artal Á:
Hospital Universitario Miguel Servet, Zaragoza, Spain
Esteban E:
Hospital Universitario Central de Asturias, Oviedo, Spain
García-Campelo R:
University Hospital A Coruña, A Coruña, Spain
Ortega-Granados AL:
Complejo Hospitalario de Jaén, Jaén, Spain
Diz P:
Complejo Asistencial Universitario de León, León, Spain
González-Larriba JL:
Hospital Clínico San Carlos, Madrid, Spain
Terrasa J:
Hospital Universitario Son Espases, Palma de Mallorca, Spain
de Las Peñas R:
Consorcio Hospitalario Provincial de Castellón, Castellón, Spain
Rodríguez-Abreu D:
Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain
Callejo Á:
AstraZeneca Spain, Madrid, Spain
Márquez G:
AstraZeneca Spain, Madrid, Spain
Provencio M:
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, Spain. Electronic address:
|