Filippo de Marinis1, Yi-Long Wu2, Gilberto de Castro3, Gee-Chen Chang4,5, Yuh-Min Chen6, Byoung Chul Cho7, Helano C Freitas8, Liyan Jiang9, Sang-We Kim10, Claudio Martin11, Giulio Metro12, Mariano Provencio13, Johan Vansteenkiste14, David Vicente15, Qing Zhou2, Miguel F Miranda16, Nicolaas A Bakker17, James R Rigas18, Parneet K Cheema19. 1. Department of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan, Italy. 2. Department of Oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, & Guangdong Academy of Medical Sciences, Guangzhou, PR China. 3. Department of Clinical Oncology, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil. 4. Department of Internal Medicine, Division of Chest Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. 5. Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 6. Department of Chest Medicine, Taipei Veterans General Hospital, & School of Medicine, National Yang-Ming Medical University, Taipei, Taiwan. 7. Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 8. Department of Medical Oncology, AC Camargo Cancer Center, São Paulo, Brazil. 9. Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, PR China. 10. Department of Oncology, Brain Tumor Center, Center for Personalized Cancer Medicine, Lung Cancer Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 11. Department of Oncology, Instituto Alexander Fleming, Buenos Aires, Argentina. 12. Department of Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, Perugia, Italy. 13. Department of Oncology, Hospital Universitario Puerta de Hierro, Majadahonda, IDHIPSA, Universidad Autónoma de Madrid, Spain. 14. Department of Respiratory Diseases, Respiratory Oncology Unit, University Hospitals KU Leuven, Leuven, Belgium. 15. Department of Clinical Oncology, H.U.V. Macarena, Seville, Spain. 16. AstraZeneca, Biometrics & Information Sciences, Cambridge, UK. 17. AstraZeneca, Oncology Business Unit, Medical, Cambridge, UK. 18. AstraZeneca, GMA Oncology TA, Gaithersburg, MD 20878, USA. 19. William Osler Health System, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON M4N 3M5, Canada.
Abstract
Aim: Osimertinib is a third-generation, irreversible, oral EGFR tyrosine kinase inhibitor. We report real-world effectiveness and safety data. Patients & methods: EGFR T790M positive advanced non-small-cell lung cancer adults, who received ≥1 prior EGFR tyrosine kinase inhibitor, received osimertinib 80 mg daily. Primary effectiveness outcome: overall survival. Secondary effectiveness outcomes included: investigator-assessed clinical response, progression-free survival, time-to-treatment discontinuation. Results: At data cutoff, 3015 patients had enrolled: 57.1% had investigator-assessed response (95% CI: 55.2-58.9). Median progression-free survival: 11.1 months (95% CI: 11.0-12.0) and median time-to-treatment discontinuation: 13.5 months (95% CI: 12.6-13.9). Interstitial lung disease/pneumonitis-like events reported in 28 (1%) patients. Conclusion: Osimertinib demonstrated clinical effectiveness similar to efficacy observed in the clinical trial program with no new safety signals.
Aim: Osimertinib is a third-generation, irreversible, oral EGFR tyrosine kinase inhibitor. We report real-world effectiveness and safety data. Patients & methods: EGFR T790M positive advanced non-small-cell lung cancer adults, who received ≥1 prior EGFR tyrosine kinase inhibitor, received osimertinib 80 mg daily. Primary effectiveness outcome: overall survival. Secondary effectiveness outcomes included: investigator-assessed clinical response, progression-free survival, time-to-treatment discontinuation. Results: At data cutoff, 3015 patients had enrolled: 57.1% had investigator-assessed response (95% CI: 55.2-58.9). Median progression-free survival: 11.1 months (95% CI: 11.0-12.0) and median time-to-treatment discontinuation: 13.5 months (95% CI: 12.6-13.9). Interstitial lung disease/pneumonitis-like events reported in 28 (1%) patients. Conclusion: Osimertinib demonstrated clinical effectiveness similar to efficacy observed in the clinical trial program with no new safety signals.
Entities:
Keywords:
ASTRIS; EGFR-TKI; T790M; lung cancer; molecular-targeted therapy; osimertinib; real world evidence
Authors: Atocha Romero; Roberto Serna-Blasco; Cristina Alfaro; Estela Sánchez-Herrero; Miguel Barquín; María Carmen Turpin; Sofía Chico; Sandra Sanz-Moreno; Alejandro Rodrigez-Festa; Raquel Laza-Briviesca; Alberto Cruz-Bermudez; Virginia Calvo; Ana Royuela; Mariano Provencio Journal: Transl Lung Cancer Res Date: 2020-06
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 Journal: BMC Cancer Date: 2021-03-06 Impact factor: 4.430