Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort
Objectives: Osimertinib is a third-generation EGFR inhibitor with activity against both sensitizing and resistance mutations. Following results of the phase III study, AURA3, which led to the approval of osimertinib worldwide, we have conducted ASTRIS with the aim of confirming the effica...
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| Language: | English |
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Sociedade Brasileira de Oncologia Clínica, Sociedade Brasileira de Cirurgia Clínica and Sociedade Brasileira de Radioterapia
2020-01-01
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| Series: | Brazilian Journal of Oncology |
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| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.5935/2526-8732.20200005 |
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| author | Luiz Henrique Araujo Gilberto de Castro Clarissa Baldotto Marcelo Graziano Custódio Pedro De-Marchi Aknar Calabrich Clarissa Mathias André Santa-Maria Maíra Takemoto Helano Freitas |
| author_facet | Luiz Henrique Araujo Gilberto de Castro Clarissa Baldotto Marcelo Graziano Custódio Pedro De-Marchi Aknar Calabrich Clarissa Mathias André Santa-Maria Maíra Takemoto Helano Freitas |
| author_sort | Luiz Henrique Araujo |
| collection | DOAJ |
| description |
Objectives: Osimertinib is a third-generation EGFR inhibitor with activity against both sensitizing and resistance mutations. Following results of the phase III study, AURA3, which led to the approval of osimertinib worldwide, we have conducted ASTRIS with the aim of confirming the efficacy and safety of osimertinib. Methods: This is a phase IV, international, multicentric, open trial assessing the efficacy and safety of osimertinib at a dose of 80mg daily, orally. Eligible patients were those with diagnosis of T790M-positive NSCLC on progression after prior EGFRTKI. Herein, we present the Brazilian experience at ASTRIS. Results: Eighty-eight patients were enrolled in Brazil between August, 2015 and March, 2017. The median age was 34-89 (years), and most were females (66%). Fiftyfour patients (61%) had received prior therapy with erlotinib, forty-two (48%) with gefitinib, and 3 (3%) with afatinib. Exon 19 deletions were the most common primary mutation in EGFR, present in 55 cases (62.5%), followed by L858R in 24 cases (27%). The response rate was 58.2% (95%CI = 46.6-69.2), and median progression-free survival was 9.4 months (95%CI = 8.2-not reached). The most common AE was pneumonia (5 cases). Only 1 patient (1.1%) had a pneumonitis-like event and 2 patients (2.3%) had a prolongation of the QTc interval. Conclusion: In a realworld setting, osimertinib constitutes a safe and effective therapeutic option for Brazilian patients with advanced T790M-positive NSCLC after progression on a prior EGFR-TKI, including those patients with central nervous system metastasis. Our findings support previous observations and add valuable information regarding osimertinib effectiveness in Brazilian patients. |
| format | Article |
| id | doaj-art-f72e0e5c961841b8921e5d1237244b99 |
| institution | Kabale University |
| issn | 2526-8732 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Sociedade Brasileira de Oncologia Clínica, Sociedade Brasileira de Cirurgia Clínica and Sociedade Brasileira de Radioterapia |
| record_format | Article |
| series | Brazilian Journal of Oncology |
| spelling | doaj-art-f72e0e5c961841b8921e5d1237244b992024-11-29T10:36:07ZengSociedade Brasileira de Oncologia Clínica, Sociedade Brasileira de Cirurgia Clínica and Sociedade Brasileira de RadioterapiaBrazilian Journal of Oncology2526-87322020-01-011610.5935/2526-8732.20200005Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohortLuiz Henrique Araujohttps://orcid.org/0000-0003-3707-7119Gilberto de Castro0Clarissa Baldotto1Marcelo Graziano Custódio2Pedro De-Marchi3Aknar Calabrich4Clarissa Mathias5André Santa-Maria6Maíra Takemoto7Helano Freitas8ICESP, Medical Oncology - São Paulo - SP - BrazilOncologia D'or, Medical Oncology - Rio de Janeiro - RJ - BrazilAstraZeneca, Medical Oncology - Cotia - SP - BrazilHospital de Câncer de Barretos, Medical Oncology - Barretos - SP - BrazilAMO, Medical Oncology - S+alvador - BA - BrazilNOB, Medical Oncology - Salvador - BA - BrazilAstraZeneca, Medical Oncology - Cotia - SP - BrazilTechTrials, Medical Oncology - São Paulo - SP - BrazilAC Camargo Cancer Center, Medical Oncology - São Paulo - SP - Brazil Objectives: Osimertinib is a third-generation EGFR inhibitor with activity against both sensitizing and resistance mutations. Following results of the phase III study, AURA3, which led to the approval of osimertinib worldwide, we have conducted ASTRIS with the aim of confirming the efficacy and safety of osimertinib. Methods: This is a phase IV, international, multicentric, open trial assessing the efficacy and safety of osimertinib at a dose of 80mg daily, orally. Eligible patients were those with diagnosis of T790M-positive NSCLC on progression after prior EGFRTKI. Herein, we present the Brazilian experience at ASTRIS. Results: Eighty-eight patients were enrolled in Brazil between August, 2015 and March, 2017. The median age was 34-89 (years), and most were females (66%). Fiftyfour patients (61%) had received prior therapy with erlotinib, forty-two (48%) with gefitinib, and 3 (3%) with afatinib. Exon 19 deletions were the most common primary mutation in EGFR, present in 55 cases (62.5%), followed by L858R in 24 cases (27%). The response rate was 58.2% (95%CI = 46.6-69.2), and median progression-free survival was 9.4 months (95%CI = 8.2-not reached). The most common AE was pneumonia (5 cases). Only 1 patient (1.1%) had a pneumonitis-like event and 2 patients (2.3%) had a prolongation of the QTc interval. Conclusion: In a realworld setting, osimertinib constitutes a safe and effective therapeutic option for Brazilian patients with advanced T790M-positive NSCLC after progression on a prior EGFR-TKI, including those patients with central nervous system metastasis. Our findings support previous observations and add valuable information regarding osimertinib effectiveness in Brazilian patients.http://www.thieme-connect.de/DOI/DOI?10.5935/2526-8732.20200005Lung neoplasmsGeneserbB-1Molecular targeted therapyNeoplasias pulmonaresGenes erbB-1Terapia direcionada molecular |
| spellingShingle | Luiz Henrique Araujo Gilberto de Castro Clarissa Baldotto Marcelo Graziano Custódio Pedro De-Marchi Aknar Calabrich Clarissa Mathias André Santa-Maria Maíra Takemoto Helano Freitas Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort Brazilian Journal of Oncology Lung neoplasms Genes erbB-1 Molecular targeted therapy Neoplasias pulmonares Genes erbB-1 Terapia direcionada molecular |
| title | Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort |
| title_full | Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort |
| title_fullStr | Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort |
| title_full_unstemmed | Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort |
| title_short | Efficacy of osimertinib in advanced T790M-positive NSCLC after progression to prior EGFR-TKI: real world data from a Brazilian cohort |
| title_sort | efficacy of osimertinib in advanced t790m positive nsclc after progression to prior egfr tki real world data from a brazilian cohort |
| topic | Lung neoplasms Genes erbB-1 Molecular targeted therapy Neoplasias pulmonares Genes erbB-1 Terapia direcionada molecular |
| url | http://www.thieme-connect.de/DOI/DOI?10.5935/2526-8732.20200005 |
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