Cargando…

Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are used for treating EGFR-mutated lung cancer, and osimertinib is effective in cases that acquired T790M mutations after treatment with the first- and second-generation EGFR-TKIs. However, no study has evaluated its safety and...

Descripción completa

Detalles Bibliográficos
Autores principales: Nakao, Akira, Hiranuma, Osamu, Uchino, Junji, Sakaguchi, Chikara, Araya, Tomoyuki, Hiraoka, Noriya, Ishizuka, Tamotsu, Takeda, Takayuki, Kawasaki, Masayuki, Goto, Yasuhiro, Imai, Hisao, Hattori, Noboru, Nakatomi, Keita, Uramoto, Hidetaka, Uryu, Kiyoaki, Fukuda, Minoru, Uchida, Yasuki, Yokoyama, Toshihide, Akai, Masaya, Mio, Tadashi, Nagashima, Seiji, Chihara, Yusuke, Tamiya, Nobuyo, Kaneko, Yoshiko, Mouri, Takako, Yamada, Tadaaki, Yoshimura, Kenichi, Fujita, Masaki, Takayama, Koichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356339/
https://www.ncbi.nlm.nih.gov/pubmed/32517152
http://dx.doi.org/10.3390/jcm9061762
Descripción
Sumario:Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are used for treating EGFR-mutated lung cancer, and osimertinib is effective in cases that acquired T790M mutations after treatment with the first- and second-generation EGFR-TKIs. However, no study has evaluated its safety and efficacy in older patients. This phase II trial (jRCTs071180002) evaluated osimertinib in T790M mutation-positive Japanese patients who were ≥75 years old and had experienced relapse or progression after previous EGFR-TKI treatment. Our previous report that enrolled 36 patients showed the overall response rate (58.3%) and disease control rate (97.2%), while this report describes the results for the progression-free survival (PFS), overall survival (OS), and safety analyses. The median PFS was 11.9 months (95% confidence interval (CI): 7.9–17.5), and the median OS was 22.0 months (95% CI: 16.0 months–not reached). The most frequent adverse events were anemia/hypoalbuminemia (27 patients, 75.0%), thrombocytopenia (21 patients, 58.3%), and paronychia/anorexia/diarrhea/neutropenia (15 patients, 41.7%). Pneumonitis was observed in four patients (11.1%), including two patients (5.6%) with Grade 3–4 pneumonitis. These results suggest that osimertinib was relatively safe and effective for non-small cell lung cancer that acquired T790M mutations after previous EGFR-TKI treatment, even among patients who were ≥75 years old.