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

Akira Nakao, Osamu Hiranuma, Junji Uchino, Chikara Sakaguchi, Tomoyuki Araya, Noriya Hiraoka, Tamotsu Ishizuka, Takayuki Takeda, Masayuki Kawasaki, Yasuhiro Goto, Hisao Imai, Noboru Hattori, Keita Nakatomi, Hidetaka Uramoto, Kiyoaki Uryu, Minoru Fukuda, Yasuki Uchida, Toshihide Yokoyama, Masaya Akai, Tadashi MioSeiji Nagashima, Yusuke Chihara, Nobuyo Tamiya, Yoshiko Kaneko, Takako Mouri, Tadaaki Yamada, Kenichi Yoshimura, Masaki Fujita, Koichi Takayama

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number1762
Pages (from-to)1-12
Number of pages12
JournalJournal of Clinical Medicine
Volume9
Issue number6
DOIs
Publication statusPublished - 06-2020

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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