A Phase II Study to Assess the Efficacy of Osimertinib in Patients With EGFR Mutation-positive NSCLC Who Developed Isolated CNS Progression (T790M-negative or Unknown) During First- or Second-generation EGFR-TKI or Systemic Disease Progression (T790M-negative) After Treatment With First- or Second-generation EGFR-TKI and Platinum-based Chemotherapy (WJOG12819L)

Masayuki Takeda, Mototsugu Shimokawa, Atsushi Nakamura, Kaname Nosaki, Yasutaka Watanabe, Terufumi Kato, Daisuke Hayakawa, Hiroshi Tanaka, Toshiaki Takahashi, Yoshihito Kogure, Motoko Tachihara, Daichi Fujimoto, Kakuhiro Yamaguchi, Naohiko Hamaguchi, Isamu Okamoto, Koichi Azuma, Kazuo Hasegawa, Nobuyuki Yamamoto, Kazuhiko Nakagawa

研究成果: Contribution to journalArticle査読

抄録

Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that has recently been established as a standard treatment option for chemotherapy-naive patients with EGFR mutation-positive non–small-cell lung cancer (NSCLC). However, only about one-half of patients who have received prior treatment with a first- or second-generation EGFR-TKI are eligible for osimertinib therapy because its indication in the second-line setting is limited to metastatic NSCLC positive for the T790M resistance mutation of EGFR. The dose-escalation part of a study in which patients received osimertinib at doses of 20 to 240 mg once daily after the development of resistance to first- or second-generation EGFR-TKIs revealed a response rate of 21% and a median progression-free survival of 2.8 months for individuals whose tumors were negative for EGFR T790M. We have now designed a phase II study of osimertinib for patients with EGFR mutation–positive NSCLC who develop isolated central nervous system progression (T790M-negative or unknown) after first- or second-generation EGFR-TKI therapy (cohort 1) or who develop systemic disease progression (T790M-negative) after first- or second-generation EGFR-TKI therapy and platinum-based chemotherapy (cohort 2). A total of 70 patients (cohort 1, n = 17; cohort 2, n = 53) will be enrolled in this study, which originated from a suggestion of a dedicated network for patients with lung cancer in Japan.

本文言語英語
ジャーナルClinical Lung Cancer
DOI
出版ステータス受理済み/印刷中 - 2021
外部発表はい

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 呼吸器内科
  • 癌研究

フィンガープリント

「A Phase II Study to Assess the Efficacy of Osimertinib in Patients With EGFR Mutation-positive NSCLC Who Developed Isolated CNS Progression (T790M-negative or Unknown) During First- or Second-generation EGFR-TKI or Systemic Disease Progression (T790M-negative) After Treatment With First- or Second-generation EGFR-TKI and Platinum-based Chemotherapy (WJOG12819L)」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

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