A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study

Yusuke Chihara, Takayuki Takeda, Yasuhiro Goto, Yoichi Nakamura, Yuko Tsuchiya-Kawano, Akira Nakao, Keisuke Onoi, Makoto Hibino, Minoru Fukuda, Ryoichi Honda, Takahiro Yamada, Ryusuke Taniguchi, Sinjiro Sakamoto, Koji Date, Seiji Nagashima, Shigeru Tanzawa, Koichi Minato, Koichi Nakatani, Miiru Izumi, Takayuki ShimoseJunji Kishimoto, Junji Uchino, Koichi Takayama

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Osimertinib is one of the standard first-line treatments for advanced non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations, because it achieves significantly longer progression-free survival (PFS) than conventional first-line treatments (hazard ratio: 0.46). However, the efficacy and safety of osimertinib as a first-line treatment for patients aged ≥75 years remain unclear. METHODS: This phase II study was performed to prospectively investigate the efficacy and safety of osimertinib for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. The primary endpoint was 1-year PFS rate; secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. RESULTS: Thirty-eight patients were included in the analysis. The 1-year PFS rate was 59.4% (95% confidence interval [CI], 46.1%-72.7%), which did not meet the primary endpoint (the threshold 1-year PFS rate of 50% predicted using data from the NEJ003 study). The most common grade 3/4 adverse events were rash/dermatitis acneiform/ALT increased/hypokalemia (2 patients, 5%). Seven patients developed pneumonitis (17.5%). There were no other cases of treatment discontinuation due to adverse events other than pneumonitis. CONCLUSION: Although this study did not meet the primary endpoint, osimertinib was tolerable for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. (Japan Registry of Clinical Trials [JRCT] ID number: jRCTs071180007).

Original languageEnglish
Pages (from-to)903-e834
JournalOncologist
Volume27
Issue number11
DOIs
Publication statusPublished - Nov 3 2022

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Fingerprint

Dive into the research topics of 'A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study'. Together they form a unique fingerprint.

Cite this