TY - JOUR
T1 - A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients
T2 - The SPIRAL-0 Study
AU - Chihara, Yusuke
AU - Takeda, Takayuki
AU - Goto, Yasuhiro
AU - Nakamura, Yoichi
AU - Tsuchiya-Kawano, Yuko
AU - Nakao, Akira
AU - Onoi, Keisuke
AU - Hibino, Makoto
AU - Fukuda, Minoru
AU - Honda, Ryoichi
AU - Yamada, Takahiro
AU - Taniguchi, Ryusuke
AU - Sakamoto, Sinjiro
AU - Date, Koji
AU - Nagashima, Seiji
AU - Tanzawa, Shigeru
AU - Minato, Koichi
AU - Nakatani, Koichi
AU - Izumi, Miiru
AU - Shimose, Takayuki
AU - Kishimoto, Junji
AU - Uchino, Junji
AU - Takayama, Koichi
N1 - Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press.
PY - 2022/11
Y1 - 2022/11
N2 - 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.
AB - 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.
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U2 - 10.1093/oncolo/oyac193
DO - 10.1093/oncolo/oyac193
M3 - Article
C2 - 36181763
AN - SCOPUS:85141889822
SN - 1083-7159
VL - 27
JO - Oncologist
JF - Oncologist
IS - 11
ER -