RT Journal Article
T1 CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.
A1 Reungwetwattana, Thanyanan
A1 Nakagawa, Kazuhiko
A1 Cho, Byoung Chul
A1 Cobo, Manuel
A1 Cho, Eun Kyung
A1 Bertolini, Alessandro
A1 Bohnet, Sabine
A1 Zhou, Caicun
A1 Lee, Ki Hyeong
A1 Nogami, Naoyuki
A1 Okamoto, Isamu
A1 Leighl, Natasha
A1 Hodge, Rachel
A1 McKeown, Astrid
A1 Brown, Andrew P
A1 Rukazenkov, Yuri
A1 Ramalingam, Suresh S
A1 Vansteenkiste, Johan
K1 Neoplasm Metastasis
K1 Lung Neoplasms
K1 Progression-Free Survival
K1 Adrenal Cortex Hormones
K1 Tyrosine Protein Kinase Inhibitors
AB Purpose We report CNS efficacy of osimertinib versus standard epidermal growth factor receptor ( EGFR) tyrosine kinase inhibitors (TKIs) in patients with untreated EGFR-mutated advanced non-small-cell lung cancer from the phase III FLAURA study. Patients and Methods Patients (N = 556) were randomly assigned to osimertinib or standard EGFR-TKIs (gefitinib or erlotinib); brain scans were not mandated unless clinically indicated. Patients with asymptomatic or stable CNS metastases were included. In patients with symptomatic CNS metastases, neurologic status was required to be stable for ≥ 2 weeks after completion of definitive therapy and corticosteroids. A preplanned subgroup analysis with CNS progression-free survival as primary objective was conducted in patients with measurable and/or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiologic review. The CNS evaluable-for-response set included patients with ≥ one measurable CNS lesion. Results Of 200 patients with available brain scans at baseline, 128 (osimertinib, n = 61; standard EGFR-TKIs, n = 67) had measurable and/or nonmeasurable CNS lesions, including 41 patients (osimertinib, n = 22; standard EGFR-TKIs, n = 19) with ≥ one measurable CNS lesion. Median CNS progression-free survival in patients with measurable and/or nonmeasurable CNS lesions was not reached with osimertinib (95% CI, 16.5 months to not calculable) and 13.9 months (95% CI, 8.3 months to not calculable) with standard EGFR-TKIs (hazard ratio, 0.48; 95% CI, 0.26 to 0.86; P = .014 [nominally statistically significant]). CNS objective response rates were 91% and 68% in patients with ≥ one measurable CNS lesion (odds ratio, 4.6; 95% CI, 0.9 to 34.9; P = .066) and 66% and 43% in patients with measurable and/or nonmeasurable CNS lesions (odds ratio, 2.5; 95% CI, 1.2 to 5.2; P = .011) treated with osimertinib and standard EGFR-TKIs, respectively. Probability of experiencing a CNS progression event was consistently lower with osimertinib versus standard EGFR-TKIs. Conclusion Osimertinib has CNS efficacy in patients with untreated EGFR-mutated non-small-cell lung cancer. These results suggest a reduced risk of CNS progression with osimertinib versus standard EGFR-TKIs.
PB American Society of Clinical Oncology
YR 2018
FD 2018-08-28
LK http://hdl.handle.net/10668/12878
UL http://hdl.handle.net/10668/12878
LA en
NO Reungwetwattana T, Nakagawa K, Cho BC, Cobo M, Cho EK, et al. CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 28:JCO2018783118
DS RISalud
RD Apr 6, 2025