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CNS response to osimertinib vs standard epidermal growth factor receptor tyrosine kinase inhibitors in patients with untreated EGFR-mutated advanced non–small-cell lung cancer

Journal of Clinical Oncology Sep 02, 2018

Reungwetwattana T, et al. - In patients with untreated epidermal growth factor receptor (EGFR)-mutated advanced non–small-cell lung cancer from the phase III FLAURA study, authors reported the CNS efficacy of osimertinib vs standard epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). In patients with untreated EGFR-mutated non–small-cell lung cancer, osimertinib was seen to have CNS efficacy. Compared to standard EGFR-TKIs, a reduced risk of CNS progression was seen with osimertinib.

Methods

  • Experts randomly assigned the patients (N=556) to osimertinib or standard EGFR-TKIs (gefitinib or erlotinib); brain scans were not mandated unless clinically indicated.
  • They included the patients with asymptomatic or stable CNS metastases.
  • Neurologic status was required to be stable for ≥ 2 weeks after completion of definitive therapy and corticosteroids in patients with symptomatic CNS metastases.
  • They conducted a preplanned subgroup analysis with CNS progression-free survival as the primary objective in patients with measurable and/or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiologic review.
  • The patients with ≥ 1 measurable CNS lesion were included in the CNS evaluable-for-response set.

Results

  • As per data, 128 (osimertinib, n=61; standard EGFR-TKIs, n=67) out of 200 patients with available brain scans at baseline demonstrated measurable and/or nonmeasurable CNS lesions, including 41 patients (osimertinib, n=22; standard EGFR-TKIs, n=19) with ≥ 1 measurable CNS lesion.
  • Findings suggested that in patients with measurable and/or nonmeasurable CNS lesions, median CNS progression-free survival 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]).
  • In patients with ≥ 1 measurable CNS lesion (odds ratio, 4.6; 95% CI, 0.9 to 34.9; P=.066), CNS objective response rates were 91% and 68% and 66% and it was 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.
  • They noted a consistently lower probability of experiencing a CNS progression event with osimertinib vs standard EGFR-TKIs.
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