JCO:BLOOM Study - Osimertinib's application in EGFRm and LM non-small cell lung cancer patients

About 3% to 4% of patients with advanced non-small cell lung cancer (NSCLC) have meninges metastasis (LMs), and in NSCLC of epithal growth factor changes (EGFRm), the incidence of LM increases to about 9%.
Osimertinib is a third-generation, irreversible EGFR-TKI that is approved for the treatment of advanced EGFRm and T790M-positive NSCLC patients with disease progress after EGFR-TKIs.
recently, a BLOOM study conducted at the National Taiwan University Hospital assessed the efficacy and safety of osimertinib in patients with advanced LMs in EGFRm, who were still progressing after treatment with EGFR-TKI.
found that Osimertinib was effective in treating LMs and that in EGFRm NSCLC and LM patients, a daily dose of 160 mg was safe and controllable, the study was published online in J Clin Oncol.
study included 41 cytologically confirmed LM patients who received osimertinib 160mg once a day.
objective response rate (ORR), reaction duration (DoR), progression-free lifetime (PFS), total lifetime (OS), pharmacodynamics (PK), and safety.
, the researchers evaluated changes in the relative baseline of CSF cytology and neurology examinations.
results showed that LM ORR and DoR of neuroradiology BICR were 62% (95% CI, 45% to 78%) and 15.2 months (95% CI, 7.5 to 17.5 months), respectively.
overall, the ORR is 41% (95% CI, 26% to 58%) and the medium DoR is 8.3 months (95% CI, 5.6 to 16.5 months).
PFS was 8.6 months (95% CI, 5.4 to 13.7 months) and the medium OS was 11.0 months (95% CI, 8.0 to 18.0 months).
11 out of 40 patients (28 percent; 95 percent CI, 15 to 44 percent) confirmed CSF tumor cell removal.
21 patients with baseline evaluation abnormalities, 12 patients (57%) had improved neural function.
adverse events and PK spectrum are consistent with previous reports of osimertinib.
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