Abstract
e20596Background: Leptomeningeal metastases (LM) occur in almost 5% of non-small cell lung cancer (NSCLC) patients and are associated with a poor prognosis (the median survival ranges from 4 to 6 weeks). The cumulative incidence of CNS involvement in EGFR-mutant (mt) NSCLC is up to 60% and higher than that of EGFR-wild (wt) NSCLC. To date, no prospective study has identified active chemotherapy for NSCLC patients with LM and therapeutic options in such patients remain limited. In retrospective studies, EGFR-TKI treatment is reported to be effective for the treatment of LM. Erlotinib (ERL) cerebrospinal fluid (CSF) concentrations are higher than those of gefitinib or afatinib. Methods: We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of ERL in patients with LM. NSCLC patients with cytologically confirmed LM were eligible. The primary endpoint was the overall cytological response rate (ORR), which was defined as “the number of patients who achieved complete remission in the CS...
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