Abstract
BackgroundThe study aimed to compare the efficacy of osimertinib plus cranial radiotherapy (RT) with osimertinib alone in advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations and brain metastases (BMs).MethodsThe clinical data of advanced NSCLC patients with BMs who received osimertinib were retrospectively collected. The patients were assigned to one of the two groups according to the therapeutic modality used: the osimertinib monotherapy group or the osimertinib plus RT group.ResultsThis was a retrospective study and 61 patients were included from December 2015 to August 2020. Forty patients received osimertinib monotherapy, and twenty-one patients received osimertinib plus RT. Radiotherapy included whole-brain radiation therapy (WBRT, n = 14), WBRT with simultaneous integrated boost (WBRT-SIB, n = 5) and stereotactic radiosurgery (SRS, n = 2). The median number of prior systemic therapies in the two groups was one. Intracranial and systemic ORR and DCR were not significantly different between the two groups. No difference in iPFS was observed between the two groups (median iPFS: 16.67 vs. 13.50 months, P = 0.836). The median OS was 29.20 months in the osimertinib plus RT group compared with 26.13 months in the osimertinib group (HR = 0.895, P = 0.826). In the L858R mutational subgroup of 31 patients, the osimertinib plus RT group had a longer OS (P = 0.046). In the exon 19 deletion mutational subgroup of 30 patients, OS in the osimertinib alone group was longer than that in the osimertinib plus RT group (P = 0.011). The incidence of any-grade adverse events was not significantly different between the osimertinib plus RT group and the osimertinib alone group (47.6% vs. 32.5%, P = 0.762). However, six patients (28.5%) experienced leukoencephalopathy in the osimertinib plus RT group, and 50% (3/6) of the leukoencephalopathy was greater than or equal to grade 3.ConclusionThe therapeutic effect of osimertinib with RT was similar to that of osimertinib alone in EGFR-positive NSCLC patients with BM. However, for patients with the L858R mutation, osimertinib plus RT could provide more benefit than osimertinib alone.
Highlights
The study aimed to compare the efficacy of osimertinib plus cranial radiotherapy (RT) with osimertinib alone in advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations and brain metastases (BMs)
Study design and patients We retrospectively reviewed the medical records of advanced NSCLC patients who were initially diagnosed with BM or progressed from BM and received osimertinib in Shandong Cancer Hospital and Institute (Jinan, Shandong, China) between December 2015 and August 2020
Thirty-four patients were excluded for using osimertinib initially because of extracranial progression, 20 patients were excluded for previous cranial radiotherapy, and 6 patients were excluded for T790M-negative mutation
Summary
The study aimed to compare the efficacy of osimertinib plus cranial radiotherapy (RT) with osimertinib alone in advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations and brain metastases (BMs). In the era of chemotherapy, agents with large molecular weights have difficulty crossing the blood–brain barrier (BBB), causing poor prognosis in patients with brain metastases [4]. With the development of targeted therapy, EGFR tyrosine kinase inhibitors (TKIs) with small molecular weights have replaced chemotherapy as first-line treatment for advanced NSCLC patients with EGFR mutations. A phase II trial indicated that in lung adenocarcinoma patients with BM and EGFR mutations receiving gefitinib, the median intracranial progressionfree survival (iPFS) was 14.5 months [7]. The CTONG0803 study enrolling patients with advanced NSCLC and asymptomatic BMs suggested that erlotinib as secondline therapy has an iPFS of 10.1 months [8]. LUX-Lung 6 showed that in patients with baseline BMs and EGFR mutations, the median time to central nervous system (CNS) progression in the afatinib group was 7.9 months longer than that in the chemotherapy group [9]
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