P3.01-028 Efficacy of Osimertinib for Brain Metastasis in Advanced NSCLC: Data from Single Center in ASTRIS Trial

Kim, J.H.; Kim, H.R.; Hong, Min Hee; Bang, Iel Soo; Kim, R.; Jung, Haeil; Cho, H.J.; Kim, H.; Cho, B.C.

doi:10.1016/j.jtho.2017.09.1469

Cited by 1 publication

(12 citation statements)

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“…Among 271 records identified in the systematic review, 324 patients with metastatic EGFR-variant NSCLC and IMD receiving osimertinib in 15 studies 19,23,24,[30][31][32][33][34][35][36][37][38][39][40][41] retrieved from the literature search fulfilled eligibility criteria for inclusion in the meta-analysis (Figure 1). 42 These consisted of 2 RCTs (AURA3 23 and FLAURA 24 ), 1 nonrandomized clinical trial, 30 four single-arm trials (AURA17, 31 ASTRIS, 32 APOLLO, 19 and a study by Peled et al 33 ), 1 pooled analysis of 2 single-arm trials 34 (AURA extension 43 and AURA2 44 ), 1 retrospective multi-institution single-arm cohort study, 35 and 6 retrospective single-institution single-arm cohort studies. [36][37][38][39][40][41] 19,23,24,[30][31][32][33][34][35][36][37][38][39]…”

Section: Study Characteristicsmentioning

confidence: 99%

“…42 These consisted of 2 RCTs (AURA3 23 and FLAURA 24 ), 1 nonrandomized clinical trial, 30 four single-arm trials (AURA17, 31 ASTRIS, 32 APOLLO, 19 and a study by Peled et al 33 ), 1 pooled analysis of 2 single-arm trials 34 (AURA extension 43 and AURA2 44 ), 1 retrospective multi-institution single-arm cohort study, 35 and 6 retrospective single-institution single-arm cohort studies. [36][37][38][39][40][41] 19,23,24,[30][31][32][33][34][35][36][37][38][39][40][41] Data were extracted from published studies and supplements. These data were pooled using a random-effects model.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Other intracranial outcomes, such as CNS progression-free survival and CNS time to response, were not reported in sufficient numbers or did not include measures of uncertainty to allow for metaanalysis. Twelve studies 9,23,24,[31][32][33][34][36][37][38][39][40] reported CNS ORR, but 2 of these studies 32,37 were excluded from the primary analysis because they did not report the numbers of patients receiving and responding to osimertinib, which were used to calculate CNS ORR.…”

Section: Cns Orr and Cns Dcrmentioning

confidence: 99%

“…Results from the evaluation of study quality are shown in eFigure 17 and eFigure 18 in the Supplement. Only 1 study 24 reported blinding of participants and personnel, and only 2 studies 32,38 reported the percentage of patients lost to follow-up. Six studies 19,23,24,31,32,34 reported pharmaceutical industry funding.…”

Section: Assessment Of Study Qualitymentioning

confidence: 99%

“…Only 1 study 24 reported blinding of participants and personnel, and only 2 studies 32,38 reported the percentage of patients lost to follow-up. Six studies 19,23,24,31,32,34 reported pharmaceutical industry funding. Overall, 6 studies 19,23,32,37,38,40 were at high risk of bias in 1 criterion, and 3 studies 30,31,34 were at high risk of bias in 2 criteria.…”

Section: Assessment Of Study Qualitymentioning

confidence: 99%

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Assessment of Effectiveness and Safety of Osimertinib for Patients With Intracranial Metastatic Disease

2020

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IMPORTANCE Intracranial metastatic disease (IMD) is a serious and life-altering complication for many patients with cancer. Targeted therapy may address the limitations of current treatments as an additional agent to achieve intracranial disease control in some patients with IMD. Given the paucity of evidence regarding effectiveness, current guidelines have not made recommendations on the use of targeted therapy. Osimertinib mesylate is a mutant epidermal growth factor receptor (EGFR) inhibitor that can penetrate the blood-brain barrier and inhibit tumor cell survival and proliferation in patients with non-small cell lung cancer (NSCLC) with specific EGFR alterations. OBJECTIVE To assess the effectiveness and safety of osimertinib in the management of IMD. DATA SOURCES Studies were selected from MEDLINE and Embase databases from their inception to September 20, 2019, using the following search query: (osimertinib OR mereletinib OR tagrisso OR tamarix OR azd9291) AND (brain metastases OR intracranial metastatic disease OR cns). STUDY SELECTION Studies reporting intracranial outcomes for patients with metastatic EGFRvariant NSCLC and IMD treated with osimertinib were included in this systematic review and metaanalysis. Among 271 records identified in the systematic review, 15 studies fulfilled eligibility criteria for inclusion in the meta-analysis. DATA EXTRACTION AND SYNTHESIS Data were extracted from published studies and supplements. These data were pooled using a random-effects model. Risk of bias was assessed using the Cochrane risk of bias tool and the modified Newcastle-Ottawa Scale. MAIN OUTCOMES AND MEASURES Information extracted included study characteristics, intracranial effectiveness measures, and safety measures. Meta-analyses of proportions were conducted to pool estimates for central nervous system (CNS) objective response rate and CNS disease control rate. RESULTS Fifteen studies reporting on 324 patients were included in the meta-analysis. The CNS objective response rate was 64% (95% CI, 53%-76%; n = 195), and CNS disease control rate was 90% (95% CI, 85%-93%; n = 246). Included studies reported complete intracranial response rates of 7% to 23%, median best decrease in intracranial lesion size of −40% to −64%, and Common Terminology Criteria for Adverse Events (version 3.0) grade 3 or higher adverse event rates of 19% to 39%. Subgroup analyses did not reveal additional sources of heterogeneity. CONCLUSIONS AND RELEVANCE Findings reported herein support a potential role for osimertinib in the treatment of patients with metastatic EGFR-variant NSCLC and IMD treated with osimertinib.

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