https://scholars.lib.ntu.edu.tw/handle/123456789/494924
標題: | CNS response to osimertinib in patients with T790M-positive advanced NSCLC: Pooled data from two phase II trials | 作者: | Goss G Tsai C.-M Shepherd F.A Ahn M.-J Bazhenova L Crinò L de Marinis F Felip E Morabito A Hodge R Cantarini M Johnson M Mitsudomi T Jänne P.A CHIH-HSIN YANG |
關鍵字: | Brain metastases; CNS; NSCLC; Osimertinib | 公開日期: | 2018 | 出版社: | Oxford University Press | 卷: | 29 | 期: | 3 | 起(迄)頁: | 687-693 | 來源出版物: | Annals of Oncology | 摘要: | Background: Central nervous system (CNS) metastases are common in patients with non-small-cell lung cancer (NSCLC). Osimertinib has shown systemic efficacy in patients with CNS metastases, and early clinical evidence shows efficacy in the CNS. To evaluate osimertinib activity further, we present a pre-specified subgroup analysis of CNS response using pooled data from two phase II studies: AURA extension (NCT01802632) and AURA2 (NCT02094261). Patients and methods: Patients with T790M-positive advanced NSCLC, who had progressed following prior epidermal growth factor receptor-tyrosine kinase inhibitor treatment, received osimertinib 80 mg od (n?411). Patients with stable, asymptomatic CNS metastases were eligible for enrolment; prior CNS treatment was allowed. Patients with>1 measurable CNS lesion (per RECIST 1.1) on baseline brain scan by blinded independent central neuroradiology review (BICR) were included in the evaluable for CNS response set (cEFR). The primary outcome for this CNS analysis was CNS objective response rate (ORR) by BICR; secondary outcomes included CNS duration of response, disease control rate (DCR) and progression-free survival (PFS). Results: Of 128 patients with CNS metastases on baseline brain scans, 50 were included in the cEFR. Confirmed CNS ORR and DCR were 54% [27/50; 95% confidence interval (CI) 39-68] and 92% (46/50; 95% CI 81-98), respectively. CNS response was observed regardless of prior radiotherapy to the brain. Median CNS duration of response (22% maturity) was not reached (range, 1-15 months); at 9 months, 75% (95% CI 53-88) of patients were estimated to remain in response. Median follow-up for CNS PFS was 11 months; median CNS PFS was not reached (95% CI, 7, not calculable). The safety profile observed in the cEFR was consistent with the overall patient population. Conclusions: Osimertinib demonstrated clinically meaningful efficacy against CNS metastases, with a high DCR, encouraging ORR, and safety profile consistent with that reported previously. ? The Author(s) 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85045927702&doi=10.1093%2fannonc%2fmdx820&partnerID=40&md5=26dd274f2539b9c8483538d429a49fb6 https://scholars.lib.ntu.edu.tw/handle/123456789/494924 |
ISSN: | 0923-7534 | DOI: | 10.1093/annonc/mdx820 | SDG/關鍵字: | osimertinib; antineoplastic agent; EGFR protein, human; epidermal growth factor receptor; osimertinib; piperazine derivative; adult; advanced cancer; Article; cancer growth; central nervous system metastasis; disease control; drug efficacy; drug safety; drug withdrawal; human; major clinical study; non small cell lung cancer; phase 2 clinical trial (topic); priority journal; progression free survival; treatment response; treatment withdrawal; aged; brain tumor; central nervous system tumor; clinical trial; female; genetics; lung tumor; male; middle aged; non small cell lung cancer; pathology; phase 2 clinical trial; secondary; Adult; Aged; Antineoplastic Agents; Brain Neoplasms; Carcinoma, Non-Small-Cell Lung; Central Nervous System Neoplasms; ErbB Receptors; Female; Humans; Lung Neoplasms; Male; Middle Aged; Piperazines; Progression-Free Survival |
顯示於: | 腫瘤醫學研究所 |
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