Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16820
Full metadata record
DC FieldValueLanguage
dc.contributor.authorRamalingam, Suresh S-
dc.contributor.authorYang, James C-H-
dc.contributor.authorLee, Chee Khoon-
dc.contributor.authorJohn, Thomas-
dc.contributor.authorKurata, Takayasu-
dc.contributor.authorNogami, Naoyuki-
dc.contributor.authorOhe, Yuichiro-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorMann, Helen-
dc.contributor.authorRukazenkov, Yuri-
dc.contributor.authorGhiorghiu, Serban-
dc.contributor.authorStetson, Daniel-
dc.contributor.authorMarkovets, Aleksandra-
dc.contributor.authorBarrett, J Carl-
dc.contributor.authorThress, Kenneth S-
dc.contributor.authorJänne, Pasi A-
dc.date2017-08-25-
dc.date.accessioned2017-08-31T05:32:44Z-
dc.date.available2017-08-31T05:32:44Z-
dc.date.issued2018-
dc.identifier.citationJournal of Clinical Oncology 2018; 36(9): 841-849en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/16820-
dc.description.abstractPurpose The Osimertinib First Time in Patients Ascending Dose (AURA) study ( ClinicalTrials.gov identifier: NCT01802632) included two cohorts of treatment-naïve patients to examine clinical activity and safety of osimertinib (an epidermal growth factor receptor [EGFR] -tyrosine kinase inhibitor selective for EGFR-tyrosine kinase inhibitor sensitizing [ EGFRm] and EGFR T790M resistance mutations) as first-line treatment of EGFR-mutated advanced non-small-cell lung cancer (NSCLC). Patients and Methods Sixty treatment-naïve patients with locally advanced or metastatic EGFRm NSCLC received osimertinib 80 or 160 mg once daily (30 patients per cohort). End points included investigator-assessed objective response rate (ORR), progression-free survival (PFS), and safety evaluation. Plasma samples were collected at or after patients experienced disease progression, as defined by Response Evaluation Criteria in Solid Tumors (RECIST), to investigate osimertinib resistance mechanisms. Results At data cutoff (November 1, 2016), median follow-up was 19.1 months. Overall ORR was 67% (95% CI, 47% to 83%) in the 80-mg group, 87% (95% CI, 69% to 96%) in the 160-mg group, and 77% (95% CI, 64% to 87%) across doses. Median PFS time was 22.1 months (95% CI, 13.7 to 30.2 months) in the 80-mg group, 19.3 months (95% CI, 13.7 to 26.0 months) in the 160-mg group, and 20.5 months (95% CI, 15.0 to 26.1 months) across doses. Of 38 patients with postprogression plasma samples, 50% had no detectable circulating tumor DNA. Nine of 19 patients had putative resistance mechanisms, including amplification of MET (n = 1); amplification of EGFR and KRAS (n = 1); MEK1, KRAS, or PIK3CA mutation (n = 1 each); EGFR C797S mutation (n = 2); JAK2 mutation (n = 1); and HER2 exon 20 insertion (n = 1). Acquired EGFR T790M was not detected. Conclusion Osimertinib demonstrated a robust ORR and prolonged PFS in treatment-naïve patients with EGFRm advanced NSCLC. There was no evidence of acquired EGFR T790M mutation in postprogression plasma samples.en_US
dc.titleOsimertinib as first-line treatment of EGFR mutation-positive advanced non-small-cell lung canceren_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleJournal of Clinical Oncologyen_US
dc.identifier.affiliationEmory University School of Medicine, Winship Cancer Institute, Atlanta, GA, USAen_US
dc.identifier.affiliationNational Taiwan University and National Taiwan University Cancer Center, Taipei, Taiwanen_US
dc.identifier.affiliationSt George Hospital, Sydney, New South Walesen_US
dc.identifier.affiliationOlivia Newton-John Cancer Research Institute, Austin Health, Heidelberg, Victoria, Australiaen_US
dc.identifier.affiliationKansai Medical University Hirakata Hospital, Osaka, Japanen_US
dc.identifier.affiliationNational Hospital Organization Shikoku Cancer Center, Matsuyama, Japanen_US
dc.identifier.affiliationNational Cancer Center Hospital East, Kashiwa-City, Japanen_US
dc.identifier.affiliationSeoul National University Hospital, Seoul, Republic of Koreaen_US
dc.identifier.affiliationAstraZeneca, Macclesfield, United Kingdomen_US
dc.identifier.affiliationAstraZeneca, Cambridge, United Kingdomen_US
dc.identifier.affiliationAstraZeneca, Waltham, MA, USAen_US
dc.identifier.affiliationDana-Farber Cancer Institute and the Belfer Center for Applied Cancer Science, Boston, MA, USAen_US
dc.identifier.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/28841389en_US
dc.identifier.doi10.1200/JCO.2017.74.7576en_US
dc.type.contentTexten_US
dc.type.austinJournal Articleen_US
local.name.researcherJohn, Thomas
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeJournal Article-
crisitem.author.deptOlivia Newton-John Cancer Research Institute-
crisitem.author.deptMedical Oncology-
crisitem.author.deptOlivia Newton-John Cancer Wellness and Research Centre-
Appears in Collections:Journal articles
Show simple item record

Page view(s)

2
checked on Mar 28, 2024

Google ScholarTM

Check


Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.