Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/22272
Full metadata record
DC FieldValueLanguage
dc.contributor.authorDrilon, Alexander-
dc.contributor.authorSiena, Salvatore-
dc.contributor.authorDziadziuszko, Rafal-
dc.contributor.authorBarlesi, Fabrice-
dc.contributor.authorKrebs, Matthew G-
dc.contributor.authorShaw, Alice T-
dc.contributor.authorde Braud, Filippo-
dc.contributor.authorRolfo, Christian-
dc.contributor.authorAhn, Myung-Ju-
dc.contributor.authorWolf, Jürgen-
dc.contributor.authorSeto, Takashi-
dc.contributor.authorCho, Byoung Chul-
dc.contributor.authorPatel, Manish R-
dc.contributor.authorChiu, Chao-Hua-
dc.contributor.authorJohn, Thomas-
dc.contributor.authorGoto, Koichi-
dc.contributor.authorKarapetis, Christos S-
dc.contributor.authorArkenau, Hendrick-Tobias-
dc.contributor.authorKim, Sang-We-
dc.contributor.authorOhe, Yuichiro-
dc.contributor.authorLi, Yu-Chung-
dc.contributor.authorChae, Young K-
dc.contributor.authorChung, Christine H-
dc.contributor.authorOtterson, Gregory A-
dc.contributor.authorMurakami, Haruyasu-
dc.contributor.authorLin, Chia-Chi-
dc.contributor.authorTan, Daniel S W-
dc.contributor.authorPrenen, Hans-
dc.contributor.authorRiehl, Todd-
dc.contributor.authorChow-Maneval, Edna-
dc.contributor.authorSimmons, Brian-
dc.contributor.authorCui, Na-
dc.contributor.authorJohnson, Ann-
dc.contributor.authorEng, Susan-
dc.contributor.authorWilson, Timothy R-
dc.contributor.authorDoebele, Robert C-
dc.date2019-12-11-
dc.date.accessioned2019-12-18T04:02:52Z-
dc.date.available2019-12-18T04:02:52Z-
dc.date.issued2020-02-
dc.identifier.citationThe Lancet. Oncology 2020; 21(2): 261-270-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/22272-
dc.description.abstractRecurrent gene fusions, such as ROS1 fusions, are oncogenic drivers of various cancers, including non-small-cell lung cancer (NSCLC). Up to 36% of patients with ROS1 fusion-positive NSCLC have brain metastases at the diagnosis of advanced disease. Entrectinib is a ROS1 inhibitor that has been designed to effectively penetrate and remain in the CNS. We explored the use of entrectinib in patients with locally advanced or metastatic ROS1 fusion-positive NSCLC. We did an integrated analysis of three ongoing phase 1 or 2 trials of entrectinib (ALKA-372-001, STARTRK-1, and STARTRK-2). The efficacy-evaluable population included adult patients (aged ≥18 years) with locally advanced or metastatic ROS1 fusion-positive NSCLC who received entrectinib at a dose of at least 600 mg orally once per day, with at least 12 months' follow-up. All patients had an Eastern Cooperative Oncology Group performance status of 0-2, and previous cancer treatment (except for ROS1 inhibitors) was allowed. The primary endpoints were the proportion of patients with an objective response (complete or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1) and duration of response, and were evaluated by blinded independent central review. The safety-evaluable population for the safety analysis included all patients with ROS1 fusion-positive NSCLC in the three trials who received at least one dose of entrectinib (irrespective of dose or duration of follow-up). These ongoing studies are registered with ClinicalTrials.gov, NCT02097810 (STARTRK-1) and NCT02568267 (STARTRK-2), and EudraCT, 2012-000148-88 (ALKA-372-001). Patients were enrolled in ALKA-372-001 from Oct 26, 2012, to March 27, 2018; in STARTRK-1 from Aug 7, 2014, to May 10, 2018; and in STARTRK-2 from Nov 19, 2015 (enrolment is ongoing). At the data cutoff date for this analysis (May 31, 2018), 41 (77%; 95% CI 64-88) of 53 patients in the efficacy-evaluable population had an objective response. Median follow-up was 15·5 monhts (IQR 13·4-20·2). Median duration of response was 24·6 months (95% CI 11·4-34·8). In the safety-evaluable population, 79 (59%) of 134 patients had grade 1 or 2 treatment-related adverse events. 46 (34%) of 134 patients had grade 3 or 4 treatment-related adverse events, with the most common being weight increase (ten [8%]) and neutropenia (five [4%]). 15 (11%) patients had serious treatment-related adverse events, the most common of which were nervous system disorders (four [3%]) and cardiac disorders (three [2%]). No treatment-related deaths occurred. Entrectinib is active with durable disease control in patients with ROS1 fusion-positive NSCLC, and is well tolerated with a manageable safety profile, making it amenable to long-term dosing in these patients. These data highlight the need to routinely test for ROS1 fusions to broaden therapeutic options for patients with ROS1 fusion-positive NSCLC. Ignyta/F Hoffmann-La Roche.-
dc.language.isoeng-
dc.titleEntrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials.-
dc.typeJournal Article-
dc.identifier.journaltitleThe Lancet. Oncology-
dc.identifier.affiliationUniversity Hospital Antwerp, Edegem, Belgiumen
dc.identifier.affiliationDepartment of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italyen
dc.identifier.affiliationNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italyen
dc.identifier.affiliationOlivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationAustin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationDivision of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UKen
dc.identifier.affiliationThe Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UKen
dc.identifier.affiliationInstitute of Cancer Sciences, Massachusetts General Hospital, Boston, MA, USAen
dc.identifier.affiliationMarlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, MD, USAen
dc.identifier.affiliationUniversity of Minnesota, Department of Medicine, Minneapolis, MN, USAen
dc.identifier.affiliationDepartment of Medicine, Northwestern University, Chicago, IL, USAen
dc.identifier.affiliationMoffitt Cancer Center, Tampa, FL, USAen
dc.identifier.affiliationArthur G James Cancer Hospital and Richard J Solove Research Institute, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USAen
dc.identifier.affiliationGenentech, South San Francisco, CA, USAen
dc.identifier.affiliationIgnyta, San Diego, CA, USAen
dc.identifier.affiliationFlinders Medical Centre and Flinders University, Adelaide, SA, Australiaen
dc.identifier.affiliationHong Kong United Oncology Centre, Hong Kong Special Administrative Region, Chinaen
dc.identifier.affiliationAix Marseille University, INSERM, CNRS, CRCM, Assistance Publique-Hôpitaux de Marseille, Marseille, Franceen
dc.identifier.affiliationWeill Cornell Medical College, New York, NY, USAen
dc.identifier.affiliationMemorial Sloan Kettering Cancer Center, New York, NY, USAen
dc.identifier.affiliationSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Koreaen
dc.identifier.affiliationYonsei Cancer Center, Seoul, South Koreaen
dc.identifier.affiliationAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Koreaen
dc.identifier.affiliationInstitute of Cancer Sciences, Medical University of Gdansk, Gdansk, Polanden
dc.identifier.affiliationFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Department of Oncology and Hemato-Oncology, Università deli Studi di Milano, Milan, Italyen
dc.identifier.affiliationCenter for Integrated Oncology, University Hospital of Cologne, Cologne, Germany-
dc.identifier.affiliationNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan-
dc.identifier.affiliationTaipei Veterans General Hospital, Taipei, Taiwan-
dc.identifier.affiliationNational Cancer Center Hospital East, Kashiwa, Japan-
dc.identifier.affiliationSarah Cannon Research Institute and Cancer Institute University College London, London, UK-
dc.identifier.affiliationNational Cancer Center Hospital, Tokyo, Japan-
dc.identifier.affiliationShizuoka Cancer Center, Tokyo, Japan-
dc.identifier.affiliationNational Taiwan University Hospital, Taipei, Taiwan-
dc.identifier.affiliationNational Cancer Centre, Singapore-
dc.identifier.affiliationSchool of Medicine, University of Colorado, Aurora, CO, USA-
dc.identifier.doi10.1016/S1470-2045(19)30690-4-
dc.identifier.orcid0000-0003-3399-5342-
dc.identifier.pubmedid31838015-
dc.type.austinJournal Article-
local.name.researcherJohn, Thomas
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
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)

10
checked on Mar 28, 2024

Google ScholarTM

Check


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