Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30217
Full metadata record
DC FieldValueLanguage
dc.contributor.authorCapdevila, Jaume-
dc.contributor.authorKlochikhin, Arkadiy-
dc.contributor.authorLeboulleux, Sophie-
dc.contributor.authorIsaev, Pavel-
dc.contributor.authorBadiu, Corin-
dc.contributor.authorRobinson, Bruce-
dc.contributor.authorHughes, Brett G M-
dc.contributor.authorKeam, Bhumsuk-
dc.contributor.authorParnis, Francis-
dc.contributor.authorElisei, Rossella-
dc.contributor.authorGajate, Pablo-
dc.contributor.authorGan, Hui K-
dc.contributor.authorKapiteijn, Ellen-
dc.contributor.authorLocati, Laura-
dc.contributor.authorMangeshkar, Milan-
dc.contributor.authorFaoro, Leonardo-
dc.contributor.authorKrajewska, Jolanta-
dc.contributor.authorJarzab, Barbara-
dc.date.accessioned2022-06-23T00:29:31Z-
dc.date.available2022-06-23T00:29:31Z-
dc.date.issued2022-05-
dc.identifier.citationThyroid 2022; 32(5): 515-524en
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/30217-
dc.description.abstractBackground: Cabozantinib inhibits pathways involved in medullary thyroid cancer (MTC). Cabozantinib is approved as 140 mg/day in capsules for MTC and 60 mg/day in tablets for other solid tumors. This study compared the two doses in progressive metastatic MTC. Methods: In this Phase 4, randomized, double-blind noninferiority (NI) trial (NCT01896479), patients with progressive metastatic MTC were randomized 1:1 to cabozantinib 60 mg/day tablet or 140 mg/day capsules. The primary end point was progression-free survival (PFS) by blinded independent radiology committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. NI would be concluded if the upper 95% confidence interval [CI] for the PFS hazard ratio (HR) was less than the NI margin, 1.58. The secondary end point was objective response rate (ORR) by BIRC per RECIST v1.1; additional end points included safety and pharmacokinetics. Results: At data cutoff (July 15, 2020), 247 patients were randomized to the 60 mg/day tablet arm (n = 123) and the 140 mg/day capsules arm (n = 124). NI was not met (median PFS 11.0 months vs. 13.9 months in the 60 and 140 mg/day arms [HR 1.24; CI 0.90-1.70; p = 0.19]). The ORR was 33% in both arms. Generally, adverse event (AE) incidence was lower in the 60 mg/day arm (Grade 3/4, 63% vs. 72%), as were dose reductions (69% vs. 81%) and treatment discontinuations due to AEs (23% vs. 36%). Initially, cabozantinib plasma concentrations were higher in the 140 mg/day arm but became similar between arms at later time points. Conclusions: PFS NI of the cabozantinib 60 mg/day tablet vs. 140 mg/day capsules was not met. The 60 mg/day tablet had the same ORR and lower rates of AEs. Clinical Trial Registry: ClinicalTrials.gov NCT01896479.en
dc.language.isoeng
dc.subjectcabozantiniben
dc.subjectcapsuleen
dc.subjectmedullary thyroid canceren
dc.subjectnoninferiorityen
dc.subjecttableten
dc.subjecttyrosine kinase inhibitoren
dc.titleA Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer.en
dc.typeJournal Articleen
dc.identifier.journaltitleThyroid : Official Journal of the American Thyroid Associationen
dc.identifier.affiliationAustin Healthen
dc.identifier.affiliationMedicine (University of Melbourne)en
dc.identifier.affiliationLa Trobe University School of Cancer Medicine, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationRoyal North Shore Hospital, St Leonards, Australiaen
dc.identifier.affiliationRoyal Brisbane & Women's Hospital, and University of Queensland, Herston, Australiaen
dc.identifier.affiliationRegional Clinical Oncology Hospital, Yaroslavl, Russian Federatioen
dc.identifier.affiliationGustave Roussy and University Paris Saclay, Villejuif, Franceen
dc.identifier.affiliationFederal State Institution Medical Radiology Research Center, Obninsk, Russian Federationen
dc.identifier.affiliation"C. I. Parhon," National Institute of Endocrinology and "C. Davila" University of Medicine and Pharmacy, Bucharest, Romaniaen
dc.identifier.affiliationSeoul National University Hospital, Seoul, Republic of Koreaen
dc.identifier.affiliationAzienda Ospedaliero Universitaria Pisana, Pisa, Italyen
dc.identifier.affiliationHospital Universitario Ramon y Cajal, Madrid, Spainen
dc.identifier.affiliationLeids Universitair Medisch Centrum, Leiden, The Netherlandsen
dc.identifier.affiliationIstituto Nazionale Dei Tumori, Milano, Italyen
dc.identifier.affiliationExelixis, Inc., Alameda, California, USAen
dc.identifier.affiliationM. Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Gliwice, Polanden
dc.identifier.affiliationAdelaide Cancer Centre, Kurralta Park, Australiaen
dc.identifier.affiliationVall Hebron University Hospital and Vall Hebron Institute of Oncology (VHIO), IOB-Quiron-Teknon, Barcelona, Spainen
dc.identifier.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/35403447/en
dc.identifier.doi10.1089/thy.2022.0027en
dc.type.contentTexten
dc.identifier.orcid0000-0002-5333-9257en
dc.identifier.orcid0000-0001-5156-7080en
dc.identifier.orcid0000-0001-7319-8546en
dc.identifier.pubmedid35403447
local.name.researcherGan, Hui K
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
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)

24
checked on Mar 28, 2024

Google ScholarTM

Check


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