dc.contributor.author | Yang, JC-H | |
dc.contributor.author | Reckamp, KL | |
dc.contributor.author | Kim, Y-C | |
dc.contributor.author | Novello, S | |
dc.contributor.author | Smit, EF | |
dc.contributor.author | Lee, J-S | |
dc.contributor.author | Su, W-C | |
dc.contributor.author | Akerley, WL | |
dc.contributor.author | Blakely, CM | |
dc.contributor.author | Groen, HJM | |
dc.contributor.author | Bazhenova, L | |
dc.contributor.author | Carcereny Costa, E | |
dc.contributor.author | Chiari, R | |
dc.contributor.author | Hsia, T-C | |
dc.contributor.author | Golsorkhi, T | |
dc.contributor.author | Despain, D | |
dc.contributor.author | Shih, D | |
dc.contributor.author | Popat, S | |
dc.contributor.author | Wakelee, H | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-09-02T10:56:32Z | |
dc.date.available | 2022-09-02T10:56:32Z | |
dc.date.issued | 2021-02-01 | |
dc.identifier | 100114 | |
dc.identifier | S2666-3643(20)30160-0 | |
dc.identifier.citation | JTO Clinical and Research Reports, 2021, 2 (2), pp. 100114 - | |
dc.identifier.issn | 2666-3643 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5387 | |
dc.identifier.eissn | 2666-3643 | |
dc.identifier.eissn | 2666-3643 | |
dc.identifier.doi | 10.1016/j.jtocrr.2020.100114 | |
dc.description.abstract | INTRODUCTION: The TIGER-3 (NCT02322281) study was initiated to compare the efficacy and safety of rociletinib, a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets EGFR T790M and common EGFR-activating mutations, versus chemotherapy in patients with NSCLC who progressed on first- or second-generation EGFR TKIs. METHODS: Patients with advanced or metastatic EGFR-mutated NSCLC with disease progression on standard therapy (previous EGFR TKI and platinum-based chemotherapy) were randomized to oral rociletinib (500 or 625 mg twice daily) or single-agent chemotherapy (pemetrexed, gemcitabine, docetaxel, or paclitaxel). RESULTS: Enrollment was halted when rociletinib development was discontinued in 2016. Of 149 enrolled patients, 75 were randomized to rociletinib (n = 53: 500 mg twice daily; n = 22: 625 mg twice daily) and 74 to chemotherapy. The median investigator-assessed progression-free survival (PFS) was 4.1 months (95% confidence interval [CI]: 2.6-5.4) in the rociletinib 500-mg group and 5.5 months (95% CI: 1.8-8.1) in the 625-mg group versus 2.5 months (95% CI: 1.4-2.9) in the chemotherapy group. An improved PFS was observed in patients with T790M-positive NSCLC treated with rociletinib (n = 25; 500 mg and 625 mg twice daily) versus chemotherapy (n = 20; 6.8 versus 2.7 mo; hazard ratio = 0.55, 95% CI: 0.28-1.07, p = 0.074). Grade 3 or higher hyperglycemia (24.0%), corrected QT prolongation (6.7%), diarrhea (2.7%), and vomiting (1.3%) were more frequent with rociletinib than chemotherapy (0%, 0%, 1.4%, and 0%, respectively). CONCLUSIONS: Rociletinib had a more favorable median PFS versus chemotherapy but had higher rates of hyperglycemia and corrected QT prolongation in patients with advanced EGFR-mutated NSCLC who progressed on previous EGFR TKI. Incomplete enrollment prevented evaluation of the primary efficacy end point. | |
dc.format | Electronic-eCollection | |
dc.format.extent | 100114 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.relation.ispartof | JTO Clinical and Research Reports | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.subject | EGFR tyrosine kinase inhibitor | |
dc.subject | Epidermal growth factor receptor mutations | |
dc.subject | Non–small cell lung cancer | |
dc.subject | Phase III randomized clinical trial | |
dc.subject | Rociletinib | |
dc.title | Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With EGFR-Mutated NSCLC: The Results of TIGER-3, a Phase 3 Randomized Study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-10-16 | |
dc.date.updated | 2022-09-02T10:55:41Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1016/j.jtocrr.2020.100114 | |
rioxxterms.licenseref.startdate | 2021-02-01 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/34589984 | |
pubs.issue | 2 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology/Thoracic Oncology (hon.) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1016/j.jtocrr.2020.100114 | |
pubs.volume | 2 | |
dc.contributor.icrauthor | Popat, Sanjay | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-02. Deposit type is initial. No. of files: 1. Files: Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With iEGFRi-Mutated NSCLC The Results of TIGER-3, a Phase.pdf | |