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dc.contributor.authorShah, MA
dc.contributor.authorShitara, K
dc.contributor.authorLordick, F
dc.contributor.authorBang, Y-J
dc.contributor.authorTebbutt, NC
dc.contributor.authorMetges, J-P
dc.contributor.authorMuro, K
dc.contributor.authorLee, K-W
dc.contributor.authorShen, L
dc.contributor.authorTjulandin, S
dc.contributor.authorHays, JL
dc.contributor.authorStarling, N
dc.contributor.authorXu, R-H
dc.contributor.authorSturtz, K
dc.contributor.authorFontaine, M
dc.contributor.authorOh, C
dc.contributor.authorBrooks, E
dc.contributor.authorXu, B
dc.contributor.authorLi, W
dc.contributor.authorLi, CJ
dc.contributor.authorBorodyansky, L
dc.contributor.authorVan Cutsem, E
dc.coverage.spatialUnited States
dc.date.accessioned2022-08-12T14:51:47Z
dc.date.available2022-08-12T14:51:47Z
dc.date.issued2022-05-26
dc.identifier699246
dc.identifier.citationClinical Cancer Research, 2022, pp. clincanres.4021.2021 -en_US
dc.identifier.issn1078-0432
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5261
dc.identifier.eissn1557-3265
dc.identifier.eissn1557-3265
dc.identifier.doi10.1158/1078-0432.CCR-21-4021
dc.description.abstractPURPOSE: To compare napabucasin (generator of reactive oxygen species) plus paclitaxel with paclitaxel only in patients with second-line advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. EXPERIMENTAL DESIGN: In the double-blind, phase III BRIGHTER study (NCT02178956), patients were randomized (1:1) to napabucasin (480 mg orally twice daily) plus paclitaxel (80 mg/m2 intravenously weekly for 3 of 4 weeks) or placebo plus paclitaxel. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety. RESULTS: Overall, 714 patients were randomized (napabucasin plus paclitaxel, n = 357; placebo plus paclitaxel, n = 357). 72.1% were male, 74.6% had gastric adenocarcinoma, and 46.2% had peritoneal metastases. The study was unblinded following an interim analysis at 380 deaths. The final efficacy analysis was performed on 565 deaths (median follow-up, 6.8 months). No significant differences were observed between napabucasin plus paclitaxel and placebo plus paclitaxel for OS (6.93 vs. 7.36 months), PFS (3.55 vs. 3.68 months), ORR (16% vs. 18%), or DCR (55% vs. 58%). Grade {greater than or equal to}3 adverse events occurred in 69.5% and 59.7% of patients administered napabucasin plus paclitaxel and placebo plus paclitaxel, respectively, with grade {greater than or equal to}3 diarrhea reported in 16.2% and 1.4%, respectively. CONCLUSION: Adding napabucasin to paclitaxel did not improve survival in patients with pretreated advanced gastric or GEJ adenocarcinoma. Consistent with previous reports, the safety profile of napabucasin was driven by manageable gastrointestinal events; grade {greater than or equal to}3 diarrhea occurred at a higher frequency with napabucasin plus paclitaxel versus placebo plus paclitaxel.
dc.formatPrint-Electronic
dc.format.extentclincanres.4021.2021 -
dc.languageeng
dc.language.isoengen_US
dc.publisherAmerican Association for Cancer Research (AACR)en_US
dc.relation.ispartofClinical Cancer Research
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.titleRandomized, double-blind, placebo-controlled phase 3 study of paclitaxel {plus minus} napabucasin in pretreated advanced gastric or gastroesophageal junction adenocarcinoma.en_US
dc.typeJournal Article
dcterms.dateAccepted2022-05-24
dc.date.updated2022-08-12T14:51:18Z
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1158/1078-0432.CCR-21-4021en_US
rioxxterms.licenseref.startdate2022-05-26
rioxxterms.typeJournal Article/Reviewen_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/35617520
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/Gastrointestinal Cancers Clinical Trials
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Gastrointestinal Cancers Clinical Trials/Gastrointestinal Cancers Clinical Trials (hon.)
pubs.publication-statusPublished online
dc.contributor.icrauthorStarling, Naureen
icr.provenanceDeposited by Mr Arek Surman on 2022-08-12. Deposit type is initial. No. of files: 1. Files: ccr-21-4021.pdf


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