Publication:
Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: The single-arm, open-label regard study

dc.contributor.authorDane, Faysal
dc.contributor.authorÖzgürdal, Kırhan
dc.contributor.authorYalçın, Şuayib
dc.contributor.authorBenekli, Mustafa
dc.contributor.authorAykan, Nuri Faruk
dc.contributor.authorYücel, İdris
dc.contributor.authorÖzkan, Metin
dc.contributor.authorSevinç, Alper
dc.contributor.authorCoşkun, Hasan Şenol
dc.contributor.authorŞanlı, Ulus Ali
dc.contributor.authorKara, İsmail Oğuz
dc.contributor.authorYumuk, Perran Fulden
dc.contributor.buuauthorEvrensel, Türkkan
dc.contributor.departmentTıp Fakültesi
dc.contributor.departmentTıbbi Onkoloji Ana Bilim Dalı
dc.contributor.orcid0000-0002-9732-5340
dc.contributor.researcheridAAJ-1027-2021
dc.contributor.scopusid6603942124
dc.date.accessioned2023-11-03T06:56:16Z
dc.date.available2023-11-03T06:56:16Z
dc.date.issued2020-03
dc.description.abstractObjectives Regorafenib improved overall survival in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies in two randomised, phase III trials, but has not been evaluated in Turkey. REGARD evaluated the safety and efficacy of regorafenib in Turkish patients with treatment-refractory mCRC. Design Open-label, single-arm, phase IIIb study conducted between July 2013 and April 2015. Setting 11 tertiary centres in Turkey. Participants Eligible patients were adults with mCRC who had disease progression within 3 months after receiving their last dose of approved standard therapies and who had an Eastern Cooperative Oncology Group performance status <= 1. Patients were excluded if they had previously received regorafenib. Of 139 patients screened, 100 were treated and completed the study, and all 100 were analysed. Fifty-eight per cent were male. Interventions Patients received oral regorafenib, 160 mg once daily, for the first 3 weeks of each 4-week cycle until disease progression, death or unacceptable toxicity. Primary and secondary outcome measures The primary endpoint was safety, assessed by incidence of treatment-emergent adverse events (TEAEs). Progression-free survival (PFS) per investigator was the primary efficacy endpoint. There were no secondary endpoints. Results The median treatment duration was 2.5 months (range 0.1 to 20.6). Ninety-six per cent of patients had at least one TEAE and 77% had a grade >= 3 TEAE. The most common grade >= 3 regorafenib-related TEAEs were hypophosphataemia (11%), fatigue (8%), hyperbilirubinaemia (6%), hand-foot skin reaction (5%), hypertension (5%), anorexia (5%) and increased alanine aminotransferase (5%). TEAEs led to dose reduction in 30% of patients. Regorafenib-related TEAEs led to treatment discontinuation in 17% of patients. Median PFS was 3.1 months (95% CI 2.9 to 3.8). Conclusion The regorafenib safety profile and PFS in REGARD were consistent with the results of previous trials of regorafenib in mCRC. Regorafenib is an option for patients in Turkey with treatment-refractory mCRC.
dc.description.sponsorshipBayer AG
dc.identifier.citationDane, F. vd. (2020). "Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: The single-arm, open-label regard study". BMJ Open, 10(3).
dc.identifier.issn2044-6055
dc.identifier.issue3
dc.identifier.scopus2-s2.0-85082516462
dc.identifier.urihttps://doi.org/10.1136/bmjopen-2018-027665
dc.identifier.urihttps://bmjopen.bmj.com/content/bmjopen/10/3/e027665.full.pdf
dc.identifier.urihttp://hdl.handle.net/11452/34772
dc.identifier.volume10
dc.identifier.wos000527801000004
dc.indexed.wosSCIE
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.relation.collaborationYurt içi
dc.relation.collaborationSanayi
dc.relation.journalBMJ Open
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectGeneral & internal medicine
dc.subjectMulticenter
dc.subjectTumors
dc.subject.emtreeAlanine aminotransferase
dc.subject.emtreeAlkaline phosphatase
dc.subject.emtreeAspartate aminotransferase
dc.subject.emtreeBevacizumab
dc.subject.emtreeCetuximab
dc.subject.emtreeFluoropyrimidine
dc.subject.emtreeIrinotecan
dc.subject.emtreeOxaliplatin
dc.subject.emtreePanitumumab
dc.subject.emtreeRegorafenib
dc.subject.emtreeTriacylglycerol lipase
dc.subject.emtreeAntineoplastic agent
dc.subject.emtreeCarbanilamide derivative
dc.subject.emtreePyridine derivative
dc.subject.emtreeRegorafenib
dc.subject.emtreeAdult
dc.subject.emtreeAged
dc.subject.emtreeAlanine aminotransferase blood level
dc.subject.emtreeAnorexia
dc.subject.emtreeArticle
dc.subject.emtreeAspartate aminotransferase blood level
dc.subject.emtreeCancer growth
dc.subject.emtreeCancer mortality
dc.subject.emtreeCancer patient
dc.subject.emtreeCancer screening
dc.subject.emtreeCancer survival
dc.subject.emtreeCohort analysis
dc.subject.emtreeDisease exacerbation
dc.subject.emtreeDrug dose reduction
dc.subject.emtreeDrug efficacy
dc.subject.emtreeDrug safety
dc.subject.emtreeDrug withdrawal
dc.subject.emtreeFatigue
dc.subject.emtreeFemale
dc.subject.emtreeHand foot syndrome
dc.subject.emtreeHepatobiliary disease
dc.subject.emtreeHuman
dc.subject.emtreeHyperbilirubinemia
dc.subject.emtreeHypertension
dc.subject.emtreeHyponatremia
dc.subject.emtreeHypophosphatemia
dc.subject.emtreeLiver failure
dc.subject.emtreeLung embolism
dc.subject.emtreeMajor clinical study
dc.subject.emtreeMalaise
dc.subject.emtreeMale
dc.subject.emtreeMedian survival time
dc.subject.emtreeMetastatic colorectal cancer
dc.subject.emtreeMultiple cycle treatment
dc.subject.emtreeOpen study
dc.subject.emtreePhase 3 clinical trial
dc.subject.emtreeProgression free survival
dc.subject.emtreeRefractory metastatic colorectal cancer
dc.subject.emtreeSepsis
dc.subject.emtreeSide effect
dc.subject.emtreeThromboembolism
dc.subject.emtreeTreatment duration
dc.subject.emtreeTriacylglycerol lipase blood level
dc.subject.emtreeTurkey (republic)
dc.subject.emtreeClinical trial
dc.subject.emtreeColorectal tumor
dc.subject.emtreeDisease exacerbation
dc.subject.emtreeDisease free survival
dc.subject.emtreeDrug administration
dc.subject.emtreeFollow up
dc.subject.emtreeKaplan meier method
dc.subject.emtreeMiddle aged
dc.subject.emtreeOral drug administration
dc.subject.emtreePathology
dc.subject.emtreeTreatment outcome
dc.subject.emtreeTurkey (bird)
dc.subject.meshAdministration, oral
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntineoplastic agents
dc.subject.meshColorectal neoplasms
dc.subject.meshDisease progression
dc.subject.meshDisease-free survival
dc.subject.meshDrug administration schedule
dc.subject.meshFemale
dc.subject.meshFollow-up studies
dc.subject.meshHumans
dc.subject.meshKaplan-meier estimate
dc.subject.meshMale
dc.subject.meshMiddle aged
dc.subject.meshPhenylurea compounds
dc.subject.meshPyridines
dc.subject.meshTreatment outcome
dc.subject.meshTurkey
dc.subject.scopusTrifluridine tipiracil; Metastatic colorectal cancer; Thymidine phosphorylase
dc.subject.wosMedicine, general & internal
dc.titleSafety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: The single-arm, open-label regard study
dc.typeArticle
dc.wos.quartileQ2
dspace.entity.typePublication
local.contributor.departmentTıp Fakültesi/Tıbbi Onkoloji Ana Bilim Dalı
local.indexed.atWOS

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