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

Basit Öğe Kaydı
dc.contributor.authorDane, Faysal
dc.contributor.authorOzgurdal, Kirhan
dc.contributor.authorYalcin, Suayib
dc.contributor.authorBenekli, Mustafa
dc.contributor.authorAykan, Nuri Faruk
dc.contributor.authorYucel, Idris
dc.contributor.authorYumuk, Perran Fulden
dc.date.accessioned2020-12-01T12:02:09Z
dc.date.available2020-12-01T12:02:09Z
dc.date.issued2020
dc.departmentEge Üniversitesien_US
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.en_US
dc.description.sponsorshipBayerBayer AGen_US
dc.description.sponsorshipThis work was supported by Bayer. Bayer provided the study medication and collaborated with the authors to design the study. Bayer worked with the investigators on the collection, analysis and interpretation of the data, and on the preparation of this report. the authors made the final decision to submit the article for publication.en_US
dc.identifier.doi10.1136/bmjopen-2018-027665en_US
dc.identifier.issn2044-6055
dc.identifier.issue3en_US
dc.identifier.pmid32220908en_US
dc.identifier.scopus2-s2.0-85082516462en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org/10.1136/bmjopen-2018-027665
dc.identifier.urihttps://hdl.handle.net/11454/62605
dc.identifier.volume10en_US
dc.identifier.wosWOS:000527801000004en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherBmj Publishing Groupen_US
dc.relation.ispartofBmj Openen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.titleSafety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD studyen_US
dc.typeArticleen_US

Dosyalar

Koleksiyon

WoS İndeksli Yayınlar Koleksiyonu
PubMed İndeksli Yayın Koleksiyonu
Scopus İndeksli Yayınlar Koleksiyonu