{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T18:34:14Z","timestamp":1772217254021,"version":"3.50.1"},"reference-count":17,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2020,3,26]],"date-time":"2020-03-26T00:00:00Z","timestamp":1585180800000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,3,2]]},"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Open-label, single-arm, phase IIIb study conducted between July 2013 and April 2015.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>11 tertiary centres in Turkey.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>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 \u22641. 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Patients received oral regorafenib, 160\u2009mg once daily, for the first 3 weeks of each 4-week cycle until disease progression, death or unacceptable toxicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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 \u22653\u2009TEAE. The most common grade \u22653 regorafenib-related TEAEs were hypophosphataemia (11%), fatigue (8%), hyperbilirubinaemia (6%), hand\u2013foot 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\" xlink:href=\"NCT01853319\">NCT01853319<\/jats:ext-link>\n                      , ClinicalTrials.gov.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-027665","type":"journal-article","created":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T07:19:49Z","timestamp":1585293589000},"page":"e027665","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct01853319","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6584-902X","authenticated-orcid":false,"given":"Faysal","family":"Dane","sequence":"first","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Marmara University Medical Faculty, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirhan","family":"Ozgurdal","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Bayer HealthCare, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u015euayib","family":"Yal\u00e7\u0131n","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hacettepe University Medical Faculty, Ankara, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mustafa","family":"Benekli","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Gazi University Medical Faculty, Ankara, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nuri Faruk","family":"Aykan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Istanbul University, Institute of Oncology, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u0130dris","family":"Y\u00fccel","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Faculty of Medicine, Ondokuz Mayis University Medical Faculty, Samsun, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Metin","family":"\u00d6zkan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Erciyes University Medical Faculty, Kayseri, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Turkkan","family":"Evrensel","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Uluda\u011f University Medical Faculty, Bursa, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alper","family":"Sevin\u00e7","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Gaziantep University Medical Faculty, Gaziantep, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hasan \u015eenol","family":"Coskun","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Akdeniz University Medical Faculty, Antalya, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulus Ali","family":"Sanli","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Ege University Medical Faculty, \u0130zmir, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ismail Oguz","family":"Kara","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, \u00c7ukurova University Medical Faculty, Adana, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8650-299X","authenticated-orcid":false,"given":"Perran Fulden","family":"Yumuk","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Marmara University Medical Faculty, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,3,26]]},"reference":[{"key":"2025121515250966000_10.3.e027665.1","unstructured":"National Comprehensive Cancer Network . 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