P-256 - An open-label trial to assess the safety of regorafenib in Turkish patients with metastatic colorectal cancer (mCRC) that progressed on standard the...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Cytotoxic agents
Colon and Rectal Cancer
Biological therapy
Presenter K. Ozgurdal
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors K. Ozgurdal1, F. Dane2, S. Yalcin3, M. Benekli4, N.F. Aykan5, I. Yucel6, M. Ozkan7, T. Evrensel8, A. Sevinc9, H.S. Coskun10, U.S. Sanli11, I.O. Kara12
  • 1Bayer HealthCare, Istanbul/TR
  • 2Marmara University Medical Faculty, Istanbul/TR
  • 3Hacettepe University Medical Faculty, Ankara/TR
  • 4Gazi University Medical Faculty, Ankara/TR
  • 5Istanbul University Medical Faculty, Istanbul/TR
  • 6Ondokuz Mayis University Medical Faculty, Samsun/TR
  • 7Erciyes University Medical Faculty, Kayseri/TR
  • 8Uludag University Medical Faculty, Bursa/TR
  • 9Gaziantep University Medical Faculty, Gaziantep/TR
  • 10Akdeniz University Medical Faculty, Antalya/TR
  • 11Ege University Medical Faculty, Bornova/TR
  • 12Cukurova University Medical Faculty, Adana/TR



Regorafenib is an oral multikinase inhibitor that significantly improved overall survival vs placebo in patients with mCRC refractory to available standard therapies in two randomized phase III trials (Grothey, et al. Lancet 2013;381:303–312; Li, et al. Ann Oncol 2014 [suppl 2]:ii114). The aim of this open-label phase III study is to characterize the safety profile of regorafenib in Turkish patients with mCRC whose disease has progressed on standard therapies.


REGARD (ClinicalTrials.gov NCT01853319) is an ongoing, open-label trial. Eligible patients are ≥18 years of age with confirmed metastatic adenocarcinoma of the colon or rectum who have progressed during or within 3 months following the last administration of approved standard therapies (a fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and an EGFR inhibitor if KRAS wild-type). Patients received regorafenib 160 mg orally once daily for weeks 1–3 of each 4-week cycle. Predefined treatment interruptions and dose reductions were permitted to manage adverse events (AEs). The primary objective is to assess safety. Planned recruitment was 100 patients.


Patients were enrolled between July 2013 and July 2014 in 11 centers in Turkey. A total of 100 patients have received regorafenib treatment: 58% men; 42% women; median age at enrollment was 57 years (range 31–78) and 22% were 65 years of age or older. Baseline ECOG performance status was 0 in 54% of patients and 1 in 46% of patients; 53% of patients had tumors with KRAS mutations and 78% had liver metastasis. Time from first diagnosis of metastatic disease to regorafenib treatment assignment was ≥18 months in 83% of patients. Four patients are currently on treatment. The final analysis will be conducted when all patients complete the study.


REGARD is the first study assessing regorafenib in a large number of Turkish patients with mCRC that progressed on standard therapy.