Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial

Center, 2009, International trends in colorectal cancer incidence rates, Cancer Epidemiol Biomarkers Prev, 18, 1688, 10.1158/1055-9965.EPI-09-0090 Cheng, 2014, Adaptation of international guidelines for metastatic colorectal cancer: an Asian consensus, Clin Colorectal Cancer, 13, 145, 10.1016/j.clcc.2014.06.004 Ku, 2012, Management of colon cancer: resource-stratified guidelines from the Asian Oncology Summit 2012, Lancet Oncol, 13, e470, 10.1016/S1470-2045(12)70424-2 Lemmens, 2010, Trends in colorectal cancer in the south of the Netherlands 1975–2007: rectal cancer survival levels with colon cancer survival, Acta Oncol, 49, 784, 10.3109/02841861003733713 Van Cutsem, 2013, Improving outcomes in colorectal cancer: where do we go from here?, Eur J Cancer, 49, 2476, 10.1016/j.ejca.2013.03.026 Hyodo, 2010, Present status and perspectives of colorectal cancer in Asia: Colorectal Cancer Working Group report in 30th Asia-Pacific Cancer Conference, Jpn J Clin Oncol, 40, i38, 10.1093/jjco/hyq125 Wilhelm, 2011, Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity, Int J Cancer, 129, 245, 10.1002/ijc.25864 Schmieder, 2014, Regorafenib (BAY 73-4506): antitumor and antimetastatic activities in preclinical models of colorectal cancer, Int J Cancer, 135, 1487, 10.1002/ijc.28669 Strumberg, 2012, Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study, Br J Cancer, 106, 1722, 10.1038/bjc.2012.153 Grothey, 2013, Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial, Lancet, 381, 303, 10.1016/S0140-6736(12)61900-X Ma, 2010, Population-based differences in treatment outcome following anticancer drug therapies, Lancet Oncol, 11, 75, 10.1016/S1470-2045(09)70160-3 Yoshino, 2014, Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations, Invest New Drugs Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 2001 Oppe, 2007 2010 Tabernero, 2014, Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial, Eur J Cancer, 50, 320, 10.1016/j.ejca.2013.09.013 Mross, 2012, A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors, Clin Cancer Res, 18, 2658, 10.1158/1078-0432.CCR-11-1900 Schultheis, 2013, Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study, Ann Oncol, 24, 1560, 10.1093/annonc/mdt056 Bruix, 2013, Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study, Eur J Cancer, 49, 3412, 10.1016/j.ejca.2013.05.028 Eisen, 2012, Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial, Lancet Oncol, 13, 1055, 10.1016/S1470-2045(12)70364-9 George, 2012, Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial, J Clin Oncol, 30, 2401, 10.1200/JCO.2011.39.9394 Demetri, 2013, Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial, Lancet, 381, 295, 10.1016/S0140-6736(12)61857-1 Sunakawa, 2013, Regorafenib in Japanese patients with solid tumors: phase I study of safety, efficacy, and pharmacokinetics, Invest New Drugs, 32, 104, 10.1007/s10637-013-9953-8 Tanaka, 2014, Tolerability and efficacy of regorafenib in patients with unresectable metastatic colorectal cancer, Gan To Kagaku Ryoho, 41, 1231 Sugihara, 2012, Safety analysis of FOLFOX4 treatment in colorectal cancer patients: a comparison between two Asian studies and four western studies, Clin Colorectal Cancer, 11, 127, 10.1016/j.clcc.2011.09.001 Guan, 2011, Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trial, Chin J Cancer, 30, 682, 10.5732/cjc.011.10188 Kang, 2013, Subgroup analysis of Asian patients in the phase III trial (GRID) of regorafenib in pretreated metastatic GIST, Ann Oncol, 24, ix6, 10.1093/annonc/mdt435.2 Ueda, 2013, Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized phase 3 AXIS trial, Jpn J Clin Oncol, 43, 616, 10.1093/jjco/hyt054 Cheng, 2009, Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial, Lancet Oncol, 10, 25, 10.1016/S1470-2045(08)70285-7 Yoo, 2010, The efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction, Jpn J Clin Oncol, 40, 980, 10.1093/jjco/hyq073 Zhou, 2012, Management of sunitinib adverse events in renal cell carcinoma patients: the Asian experience, Asia Pac J Clin Oncol, 8, 132, 10.1111/j.1743-7563.2012.01525.x Grothey, 2013, Time profile of adverse events (AEs) from regorafenib (REG) treatment for metastatic colorectal cancer (mCRC) in the phase III CORRECT study, Proc Am Soc Clin Oncol, 31 DeSimone, 2015, Nightly dosing of regorafenib, Proc Am Soc Clin Oncol, 33 Tabchi, 2014, Regorafenib: start low and go slow, Target Oncol