{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:58:47Z","timestamp":1775696327547,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,1,28]],"date-time":"2020-01-28T00:00:00Z","timestamp":1580169600000},"content-version":"vor","delay-in-days":0,"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>In the phase 3 CONCUR trial (NCT01584830), regorafenib improved overall survival (OS) <jats:italic>versus<\/jats:italic> placebo in Asian patients with treatment\u2010refractory metastatic colorectal cancer (mCRC). We conducted a post hoc subgroup analysis of Chinese patients in CONCUR.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults with mCRC progressing despite at least two prior treatment regimens and Eastern Cooperative Oncology Group performance status 0\u20131 were randomized 2:1 to regorafenib 160\u00a0mg once daily or placebo for the first 3\u00a0weeks of each 4\u2010week cycle. Dose modifications were permitted. The primary endpoint was OS. Secondary endpoints included progression\u2010free survival, objective overall response, disease control rate, and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 172 Chinese patients were randomized and treated (regorafenib <jats:italic>n<\/jats:italic>\u00a0=\u00a0112, placebo <jats:italic>n<\/jats:italic>\u00a0=\u00a060). OS was significantly improved with regorafenib <jats:italic>versus<\/jats:italic> placebo (8.4 <jats:italic>vs<\/jats:italic> 6.2\u00a0months, respectively; hazard ratio [HR] 0.56, 95% CI 0.39\u20130.80; one\u2010sided <jats:italic>P<\/jats:italic>\u00a0=\u00a00.000632), as was progression\u2010free survival (HR 0.32, 95% CI 0.22\u20130.47; one\u2010sided <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.000001). The most common drug\u2010related grade\u00a0\u2265\u00a03 treatment\u2010emergent adverse events (TEAEs; regorafenib, placebo) were hand\u2013foot skin reaction (19%, 0%), hypertension (13%, 3%), hypophosphatemia (7%, 0%), increased alanine aminotransferase (6%, 0%), and increased aspartate aminotransferase (5%, 0%). In patients receiving regorafenib and placebo, respectively, TEAEs led to treatment discontinuation in 14% and 7%, dose reduction in 39% and 0%, and dose interruption in 64% and 20%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This retrospective analysis showed that regorafenib provided an OS benefit over placebo for Chinese patients with previously treated mCRC. TEAEs were consistent with the regorafenib safety profile and manageable with treatment modifications.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jgh.14974","type":"journal-article","created":{"date-parts":[[2020,1,4]],"date-time":"2020-01-04T07:15:05Z","timestamp":1578122105000},"page":"1307-1316","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Regorafenib in Chinese patients with metastatic colorectal cancer: Subgroup analysis of the phase 3 <scp>CONCUR<\/scp> trial"],"prefix":"10.1111","volume":"35","author":[{"given":"Jianming","family":"Xu","sequence":"first","affiliation":[{"name":"The 307 Hospital of PLA Cancer Center  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rui\u2010Hua","family":"Xu","sequence":"additional","affiliation":[{"name":"Sun Yat\u2010Sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shukui","family":"Qin","sequence":"additional","affiliation":[{"name":"Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongming","family":"Pan","sequence":"additional","affiliation":[{"name":"Sir Run Run Shaw Hospital  Hangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuxian","family":"Bai","sequence":"additional","affiliation":[{"name":"Harbin Medical University Cancer Hospital  Harbin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yihebali","family":"Chi","sequence":"additional","affiliation":[{"name":"Cancer Hospital Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liwei","family":"Wang","sequence":"additional","affiliation":[{"name":"Shanghai First People's Hospital  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng","family":"Bi","sequence":"additional","affiliation":[{"name":"West China Hospital Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Cheng","sequence":"additional","affiliation":[{"name":"Jilin Provincial Tumor Hospital  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianshu","family":"Liu","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dong","family":"Ma","sequence":"additional","affiliation":[{"name":"Guangdong General Hospital  Guangdong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Shen","sequence":"additional","affiliation":[{"name":"Peking University Cancer Hospital &amp; Institute  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Ba","sequence":"additional","affiliation":[{"name":"Tianjin Medical University Cancer Hospital  Tianjin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Liang","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Medical College Qingdao University  Shandong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of the 4th Military Medical University  Xi'an China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas C C","family":"Yau","sequence":"additional","affiliation":[{"name":"Queen Mary Hospital University of Hong Kong  Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brigette B","family":"Ma","sequence":"additional","affiliation":[{"name":"Prince of Wales Hospital The Chinese University of Hong Kong  Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kun\u2010Huei","family":"Yeh","sequence":"additional","affiliation":[{"name":"National Taiwan University Hospital and National Taiwan University Cancer Center  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jen\u2010Kou","family":"Lin","sequence":"additional","affiliation":[{"name":"Taipei Veterans General Hospital  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Kappeler","sequence":"additional","affiliation":[{"name":"Bayer AG  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"JoAnn","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Bayer HealthCare Pharmaceuticals  Whippany New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joachim","family":"Kalmus","sequence":"additional","affiliation":[{"name":"Bayer AG  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Li","sequence":"additional","affiliation":[{"name":"Tongji University Shanghai East Hospital  Shanghai China"},{"name":"Fudan University Shanghai Cancer Center  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,1,28]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-09-0090"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.20038"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2015-310912"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21338"},{"key":"e_1_2_6_6_1","unstructured":"National Comprehensive Cancer Network.Clinical practice guidelines in oncology (NCCN guidelines): colon cancer. Version 4.2018.2018."},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw235"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.25864"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61900-X"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)70156-7"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-014-0154-x"},{"key":"e_1_2_6_12_1","unstructured":"European Organisation for Research and Treatment of Cancer.EORTC QLQ\u2010C30 scoring manual 3rd edn.2001."},{"key":"e_1_2_6_13_1","unstructured":"OppeM RabinR deCharroF.EuroQol EQ\u20105D user guide version 1.2007."},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-5-70"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-8-4"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.1.139"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61857-1"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-11-1900"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2012.153"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2013.05.028"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32453-9"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyt054"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyq073"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdv233.258"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2018-0072"},{"key":"e_1_2_6_26_1","first-page":"726A","article-title":"Time course of treatment\u2010emergent adverse events (TEAEs) in the randomized, controlled phase 3 RESORCE trial of regorafenib for patients with hepatocellular carcinoma progressing on sorafenib treatment [Abstract]","volume":"66","author":"Merle P","year":"2017","journal-title":"Hepatology"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30272-4"}],"container-title":["Journal of Gastroenterology and Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjgh.14974","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jgh.14974","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jgh.14974","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jgh.14974","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T21:54:18Z","timestamp":1693950858000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jgh.14974"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1,28]]},"references-count":26,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2020,8]]}},"alternative-id":["10.1111\/jgh.14974"],"URL":"https:\/\/doi.org\/10.1111\/jgh.14974","archive":["Portico"],"relation":{},"ISSN":["0815-9319","1440-1746"],"issn-type":[{"value":"0815-9319","type":"print"},{"value":"1440-1746","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1,28]]},"assertion":[{"value":"2019-05-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-01-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-01-28","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}