Xu J.Xu R.-H.Qin S.Pan H.Bai Y.Chi Y.Wang L.Bi F.Cheng Y.Liu T.Ma D.Shen L.Ba Y.Liang J.Wang X.Yau T.C.C.Ma B.B.KUN-HUEI YEHLin J.-K.Kappeler C.Shapiro J.Kalmus J.Li J.2021-01-282021-01-2820200815-9319https://www.scopus.com/inward/record.uri?eid=2-s2.0-85078807009&doi=10.1111%2fjgh.14974&partnerID=40&md5=d6efce4b7e664f88400fdde0f78acf99https://scholars.lib.ntu.edu.tw/handle/123456789/543435Background and Aim: In the phase 3 CONCUR trial (NCT01584830), regorafenib improved overall survival (OS) versus placebo in Asian patients with treatment-refractory metastatic colorectal cancer (mCRC). We conducted a post hoc subgroup analysis of Chinese patients in CONCUR. Methods: Adults with mCRC progressing despite at least two prior treatment regimens and Eastern Cooperative Oncology Group performance status 0–1 were randomized 2:1 to regorafenib 160?mg once daily or placebo for the first 3?weeks of each 4-week cycle. Dose modifications were permitted. The primary endpoint was OS. Secondary endpoints included progression-free survival, objective overall response, disease control rate, and safety. Results: A total of 172 Chinese patients were randomized and treated (regorafenib n?=?112, placebo n?=?60). OS was significantly improved with regorafenib versus placebo (8.4 vs 6.2?months, respectively; hazard ratio [HR] 0.56, 95% CI 0.39–0.80; one-sided P?=?0.000632), as was progression-free survival (HR 0.32, 95% CI 0.22–0.47; one-sided P?<?0.000001). The most common drug-related grade???3 treatment-emergent adverse events (TEAEs; regorafenib, placebo) were hand–foot 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%. Conclusions: 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. ? 2020 The Authors. Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, LtdChinese; clinical trial; colorectal cancer; regorafenib[SDGs]SDG3alanine aminotransferase; alkaline phosphatase; amylase; aspartate aminotransferase; bevacizumab; bilirubin; cetuximab; gamma glutamyltransferase; panitumumab; placebo; regorafenib; triacylglycerol lipase; carbanilamide derivative; pyridine derivative; regorafenib; abdominal pain; acute kidney failure; adult; aged; alanine aminotransferase blood level; alkaline phosphatase blood level; amylase blood level; anemia; anorexia; Article; aspartate aminotransferase blood level; atrial fibrillation; bilirubin blood level; cancer chemotherapy; cancer control; cancer patient; cancer prognosis; cancer survival; Chinese; controlled study; desquamation; diarrhea; drug dose reduction; drug efficacy; drug fatality; drug rechallenge; drug safety; drug withdrawal; Eastern Cooperative Oncology Group performance status; fatigue; female; fever; functional status assessment; gamma glutamyl transferase blood level; hand foot syndrome; health status; heart arrest; heart failure; heart muscle conduction disturbance; hoarseness; human; hyperbilirubinemia; hypertension; hypokalemia; hypophosphatemia; ischemia; leukopenia; maculopapular rash; major clinical study; male; metastatic colorectal cancer; multicenter study (topic); multiple cycle treatment; myalgia; neutropenia; oral mucositis; outcome assessment; overall response rate; overall survival; patient-reported outcome; peripheral occlusive artery disease; phase 3 clinical trial (topic); post hoc analysis; priority journal; progression free survival; proteinuria; quality of life; randomized controlled trial (topic); rash; retrospective study; side effect; skin manifestation; thrombocytopenia; treatment interruption; treatment response; triacylglycerol lipase blood level; vagina disease; visceral arterial ischemia; wound infection; Asian continental ancestry group; colorectal tumor; disease free survival; double blind procedure; metastasis; middle aged; mortality; phase 3 clinical trial (topic); safety; very elderly; Adult; Aged; Aged, 80 and over; Asian Continental Ancestry Group; Clinical Trials, Phase III as Topic; Colorectal Neoplasms; Disease-Free Survival; Double-Blind Method; Female; Humans; Male; Middle Aged; Neoplasm Metastasis; Phenylurea Compounds; Pyridines; Retrospective Studies; Safetyjournal article10.1111/jgh.14974319009592-s2.0-85078807009