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Article: Regorafenib in Chinese patients with metastatic colorectal cancer: subgroup analysis of the phase 3 CONCUR trial

TitleRegorafenib in Chinese patients with metastatic colorectal cancer: subgroup analysis of the phase 3 CONCUR trial
Authors
KeywordsRegorafenib
Colorectal cancer
Chinese
Clinical trial
Issue Date2020
PublisherWiley-Blackwell Publishing Asia. The Journal's web site is located at http://www.blackwellpublishing.com/journals/JGH
Citation
Journal of Gastroenterology and Hepatology, 2020, Epub 2020-01-03 How to Cite?
AbstractBackground 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 (PFS), 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 PFS (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.
Persistent Identifierhttp://hdl.handle.net/10722/279462
ISSN
2019 Impact Factor: 3.437
2015 SCImago Journal Rankings: 1.190

 

DC FieldValueLanguage
dc.contributor.authorXu, J-
dc.contributor.authorXu, R-
dc.contributor.authorQin, S-
dc.contributor.authorPan, H-
dc.contributor.authorBai, Y-
dc.contributor.authorChi, Y-
dc.contributor.authorWang, L-
dc.contributor.authorBi, F-
dc.contributor.authorCheng, Y-
dc.contributor.authorLiu, T-
dc.contributor.authorMa, D-
dc.contributor.authorShen, L-
dc.contributor.authorBa, Y-
dc.contributor.authorLiang, J-
dc.contributor.authorWang, X-
dc.contributor.authorYau, TCC-
dc.contributor.authorMa, BB-
dc.contributor.authorYeh, KH-
dc.contributor.authorLin, JK-
dc.contributor.authorKappeler, C-
dc.contributor.authorShapiro, JA-
dc.contributor.authorKalmus, J-
dc.contributor.authorLi, J-
dc.date.accessioned2019-11-01T07:17:50Z-
dc.date.available2019-11-01T07:17:50Z-
dc.date.issued2020-
dc.identifier.citationJournal of Gastroenterology and Hepatology, 2020, Epub 2020-01-03-
dc.identifier.issn0815-9319-
dc.identifier.urihttp://hdl.handle.net/10722/279462-
dc.description.abstractBackground 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 (PFS), 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 PFS (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.-
dc.languageeng-
dc.publisherWiley-Blackwell Publishing Asia. The Journal's web site is located at http://www.blackwellpublishing.com/journals/JGH-
dc.relation.ispartofJournal of Gastroenterology and Hepatology-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectRegorafenib-
dc.subjectColorectal cancer-
dc.subjectChinese-
dc.subjectClinical trial-
dc.titleRegorafenib in Chinese patients with metastatic colorectal cancer: subgroup analysis of the phase 3 CONCUR trial-
dc.typeArticle-
dc.identifier.emailYau, TCC: tyaucc@hku.hk-
dc.identifier.authorityYau, TCC=rp01466-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1111/jgh.14974-
dc.identifier.pmid31900959-
dc.identifier.scopuseid_2-s2.0-85078807009-
dc.identifier.hkuros308503-
dc.publisher.placeAustralia-

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