• J. Gastroenterol. Hepatol. · Aug 2020

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

    • Jianming Xu, Rui-Hua Xu, Shukui Qin, Hongming Pan, Yuxian Bai, Yihebali Chi, Liwei Wang, Feng Bi, Ying Cheng, Tianshu Liu, Dong Ma, Lin Shen, Yi Ba, Jun Liang, Xin Wang, Yau Thomas C C TCC Queen Mary Hospital University of Hong Kong, Hong Kong, China., Brigette B Ma, Kun-Huei Yeh, Jen-Kou Lin, Christian Kappeler, JoAnn Shapiro, Joachim Kalmus, and Jin Li.
    • The 307 Hospital of PLA Cancer Center, Beijing, China.
    • J. Gastroenterol. Hepatol. 2020 Aug 1; 35 (8): 1307-1316.

    Background And AimIn 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.MethodsAdults 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.ResultsA 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%.ConclusionsThis 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, Ltd.

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