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

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收录情况： ◇ SCIE

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机构： [1]The 307 Hospital of PLA Cancer Center, Beijing, China. [2]Sun Yat-Sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. [3]Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China. [4]Sir Run Run Shaw Hospital, Hangzhou, China. [5]Harbin Medical University Cancer Hospital, Harbin, China. [6]Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China. [7]Shanghai First People's Hospital, Shanghai, China. [8]West China Hospital, Sichuan University, Chengdu, China. [9]Jilin Provincial Tumor Hospital, Changchun, China. [10]Zhongshan Hospital, Fudan University, Shanghai, China. [11]Guangdong General Hospital, Guangdong, China. [12]Peking University Cancer Hospital &amp [13]Institute, Beijing, China. [13]Tianjin Medical University Cancer Hospital, Tianjin, China. [14]Affiliated Hospital of Medical College, Qingdao University, Shandong, China. [15]The First Affiliated Hospital of the 4th Military Medical University, Xi'an, China. [16]Queen Mary Hospital University of Hong Kong, Hong Kong, China. [17]Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China. [18]National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan. [19]Taipei Veterans General Hospital, Taipei, Taiwan. [20]Bayer AG, Berlin, Germany. [21]Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA. [22]Tongji University Shanghai East Hospital, Shanghai, China. [23]Fudan University Shanghai Cancer Center, Shanghai, China.

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关键词： Chinese clinical trial colorectal cancer regorafenib

摘要：

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. 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. 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%. 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, Ltd.

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出版当年[2020]版：

大类 | 3 区医学

小类 | 3 区胃肠肝病学

最新[2023]版：

大类 | 3 区医学

小类 | 3 区胃肠肝病学

JCR分区：

出版当年[2020]版：

Q2 GASTROENTEROLOGY & HEPATOLOGY

最新[2023]版：

Q2 GASTROENTEROLOGY & HEPATOLOGY

影响因子： 3.7 最新[2023版] 3.9 最新五年平均 4.029 出版当年[2020版] 4.144 出版当年五年平均 3.437 出版前一年[2019版] 4.369 出版后一年[2021版]

第一作者：

第一作者机构： [1]The 307 Hospital of PLA Cancer Center, Beijing, China.

通讯作者：

通讯机构： [22]Tongji University Shanghai East Hospital, Shanghai, China. [23]Fudan University Shanghai Cancer Center, Shanghai, China. [*1]Tongji University Shanghai East Hospital, 150 Jimo Road, Pudong Xinqu,Shanghai, China.

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

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