Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.
Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.
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DOI：
10.1007/s10637-014-0154-x
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发表时间：
2015-06
影响因子：
3.4
通讯作者：
Ohtsu A
中科院分区：
文献类型：
--
作者：
Yoshino T;Komatsu Y;Yamada Y;Yamazaki K;Tsuji A;Ura T;Grothey A;Van Cutsem E;Wagner A;Cihon F;Hamada Y;Ohtsu A
在国际III期随机双盲CORRECT试验中，与安慰剂相比，瑞格非尼显著延长了所有标准治疗均进展的转移性结直肠癌（mCRC）患者的总生存期（OS）。这项事后分析评价了CORRECT试验中瑞戈非尼在日本和非日本亚群中的疗效和安全性。方法患者按2：1随机分为瑞戈非尼组和安慰剂组，每4周为1周期，治疗1-3周。主要终点是OS。使用描述性统计量评估结局。结果100例日本患者和660例非日本患者被随机分配至瑞戈非尼组（n = 67和n = 438）或安慰剂组（n = 33和n = 222）。瑞戈非尼在日本和非日本亚群中具有一致的OS获益，风险比分别为0.81（95%置信区间[CI] 0.43-1.51）和0.77（95% CI 0.62-0.94）。与非日本亚群相比，日本亚群中瑞戈非尼相关手足皮肤反应、高血压、蛋白尿、血小板减少症和脂肪酶升高的发生率更高，但通常可管理。结论瑞戈非尼在日本和非日本亚群中的疗效相似，不良事件可管理，表明该药物可能成为mCRC患者的标准治疗。本文的在线版本（doi：10.1007/s10637-014-0154-x）包含补充材料，可供授权用户使用。
Background In the international, phase III, randomized, double-blind CORRECT trial, regorafenib significantly prolonged overall survival (OS) versus placebo in patients with metastatic colorectal cancer (mCRC) that had progressed on all standard therapies. This post hoc analysis evaluated the efficacy and safety of regorafenib in Japanese and non-Japanese subpopulations in the CORRECT trial. Methods Patients were randomized 2 : 1 to regorafenib 160 mg once daily or placebo for weeks 1–3 of each 4-week cycle. The primary endpoint was OS. Outcomes were assessed using descriptive statistics. Results One hundred Japanese and 660 non-Japanese patients were randomized to regorafenib (n = 67 and n = 438) or placebo (n = 33 and n = 222). Regorafenib had a consistent OS benefit in the Japanese and non-Japanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.43–1.51) and 0.77 (95 % CI 0.62–0.94), respectively. Regorafenib-associated hand–foot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the non-Japanese subpopulation, but were generally manageable. Conclusion Regorafenib appears to have comparable efficacy in Japanese and non-Japanese subpopulations, with a manageable adverse-event profile, suggesting that this agent could potentially become a standard of care in patients with mCRC. The online version of this article (doi:10.1007/s10637-014-0154-x) contains supplementary material, which is available to authorized users.
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影响因子：
8.8
作者：
Strumberg D;Scheulen ME;Schultheis B;Richly H;Frost A;Büchert M;Christensen O;Jeffers M;Heinig R;Boix O;Mross K
通讯作者：
Mross K
影响因子：
2.4
作者：
Ueda, Takeshi;Uemura, Hirotsugu;Akaza, Hideyuki
通讯作者：
Akaza, Hideyuki
影响因子：
6.4
作者：
Wilhelm, Scott M.;Dumas, Jacques;Zopf, Dieter
通讯作者：
Zopf, Dieter
影响因子：
3.4
作者：
Sunakawa, Yu;Furuse, Junji;Okusaka, Takuji;Ikeda, Masafumi;Nagashima, Fumio;Ueno, Hideki;Mitsunaga, Shuichi;Hashizume, Kensei;Ito, Yuichiro;Sasaki, Yasutsuna
通讯作者：
Sasaki, Yasutsuna
影响因子：
2.4
作者：
Yoshino, Takayuki;Boku, Narikazu;Ono, Hiroyuki
通讯作者：
Ono, Hiroyuki