3期临床试验发现regorafenib能够提高结直肠癌患者的生存率

一个国际性的三期临床试验发现：一种名为regorafenib的研究性药物在治疗转移性结肠癌患者时，能够减缓肿瘤的进展和延长患者生命。

该研究结果由三藩市MayoClinic肿瘤科的AxelGrothey博士发表在美国临床肿瘤协会的《胃肠道癌症研究论文集》上。试验的主要研究者在美国。

“多年来，标准化疗未能阻止肿瘤生长，并且医生已经黔驴技穷无法为患者提供有效的药物，故而转移性结肠癌患者面临灾难性的困境，”Grothey博士说道，“八年来，对于无法用药的结肠癌患者，这是第一种显示出提高整体生存率的新型药物。”

研究人员在美国、欧洲、澳大利亚和中国对regorafenib同时进行了随机、安慰剂对照的三期临床试验。他们评判了760例行标准化疗的患者的生存结果。Regorafenib是一种多激酶抑制剂，该制剂起到抑制肿瘤血管生成、肿瘤细胞增殖以及灭活被各种生物途径激活的肿瘤。

研究人员发现，治疗转移性结肠癌的结果表明，以该药治疗组比安慰剂组增加了29%的总体生存率。以该药物进行治疗的患者平均生存时间增加了5~6.5个月，具有显著意义性的增长。总体而言，regorafenib可将病人死于癌症的风险下降23%左右。

该实验中最大的研究组是美国的MayoClinic，在计划进度上提前了一年多的时间。

“所有被认可的标准疗法对转移性结肠癌患者预后均较差，”Grothey说，“目前来说，这是第一种也是唯一一种在整体生存率方面有着显著统计意义的药物。”

摘要号：3502

题目：Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC).

regorafenib 治疗转移性结直肠癌(mCRC)的III期CORRECT研究

摘要：

Background: Regorafenib (REG) is an oral multi-kinase inhibitor. The CORRECT trial was conducted to evaluate REG in patients (pts) with mCRC who had progressed after all approved standard therapies.

Methods: Enrollment criteria included documented mCRC and progression during or ≤3 months after last standard therapy. Pts were randomized 2:1 to receive best supportive care plus either REG (160 mg od po, 3 wks on/1 wk off) or placebo (PL). The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall response rate, disease control rate, safety and quality of life (QoL). Efficacy analyses across prespecified subgroups were evaluated using univariate Cox regression.

Results: 760 pts were randomized (REG: 505; PL: 255). The OS primary endpoint was met at a preplanned interim analysis. OS and PFS were significantly improved in REG arm compared to PL arm: hazard ratio (HR) for OS 0.77 (95% CI 0.64-0.94, 1-sided p=0.0052), median OS 6.4 vs 5.0 mos; HR for PFS 0.49 (95% CI 0.42-0.58, 1-sided p<0.000001), median PFS 1.9 vs 1.7 mos. Comparable OS and PFS benefits were observed in exploratory subgroup analyses by region, age, time from diagnosis of mCRC to randomization, prior lines of treatment, and KRAS status (shown in table). The most common grade 3+ AEs related to REG were hand-foot skin reaction (16.6%), fatigue (9.6%), hypertension (7.2%), diarrhea (7.2%) and rash/desquamation (5.8%). QoL data will be presented.

Conclusions: REG demonstrated statistically significant improvement in OS and PFS over PL, as well as comparable efficacy benefits across pt subgroups analyzed.

编辑: xy 作者:丁香园通讯员

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