国产肠癌靶向药呋喹替尼:三期临床试验,大获成功
  • 416例患者参与FRESCO试验以验证呋喹替尼用于mCRC患者三线治疗的疗效和安全性(三期临床实验);
  • 呋喹替尼可显著改善mCRC患者的OS,风险比0.65,中位OS为9.30个月;
  • 所有次级终点如PFS、客观缓解率和疾病控制率,具有统计学显著作用;
  • 最常见不良反应(≥3级):高血压(21.6%)、手足皮肤反应(10.8%)、蛋白尿(3.2%)和腹泻(3.2%);
  • 呋喹替尼治疗mCRC对延长患者OS具有统计学和临床意义,且药物具有很好的耐受性与安全性。
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A randomized, double-blind, placebo-controlled, multi-centered phase 3 trial comparing fruquintinib versus placebo plus best supportive care in Chinese patients with metastatic colorectal cancer (FRESCO)

一个三期临床抗肿瘤实验:随机、双盲、安慰剂对照、多中心以及最佳治疗支持比较呋喹替尼与安慰剂治疗中国转移性结直肠癌患者疗效

2017-06-05

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Background: Treatment options for third-line metastatic colorectal cancer (mCRC) patients remain limited in China. Fruquintinib, an oral kinase inhibitor selectively targeting vascular endothelial growth factor receptors, in a phase II study was found to significantly improve progression free survival (“PFS”) in patients with mCRC as compared to placebo (ESMO abs#2111). Based on these results, a Phase III registration trial, FRESCO, was carried out to confirm fruquintinib’s efficacy and safety in third-line mCRC patients (clinicaltrials.gov # NCT02314819).
Methods: This is a randomized, double-blind, placebo-controlled, multi-center phase III trial. Patients with mCRC who have failed at least 2 lines of systemic chemotherapy were enrolled from 28 centers in China. Patients were stratified based on prior anti-VEGF therapy and K-ras status and randomized to a fruquintinib or placebo arm in a 2:1 ratio. The primary endpoint was overall survival (“OS”) which was analyzed in the intent-to-treat population.
Results: Between December 12, 2014 and May 13, 2016, 416 patients were randomized. Protocol predefined number of OS events for final analysis was reached on January 17, 2017. Fruquintinib significantly improved OS comparing to placebo with a hazard ratio of 0.65 (95% CI: 0.51-0.83; two sided p<0.001). Median OS was 9.30 months [95% CI 8.18-10.45] in the fruquintinib group versus 6.57 months [95% CI 5.88-8.11] in the placebo group. Statistically significant benefits were also seen with fruquintinib in all secondary endpoints, such as PFS, objective response rate and disease control rate. The most frequent fruquintinib-related ≥ Grade 3 treatment emerged adverse events included hypertension (21.6%), hand-foot skin reaction (10.8%), proteinuria (3.2%) and diarrhea (3.2%).
Conclusions: In this phase III confirmatory trial, fruquintinib demonstrated a statistically significant and clinically meaningful OS benefit as compared with placebo in mCRC patients in China. Fruquintinib was well tolerated with a safety profile that is consistent with what was reported previously.

All Authors:
Jin Li

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