AKT抑制剂哌立福新（Perifosine），多项2期，三期临床有效。（肾癌、肠癌等），贴上6月22日发表的肾癌2期结果。就不知这药yl好不好弄，如果好弄，就是一种不错的选择。
Cancer：哌立福新（Perifosine）单药治疗肾细胞癌具有抗癌活性
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)（如下称“公司”）今日宣布该公司口服抗癌药物-哌立福新（perifosine）治疗肾细胞癌的两个II期临床试验数据，其内容已发表于2012年6月期的美国癌症学会出版物-《癌症》中。文章标题为“新的蛋白激酶抑制剂-哌立福新，用于治疗那些采用血管内皮生长因子靶向治疗后病情仍持续恶化的晚期肾细胞癌患者的两个II期临床试验。”本文作者有D.C. Cho, T.E. Hutson, W. Samlowski, P. Sportelli, B. Somer, P. Richards, J.A. Sosman, I. Puzanov,Michaelson, K.T. Flaherty博士，Flaherty, R.A. Figlin 和N.J. Vogelzang。文章概述哌立福新单一疗法治疗肾细胞癌，其药物活性类似于目前二线药物。试验中可观测到客观的肿瘤反应及长期的病情稳定性。哌立福新剂量为100mg/日，在试验中表现出良好的耐受性。作者得出结论，应对该药物开展进一步研究，即联合现有治疗方法用于此类适应症的临床试验。
临床试验
开展两项无对照，非盲II期临床试验（#228和#231）评估哌立福新用于治疗那些采用血管内皮生长因子（VEGF）靶向治疗后病情仍持续恶化的晚期肾细胞癌患者的有效性和安全性。
#228试验纳入24例晚期肾细胞癌患者，口服哌立福新（100mg/日）。231#试验分两组每日口服哌立福新（100mg/日）：A组纳入32例先前未服用任何mTOR抑制剂的晚期肾细胞癌患者， B组纳入18例曾服用mTOR抑制剂的晚期肾细胞癌患者。
研究结果
#228试验中，有1例患者病情达到部分缓解，有11例患者取得最佳疗效（即病情稳定）。中位无进展生存期为14.2周。
#231试验中，有5例患者病情达到部分缓解，有16例患者取得最佳疗效（即病情稳定）。无论患者是否服用mTOR抑制剂治疗，中位无进展生存期均为14周。
总的来说，哌立福新耐受性良好，极少发生3-4级不良反应。最常见的不良反应有恶心，腹泻，肌肉疼痛和乏力。
Aeterna Zentaris总裁兼首席执行官，Juergen Engel博士表示，“这些数据表明，单一疗法中哌立福新的抗癌活性及良好的耐受性。作者结论：我们应进一步开展哌立福新的III期临床试验，即联合硼替佐米与地塞米松合并用药治疗多发性骨髓瘤的综合治疗研发计划。”
Two phase 2 trials of the novel Akt inhibitor perifosine in patients with advanced renal cell carcinoma after progression on vascular endothelial growth factor-targeted therapy.
Cancer 2012;:
Cho DC Hutson TE Samlowski W Sportelli P Somer B Richards P Sosman JA Puzanov I Michaelson MD Flaherty KT Figlin RA Vogelzang NJ
Division of Hematology and Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada. dcho1@bidmc.harvard.edu.
Abstract
BACKGROUND: The clinical activity of allosteric inhibitors of mammalian target of rapamycin (mTOR) inhibitors in renal cell carcinoma (RCC) may be limited by upstream activation of phosphatidylinositol 3 (PI3)-kinase/Akt resulting from mTOR1 inhibition. On the basis of this rationale, 2 independent phase 2 trials (Perifosine 228 and 231) were conducted to assess the efficacy and safety of the novel Akt inhibitor perifosine in patients with advanced RCC who had failed on previous vascular endothelial growth factor (VEGF)-targeted therapy.
METHODS: In the Perifosine 228 trial, 24 patients with advanced RCC received oral perifosine (100 mg daily). Perifosine 231 enrolled 2 groups that received daily oral perifosine (100 mg daily): Group A comprised 32 patients who had received no prior mTOR inhibitor, and Group B comprised 18 patients who had received 1 prior mTOR inhibitor.
RESULTS: In the Perifosine 228 trial, 1 patient achieved a partial response (objective response rate, 4%; 95% confidence interval, 0.7%-20%), and 11 patients (46%) had stable disease as their best response. The median progression-free survival was 14.2 weeks (95% confidence interval, 7.7-21.6 weeks). In the Perifosine 231 trial, 5 patients achieved a partial response (objective response rate, 10%; 95% confidence interval, 4.5%-22.2%) and 16 patients (32%) had stable disease as their best response. The median progression-free survival was 14 weeks (95% confidence interval, 12.9, 20.7 weeks). Overall, perifosine was well tolerated, and there were very few grade 3 and 4 events. The most common toxicities included nausea, diarrhea, musculoskeletal pain, and fatigue. CONCLUSIONS: Although perifosine demonstrated activity in patients with advanced RCC after failure on VEGF-targeted therapy, its activity was not superior to currently available second-line agents. Nonetheless, perifosine may be worthy of further study in RCC in combination with other currently available therapies. Cancer 2012. © 2012 American Cancer Society.
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