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【medical-news】北美脑瘤协会会议文章：恶性胶质
PURPOSE: A phase II study was undertaken in patients with recurrent malignant glioma to determine the efficacy and safety of tipifarnib, a farnesyltransferase inhibitor, dosed at the respective maximum-tolerated dose (MTD) for patients receiving and not receiving enzyme-inducing antiepileptic drugs (EIAEDs). Because tipifarnib undergoes extensive hepatic metabolism, MTD is doubled in patients on EIAEDs. The population included 67 patients with glioblastoma multiforme (GBM) and an exploratory group of 22 patients with anaplastic glioma (AG).
PATIENTS AND METHODS: Patients received tipifarnib (300 and 600 mg bid for 21 days every 4 weeks in non-EIAED and EIAED patients, respectively). All patients were assessable for efficacy and safety.
RESULTS: Two AG patients (9.1%) and eight GBM patients (11.9%) had progression-free survival (PFS) more than 6 months. Among the latter eight GBM patients, six of 36 patients (16.7%; 95% CI, 7% to 32%) were not receiving EIAEDs and two of 31 patients (6.5%; 95% CI, 1% to 20%) were receiving EIAEDs. Four patients had partial responses in group A GBM and one patient had a partial response group B GBM. An exploratory comparison of PFS between GBM groups A and B was statistically significant (P = .01). Patients not receiving EIAEDs had a higher incidence and increased severity of hematologic events. However, the incidence and severity of rash (the previously determined dose-limiting toxicity in patients receiving EIAEDs) seemed similar in EIAED and non-EIAED subgroups.
CONCLUSION: Tipifarnib (300 mg bid for 21 days every 4 weeks) shows modest evidence of activity in patients with recurrent GBM who are not receiving EIAEDs and is generally well tolerated in this population. 认领此篇。 替匹法尼在服用和未服用酵素诱导型抗癫痫药的恶性胶质瘤复发患者中的二期试验：北美脑肿瘤协会研究
目的：在恶性胶质瘤复发患者中的二期研究旨在确定替匹法尼，一种法尼酰基转移酶抑制剂，在最大耐受剂量下分别对服用和未服用酵素诱导型抗癫痫药患者的有效性和安全性。由于替匹法尼能增加肝脏的代谢率，所以服用了酵素诱导型抗癫痫药患者的最大耐受剂量是未服用者的两倍。此次研究包括67名胶质母细胞瘤患者和22名间变性胶质瘤的患者。
对象和方法：患者服用替匹法尼（未服用酵素诱导型抗癫痫药组和服用酵素诱导型抗癫痫药组每4周分别服用300mg和600mg剂量21天，每天两次）。对全部患者进行有效性和安全性的评估。
结果：2个间变性胶质瘤患者（9.1%）和8个胶质母细胞瘤患者（11.9%）的无进展生存期超过6个月。在后8位胶质母细胞瘤患者中，6名（16.7%; 95% CI, 7% to 32%）患者来自36名未服用酵素诱导型抗癫痫药患者组，还有2名(6.5%; 95% CI, 1% to 20%)患者来自31名服用酵素诱导型抗癫痫药患者组。4名胶质母细胞瘤A组的患者和1名胶质母细胞瘤B组的患者有部分反应。在胶质母细胞瘤A，B组间的无进展生存期的探测性比较有统计学意义(P = .01)。未服用患者酵素诱导型抗癫痫药的患者发生血液学事件的几率和风险增加。然而，在服用和未服用酵素诱导型抗癫痫药两组的出疹（已经证实的服用酵素诱导型抗癫痫药患者的剂量限制性毒性）的几率和风险相近。
结论：替匹法尼（每4周300mg剂量21天，每天2次）对未服用酵素诱导型抗癫痫药的胶质母细胞瘤复发患者被证实有效并且能被很好的耐受 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-02-10 05:14
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