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首页> 外文期刊>Journal of clinical neuroscience: official journal of the Neurosurgical Society of Australasia >Phase 2 trial of temozolomide and pegylated liposomal doxorubicin in the treatment of patients with glioblastoma multiforme following concurrent radiotherapy and chemotherapy.
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Phase 2 trial of temozolomide and pegylated liposomal doxorubicin in the treatment of patients with glioblastoma multiforme following concurrent radiotherapy and chemotherapy.

机译：替莫唑胺和聚乙二醇化脂质体阿霉素在同时放疗和化疗后治疗多形性胶质母细胞瘤患者的2期试验。

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摘要

Concurrent and post-radiotherapy temozolomide (T) significantly improves survival in patient with newly diagnosed glioblastoma multiforme. We aimed to assess the activity of the combination of T and pegylated liposomal doxorubicin (PLD) in this population. A combination of T (days 1-5, 200mg/m(2) orally) and PLD (day 1, 40 mg/m(2) intravenous) was given every 4 weeks for six cycles following chemo-radiotherapy as a post-operative treatment. The primary endpoint was 6-month progression free survival (6PFS). Of the 40 patients who enrolled (53 years median age, 73% male), the 6PFS was 58% (95% confidence interval [CI], 41-72%). The median time to progression was 6.2 months (95% CI, 5.6-8.0 months) and overall survival (OS) was 13.4 months (95% CI, 12.7-15.8 months). Thirty-four patients had measurable disease: one had a complete response (3%), 28 had stable disease (82%), and five had progressive disease (15%). Treatment was well tolerated: hematological toxicity included grade 3 neutropenia (8%). Grade 3 non-hematologic toxicity included nausea and vomiting (8%) and palmar-plantar toxicity (5%). We concluded that combination T and PLD is well tolerated but does not add significant clinical benefit regarding 6PFS and OS.
机译：并发放疗后的替莫唑胺（T）可以显着提高新诊断的胶质母细胞瘤患者的生存率。我们旨在评估该人群中T和聚乙二醇化脂质体阿霉素（PLD）组合的活性。放化疗后每4周给予T（第1-5天，口服200mg / m（2））和PLD（第1天，静脉注射40mg / m（2）），为术后六个周期的六个周期治疗。主要终点为6个月无进展生存期（6PFS）。在40名患者中（中位年龄53岁，男性73％），6PFS为58％（95％置信区间[CI]，41-72％）。进展的中位时间为6.2个月（95％CI，5.6-8.0个月），总生存期（OS）为13.4个月（95％CI，12.7-15.8个月）。 34例患者的疾病可测量：1例完全缓解（3％），28例稳定疾病（82％），5例进行性疾病（15％）。治疗耐受性良好：血液学毒性包括3级中性粒细胞减少（8％）。 3级非血液学毒性包括恶心和呕吐（8％）和掌-毒性（5％）。我们得出的结论是，T和PLD组合具有良好的耐受性，但是对于6PFS和OS并没有增加明显的临床益处。

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