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机构地区:[1]北京三博脑科医院 [2]首都医科大学第十一临床医学院神经肿瘤化疗科,北京100093
出 处:《中国新药与临床杂志》2015年第4期310-314,共5页Chinese Journal of New Drugs and Clinical Remedies
基 金:首都医科大学基础-临床科研合作基金(13JL46);国家临床重点专科建设项目(SG2011-03-1-2)
摘 要:目的初步评估新型抗肿瘤血管生成药物重组人血管内皮抑制素(rh-ES)联合细胞毒药物伊立替康(CPT11)及替莫唑胺(TMZ)作为复发胶质母细胞瘤(GBM)挽救治疗的有效性和耐受性。方法 11例复发GBM患者进入研究,3例患者接受rh-ES联合CPT11治疗,8例患者接受rh-ES联合CPT11及TMZ治疗。按RANO标准评价疗效,不良反应评价按常见不良反应事件评价标准4.0版进行。随访及统计无进展生存时间(PFS)、6个月无进展生存率(PFS6)和总生存时间(OS)。结果 11例复发GBM患者中4例部分缓解,3例疾病稳定,4例疾病进展;中位PFS 5.5个月,PFS6 36%,中位OS 7.1个月。不良反应主要为可逆性的Ⅲ度(9%)和Ⅳ度(18%)中性粒细胞减少,无严重不良事件发生。结论 rh-ES联合CPT11及TMZ作为复发GBM的挽救化疗有效且耐受性好,值得进一步扩大病例深入研究。AIM To evaluate the efficacy and toxicities of recombinant human endostatin (rh-ES) in combination with irinotecan and temozolomide as salvage therapy for recurrent glioblastoma. METHODS Totally 11 patients with recurrent glioblastoma were involved, 3 received rh- ES+ irinotecan and 8 received rh- ES+ irinoteean +temozolomide. Response to therapy was assessed by brain MRI based on Response Assessment in Neuro - Oncology (RANO) Criteria. Progression - free survival (PFS) , 6 - month progression - free survival (PFS6), and overall survival (OS) were estimated using Kaplan-Meier methods. Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. RESULTS In the overall 11 patients, responses to the therapy were as follows: 0 complete response, 4 partial response, 3 stable disease, and 4 progressive disease; median PFS 5.5 months, PFS6 36%, median OS 7.1 months. The most common adverse event was neutropenia (9% of grade 3 and 18% of grade 4). CONCLUSION rh-ES, in combination with irinotecan and temozolomide, was active and well tolerated in treatment of recurrent glioblastoma.
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