Bevacizumab plus irinotecan in recurrent malignant glioma shows high overall survival in a multicenter retrospective pooled series of the Spanish Neuro-Oncology Research Group (GEINO)
Bevacizumab plus irinotecan in recurrent malignant glioma shows high overall survival in a multicenter retrospective pooled series of the Spanish Neuro-Oncology Research Group (GEINO)
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DOI：
10.1097/cad.0b013e3283534d3e
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发表时间：
2012-07-01
影响因子：
2.3
通讯作者：
Perez-Martin, Xavier
中科院分区：
文献类型：
--
作者：
Gila, Miguel J.;de las Penas, Ramon;Perez-Martin, Xavier
复发性恶性胶质瘤（MG）没有“标准治疗”。我们的目的是在一项回顾性汇总的复发性MG患者系列中证实贝伐单抗10 mg/kg联合伊立替康125 mg/m2（或340 mg/m2，如果是酶诱导抗癫痫药物）每2周一次，最长持续1年的疗效和安全性。入选标准如下：年龄18岁及以上，MG组织学，放疗和替莫唑胺后进展，Karnofsky体力状态（KPS）至少60，签署贝伐珠单抗同情使用的知情同意书。使用Macdonald标准通过MRI评估缓解，并每8周评价一次FLAIR序列。共入组130例患者; 72%患有胶质母细胞瘤（GBM）。患者的中位年龄为53岁（20-78岁）;中位KPS为80%;既往化疗线的中位数量为2（1-5）; MG诊断和入选之间的中位间隔为14.6个月（2-166）;贝伐珠单抗输注的中位数量为8（1-39）。中位随访时间为7.2个月（1-47）。GBM的中位总生存期（OS）为8.8个月，间变性胶质瘤（AG）为11.2个月。GBM的中位无进展生存期为5.1个月，AG为4.6个月。GBM的应答率为56%，AG为68%。在49%和45%的患者中观察到神经系统和KPS改善。只有KPS低于80%与较差的显著应答率相关（比值比，0.57; 95%置信区间，0.22-0.96）。最常见的3-4级毒性为虚弱（7%）、腹泻（6%）和血栓栓塞事件（5%）。有5例中毒死亡（4%）。与历史数据相比，贝伐珠单抗联合伊立替康治疗复发性MG可改善缓解、无进展生存期和OS。至少80%的KPS是响应和OS的预测因子，Anti-Cancer Drugs 23：659-665（C）2012 Wolters Kluwer Health破垂直条Lippincott威廉姆斯& Wilkins。
There is no 'standard of care' for recurrent malignant glioma (MG). Our aim is to confirm the efficacy and safety of bevacizumab 10 mg/kg plus irinotecan 125mg/m(2) (or 340mg/m(2) if enzyme-inducing antiepileptic drugs) every 2 weeks for a maximum of 1 year in a retrospective pooled series of patients with recurrent MG. The inclusion criteria were as follows: age 18 years and above, histology of MG, progression after radiation and temozolomide, Karnofsky performance status (KPS) of at least 60, and signed informed consent for bevacizumab compassionate use. Response was assessed by MRI using the Macdonald criteria and evaluation of the FLAIR sequence every 8 weeks. A total of 130 patients were enrolled; 72% had glioblastoma (GBM). The median age of the patients was 53 years (20-78); the median KPS was 80%; the median number of prior chemotherapy lines was 2 (1-5); the median interval between the diagnosis of MG and inclusion was 14.6 months (2-166); and the median number of bevacizumab infusions was 8 (1-39). The median follow-up duration was 7.2 months (1-47). The median overall survival (OS) was 8.8 months for GBM and 11.2 months for anaplastic glioma (AG). The median progression-free survival was 5.1 months for GBM and 4.6 months for AG. The response rate was 56% for GBM and 68% for AG. Neurological and KPS improvements were observed in 49 and 45% of patients. Only KPS less than 80% was associated with a worse significant response rate (odds ratio, 0.57; 95% confidence interval, 0.22-0.96). The most frequent grades 3-4 toxicities were asthenia (7%), diarrhea (6%), and thromboembolic events (5%). There were five toxic deaths (4%). Bevacizumab plus irinotecan in recurrent MG improves responses, progression-free survival, and OS compared with historical data. KPS of at least 80% was a predictive factor for response and OS. Anti-Cancer Drugs 23: 659-665 (C) 2012 Wolters Kluwer Health broken vertical bar Lippincott Williams & Wilkins.