Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review.
Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review.
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DOI：
10.1186/s12957-016-0975-5
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发表时间：
2016-08-24
影响因子：
3.2
通讯作者：
Stea B
中科院分区：
文献类型：
--
作者：
Ashby LS;Smith KA;Stea B
自2003年以来，只有两种化疗药物，在III期试验中评估，已被美国食品和药物管理局批准用于治疗新诊断的高级别胶质瘤（HGG）：Gliadel wafers（颅内植入局部化疗）和替莫唑胺（TMZ）（全身化疗）。这两种药物都不是治愈性的，但与单独放疗（RT）相比，每种药物都能改善中位总生存期（OS）。到目前为止，没有III期试验已经测试了这些药物在序贯联合使用时的效果;然而，一些较小的试验报告了有利的结果。我们进行了系统的文献综述，以评估Gliadel晶片与标准RT（60戈伊）联合使用以及同时辅助TMZ（RT/TMZ）治疗新诊断的HGG。进行了1995年1月至2015年9月期间的文献检索。提取数据并进行分类，确定平均值和范围。共有11篇文献符合标准，3项前瞻性试验和8项回顾性研究，代表了411例接受Gliadel加标准RT/TMZ的患者。患者的年龄、性别和体能状态相似。中位OS的加权平均值为18.2个月（10项试验，n = 379，范围12.7 - 21.3个月），中位无进展生存期的加权平均值为9.7个月（7项试验，n = 287，范围7 - 12.9个月）。最常报告的3级和4级不良事件为骨髓抑制（10.22%）、神经功能缺损（7.8%）和愈合异常（4.3%）。不良事件反映了Gliadel wafer和RT/TMZ独特的独立安全性特征，几乎没有证据表明它们连续组合使用会增强毒性。在11个确定的试验中，强烈建议将Gliadel晶片与RT/TMZ顺序组合的益处增加。在各自的III期试验中，中位OS比Gliadel晶片或TMZ单独使用时观察到的改善了3 - 4个月。Gliadel + RT/TMZ的大型前瞻性试验是必要的。
Since 2003, only two chemotherapeutic agents, evaluated in phase III trials, have been approved by the US Food and Drug Administration for treatment of newly diagnosed high-grade glioma (HGG): Gliadel wafers (intracranially implanted local chemotherapy) and temozolomide (TMZ) (systemic chemotherapy). Neither agent is curative, but each has been shown to improve median overall survival (OS) compared to radiotherapy (RT) alone. To date, no phase III trial has tested these agents when used in sequential combination; however, a number of smaller trials have reported favorable results. We performed a systematic literature review to evaluate the combination of Gliadel wafers with standard RT (60 Gy) plus concurrent and adjuvant TMZ (RT/TMZ) for newly diagnosed HGG. A literature search was conducted for the period of January 1995 to September 2015. Data were extracted and categorized, and means and ranges were determined. A total of 11 publications met criteria, three prospective trials and eight retrospective studies, representing 411 patients who received Gliadel plus standard RT/TMZ. Patients were similar in age, gender, and performance status. The weighted mean of median OS was 18.2 months (ten trials, n = 379, range 12.7 to 21.3 months), and the weighted mean of median progression-free survival was 9.7 months (seven trials, n = 287, range 7 to 12.9 months). The most commonly reported grade 3 and 4 adverse events were myelosuppression (10.22 %), neurologic deficit (7.8 %), and healing abnormalities (4.3 %). Adverse events reflected the distinct independent safety profiles of Gliadel wafers and RT/TMZ, with little evidence of enhanced toxicity from their use in sequential combination. In the 11 identified trials, an increased benefit from sequentially combining Gliadel wafers with RT/TMZ was strongly suggested. Median OS tended to be improved by 3 to 4 months beyond that observed for Gliadel wafers or TMZ when used alone in the respective phase III trials. Larger prospective trials of Gliadel plus RT/TMZ are warranted.