Gliadel wafers in the treatment of malignant glioma: a systematic review.
Gliadel wafers in the treatment of malignant glioma: a systematic review.
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DOI：
10.3747/co.2007.147
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发表时间：
2007-10-01
期刊：
影响因子：
--
通讯作者：
Laperriere, N
中科院分区：
文献类型：
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作者：
Perry, J;Chambers, A;Laperriere, N
问题：使用卡莫司汀负载聚合物进行间质化疗的安全性和有效性如何（Gliadel wafers：MGI Pharma，布卢明顿，MN，U.S.A.）治疗新诊断或复发的恶性胶质瘤（即多形性胶质母细胞瘤、间变性星形细胞瘤、间变性少突星形细胞瘤和间变性少突胶质细胞瘤）？前景：恶性胶质瘤是成人最常见的原发性脑肿瘤。总体而言，系统治疗在该患者人群中的疗效令人失望，需要新的治疗方法。由于几个随机对照试验（RCTS）调查的安全性和有效性的Gliadel是可用的，神经肿瘤疾病网站组的癌症护理安大略的计划，在循证护理决定，一个系统的审查证据是必要的。对medline、embase和科克伦图书馆数据库进行系统检索，以获得相关证据。选择纳入比较Gliadel晶片治疗与安慰剂或替代治疗的完整发表的RCTS报告。前瞻性队列研究也包括在内。结果：两个RCTS，比较新诊断的恶性胶质瘤患者Gliadel安慰剂。两项RCTS均报告，与对照组患者相比，接受Gliadel的患者具有显著的生存获益。获得了一项RCT和一项前瞻性队列研究，研究了Gliadel在复发性恶性胶质瘤患者中的作用。rct显示，只有在调整预后因素后，Gliadel才有显著的生存获益，而前瞻性队列研究报告称，与历史对照组相比，Gliadel没有生存获益。所有三个RCTS报告了治疗组和对照组的不良事件发生率相似。最常见的不良事件是惊厥，混乱，脑水肿，感染，轻偏瘫，失语症，和visual field defects.CONCLUSIONS：Gliadel是一种选择与新诊断的恶性胶质瘤的患者近总切除术是可能的。没有证据可以比较Gliadel与全身治疗，应根据患者个体情况决定是否将Gliadel与全身治疗联合使用联合收割机。从Gliadel中获益的患者人群（年龄、组织学和体能状态）尚不清楚;需要进一步研究。Gliadel也是可手术切除的复发性恶性胶质瘤患者的一种选择。
QUESTION: What is the safety and efficacy of interstitial chemotherapy with carmustine-loaded polymers (Gliadel wafers: MGI Pharma, Bloomington, MN, U.S.A.) in the treatment of newly diagnosed or recurrent malignant glioma (that is, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligoastrocytoma, and anaplastic oligodendroglioma)?PERSPECTIVES: Malignant glioma is the most common type of primary brain tumour in adults. In general, efficacy of systemic therapy in this patient population has been disappointing, and novel treatment approaches are needed. Because several randomized controlled trials (RCTS) investigating the safety and efficacy of Gliadel are available, the Neuro-oncology Disease Site Group of Cancer Care Ontario's Program in Evidence-Based Care decided that a systematic review of the evidence was necessary.OUTCOMES: The outcomes of interest for this review were overall survival, adverse events, and quality of life.METHODOLOGY: Systematic searches of the medline, embase, and Cochrane Library databases were conducted for relevant evidence. Fully-published reports of RCTS comparing treatment with Gliadel wafers to placebo or alternative treatment were selected for inclusion. Prospective cohort studies were also included.RESULTS: Two RCTS that compared Gliadel to placebo in patients with newly diagnosed malignant glioma were obtained. Both RCTS reported a significant survival benefit for patients who received Gliadel as compared with patients in the control group. One RCT and one prospective cohort study were obtained that examined the role of Gliadel in patients with recurrent malignant glioma. The rct demonstrated a significant survival benefit for Gliadel only after adjustment for prognostic factors, and the prospective cohort study reported no survival benefit for Gliadel as compared with a historical control group. All three RCTS reported similar rates of adverse events in the treatment and control groups. The most frequently reported adverse events were convulsions, confusion, brain edema, infection, hemiparesis, aphasia, and visual field defects.CONCLUSIONS: Gliadel is an option for selected patients with newly diagnosed malignant glioma where a near gross total resection is possible. No evidence is available comparing Gliadel with systemic therapy, and a decision to combine Gliadel with systemic therapy should be made for patients individually. The patient population that would benefit from Gliadel (age, histology, and performance status) is unclear; further investigation is needed. Gliadel is also an option for patients with surgically resectable recurrent malignant glioma.