Guilford公司2月26日宣称，FDA已批准GilladelWafer(格立得植入剂)用于辅助手术和放疗治疗高度恶性神经胶质瘤。　　
Gliadelwafer是目前上市的唯一一种可将化疗药物直接传输到脑部癌症病灶处的癌症疗法，它可绕过血脑屏障，使脑部其他部位尽可能少地受到药物影响。　　
Gliadelwafer由含有7.7mg卡氯芥的生物降解聚合材料构成。当手术将脑瘤清除后，可在病灶空穴内植入最多达8个的Gliadelwafer。这些Gliadelwafer可以慢慢溶解，直接向肿瘤处释放高浓度的BCNU，同时将药物对身体其他部位的影响降至最小。　　
在14个国家38个医学中心进行的III期双盲，安慰剂对照的临床试验中，240名接受了初次手术切除高度恶性神经瘤的男女患者随机在切除空穴中植入Gliadelwafer或安慰剂，接着两周后进行放疗。　　
240名病人中的239名接受了48个月的跟踪访问。在最后一次的随访中，有11名病人仍健在，其中9人是Gliadelwafer治疗组，2人为安慰剂组。Gliadelwafer组的平均存活期从11.6个月延长至13.9个月。在治疗后三年四年中，整个死亡危险减少了，这从危险机率为0.73这一数值中可得以反映。(95%CI:0.56-0.95;p<0.05).

什么是格立得植入剂(Gliadel Wafer)
格立得植入剂Gliadel Wafer是以无水聚合物(polyanhydride copolymer)包裹抗癌作用药物carmustine所制成的抗癌药品，外形为灰白至淡黄色的圆形药片，直径约1.45公分、厚约1厘米的无菌植入剂。每片格立得植入剂Gliadel Wafer含有7.7mg carmustine，分散在polifeprosan 20聚合物中。
Carmustine是治疗脑癌的一个重要化学药物，属于亚硝尿素类的抗恶性肿瘤剂，能够有效抑制DNA、RNA与蛋白质的合成而杀死癌细胞。
Polifeprosan 20由(p-carboxyphenoxy)propane(CPP)及sebacic acid(SA)以摩尔比例20：80组成，负责控制carmustine的局部传送。

Watch GLIADEL® Wafer
The video depicts GLIADEL Wafer implantation and how GLIADEL Wafer is designed to work.
GLIADEL Wafer Implantation Guides
Indications
GLIADEL® Wafer (polifeprosan 20 with carmustine implant) is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation.

GLIADEL Wafer is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

Important Safety Information
GLIADEL® Wafer (polifeprosan 20 with carmustine implant) should not be given to patients who have demonstrated a previous hypersensitivity to carmustine or any of the components of GLIADEL Wafer.

Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL Wafer, including 1 case leading to brain herniation.

Carmustine, the active component of GLIADEL Wafer, can cause fetal harm when administered to a pregnant woman. It is recommended that patients receiving GLIADEL Wafer discontinue nursing.

Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation.

CT and MRI of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of GLIADEL Wafer. This enhancement may represent edema and inflammation caused by GLIADEL Wafer or tumor progression.

The short-term and long-term toxicity profiles of GLIADEL Wafer when given in conjunction with chemotherapy have not been fully explored.

The following 4 categories of adverse events are possibly related to treatment with GLIADEL Wafer:

Seizures: In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving GLIADEL Wafer and 37.5% in patients receiving placebo. Grand mal seizures occurred in 5% of GLIADEL Wafer–treated patients and 4.2% of placebo-treated patients. The incidence of seizures within the first 5 days after wafer implantation was 2.5% in the GLIADEL Wafer group and 4.2% in the placebo group.

In the surgery for recurrent disease trial, the incidence of post-operative seizures was 19% in both patients receiving GLIADEL Wafer and placebo. In this study, 12/22 (54%) of patients treated with GLIADEL Wafer and 2/22 (9%) of placebo patients experienced the first new or worsened seizure within the first 5 post-operative days.

The median time to onset of the first new or worsened post-operative seizure was 3.5 days in patients treated with GLIADEL Wafer and 61 days in placebo patients.
Brain Edema: In the initial surgery trial, brain edema was noted in 22.5% of patients treated with GLIADEL Wafer and in 19.2% of patients treated with placebo. Development of brain edema with mass effect (due to tumor recurrences, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Wafer or its remnants.
Healing Abnormalities: The following healing abnormalities have been reported in GLIADEL Wafer clinical trials: wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid leak. In the initial surgery trial, healing abnormalities occurred in 15.8% of GLIADEL Wafer–treated patients and in 11.7% of placebo recipients. Cerebrospinal fluid leaks occurred in 5% of GLIADEL Wafer recipients and 0.8% of those given placebo.

During surgery, a water-tight dural closure should be obtained to minimize the risk of cerebrospinal fluid leak. In the surgery for recurrent disease trial, the incidence of healing abnormalities was 14% in GLIADEL Wafer–treated patients and 5% in patients receiving placebo wafers.
Intracranial Infection: In the initial surgery trial, the incidence of brain abscess or meningitis was 5% in patients treated with GLIADEL Wafer and 6% in patients receiving placebo. In the recurrent setting, the incidence of brain abscess or meningitis was 4% in GLIADEL Wafer patients and 1% in patients receiving placebo.

格立得植入剂Gliadel Wafer的使用方式
格立得植入剂Gliadel Wafer是设计为能够直接将carmustine释放至脑部残存的肿瘤组织。手术切除脑瘤后，将格立得植入剂Gliadel Wafer直接植入脑瘤移除后之空腔，视空腔之大小及形状，尽可能植入8片共含有carmustine 61.6mg。若空腔不许可放入8片，则植入容许的最多数量。植入格立得植入剂Gliadel Wafer后，不须要再手术取出。超过70%的polifeprosan 20于三星期内分解，分解后经由肾臟代谢成二氧化碳排出体外。

How GLIADEL® Wafer is Used
GLIADEL Wafer is implanted in the brain along the walls and floor of the cavity created after a malignant glioma has been surgically removed. Up to 8 wafers may be placed in the area where the tumor was located. The number of wafers implanted depends on the size of the space left after the removal of the tumor. As they dissolve, the wafers release carmustine into the surrounding cells.
GLIADEL Wafer is implanted in the brain along the walls and floor of the cavity created after a malignant glioma has been surgically removed.
A surgeon may place up to 8 wafers. The graphic above shows a cavity in which 6 wafers were implanted.
Important Questions About GLIADEL Wafer
Indications
GLIADEL® Wafer (polifeprosan 20 with carmustine implant) is indicated in patients with newly diagnosed
high-grade malignant glioma as an adjunct to surgery and radiation.

GLIADEL Wafer is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

Important Safety Information
You should not be given GLIADEL Wafer if you are allergic to carmustine or any of the components of GLIADEL Wafer.

If you are undergoing surgery for malignant glioma and implantation of GLIADEL Wafer, you should be monitored closely for known complications, including convulsions, infections, abnormal wound healing, and swelling of the brain.

If you are pregnant or are planning to become pregnant, you should understand that carmustine, the active component of GLIADEL Wafer, can cause harm to the fetus if given to a pregnant woman. It is not known if either carmustine, or other components of GLIADEL Wafer are excreted in human milk. Many drugs are excreted in human milk and there is a risk for serious side effects from carmustine in nursing infants; therefore discontinuation of nursing is recommended if you will be receiving GLIADEL Wafer.

It is possible that if GLIADEL Wafers are not implanted properly, they could block the flow of cerebrospinal fluid and might cause abnormal accumulation of fluid in the brain (obstructive hydrocephalus).

The short-term and long-term safety of GLIADEL Wafer when given together with chemotherapy is not fully known.

Following surgery to remove a brain tumor and implantation of GLIADEL Wafer, the following side effects have been reported in clinical studies:

Seizures (convulsions): In clinical studies, seizures have occurred within days or several weeks following implantation of GLIADEL Wafer. Both new seizures and worsening of seizures have been reported.

Brain Swelling: Brain swelling has occurred in clinical studies. In some cases, brain swelling may require another surgery, and removal of GLIADEL Wafers or remnants of the wafers may be required.

Abnormal wound healing: In clinical studies, abnormal healing of the surgical wound has occurred following implantation of GLIADEL Wafer. These abnormalities included reopening of the surgical area, leaking of brain or spinal fluid, delays in healing, or other abnormalities in how the wound heals.

Brain Infections: In clinical studies, brain infections, including meningitis, have occurred following implantation of GLIADEL Wafer.

Please read the full Prescribing Information and discuss it with your doctor or healthcare professional. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

格立得植入剂Gliadel Wafer的历史发展
格立得植入剂Gliadel Wafer是由美国Johns Hopkins医院的医师和研究人员(polymer-brain tumor treatment group)共同研究开发的创新药物。
1996年美国药物食品管理局(FDA)核准格立得植入剂Gliadel Wafer用于复发性多形性神经胶质细胞瘤的手术辅助。
2003年美国药物食品管理局(FDA)核准格立得植入剂Gliadel Wafer用于新诊断的高度恶性神经胶质瘤病人的手术与放射线治疗辅助及复发性多形性神经胶母细胞瘤病人的手术辅助。
欧洲各国亦已核准药物食品管理局(FDA)核准格立得植入剂Gliadel Wafer作为新诊断的高度恶性神经胶质瘤病人的手术与放射线治疗辅助及复发性多形性神经胶母细胞瘤病人的手术辅助。
美国癌症中心联盟(National Comprehensive Cancer Network,NCCN)已将格立得植入剂Gliadel Wafer列为治疗恶性脑瘤的建议处理方式。
2012年台湾行政院卫生署许可格立得植入剂Gliadel Wafer进入台湾，经销商百博生技有限公司