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Lawrence Kleinberg
Polifeprosan 20 with carmustine (GLIADEL(®)) polymer implant wafer is a biodegradable compound containing 3.85% carmustine (BCNU, bischloroethylnitrosourea) implanted in the brain at the time of planned tumor surgery, which then slowly degrades to release the BCNU chemotherapy directly into the brain thereby bypassing the blood-brain barrier. Carmustine implant wafers were demonstrated to improve survival in randomized placebo-controlled trials in patients undergoing a near total resection of newly diagnosed or recurrent malignant glioma...
2016: Patient Preference and Adherence
Lynn S Ashby, Kris A Smith, Baldassarre Stea
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...
August 24, 2016: World Journal of Surgical Oncology
Kiyotaka Saito, Kouji Yamasaki, Kiyotaka Yokogami, Asya Ivanova, Go Takeishi, Yuichiro Sato, Hideo Takeshima
Although carmustine (Gliadel) wafers improve local tumor control and extend the overall survival in patients with malignant glioma, adverse effects have been documented. The authors report the first case of eosinophilic meningitis triggered by the placement of Gliadel wafers. A 61-year-old man with a history of alimentary allergy and glioblastoma in the right frontal lobe underwent resection followed by the implantation of Gliadel wafers. Three weeks later he suffered the sudden onset of headache, vomiting, and progressive consciousness disturbance...
June 10, 2016: Journal of Neurosurgery
Yuan-Yun Tseng, Yi-Chuan Kau, Shih-Jung Liu
INTRODUCTION: Glioblastoma multiforme (GBM) is the most prevalent primary neoplasm of the brain. Moreover, the prognosis of patients with GBM has been poor, with almost uniform progressive neurological impairment and rapid death. Despite the availability of multimodal treatments through surgery, focal radiation, and chemotherapy, no major progress has been reported until recently. AREA COVERED: The development of interstitial biodegradable carmustine wafers (Gliadel) for treating selected patients with malignant gliomas has resulted in marginal survival benefits in such patients (only approximately 2 months longer than that of those who did not receive the treatment)...
June 1, 2016: Expert Opinion on Drug Delivery
Chibawanye I Ene, John D Nerva, Ryan P Morton, Ariana S Barkley, Jason K Barber, Andrew L Ko, Daniel L Silbergeld
BACKGROUND: Carmustine (BCNU) wafers (Gliadel) prolongs local disease control and progression-free survival (PFS) in patients with malignant gliomas. However, in metastatic brain tumors, there is a paucity of evidence in support of its safety and efficacy. The goal of this study was to assess the safety and efficacy of Gliadel wafers in patients with metastatic brain tumors. METHODS: We retrospectively reviewed the University of Washington experience with Gliadel wafers for metastatic brain tumors between 2000 and 2015...
2016: Surgical Neurology International
Jeffrey D Voigt, Gene Barnett
BACKGROUND: The objective of this analysis was to determine the value (incremental cost/increment benefit) of a brain LITT system versus employing current surgical options recommended by NCCN guidelines, specifically open resection (i.e. craniotomy) methods or biopsy (collectively termed CURRENT TREATMENTS) in patients where maximal safe resection may not be feasible. As has been demonstrated in the literature, extent of resection/ablation with minimal complications are independently related to overall survival...
2016: Cost Effectiveness and Resource Allocation: C/E
Betty M Tyler, Ann Liu, Eric W Sankey, Antonella Mangraviti, Michael A Barone, Henry Brem
After over 50 years of scientific contribution under the leadership of Harvey Cushing and later Walter Dandy, the Johns Hopkins Hunterian Laboratory entered a period of dormancy between the 1960s and early 1980s. In 1984, Henry Brem reinstituted the Hunterian Neurosurgical Laboratory, with a new focus on localized delivery of therapies for brain tumors, leading to several discoveries such as new antiangiogenic agents and Gliadel chemotherapy wafers for the treatment of malignant gliomas. Since that time, it has been the training ground for 310 trainees who have dedicated their time to scientific exploration in the lab, resulting in numerous discoveries in the area of neurosurgical research...
June 2016: Academic Medicine: Journal of the Association of American Medical Colleges
Yosuke Masuda, Eiichi Ishikawa, Tetsuya Yamamoto, Masahide Matsuda, Hiroyoshi Akutsu, Hidehiro Kohzuki, Kei Nakai, Emiko Okamoto, Shingo Takano, Tomohiko Masumoto, Akira Matsumura
BACKGROUND: Carmustine (BCNU) wafer (Gliadel(®) Wafer) implantation after tumor resection is an approved treatment for high-grade glioma (HGG). These wafers change various characteristics on early postoperative magnetic resonance imaging (ep-MRI) including slight expansion of high-intensity areas on T2-weighted imaging (ep-T2-HIAs) into adjacent parenchyma without restricted diffusivity. We assessed the frequency of the ep-T2-HIAs after BCNU wafer implantation in HGG patients. Moreover, we focused on ep-T2-HIA expansion and its relation to delayed cerebral edema...
July 11, 2016: Magnetic Resonance in Medical Sciences: MRMS
S-Y Yen, S-R Chen, J Hsieh, Y-S Li, S-E Chuang, H-M Chuang, M-H Huang, S-Z Lin, H-J Harn, T-W Chiou
Glioblastoma multiforme (GBM) is the most common and aggressive brain tumour. The neoplasms are difficult to resect entirely because of their highly infiltration property and leading to the tumour edge is unclear. Gliadel wafer has been used as an intracerebral drug delivery system to eliminate the residual tumour. However, because of its local low concentration and short diffusion distance, patient survival improves non-significantly. Axl is an essential regulator in cancer metastasis and patient survival...
April 28, 2016: Oncogene
Rachel Grossman, Peter Burger, Ethan Soudry, Betty Tyler, Kaisorn L Chaichana, Jon Weingart, Alessandro Olivi, Gary L Gallia, David Sidransky, Alfredo Quiñones-Hinojosa, Xiaobu Ye, Henry Brem
We examined the relationship between the O(6)-methylguanine-methyltransferase (MGMT) methylation status and clinical outcomes in newly diagnosed glioblastoma multiforme (GBM) patients who were treated with Gliadel wafers (Eisai, Tokyo, Japan). MGMT promoter methylation has been associated with increased survival among patients with GBM who are treated with various alkylating agents. MGMT promoter methylation, in DNA from 122 of 160 newly diagnosed GBM patients treated with Gliadel, was determined by a quantitative methylation-specific polymerase chain reaction, and was correlated with overall survival (OS) and recurrence-free survival (RFS)...
December 2015: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
Wei-kang Xing, Chuan Shao, Zhen-yu Qi, Chao Yang, Zhong Wang
BACKGROUND: Standard treatment for high-grade glioma (HGG) includes surgery followed by radiotherapy and/or chemotherapy. Insertion of carmustine wafers into the resection cavity as a treatment for malignant glioma is currently a controversial topic among neurosurgeons. Our meta-analysis focused on whether carmustine wafer treatment could significantly benefit the survival of patients with newly diagnosed glioblastoma multiforme (GBM). METHOD: We searched the PubMed and Web of Science databases without any restrictions on language using the keywords "Gliadel wafers", "carmustine wafers", "BCNU wafers", or "interstitial chemotherapy" in newly diagnosed GBM for the period from January 1990 to March 2015...
2015: Drug Design, Development and Therapy
Michiharu Yoshida, Shigeru Yamaguchi, Yukitomo Ishi, Shogo Endo, Hiroaki Motegi, Hiroyuki Kobayashi, Katsuyuki Asaoka, Yuuta Kamoshima, Shunsuke Terasaka, Kiyohiro Houkin
BACKGROUND: In Japan, patients with malignant glioma have been treated with BCNU wafers (Gliadel®) since January 2013. Several adverse events(AEs)associated with implantation of BCNU wafers, including cerebral edema or cyst formation, are recognized. Here, we report a retrospective review of the experience with implantation of BCNU wafers in our institutions and our findings regarding the risk factors for the AEs. METHODS: We reviewed the records of patients with malignant glioma who were implanted with BCNU wafers between April 2013 and September 2014...
July 2015: No Shinkei Geka. Neurological Surgery
Antonella Mangraviti, Betty Tyler, Henry Brem
The advent of interstitial chemotherapy has significantly increased therapeutic options for patients with malignant glioma. Interstitial chemotherapy can deliver high concentrations of chemotherapeutic agents, directly at the site of the brain tumor while bypassing systemic toxicities. Gliadel, a locally implanted polymer that releases the alkylating agent carmustine, given alone and in combination with various other antitumor and resistance modifying therapies, has significantly increased the median survival for patients with malignant glioma...
2015: Surgical Neurology International
Sajeel A Chowdhary, Timothy Ryken, Herbert B Newton
Carmustine wafers (CW; Gliadel(®) wafers) are approved to treat newly-diagnosed high-grade glioma (HGG) and recurrent glioblastoma. Widespread use has been limited for several reasons, including concern that their use may preclude enrollment in subsequent clinical trials due to uncertainty about confounding of results and potential toxicities. This meta-analysis estimated survival following treatment with CW for HGG. A literature search identified relevant studies. Overall survival (OS), median survival, and adverse events (AEs) were summarized...
April 2015: Journal of Neuro-oncology
Yun-Dong Zhang, Ruo-Yi Dai, Zhuo Chen, Yi-Hua Zhang, Xu-Zhi He, Ji Zhou
The aim of this study was to a conduct a systematic review of carmustine wafers (Gliadel wafers) for the treatment of glioblastoma multiforme (GBM) to assess the survival benefit and safety of this therapy. The inclusion criteria were 1) prospective or retrospective clinical trial; 2) patients who had undergone resection for primary GBM or first recurrence of GBM with or without carmustine wafer implantation; 3) patients with malignant gliomas that included GBM; 4) outcomes including survival analysis of the GBM population...
2014: Turkish Neurosurgery
Sean A Grimm, Marc C Chamberlain
Glioblastoma is the most common malignant primary brain tumor. Cures are rare and median survival varies from several to 22 months. Standard treatment for good performance patients consists of maximal safe surgical resection followed by radiotherapy with concurrent temozolomide (TMZ) chemotherapy and six cycles of postradiotherapy TMZ. At recurrence, treatment options include repeat surgery (with or without Gliadel wafer placement), reirradiation or systemic therapy. Most patients with good performance status are treated with cytotoxic chemotherapy or targeted biologic therapy following or in lieu of repeat surgery...
September 2012: CNS Oncology
Ke Sai, Ming-Gu Zhong, Jian Wang, Yin-Sheng Chen, Yong-Gao Mou, Chao Ke, Xiang-Heng Zhang, Qun-Ying Yang, Fu-Hua Lin, Cheng-Cheng Guo, Zheng-He Chen, Jing Zeng, Yan-Chun Lv, Xiang Li, Wen-Chang Gao, Zhong-Ping Chen
OBJECTIVES: Malignant gliomas are common primary brain tumors with dismal prognosis. The blood-brain barrier and unacceptable systemic toxicity limit the employment of chemotherapeutic agents. BCNU-impregnated biodegradable polymers (Gliadel®) have been demonstrated to prolong the survival of patients with malignant gliomas. Until now, no biodegradable drug delivery system has been commercially available in China. In the present study, we evaluated the safety of implants with high-dose BCNU in Chinese patients with recurrent malignant gliomas...
August 15, 2014: Journal of the Neurological Sciences
D Cecchin, I Schiorlin, A Della Puppa, G Lombardi, P Zucchetta, V Bodanza, M P Gardiman, G Rolma, A C Frigo, F Bui
Introduction. Early signs of response after applying wafers of carmustine-loaded polymers (gliadel) are difficult to assess with imaging because of time-related imaging changes. (99m)Tc-sestamibi (MIBI) brain single-photon emission tomography (SPET) has reportedly been used to reveal areas of cellularity distinguishing recurrent neoplasm from radionecrosis. Our aim was to explore the role of MIBI SPET in assessing response soon after gliadel application in glioblastoma multiforme (GBM). Methods. We retrospectively reviewed the charts on 28 consecutive patients with a radiological diagnosis of GBM who underwent MIBI SPET/CT before surgery (with intracavitary gliadel placement in 17 patients), soon after surgery, and at 4 months...
2014: BioMed Research International
Tomokazu Aoki, Ryo Nishikawa, Kazuhiko Sugiyama, Naosuke Nonoguchi, Noriyuki Kawabata, Kazuhiko Mishima, Jun-ichi Adachi, Kaoru Kurisu, Fumiyuki Yamasaki, Teiji Tominaga, Toshihiro Kumabe, Keisuke Ueki, Fumi Higuchi, Tetsuya Yamamoto, Eiichi Ishikawa, Hideo Takeshima, Shinji Yamashita, Kazunori Arita, Hirofumi Hirano, Shinobu Yamada, Masao Matsutani
Carmustine (BCNU) implants (Gliadel(®) Wafer, Eisai Inc., New Jersey, USA) for the treatment of malignant gliomas (MGs) were shown to enhance overall survival in comparison to placebo in controlled clinical trials in the United States and Europe. A prospective, multicenter phase I/II study involving Japanese patients with MGs was performed to evaluate the efficacy, safety, and pharmacokinetics of BCNU implants. The study enrolled 16 patients with newly diagnosed MGs and 8 patients with recurrent MGs. After the insertion of BCNU implants (8 sheets maximum, 61...
2014: Neurologia Medico-chirurgica
Rahul Surendra Shah, Bobak Homapour, Elizabeth Casselden, James Geoffrey Barr, Paul L Grundy, Howard L Brydon
OBJECT: Significant haemorrhage following intracranial tumour resection may occur in 1-2% of cases and the majority occur within the first few hours post-operatively. Implantation of carmustine wafers has been associated with increased operative site complications in some series, but post-operative haematoma is not routinely reported. We analyzed the characteristics of post-operative haemorrhage after carmustine wafer insertion. METHODS: We performed a retrospective audit of surgical site haematoma after tumour resection and insertion of carmustine wafers in two neurosurgical units in the UK (University Hospital of North Staffordshire, Stoke-on-Trent, March 2003 - July 2012; Wessex Neurological Centre, Southampton, October 2005 - January 2013)...
August 2014: British Journal of Neurosurgery
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