悪性神経膠腫に対するBCNU wafer
BCNU waferは, 悪性神経膠腫の摘出後に局所投与する化学療法剤で, 日本では2013年より認可された. 本論文では, 自験例も含めた知見を含め, BCNU waferの概要, 動態ならびに治療成績について概説する. BCNU waferは, BCNU 7.7mgを含有する徐放性調剤である. 悪性神経膠腫の再発の多くが局所再発であることから, 局所制御を目的とした本剤は有用であると期待できる. In vitroやin vivoの研究においては, 留置後高濃度のBCNUが局所に数週間にわたり分布するとされる. 臨床例においても, 摘出腔内では, 少なくとも留置後1週間は数μmol/lの高濃...
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| Published in | 脳神経外科ジャーナル Vol. 25; no. 11; pp. 882 - 888 |
|---|---|
| Main Author | |
| Format | Journal Article |
| Language | Japanese |
| Published |
日本脳神経外科コングレス
2016
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0917-950X 2187-3100 |
| DOI | 10.7887/jcns.25.882 |
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| Abstract | BCNU waferは, 悪性神経膠腫の摘出後に局所投与する化学療法剤で, 日本では2013年より認可された. 本論文では, 自験例も含めた知見を含め, BCNU waferの概要, 動態ならびに治療成績について概説する. BCNU waferは, BCNU 7.7mgを含有する徐放性調剤である. 悪性神経膠腫の再発の多くが局所再発であることから, 局所制御を目的とした本剤は有用であると期待できる. In vitroやin vivoの研究においては, 留置後高濃度のBCNUが局所に数週間にわたり分布するとされる. 臨床例においても, 摘出腔内では, 少なくとも留置後1週間は数μmol/lの高濃度のBCNUが分布していた. 治療効果についてのメタアナリシスの結果から, 初発例におけるStupp regimenへの追加効果は期待できるが, 再発例については十分なエビデンスがないと考えられる. しかし, 使用期間も短く, 今後のさらなる臨床研究の結果が待たれる. |
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| AbstractList | BCNU waferは, 悪性神経膠腫の摘出後に局所投与する化学療法剤で, 日本では2013年より認可された. 本論文では, 自験例も含めた知見を含め, BCNU waferの概要, 動態ならびに治療成績について概説する. BCNU waferは, BCNU 7.7mgを含有する徐放性調剤である. 悪性神経膠腫の再発の多くが局所再発であることから, 局所制御を目的とした本剤は有用であると期待できる. In vitroやin vivoの研究においては, 留置後高濃度のBCNUが局所に数週間にわたり分布するとされる. 臨床例においても, 摘出腔内では, 少なくとも留置後1週間は数μmol/lの高濃度のBCNUが分布していた. 治療効果についてのメタアナリシスの結果から, 初発例におけるStupp regimenへの追加効果は期待できるが, 再発例については十分なエビデンスがないと考えられる. しかし, 使用期間も短く, 今後のさらなる臨床研究の結果が待たれる. |
| Author | 大上, 史朗 |
| Author_xml | – sequence: 1 fullname: 大上, 史朗 organization: 愛媛大学大学院医学系研究科脳神経外科学 |
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| References | 20) Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO ; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups ; National Cancer Institute of Canada Clinical Trials Group : Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352 : 987-996, 2005. 3) Brem H, Piantadosi S, Burger PC, Walker M, Selker R, Vick NA, Black K, Sisti M, Brem S, Mohr G, Muller P, Morawetz R, Schold CS : Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. The Polymer-brain Tumor Treatment Group. Lancet 345 : 1008-1012, 1995. 9) Fung LK, Ewend MG, Sills A, Sipos EP, Thompson R, Watts M, Colvin OM, Brem H, Saltzman WM : Pharmacokinetics of interstitial delivery of carmustine, 4-hydroperoxycyclophosphamide, and paclitaxel from a biodegradable polymer implant in the monkey brain. Cancer Res 58 : 672-684, 1998. 2) Brem H, Mahaley MS Jr, Vick NA, Black KL, Schold SC Jr, Burger PC, Friedman AH, Ciric IS, Eller TW, Cozzens JW, Kenealy JN : Interstitial chemotherapy with drug polymer implants for the treatment of recurrent gliomas. J Neurosurg 74 : 441-446, 1991. 22) Westphal M, Hilt DC, Bortey E, Delavault P, Olivares R, Warnke PC, Whittle IR, Jääskeläinen J, Ram Z : A phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel wafers) in patients with primary malignant glioma. Neuro Oncol 5 : 79-88, 2003. 21) Ulmer S, Spalek K, Nabavi A, Schultka S, Mehdorn HM, Kesari S, Dörner L : Temporal changes in magnetic resonance imaging characteristics of Gliadel wafers and of the adjacent brain parenchyma. Neuro Oncol 14 : 482-490, 2012. 23) Westphal M, Ram Z, Riddle V, Hilt D, Bortey E ; Executive Committee of the Gliadel Study Group : Gliadel wafer in initial surgery for malignant glioma : long-term follow-up of a multicenter controlled trial. Acta Neurochir (Wien) 148 : 269-275 ; discussion 275, 2006. 11) Giese A, Kucinski T, Knopp U, Goldbrunner R, Hamel W, Mehdorn HM, Tonn JC, Hilt D, Westphal M : Pattern of recurrence following local chemotherapy with biodegradable carmustine (BCNU) implants in patients with glioblastoma. J Neurooncol 66 : 351-360, 2004. 10) Gaspar LE, Fisher BJ, Macdonald DR, LeBer DV, Halperin EC, Schold SC Jr, Cairncross JG : Supratentorial malignant glioma : patterns of recurrence and implications for external beam local treatment. Int J Radiat Oncol Biol Phys 24 : 55-57, 1992. 19) Sonoda Y, Saito R, Kanamori M, Kumabe T, Uenohara H, Tominaga T : The association of subventricular zone involvement at recurrence with survival after repeat surgery in patients with recurrent glioblastoma. Neurol Med Chir (Tokyo) 54 : 302-309, 2014. 14) Gutenberg A, Lumenta CB, Braunsdorf WE, Sabel M, Mehdorn HM, Westphal M, Giese A : The combination of carmustine wafers and temozolomide for the treatment of malignant gliomas. A comprehensive review of the rationale and clinical experience. J Neurooncol 113 : 163-174, 2013. 15) Mangraviti A, Tyler B, Brem H : Interstitial chemotherapy for malignant glioma : Future prospects in the era of multimodal therapy. Surg Neurol Int 6 (Suppl 1) : S78-84, 2015. 4) Chowdhary SA, Ryken T, Newton HB : Survival outcomes and safety of carmustine wafers in the treatment of high-grade gliomas : a meta-analysis. J Neurooncol 122 : 367-382, 2015. 17) Ohue S, Kohno S, Inoue A, Yamashita D, Matsumoto S, Suehiro S, Kumon Y, Kikuchi K, Ohnishi T : Surgical results of tumor resection using tractography-integrated navigation-guided fence-post catheter techniques and motor-evoked potentials for preservation of motor function in patients with glioblastomas near the pyramidal tracts. Neurosurg Rev 38 : 293-306, 2015. 24) Wu MP, Tamada JA, Brem H, Langer R : In vivo versus in vitro degradation of controlled release polymers for intracranial surgical therapy. J Biomed Mater Res 28 : 387-395, 1994. 18) Ohue S, Kohno S, Inoue A, Yamashita D, Suehiro S, Seno T, Kumon Y, Kikuchi K, Ohnishi T : Evaluation of serial changes on computed tomography and magnetic resonance imaging after implantation of carmustine wafers in patients with malignant gliomas for differential diagnosis of tumor recurrence. J Neurooncol 126 : 119-126, 2016. 5) Dang W, Daviau T, Brem H : Morphological characterization of polyanhydride biodegradable implant gliadel during in vitro and in vivo erosion using scanning electron microscopy. Pharm Res 13 : 683-691, 1996. 7) Dörner L, Ulmer S, Rohr A, Mehdorn HM, Nabavi A : Space-occupying cyst development in the resection cavity of malignant gliomas following Gliadel® implantation—incidence, therapeutic strategies, and outcome. J Clin Neurosci 18 : 347-351, 2011. 16) Oh J, Sahgal A, Sanghera P, Tsao MN, Davey P, Lam K, Symons S, Aviv R, Perry JR : Glioblastoma : patterns of recurrence and efficacy of salvage treatments. Can J Neurol Sci 38 : 621-625, 2011. 12) Giese A, Bock HC, Kantelhardt SR, Rohde V : Risk management in the treatment of malignant gliomas with BCNU wafer implants. Cent Eur Neurosurg 71 : 199-206, 2010. 13) Grossman SA, Reinhard C, Colvin OM, Chasin M, Brundrett R, Tamargo RJ, Brem H : The intracerebral distribution of BCNU delivered by surgically implanted biodegradable polymers. J Neurosurg 76 : 640-647, 1992. 6) Dang W, Daviau T, Ying P, Zhao Y, Nowotmik D, Clow CS, Tyler B, Brem H : Effects of GLIADEL® wafer initial molecular weight on the erosion of wafer and release of BCNU. J Controlled Release 42 : 83-92, 1996. 8) Fleming AB, Saltzman WM : Pharmacokinetics of the carmustine implant. Clin Pharmacokinet 41 : 403-419, 2002. 1) Aoki T, Nishikawa R, Sugiyama K, Nonoguchi N, Kawabata N, Mishima K, Adachi J, Kurisu K, Yamasaki F, Tominaga T, Kumabe T, Ueki K, Higuchi F, Yamamoto T, Ishikawa E, Takeshima H, Yamashita S, Arita K, Hirano H, Yamada S, Matsutani M, NPC-08 study group : A multicenter phase Ⅰ/Ⅱ study of the BCNU implant (Gliadel (®) Wafer) for Japanese patients with malignant gliomas. Neurol Med Chir (Tokyo) 54 : 290-301, 2014. |
| References_xml | – reference: 7) Dörner L, Ulmer S, Rohr A, Mehdorn HM, Nabavi A : Space-occupying cyst development in the resection cavity of malignant gliomas following Gliadel® implantation—incidence, therapeutic strategies, and outcome. J Clin Neurosci 18 : 347-351, 2011. – reference: 8) Fleming AB, Saltzman WM : Pharmacokinetics of the carmustine implant. Clin Pharmacokinet 41 : 403-419, 2002. – reference: 18) Ohue S, Kohno S, Inoue A, Yamashita D, Suehiro S, Seno T, Kumon Y, Kikuchi K, Ohnishi T : Evaluation of serial changes on computed tomography and magnetic resonance imaging after implantation of carmustine wafers in patients with malignant gliomas for differential diagnosis of tumor recurrence. J Neurooncol 126 : 119-126, 2016. – reference: 13) Grossman SA, Reinhard C, Colvin OM, Chasin M, Brundrett R, Tamargo RJ, Brem H : The intracerebral distribution of BCNU delivered by surgically implanted biodegradable polymers. J Neurosurg 76 : 640-647, 1992. – reference: 21) Ulmer S, Spalek K, Nabavi A, Schultka S, Mehdorn HM, Kesari S, Dörner L : Temporal changes in magnetic resonance imaging characteristics of Gliadel wafers and of the adjacent brain parenchyma. Neuro Oncol 14 : 482-490, 2012. – reference: 22) Westphal M, Hilt DC, Bortey E, Delavault P, Olivares R, Warnke PC, Whittle IR, Jääskeläinen J, Ram Z : A phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel wafers) in patients with primary malignant glioma. Neuro Oncol 5 : 79-88, 2003. – reference: 6) Dang W, Daviau T, Ying P, Zhao Y, Nowotmik D, Clow CS, Tyler B, Brem H : Effects of GLIADEL® wafer initial molecular weight on the erosion of wafer and release of BCNU. J Controlled Release 42 : 83-92, 1996. – reference: 5) Dang W, Daviau T, Brem H : Morphological characterization of polyanhydride biodegradable implant gliadel during in vitro and in vivo erosion using scanning electron microscopy. Pharm Res 13 : 683-691, 1996. – reference: 17) Ohue S, Kohno S, Inoue A, Yamashita D, Matsumoto S, Suehiro S, Kumon Y, Kikuchi K, Ohnishi T : Surgical results of tumor resection using tractography-integrated navigation-guided fence-post catheter techniques and motor-evoked potentials for preservation of motor function in patients with glioblastomas near the pyramidal tracts. Neurosurg Rev 38 : 293-306, 2015. – reference: 19) Sonoda Y, Saito R, Kanamori M, Kumabe T, Uenohara H, Tominaga T : The association of subventricular zone involvement at recurrence with survival after repeat surgery in patients with recurrent glioblastoma. Neurol Med Chir (Tokyo) 54 : 302-309, 2014. – reference: 23) Westphal M, Ram Z, Riddle V, Hilt D, Bortey E ; Executive Committee of the Gliadel Study Group : Gliadel wafer in initial surgery for malignant glioma : long-term follow-up of a multicenter controlled trial. Acta Neurochir (Wien) 148 : 269-275 ; discussion 275, 2006. – reference: 3) Brem H, Piantadosi S, Burger PC, Walker M, Selker R, Vick NA, Black K, Sisti M, Brem S, Mohr G, Muller P, Morawetz R, Schold CS : Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. The Polymer-brain Tumor Treatment Group. Lancet 345 : 1008-1012, 1995. – reference: 14) Gutenberg A, Lumenta CB, Braunsdorf WE, Sabel M, Mehdorn HM, Westphal M, Giese A : The combination of carmustine wafers and temozolomide for the treatment of malignant gliomas. A comprehensive review of the rationale and clinical experience. J Neurooncol 113 : 163-174, 2013. – reference: 20) Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO ; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups ; National Cancer Institute of Canada Clinical Trials Group : Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352 : 987-996, 2005. – reference: 4) Chowdhary SA, Ryken T, Newton HB : Survival outcomes and safety of carmustine wafers in the treatment of high-grade gliomas : a meta-analysis. J Neurooncol 122 : 367-382, 2015. – reference: 10) Gaspar LE, Fisher BJ, Macdonald DR, LeBer DV, Halperin EC, Schold SC Jr, Cairncross JG : Supratentorial malignant glioma : patterns of recurrence and implications for external beam local treatment. Int J Radiat Oncol Biol Phys 24 : 55-57, 1992. – reference: 12) Giese A, Bock HC, Kantelhardt SR, Rohde V : Risk management in the treatment of malignant gliomas with BCNU wafer implants. Cent Eur Neurosurg 71 : 199-206, 2010. – reference: 15) Mangraviti A, Tyler B, Brem H : Interstitial chemotherapy for malignant glioma : Future prospects in the era of multimodal therapy. Surg Neurol Int 6 (Suppl 1) : S78-84, 2015. – reference: 16) Oh J, Sahgal A, Sanghera P, Tsao MN, Davey P, Lam K, Symons S, Aviv R, Perry JR : Glioblastoma : patterns of recurrence and efficacy of salvage treatments. Can J Neurol Sci 38 : 621-625, 2011. – reference: 1) Aoki T, Nishikawa R, Sugiyama K, Nonoguchi N, Kawabata N, Mishima K, Adachi J, Kurisu K, Yamasaki F, Tominaga T, Kumabe T, Ueki K, Higuchi F, Yamamoto T, Ishikawa E, Takeshima H, Yamashita S, Arita K, Hirano H, Yamada S, Matsutani M, NPC-08 study group : A multicenter phase Ⅰ/Ⅱ study of the BCNU implant (Gliadel (®) Wafer) for Japanese patients with malignant gliomas. Neurol Med Chir (Tokyo) 54 : 290-301, 2014. – reference: 2) Brem H, Mahaley MS Jr, Vick NA, Black KL, Schold SC Jr, Burger PC, Friedman AH, Ciric IS, Eller TW, Cozzens JW, Kenealy JN : Interstitial chemotherapy with drug polymer implants for the treatment of recurrent gliomas. J Neurosurg 74 : 441-446, 1991. – reference: 11) Giese A, Kucinski T, Knopp U, Goldbrunner R, Hamel W, Mehdorn HM, Tonn JC, Hilt D, Westphal M : Pattern of recurrence following local chemotherapy with biodegradable carmustine (BCNU) implants in patients with glioblastoma. J Neurooncol 66 : 351-360, 2004. – reference: 9) Fung LK, Ewend MG, Sills A, Sipos EP, Thompson R, Watts M, Colvin OM, Brem H, Saltzman WM : Pharmacokinetics of interstitial delivery of carmustine, 4-hydroperoxycyclophosphamide, and paclitaxel from a biodegradable polymer implant in the monkey brain. Cancer Res 58 : 672-684, 1998. – reference: 24) Wu MP, Tamada JA, Brem H, Langer R : In vivo versus in vitro degradation of controlled release polymers for intracranial surgical therapy. J Biomed Mater Res 28 : 387-395, 1994. |
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| Snippet | BCNU waferは, 悪性神経膠腫の摘出後に局所投与する化学療法剤で, 日本では2013年より認可された. 本論文では, 自験例も含めた知見を含め, BCNU waferの概要, 動態ならびに治療成績について概説する. BCNU waferは, BCNU 7.7mgを含有する徐放性調剤である.... |
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| Title | 悪性神経膠腫に対するBCNU wafer |
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