Polifeprosan 20, 3.85% carmustine slow release wafer in malignant glioma: patient selection and perspectives on a low-burden therapy

References

• StuppRTaillibertSKannerAAMaintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trialJAMA2015314232535254326670971
   PubMed Web of Science ®Google Scholar
• PitzMWDesaiAGrossmanSABlakeleyJOTissue concentration of systemically administered antineoplastic agents in human brain tumorsJ Neurooncol2011104362963821400119
   PubMed Web of Science ®Google Scholar
• WestphalMHiltDCBorteyEA phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel wafers) in patients with primary malignant gliomaNeuro Oncol200352798812672279
   PubMed Web of Science ®Google Scholar
• WestphalMRamZRiddleVHiltDBorteyEExecutive Committee of the Gliadel Study GroupGliadel wafer in initial surgery for malignant glioma: long-term follow-up of a multicenter controlled trialActa Neurochir (Wien)20061483269275 discussion 27516482400
   PubMed Web of Science ®Google Scholar
• BremHPiantadosiSBurgerPCPlacebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. The Polymer-brain Tumor Treatment GroupLancet19953458956100810127723496
   PubMed Web of Science ®Google Scholar
• MehtaAILinningerALesniakMSEngelhardHHCurrent status of intratumoral therapy for glioblastomaJ Neurooncol201512511726233248
   PubMed Web of Science ®Google Scholar
• DoolittleNDMuldoonLLCulpAYNeuweltEADelivery of chemotherapeutics across the blood-brain barrier: challenges and advancesAdv Pharmacol20147120324325307218
   PubMedGoogle Scholar
• FlemingABSaltzmanWMPharmacokinetics of the carmustine implantClin Pharmacokinet200241640341912074689
   PubMed Web of Science ®Google Scholar
• DombAJIsraelZHElmalakOTeomimDBentolilaAPreparation and characterization of carmustine loaded polyanhydride wafers for treating brain tumorsPharm Res199916576276510350022
   PubMed Web of Science ®Google Scholar
• DombAJRockMSchwartzJMetabolic disposition and elimination studies of a radiolabelled biodegradable polymeric implant in the rat brainBiomaterials19941596816887948590
   PubMed Web of Science ®Google Scholar
• DombAGliadel – a preparation for the supplementary treatment of brain cancerHarefuah19991373–412713110959302
   PubMedGoogle Scholar
• DombAJRockMPerkinCYipchuckGBroxupBVillemureJGExcretion of a radiolabelled anticancer biodegradable polymeric implant from the rabbit brainBiomaterials19951614106910728519927
   PubMed Web of Science ®Google Scholar
• GrossmanSAReinhardCColvinOMThe intracerebral distribution of BCNU delivered by surgically implanted biodegradable polymersJ Neurosurg19927646406471545259
   PubMed Web of Science ®Google Scholar
• FungLKEwendMGSillsAPharmacokinetics of interstitial delivery of carmustine, 4-hydroperoxycyclophosphamide, and paclitaxel from a biodegradable polymer implant in the monkey brainCancer Res19985846726849485020
   PubMed Web of Science ®Google Scholar
• ChowdharySARykenTNewtonHBSurvival outcomes and safety of carmustine wafers in the treatment of high-grade gliomas: a meta-analysisJ Neurooncol2015122236738225630625
   PubMed Web of Science ®Google Scholar
• KleinbergLPolifeprosan 20, 3.85% carmustine slow-release wafer in malignant glioma: evidence for role in era of standard adjuvant temozolomideCore Evid2012711513023118709
   PubMedGoogle Scholar
• StuppRMasonWPvan den BentMJEuropean Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy GroupsNational Cancer Institute of Canada Clinical Trials GroupRadiotherapy plus concomitant and adjuvant temozolomide for glioblastomaN Engl J Med20053521098799615758009
   PubMed Web of Science ®Google Scholar
• StuppRHegiMEMasonWPEffects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trialLancet Oncol200910545946619269895
   PubMed Web of Science ®Google Scholar
• MirimanoffROGorliaTMasonWRadiotherapy and temozolomide for newly diagnosed glioblastoma: recursive partitioning analysis of the EORTC 26981/22981-NCIC CE3 phase III randomized trialJ Clin Oncol200624162563256916735709
   PubMed Web of Science ®Google Scholar
• HegiMEDiserensACGorliaTMGMT gene silencing and benefit from temozolomide in glioblastomaN Engl J Med200535210997100315758010
   PubMed Web of Science ®Google Scholar
• GrossmanRBurgerPSoudryEMGMT inactivation and clinical response in newly diagnosed GBM patients treated with GliadelJ Clin Neurosci201522121938194226249244
   PubMed Web of Science ®Google Scholar
• NoelGSchottRFroelichSRetrospective comparison of chemo-radiotherapy followed by adjuvant chemotherapy, with or without prior gliadel implantation (carmustine) after initial surgery in patients with newly diagnosed high-grade gliomasInt J Radiat Oncol Biol Phys201282274975521300471
   PubMed Web of Science ®Google Scholar
• BockHCPuchnerMJLohmannFFirst-line treatment of malignant glioma with carmustine implants followed by concomitant radiochemotherapy: a multicenter experienceNeurosurg Rev201033444144920706757
   PubMed Web of Science ®Google Scholar
• SalmaggiAMilanesiISilvaniAProspective study of carmustine wafers in combination with 6-month metronomic temozolomide and radiation therapy in newly diagnosed glioblastoma: preliminary resultsJ Neurosurg2013118482182923350777
   PubMed Web of Science ®Google Scholar
• GutenbergABockHCBruckWMGMT promoter methylation status and prognosis of patients with primary or recurrent glioblastoma treated with carmustine wafersBr J Neurosurg201327677277823662801
   PubMed Web of Science ®Google Scholar
• Lechapt-ZalcmanELevalletGDugueAEO(6)-methylguanine-DNA methyltransferase (MGMT) promoter methylation and low MGMT-encoded protein expression as prognostic markers in glioblastoma patients treated with biodegradable carmustine wafer implants after initial surgery followed by radiotherapy with concomitant and adjuvant temozolomideCancer2012118184545455422359215
   PubMed Web of Science ®Google Scholar
• BremHMahaleyMSJrVickNAInterstitial chemotherapy with drug polymer implants for the treatment of recurrent gliomasJ Neurosurg19917434414461993909
   PubMed Web of Science ®Google Scholar
• OliviAGrossmanSATatterSNew Approaches to Brain Tumor Therapy CNS ConsortiumDose escalation of carmustine in surgically implanted polymers in patients with recurrent malignant glioma: a new approaches to brain tumor therapy CNS consortium trialJ Clin Oncol20032191845184912721262
   PubMed Web of Science ®Google Scholar
• WalkerMDAlexanderEJrHuntWEEvaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas. A cooperative clinical trialJ Neurosurg1978493333343355604
   PubMed Web of Science ®Google Scholar
• WalkerMDGreenSBByarDPRandomized comparisons of radiotherapy and nitrosoureas for the treatment of malignant glioma after surgeryN Engl J Med198030323132313297001230
   PubMed Web of Science ®Google Scholar
• BurgerPCMalignant astrocytic neoplasms: classification, pathologic anatomy, and response to treatmentSemin Oncol198613116263006257
   PubMed Web of Science ®Google Scholar
• NiederCGrosuALMollsMA comparison of treatment results for recurrent malignant gliomasCancer Treat Rev200026639740911139371
   PubMed Web of Science ®Google Scholar
• BremHEwendMGPiantadosiSGreenhootJBurgerPCSistiMThe safety of interstitial chemotherapy with BCNU-loaded polymer followed by radiation therapy in the treatment of newly diagnosed malignant gliomas: phase I trialJ Neurooncol19952621111238787853
   PubMed Web of Science ®Google Scholar
• ValtonenSTimonenUToivanenPInterstitial chemotherapy with carmustine-loaded polymers for high-grade gliomas: a randomized double-blind studyNeurosurgery19974114448 discussion 48–499218294
   PubMed Web of Science ®Google Scholar
• NHS: National Institute for Health and Clinical Excellence [webpage on the Internet]Carmustine implants and temozolomide for the treatment of newly diagnsoed high-grade glioma Available from: www.nice.org.uk/TA121Accessed July 29, 2016
   Google Scholar
• BrandesAATosoniASpagnolliFDisease progression or pseudoprogression after concomitant radiochemotherapy treatment: pitfalls in neurooncologyNeuro Oncol200810336136718401015
   PubMed Web of Science ®Google Scholar
• ChamberlainMCPseudoprogression in glioblastomaJ Clin Oncol200826264359 author reply 4359–436018779626
   PubMed Web of Science ®Google Scholar
• KleinbergLRWeingartJBurgerPClinical course and pathologic findings after Gliadel and radiotherapy for newly diagnosed malignant glioma: implications for patient managementCancer Invest20042211915069758
   PubMed Web of Science ®Google Scholar
• ColenRRZinnPOHazanySMagnetic resonance imaging appearance and changes on intracavitary Gliadel wafer placement: a pilot studyWorld J Radiol201131126627222132297
   PubMedGoogle Scholar
• HammoudDABeldenCJHoACThe surgical bed after BCNU polymer wafer placement for recurrent glioma: serial assessment on CT and MR imagingAJR Am J Roentgenol200318051469147512704070
   PubMed Web of Science ®Google Scholar
• MasudaYIshikawaEYamamotoTEarly postoperative expansion of parenchymal high-intensity areas on T2-weighted imaging predicts delayed cerebral edema caused by carmustine wafer implantation in patients with high-grade gliomaMagn Reson Med Sci Epub20151228
   Web of Science ®Google Scholar
• AttenelloFJMukherjeeDDatooGUse of Gliadel (BCNU) wafer in the surgical treatment of malignant glioma: a 10-year institutional experienceAnn Surg Oncol200815102887289318636295
   PubMed Web of Science ®Google Scholar
• ChaichanaKLKoneLBettegowdaCRisk of surgical site infection in 401 consecutive patients with glioblastoma with and without carmustine wafer implantationNeurol Res201537871772625916669
   PubMed Web of Science ®Google Scholar
• GieseABockHCKantelhardtSRRohdeVRisk management in the treatment of malignant gliomas with BCNU wafer implantsCen Eur Neurosurg2010714199206
   PubMedGoogle Scholar
• XingWKShaoCQiZYYangCWangZThe role of Gliadel wafers in the treatment of newly diagnosed GBM: a meta-analysisDrug Des Devel Ther2015933413348
   PubMed Web of Science ®Google Scholar
• SalvatiMD’eliaAFratiABrognaCSantoroADelfiniRSafety and feasibility of the adjunct of local chemotherapy with biodegradable carmustine (BCNU) wafers to the standard multimodal approach to high grade gliomas at first diagnosisJ Neurosurg Sci20115511621464805
   PubMed Web of Science ®Google Scholar
• SalmaggiADuriSSilvaniALoco-regional treatments in first-diagnosis glioblastoma: literature review on association between Stupp protocol and GliadelNeurol Sci201132suppl 2S241S24521983866
   PubMed Web of Science ®Google Scholar
• PerryJChambersASpithoffKLaperriereNGliadel wafers in the treatment of malignant glioma: a systematic reviewCurr Oncol200714518919417938702
   PubMedGoogle Scholar
• PanEMitchellSBTsaiJSA retrospective study of the safety of BCNU wafers with concurrent temozolomide and radiotherapy and adjuvant temozolomide for newly diagnosed glioblastoma patientsJ Neurooncol200888335335718389176
   PubMed Web of Science ®Google Scholar
• MeneiPMetellusPParot-SchinkelENeuro-oncology Club of the French Society of NeurosurgeryBiodegradable carmustine wafers (Gliadel) alone or in combination with chemoradiotherapy: the French experienceAnn Surg Oncol20101771740174620443147
   PubMed Web of Science ®Google Scholar
• McGirtMJThanKDWeingartJDGliadel (BCNU) wafer plus concomitant temozolomide therapy after primary resection of glioblastoma multiformeJ Neurosurg2009110358358819046047
   PubMed Web of Science ®Google Scholar
• McGirtMJBremHCarmustine wafers (Gliadel) plus concomitant temozolomide therapy after resection of malignant astrocytoma: growing evidence for safety and efficacyAnn Surg Oncol20101771729173120422453
   PubMed Web of Science ®Google Scholar
• AffrontiMLHeeryCRHerndonJE2ndOverall survival of newly diagnosed glioblastoma patients receiving carmustine wafers followed by radiation and concurrent temozolomide plus rotational multiagent chemotherapyCancer2009115153501351119514083
   PubMed Web of Science ®Google Scholar
• DixitSHingoraniMAchawalSScottIRetrospective comparison of chemoradiotherapy followed by adjuvant chemotherapy, with or without previous gliadel implantation (carmustine) after initial surgery in patients with newly diagnosed high-grade gliomas: in regard to Noel et al. (Int J Radiat Oncol Biol Phys. 2011. DOI:10.1016/j.ijrobp.2010.11.073)Int J Radiat Oncol Biol Phys20118151593
   Web of Science ®Google Scholar
• GopferichAErosion of composite polymer matricesBiomaterials19971853974039061180
   PubMed Web of Science ®Google Scholar
• La RoccaRVMehdornHMLocalized BCNU chemotherapy and the multimodal management of malignant gliomaCurr Med Res Opin200925114916019210148
   PubMed Web of Science ®Google Scholar
• DuntzeJLitreCFEapCImplanted carmustine wafers followed by concomitant radiochemotherapy to treat newly diagnosed malignant gliomas: prospective, observational, multicenter study on 92 casesAnn Surg Oncol20132062065207223212763
   PubMed Web of Science ®Google Scholar
• PalludJAudureauENoelGClub de Neuro-Oncologie of the Société Française de NeurochirurgieLong-term results of carmustine wafer implantation for newly diagnosed glioblastomas: a controlled propensity-matched analysis of a French multicenter cohortNeuro Oncol201517121609161926185110
   PubMed Web of Science ®Google Scholar
• ArifinDYLeeKYWangCHSmithKARole of convective flow in carmustine delivery to a brain tumorPharm Res200926102289230219639394
   PubMed Web of Science ®Google Scholar
• WalterKACahanMAGurAInterstitial taxol delivered from a biodegradable polymer implant against experimental malignant gliomaCancer Res1994548220722127909720
   PubMed Web of Science ®Google Scholar
• WilliamsJADillehayLETabassiKSiposEFahlmanCBremHImplantable biodegradable polymers for IUdR radiosensitization of experimental human malignant gliomaJ Neurooncol19973231811929049879
   PubMed Web of Science ®Google Scholar
• YuanXDillehayLEWilliamsJRWilliamsJASynthetic, implantable polymers for IUdR radiosensitization of experimental human malignant gliomaCancer Biother Radiopharm199914318720210850303
   PubMed Web of Science ®Google Scholar
• BremSTylerBLiKLocal delivery of temozolomide by biodegradable polymers is superior to oral administration in a rodent glioma modelCancer Chemother Pharmacol200760564365017256133
   PubMed Web of Science ®Google Scholar
• SampathPRhinesLDDiMecoFTylerBMParkMCBremHInterstitial docetaxel (taxotere), carmustine and combined interstitial therapy: a novel treatment for experimental malignant gliomaJ Neurooncol200680191716636748
   PubMed Web of Science ®Google Scholar
• StormPBMoriarityJLTylerBBurgerPCBremHWeingartJPolymer delivery of camptothecin against 9L gliosarcoma: release, distribution, and efficacyJ Neurooncol200256320921712061726
   PubMed Web of Science ®Google Scholar
• WeingartJDThompsonRCTylerBColvinOMBremHLocal delivery of the topoisomerase I inhibitor camptothecin sodium prolongs survival in the rat intracranial 9L gliosarcoma modelInt J Cancer19956256056097665233
   PubMed Web of Science ®Google Scholar
• YuanXTabassiKWilliamsJAImplantable polymers for tirapazamine treatments of experimental intracranial malignant gliomaRadiat Oncol Investig199974218230
   PubMedGoogle Scholar
• YenSYChenSRHsiehJBiodegradable interstitial release polymer loading a novel small molecule targeting Axl receptor tyrosine kinase and reducing brain tumour migration and invasionOncogene201635172156216526257061
   PubMed Web of Science ®Google Scholar
• YovinoSKleinbergLGrossmanSANarayananMFordEThe etiology of treatment-related lymphopenia in patients with malignant gliomas: modeling radiation dose to circulating lymphocytes explains clinical observations and suggests methods of modifying the impact of radiation on immune cellsCancer Invest201331214014423362951
   PubMed Web of Science ®Google Scholar
• KleinbergLGrossmanSAPiantadosiSZeltzmanMWharamMThe effects of sequential versus concurrent chemotherapy and radiotherapy on survival and toxicity in patients with newly diagnosed high-grade astrocytomaInt J Radiat Oncol Biol Phys199944353554310348282
   PubMed Web of Science ®Google Scholar
• GrossmanSAYeXLesserGNABTT CNS ConsortiumImmunosuppression in patients with high-grade gliomas treated with radiation and temozolomideClin Cancer Res201117165473548021737504
   PubMed Web of Science ®Google Scholar
• CampianJLYeXBrockMGrossmanSATreatment-related lymphopenia in patients with stage III non-small-cell lung cancerCancer Invest201331318318823432821
   PubMed Web of Science ®Google Scholar
• WildATHermanJMDholakiaASLymphocyte-sparing effect of stereotactic body radiation therapy in patients with unresectable pancreatic cancerInt J Radiat Oncol Biol Phys201694357157926867885
   PubMed Web of Science ®Google Scholar
• CampianJLSaraiGYeXMarurSGrossmanSAAssociation between severe treatment-related lymphopenia and progression-free survival in patients with newly diagnosed squamous cell head and neck cancerHead Neck201436121747175324174270
   PubMed Web of Science ®Google Scholar
• MathiosDPhallenJParkCPD-1 blockade shows synergistic survival, anti-tumor immune response and long-term memory with interstitial but not systemic chemotherapy: study in a murine glioblas-toma modelNeuro Oncol201416110
   Web of Science ®Google Scholar
• StuppRGanderMLeyvrazSNewlandsECurrent and future developments in the use of temozolomide for the treatment of brain tumoursLancet Oncol20012955256011905710
   PubMed Web of Science ®Google Scholar