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dc.contributor.authorPlotkin, Scott Randall
dc.contributor.authorHalpin, Chris
dc.contributor.authorBlakeley, Jaishri O.
dc.contributor.authorSlattery, William H.
dc.contributor.authorWelling, Duane Bradley
dc.contributor.authorChang, Susan M.
dc.contributor.authorLoeffler, Jay Steven
dc.contributor.authorHarris, Gordon J.
dc.contributor.authorSorensen, A
dc.contributor.authorMcKenna, Michael John
dc.contributor.authorBarker, Frederick George
dc.date.accessioned2017-05-30T20:34:51Z
dc.date.issued2009
dc.identifierQuick submit: 2017-04-22T19:35:21-0400
dc.identifier.citationPlotkin, Scott R., Chris Halpin, Jaishri O. Blakeley, William H. Slattery, D. Bradley Welling, Susan M. Chang, Jay S. Loeffler, et al. 2009. “Suggested Response Criteria for Phase II Antitumor Drug Studies for Neurofibromatosis Type 2 Related Vestibular Schwannoma.” Journal of Neuro-Oncology 93 (1) (May): 61–77. doi:10.1007/s11060-009-9867-7.en_US
dc.identifier.issn0167-594Xen_US
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:32749929
dc.description.abstractNeurofibromatosis type 2 (NF2) is a tumor suppressor gene syndrome characterized by multiple schwannomas, especially vestibular schwannomas (VS), and meningiomas. Anticancer drug trials are now being explored, but there are no standardized endpoints in NF2. We review the challenges of NF2 clinical trials and suggest possible response criteria for use in initial phase II studies. We suggest two main response criteria in such trials. Objective radiographic response is defined as a durable 20% or greater reduction in VS volume based on postcontrast T1-weighted MRI images collected with 3 mm or finer cuts through the internal auditory canal. Hearing response is defined as a statistically significant improvement in word recognition scores using 50-word recorded lists in audiology. A possible composite endpoint incorporating both radiographic response and hearing response is outlined. We emphasize pitfalls in response assessment and suggest guidelines to minimize misinterpretations of response. We also identify research goals in NF2 to facilitate future trial conduct, such as identifying the expectations for time to tumor progression and time to measurable hearing loss in untreated NF2-related VS, and the relation of both endpoints to patient prognostic factors (such as age, baseline tumor volume, and measures of disease severity). These data would facilitate future use of endpoints based on stability of tumor size and hearing, which might be more appropriate for testing certain drugs. We encourage adoption of standardized endpoints early in the development of phase II trials for this population to facilitate comparison of results across trials of different agents.en_US
dc.language.isoen_USen_US
dc.publisherSpringer Natureen_US
dc.relation.isversionofdoi:10.1007/s11060-009-9867-7en_US
dc.relation.hasversionhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4036446/en_US
dash.licenseLAA
dc.subjectVestibular schwannomaen_US
dc.subjectAcoustic neuromaen_US
dc.subjectNeurofibromatosis type 2en_US
dc.subjectTrial designen_US
dc.subjectPhase II trialen_US
dc.titleSuggested response criteria for phase II antitumor drug studies for neurofibromatosis type 2 related vestibular schwannomaen_US
dc.typeJournal Articleen_US
dc.date.updated2017-04-22T23:35:10Z
dc.description.versionAccepted Manuscripten_US
dc.relation.journalJournal of Neuro-Oncologyen_US
dash.depositing.authorPlotkin, Scott Randall
dc.date.available2009
dc.date.available2017-05-30T20:34:51Z
dc.identifier.doi10.1007/s11060-009-9867-7*
workflow.legacycommentscat.completeen_US
dash.authorsorderedfalse
dash.contributor.affiliatedBarker, Frederick
dash.contributor.affiliatedMcKenna, Michael
dash.contributor.affiliatedWelling, Duane
dash.contributor.affiliatedSorensen, Alma Gregory
dash.contributor.affiliatedHarris, Gordon
dash.contributor.affiliatedLoeffler, Jay
dash.contributor.affiliatedPlotkin, Scott


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