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Extending the Continual Reassessment Method to accommodate step‐up dosing in Phase I trials
dc.contributor.authorBraun, Thomas M.
dc.contributor.authorMercier, Francois
dc.date.accessioned2022-09-26T16:03:36Z
dc.date.available2023-10-26 12:03:34en
dc.date.available2022-09-26T16:03:36Z
dc.date.issued2022-09-10
dc.identifier.citationBraun, Thomas M.; Mercier, Francois (2022). "Extending the Continual Reassessment Method to accommodate step‐up dosing in Phase I trials." Statistics in Medicine 41(20): 3975-3990.
dc.identifier.issn0277-6715
dc.identifier.issn1097-0258
dc.identifier.urihttps://hdl.handle.net/2027.42/174811
dc.publisherWiley Periodicals, Inc.
dc.subject.otherconditional probability
dc.subject.otheradaptive clinical trial
dc.subject.otherBayesian inference
dc.subject.otherdose escalation
dc.subject.otherfractionated dosing
dc.subject.otherup‐titration
dc.titleExtending the Continual Reassessment Method to accommodate step‐up dosing in Phase I trials
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelMedicine (General)
dc.subject.hlbsecondlevelStatistics and Numeric Data
dc.subject.hlbsecondlevelPublic Health
dc.subject.hlbtoplevelHealth Sciences
dc.subject.hlbtoplevelScience
dc.subject.hlbtoplevelSocial Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/174811/1/sim9487-sup-0001-supinfo.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/174811/2/sim9487.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/174811/3/sim9487_am.pdf
dc.identifier.doi10.1002/sim.9487
dc.identifier.sourceStatistics in Medicine
dc.identifier.citedreferenceFernandes LL, Taylor JMG, Murray S. Adaptive phase I clinical trial design using Markov models for conditional probability of toxicity. J Biopharm Stat. 2016; 26: 475 ‐ 498.
dc.identifier.citedreferenceBraun TM, Yuan Z, Thall PF. Determining a maximum tolerated schedule of a cytotoxic agent. Biometrics. 2005; 61: 335 ‐ 343.
dc.identifier.citedreferenceBraun TM, Thall PF, Nguyen H, Lima M. Simultaneously optimizing dose and schedule of a new cytotoxic agent. Clin Trials. 2007; 4: 113 ‐ 124.
dc.identifier.citedreferenceCheung YK, Chappell R. Sequential designs for phase I clinical trials with late‐onset toxicities. Biometrics. 2000; 56: 1177 ‐ 1182.
dc.identifier.citedreferenceGunhan BK, Weber S, Friede T. A Bayesian time‐to‐event pharmacokinetic model for phase I dose‐escalation trials with multiple schedules. Stat Med. 2020; 39: 3986 ‐ 4000.
dc.identifier.citedreferenceGerard E, Zohar S, Thai H‐T, Lorenzato C, Riviere M‐K, Ursino M. Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics. Biometrics. 2021; 78: 300 ‐ 312. doi: 10.1111/biom.13433:1‐13
dc.identifier.citedreferenceStein AM, Grupp SA, Levine JE, et al. Tisagenlecleucel model‐based cellular kinetic analysis of chimeric antigen receptor‐T cells. CPT Pharmacometr Syst Pharmacol. 2019; 8: 285 ‐ 295.
dc.identifier.citedreferenceJiang X, Chen X, Jaiprasart P, Carpenter TJ, Zhou R, Wang W. Development of a minimal physiologically‐based pharmacokinetic/pharmacodynamic model to characterize target cell depletion and cytokine release for T cell‐redirecting bispecific agents in humans. Eur J Pharm Sci. 2020; 146: 105260.
dc.identifier.citedreferenceFrey NV, Shaw PA, Hexner EO, et al. Optimizing chimeric antigen receptor T‐cell therapy for adults with acute lymphoblastic leukemia. J Clin Oncol. 2020; 38: 415 ‐ 422.
dc.identifier.citedreferenceBartlett NL, Sehn LH, Assouline SE, et al. Managing cytokine release syndrome (CRS) and neurotoxicity with step‐up dosing of mosunetuzumab in relapsed/refractory (R/R) B‐cell non‐Hodgkin lymphoma (NHL). J Clin Oncol. 2019; 37: 7518.
dc.identifier.citedreferenceColin P, Micallef S, Delattre M, Mancini P, Parent E. Towards using a full spectrum of early clinical trial data: a retrospective analysis to compare potential longitudinal categorical models for molecular targeted therapies in oncology. Stat Med. 2015; 34: 2999 ‐ 3016.
dc.identifier.citedreferenceConaway MR, Petroni GR. The impact of early‐phase trial design in the drug development process. Clin Cancer Res. 2019; 25: 819 ‐ 827.
dc.identifier.citedreferenceO’Quigley J, Paoletti X, Maccario J. Non‐parametric optimal design in dose finding studies. Biostatistics. 2002; 3: 51 ‐ 56.
dc.identifier.citedreferenceLee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transpl. 2019; 25: 625 ‐ 638.
dc.identifier.citedreferenceTighiouart M, Rogatko A. Dose finding with escalation with overdose control (EWOC) in cancer clinical trials. Stat Sci. 2010; 25: 217 ‐ 226.
dc.identifier.citedreferenceBraun TM. The current design of oncology phase I clinical trials: progressing from algorithms to statistical models. Chin Clin Oncol. 2014; 3: 1 ‐ 11.
dc.identifier.citedreferenceBraun TM. Generalizing the TITE‐CRM to adapt for early‐ and late‐onset toxicities. Stat Med. 2006; 25: 2071 ‐ 2083.
dc.identifier.citedreferenceWages NA, O’Quigley J, Conaway MR. Phase I design for completely or partially ordered treatment schedules. Stat Med. 2014; 33: 569 ‐ 579.
dc.identifier.citedreferenceO’Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics. 1990; 46: 33 ‐ 48.
dc.identifier.citedreferenceGődel P, Shimabukuro‐Vornhagen A, Bergwelt‐Baildon M. Understanding cytokine release syndrome. Intens Care Med. 2018; 44: 371 ‐ 373.
dc.identifier.citedreferenceLee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014; 124: 188 ‐ 195.
dc.identifier.citedreferenceForan AE, Nadel HR, Lee AF, Savage KJ, Deyell RJ. Nivolumab in the treatment of refractory pediatric Hodgkin lymphoma. J Pediatr Hematol/Oncol. 2017; 39: e263 ‐ e266.
dc.identifier.citedreferenceRassy EE, Assi T, Rizkallah J, Kattan J. Diffuse edema suggestive of cytokine release syndrome in a metastatic lung carcinoma patient treated with pembrolizumab. Immunotherapy. 2017; 9: 309 ‐ 311.
dc.identifier.citedreferenceRotz SJ, Leino D, SS, Mangino JL, Turpin BK, Pressey JG. Severe cytokine release syndrome in a patient receiving PD‐1‐directed therapy. Pediatr Blood Cancer. 2017; 64: e26642.
dc.identifier.citedreferenceZhao L, Yang Y, Li W, Li T, Gao Q. Nivolumab‐induced cytokine‐release syndrome in relapsed/refractory Hodgkin’s lymphoma: a case report and literature review. Immunotherapy. 2018; 10: 913 ‐ 917.
dc.identifier.citedreferenceDimitriou F, Matter AV, Mangana J, et al. Cytokine release syndrome during sequential treatment with immune checkpoint inhibitors and kinase inhibitors for metastatic melanoma. J Immunother. 2019; 42: 29 ‐ 32.
dc.identifier.citedreferenceHonjo O, Kubo T, Sugaya F, Nishizaka T. Severe cytokine release syndrome resulting in purpura fulminans despite successful response to nivolumab therapy in a patient with pleomorphic carcinoma of the lung: a case report. J Immuno Ther Cancer. 2019; 7: 97.
dc.identifier.citedreferenceKogure Y, Ishii Y, Oki M. Cytokine release syndrome with pseudoprogression in a patient with advanced non‐small cell lung cancer treated with pembrolizumab. J Thor Oncol. 2019; 14: e55 ‐ e57.
dc.identifier.citedreferenceOda H, Ishihara M, Miyahara Y, et al. First case of cytokine release syndrome after nivolumab for gastric cancer. Case Rep Oncol. 2019; 12: 147 ‐ 156.
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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