Early Trial Discontinuation in Toxicity-Driven, Dose-Escalating, Phase I Cancer Trials: Occurrence, Outcomes and Predictive Factors

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• 作者：Sophie Cousin ; Philippe A. Cassier ; Carlos Gomez-Roca…
• 刊名：Pharmaceutical Medicine
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：30
• 期：1
• 页码：49-55
• 全文大小：545 KB
• 参考文献：1.Olmos D, A’Hern RP, Marsoni S, Morales R, Gomez-Roca C, Verweij J, et al. Patient selection for oncology phase I trials: a multi-institutional study of prognostic factors. J Clin Oncol. 2012;30:996–1004.PubMed CrossRef
  2.Ploquin A, Olmos D, Ferté C, Cassier PA, Kramar A, Duhamel A, et al. Life-expectancy of patients enrolled in phase 1 clinical trials: a systematic review of published prognostic models. Crit Rev Oncol Hematol. 2012;83:242–8.PubMed CrossRef
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  5.Rodón J, Saura C, Dienstmann R, Vivancos A, Ramón y Cajal S, Baselga J, et al. Molecular prescreening to select patient population in early clinical trials. Nat Rev Clin Oncol. 2010;9:359–66.CrossRef
  6.Garrido-Laguna I, Janku F, Vaklavas C, Falchook GS, Fu S, Hong DS, et al. Validation of the Royal Marsden Hospital prognostic score in patients treated in the Phase I Clinical Trials Program at the MD Anderson Cancer Center. Cancer. 2012;118:1422–8.PubMed CrossRef
  7.Chau NG, Florescu A, Chan KK, Wang L, Chen EX, Bedard P, et al. Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection ? BMC Cancer. 2011;11:426.PubMed PubMedCentral CrossRef
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  12.Arkenau HT, Olmos D, Ang JE, Barriuso J, Karavasilis V, Ashley S, et al. 90-days mortality rate in patients treated within the context of a phase-I trial: how should we identify patients who should not go on trial? Eur J Cancer. 2008;44:1536–40.PubMed CrossRef
  13.Arkenau HT, Barriuso J, Olmos D, Ang JE, de Bono J, Judson I, et al. Prospective validation of a prognostic score to improve patient selection for oncology phase I trials. J Clin Oncol. 2009;16:2692–8.CrossRef
  14.Ploquin A, Olmos D, Lacombe D, A’Hern R, Duhamel A, Twelves C, et al. Prediction of early death among patients enrolled in phase I trials: development and validation of a new model based on platelet count and albumin. Br J Cancer. 2012;107:1025–30.PubMed PubMedCentral CrossRef
  15.Blattenberger G, Lad F. Separating the Brier score into calibration and refinement component: a graphical exposition. Am Stat. 1985;39:26–32.
  16.Wheler J, Tsimberidou AM, Hong D, Naing A, Falchook G, Piha-Paul S, et al. Survival of 1,181 patients in a phase I clinic: the MD Anderson Clinical Center for targeted therapy experience. Clin Cancer Res. 2012;18:2922–9.PubMed PubMedCentral CrossRef
  
• 作者单位：Sophie Cousin (1)
  Philippe A. Cassier (2)
  Carlos Gomez-Roca (3)
  Nicolas Isambert (4)
  Nuria Kotecki-Borghesi (1)
  Sylvie Zanetta (4)
  Louis Tassy (2)
  Anne-Laure Simonet-Lamm (4)
  Eleonora De Maio (3)
  Catherine Terret (2)
  Juliette Bouchet (3)
  Jean-Pierre Delord (3)
  Nicolas Penel (1) (5)
  
  1. Medical Oncology Department, Centre Oscar Lambret, 3, rue F Combemale, 59020, Lille Cedex, France
  2. Medical Oncology Department, Centre Léon Bérard, Lyon, France
  3. Medical Oncology Department, Institut Claudius Regaud, Toulouse, France
  4. Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France
  5. Clinical Research and Methodological Platform of SIRIC OncoLille Consortium, Research Unit EA2694, Lille-Nord-de-France University, Medical School, Lille, France
  
• 刊物主题：Pharmaceutical Sciences/Technology; Pharmacotherapy; Pharmacology/Toxicology;
• 出版者：Springer International Publishing
• ISSN：1179-1993

文摘

Introduction The selection of patients for phase I cancer trials remains challenging. Patients who dropout of the trial before completion need to be replaced and this can result in significant delays to trial completion.