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Evaluation of Treatment Effect with Paired Failure Times in a Single-Arm Phase II Trial in Oncology
المؤلفون المشاركون
Texier, Matthieu
Rotolo, Federico
Ducreux, Michel
Bouché, Olivier
Pignon, Jean-Pierre
Michiels, Stefan
المصدر
Computational and Mathematical Methods in Medicine
العدد
المجلد 2018، العدد 2018 (31 ديسمبر/كانون الأول 2018)، ص ص. 1-8، 8ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2018-01-11
دولة النشر
مصر
عدد الصفحات
8
التخصصات الرئيسية
الملخص EN
In early phase clinical trials of cytotoxic drugs in oncology, the efficacy is typically evaluated based on the tumor shrinkage.
However, this criterion is not always appropriate for more recent cytostatic agents, and alternative endpoints have been proposed.
The growth modulation index (GMI), defined as the ratio between the times to progression in two successive treatment lines, has been proposed for a single-arm phase II trials.
The treatment effect is evaluated by estimating the rate of patients having a GMI superior to a given threshold.
To estimate this rate, we investigated a parametric method based on the distribution of the times to progression and a nonparametric one based on a midrank estimator.
Through simulations, we studied their operating characteristics and the impact of different design parameters (censoring, dependence, and distribution) on them.
In these simulations, the nonparametric estimator slightly underestimated the rate and had slightly overconservative confidence intervals in some cases.
Conversely, the parametric estimator overestimated the rate and had anticonservative confidence intervals in some cases.
The nonparametric method appeared to be more robust to censoring than the parametric one.
In conclusion, we recommend the nonparametric method, but the parametric method can be used as a supplementary tool.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Texier, Matthieu& Rotolo, Federico& Ducreux, Michel& Bouché, Olivier& Pignon, Jean-Pierre& Michiels, Stefan. 2018. Evaluation of Treatment Effect with Paired Failure Times in a Single-Arm Phase II Trial in Oncology. Computational and Mathematical Methods in Medicine،Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1131797
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Texier, Matthieu…[et al.]. Evaluation of Treatment Effect with Paired Failure Times in a Single-Arm Phase II Trial in Oncology. Computational and Mathematical Methods in Medicine No. 2018 (2018), pp.1-8.
https://search.emarefa.net/detail/BIM-1131797
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Texier, Matthieu& Rotolo, Federico& Ducreux, Michel& Bouché, Olivier& Pignon, Jean-Pierre& Michiels, Stefan. Evaluation of Treatment Effect with Paired Failure Times in a Single-Arm Phase II Trial in Oncology. Computational and Mathematical Methods in Medicine. 2018. Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1131797
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1131797
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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