×

zbMATH — the first resource for mathematics

The continual reassessment method for multiple toxicity grades: a Bayesian quasi-likelihood approach. (English) Zbl 1124.62084
Summary: We consider the case of phase I trials for treatment of cancer or other severe diseases in which grade information is available about the severity of toxicity. Most dose allocation procedures dichotomize toxicity grades based on being dose limiting, which may not work well for severe and possibly irreversible toxicities such as renal, liver, and neurological toxicities, or toxicities with long duration. We propose a simple extension to the continual reassessment method (CRM), called Quasi-CRM, to incorporate grade information. Toxicity grades are first converted to numeric scores that reflect their impacts on the dose allocation procedure, and then incorporated into the CRM using the quasi-Bernoulli likelihood. A simulation study demonstrates that the Quasi-CRM is superior to the standard CRM and comparable to a univariate version of the B. N. Bekele and P. F. Thall method [J. Am. Stat. Assoc. 99, No. 465, 26–35 (2004)]. We also present a sensitivity analysis of the new method with respect to toxicity scores, and discuss practical issues, such as extending the simple algorithmic up-and-down designs.

MSC:
62P10 Applications of statistics to biology and medical sciences; meta analysis
PDF BibTeX XML Cite
Full Text: DOI
References:
[1] Babb, Cancer phase I clinical trials: Efficient dose escalation with overdose control, Statistics in Medicine 17 pp 1103– (1998)
[2] Bekele, Dose-finding based on multiple toxicities in a soft tissue sarcoma trial, Journal of the American Statistical Association 99 pp 26– (2004) · Zbl 1089.62523
[3] Carota, Semiparametric regression for count data, Biometrika 89 pp 265– (2002) · Zbl 1017.62035
[4] Chevret, The continual reassessment method in cancer phase I clinical trials: A simulation study, Statistics in Medicine 12 pp 1093– (1993)
[5] Goodman, Some practical improvements in the continual reassessment method for phase I studies, Statistics in Medicine 14 pp 1149– (1995)
[6] Gourieroux, Pseudo maximum likelihood methods: Theory, Econometrica 52 pp 681– (1984) · Zbl 0575.62031
[7] McCullagh, Generalized Linear Models (1989) · Zbl 0588.62104
[8] National Cancer Institute., Common Toxicity Criteria for Adverse Events v3.0 (CTCAE) (2003)
[9] O’Quigley, Curve-free and model-based continual reassessment method designs, Biometrics 58 pp 245– (2002) · Zbl 1209.62318
[10] O’Quigley, Continual reassessment method: A likelihood approach, Biometrics 52 pp 673– (1991) · Zbl 0925.62454
[11] O’Quigley, Continual reassessment method: A practical design for phase I clinical trials in cancer, Biometrics 46 pp 33– (1990) · Zbl 0715.62242
[12] Papke, Econometric methods for fractional response variables with an application to 401(k) plan participation rates, Journal of Applied Econometrics 11 pp 619– (1996)
[13] Robertson, Order Restricted Statistical Inference (1988)
[14] Storer, Design and analysis of phase I clinical trials, Biometrics 45 pp 925– (1989) · Zbl 0715.62241
[15] Wang, Designs for phase I cancer clinical trials with differentiation of graded toxicity, Communications in Statistics-Theory and Method 29 pp 975– (2000) · Zbl 1012.62115
This reference list is based on information provided by the publisher or from digital mathematics libraries. Its items are heuristically matched to zbMATH identifiers and may contain data conversion errors. It attempts to reflect the references listed in the original paper as accurately as possible without claiming the completeness or perfect precision of the matching.