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Patient-Specific Dose Adjustment in the Cancer Clinical Trial Setting

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Abstract

Clinical trials of new anticancer therapies are critically important tools in the search for more effective cancer treatments. According to the current paradigm for the clinical evaluation of new cancer therapies, (A) the dose of a therapeutic agent is not adjusted to accommodate individual patient differences, and (B) the exploration of a working-dose of new cancer therapies is mainly restricted to phase I trials. Rogatko et al. proposed that (A′) the dose should be finetuned using patient-specific attributes, and (B′) the search for the optimal dose should be extended beyond phase I and into phases II and III.

In this paper, we discuss how phase I design methods can be used to update the working dose for phases II and III and how finetuning the dose may involve the utilization of patient-specific attributes to obtain a personalized treatment regimen. As a result, we expect that more patients will be treated with potentially therapeutic doses of promising agents and fewer patients will have to experience the detrimental effects of a toxic dose.

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Acknowledgements

This paper was supported in part by grants from Georgia Cancer Coalition, Distinguished Cancer Clinicians and Scientists Program (to Dr Rogatko), Robert W. Woodruff Health Sciences Center Fund (to Dr Rogatko), and NIH/ NCI Grants No. 1 P01 CA116676 (to Drs Rogatko and Tighiouart) and P20 CA103735 (to Dr Rogatko).

The authors have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. Winship Cancer Institute, Emory University, Atlanta, Georgia, USA

    André Rogatko, Pulak Ghosh, Brani Vidakovic & Mourad Tighiouart

  2. Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, 147 S. Robertson Blvd. Ste. 100, Los Angeles, California, 90048, USA

    André Rogatko

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  1. André Rogatko
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  2. Pulak Ghosh
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  3. Brani Vidakovic
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  4. Mourad Tighiouart
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Correspondence to André Rogatko.

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Rogatko, A., Ghosh, P., Vidakovic, B. et al. Patient-Specific Dose Adjustment in the Cancer Clinical Trial Setting. Pharm Med 22, 345–350 (2008). https://doi.org/10.1007/BF03256730

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