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- Title
Patient-Specific Dose Adjustment in the Cancer Clinical Trial Setting.
- Authors
Rogatko, André; Ghosh, Pulak; Vidakovic, Brani; Tighiouart, Mourad
- 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.
- Subjects
DRUG dosage; ANTINEOPLASTIC agents; CANCER treatment; CLINICAL trials; DRUG overdose; DRUG side effects
- Publication
Pharmaceutical Medicine, 2008, Vol 22, Issue 6, p345
- ISSN
1178-2595
- Publication type
Article
- DOI
10.1007/BF03256730