Novel Oncology Drug Development Strategies in the Era of Personalised Medicine

Lemech, Charlotte; Kristeleit, Rebecca; Arkenau, Hendrik‐Tobias

doi:10.5772/26984

Cited by 2 publications

(2 citation statements)

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“…Oncology drug development is increasingly shifting from a one size fits all paradigm towards a personalized, biomarker-driven approach taking intra-and inter-patient tumor heterogeneity into account. 1,2 Until recently, biomarkers have commonly been identified retrospectively, often after late stage failure of large randomized phase III trials. Well-known examples are the development of the EGFR small molecules, gefitinib and erlotinib, in non-small cell lung cancer where only retrospective analyses identified a subset of patients who gained benefit from these drugs.…”

Section: Introductionmentioning

confidence: 99%

Research biopsies in the context of early phase oncology studies: clinical and ethical considerations

Saggese¹,

Dua²,

Simmons³

et al. 2013

Oncol Rev

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The Personalized Medicine approach in oncology is a direct result of an improved understanding of complex tumor biology and advances in diagnostic technologies. In recent years, there has been an increased demand for archival and fresh tumor analysis in early clinical trials to foster proof-of-concept biomarker development, to understand resistance mechanisms, and ultimately to assess biological response. Although phase I studies are aimed at defining drug safety, pharmacokinetics, and to recommend a phase II dose for further testing, there is now increasing evidence of mandatory tumor biopsies even at the earliest dose-finding stages of drug development. The increasing demand for fresh tumor biopsies adds to the complexity of novel phase I studies and results in different challenges, ranging from logistical support to ethical concerns. This paper investigates key issues, including patients’ perceptions of research biopsies, the need for accurate informed consent, and alternative strategies that may guide the drug development process.

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Section: Introductionmentioning

confidence: 99%