P84 Response monitoring with positron emission tomography (PET) in patients with advanced non-small-cell lung cancer (NSCLC) treated with bevacizumab and erlotinib: a phase II study

Langen, Adrianus De; Hoekstra, O. S.; Dingemans, A.; Groen, Henk; Boogaart, V. van den; Pruijm, J.; Kappert, Peter; Smit, E.F.

doi:10.1016/s1359-6349(08)70049-1

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“…In the specific setting of FDG PET, multiple studies have evaluated the role of FDG PET in assessing response to treatment in non small cell lung cancer (NSCLC), esophageal cancer, head and neck cancer, breast cancer, and many other tumors (1,6,14,32,33). To date, these studies have been primarily performed in single institutions with small numbers of patients.…”

Section: Novel Imaging Modalities Of Key Interestmentioning

confidence: 99%

Validation of novel imaging methodologies for use as cancer clinical trial end-points

Sargent¹,

Rubinstein²,

Schwartz³

et al. 2009

European Journal of Cancer

103

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The success or failure of a clinical trial, of any phase, depends critically on the choice of an appropriate primary endpoint. In the setting of phase II and III cancer clinical trials, imaging endpoints have historically, and continue presently to play a major role in determining therapeutic efficacy. The primary goal of this paper is to discuss the validation of imaging-based markers as endpoints for Phase II clinical trials of cancer therapy. Specifically, we outline the issues that must be considered, and the criteria that would need to be satisfied, for an imaging endpoint to supplement or potentially replace RECIST- defined tumor status as a phase II clinical trial endpoint. The key criteria proposed to judge the utility of a new endpoint primarily relate to its ability to accurately and reproducibly predict the eventual phase III endpoint for treatment effect, which is usually assessed by a difference between two arms on progression free or overall survival, at both the patient and more importantly, at the trial level. As will be demonstrated, the level of evidence required to formally and fully validate a new imaging marker as an appropriate endpoint for phase II trials is substantial. In many cases, this level of evidence will only become available by conducting a series of coordinated prospectively designed multicenter clinical trials culminating in a formal meta-analysis. We also include a discussion of situations where flexibility may be required, relative to the ideal rigorous evaluation, to accommodate inevitable real-world feasibility constraints.

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