Article
Di Maria Jiang, Kelvin K. W. Chan, Raymond W. Jang, Christopher Booth, Geoffrey Liu, Eitan Amir, Robert Mason, Louis Everest, Elena Elimova
Assessment of Whether the American Society of Clinical Oncology's Value Framework and the European Society for Medical Oncology's Magnitude of Clinical Benefit
Summary
The ASCO-VF and ESMO-MCBS frameworks currently lack the ability to measure absolute survival benefit, which limits their effectiveness in comparing clinical benefits across different drugs and in establishing value. The authors of the ASCO framework have acknowledged the need for both relative and absolute benefit gains. RMST (Restricted Mean Survival Time) difference is suggested as a direct measure of absolute clinical benefit and could be incorporated into these frameworks to enhance their measurement capabilities. It is recommended that RCTs (Randomized Controlled Trials) report RMST-based measures of treatment effects alongside other common measures to provide a comprehensive view of survival benefits.
The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) have independently published value frameworks that allow for the systematic assessment of clinical benefit of anticancer drugs with the aim of establishing the value of these therapies. Both frameworks consist of a preliminary survival benefit score that is further adjusted by incorporating other value dimensions such as toxic effects and quality of life.
The ASCO Value Framework (ASCO-VF) incorporates only hazard ratios (HRs) in order to construct clinical benefit scores (CBSs), whereas the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) considers HRs and absolute gains in median survival in order to generate preliminary magnitude of clinical benefit grades (PMCBGs). The inclusion of HRs in the calculation of CBSs in both frameworks suggests that they likely measure relative rather than absolute survival benefit (this is also explicitly stated by ASCO regarding their framework). Although both frameworks were not designed to solely measure absolute survival benefit, calculating the CBS as a relative measure does not seem to correspond with the frameworks’ intended uses...
ASCO, ESMO, value frameworks, randomized controlled trials, ASCO-CBS, ESMO-PMCBG
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