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Definitions of clinical benefit differ between oncology society frameworks
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Weak-to-moderate correlations between the ASCO Value Framework and European Society for Medical Oncology Magnitude of Clinical Benefit Scale suggest the societies measure clinical benefit differently, according to study findings published in the Journal of Clinical Oncology.
Quality-of-life measures and funding recommendations also did not correlate well with the frameworks.
“Revisions are recommended for both the ASCO and ESMO frameworks to reflect how scoring should be carried out in situations the current framework versions did not address explicitly, leaving room for inconsistent interpretation and scoring,” Kelvin Kar-Wing Chan, MD, FRCPC, MSc, PhD, associate scientist at Sunnybrook Research Institute in Toronto, Canada, and colleagues wrote.
The ASCO Value Framework, released in 2015, measures — in the form of a scale — the clinical benefit and toxicity of a certain regimen to calculate a “net health benefit” score. Doctors and patients can compare this score with the cost of cancer treatment to determine the best course of action for a patient.
The ESMO Magnitude of Clinical Benefit Scale (MCBS) was developed to assess the magnitude of clinical benefit for cancer medicines. It uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anticancer treatment, according to the ESMO website.
Whether the two frameworks measure similar constructs of clinical benefit and how they relate to quality of life and funding recommendations in the United Kingdom and Canada had been unclear.
Chan and colleagues reviewed randomized clinical trials of oncology drug approvals by the FDA, European Medicines Agency and Health Canada between 2006 and August 2015. At least two independent reviewers identified and scored 317 studies using the ASCO version 1 framework, ASCO version 2 framework and ESMO-MCBS.
The researchers measured Spearman correlation coefficients to assess construct between frameworks, or the similarity between their measures.
Final analysis included 109 studies. Among these, 108 scores were measured via ASCO version 1, 111 scores via ASCO version 2 and 83 scores via ESMO-MCBS.
The correlation coefficient was 0.36 (95% CI, 0.15-0.54) between ASCO version 1 and ESMO-MCBS; 0.17 (95% CI, 0.06 to 0.37) between ASCO version 2 and ESMO-MCBS; and 0.5 (95% CI, 0.35-0.63) between ASCO version 1 and ASCO version 2. All sensitivity analyses conferred similar results.
Researchers also used the Spearmen rank coefficient to assess criterion validity of each the frameworks against quality-adjusted life-years and National Institute for Health and Care Excellence (NICE) and the pan-Canadian Oncology Drug Review (NICE/pCODR) recommendations.
Researchers identified 22 incremental QALYs from NICE reports and 50 from pCODR reports.
The NICE QALY coefficients included 0.45 (95% CI, 0.04-0.73) on ASCO version 1; 0.53 (95% CI, 0.14-0.78) on ASCO version 2; and 0.46 (95% CI, 0.02 to 0.77) on ESMO-MCBS.
The pCODR QALY coefficients included 0.19 (95% CI, 0.09 to 0.45) for ASCO version 1; 0.2 (95% CI, 0.08 to 0.46) on ASCO version 2; and 0.36 (95% CI, 0.04-0.61) on ESMO-MCBS.
Univariable logistic regression analysis showed funding recommendations by NICE and pCODR were not associated with any of the scores.
Interrater reliability appeared good for all frameworks.
The findings by Cheng and colleagues returned a different conclusion than a similar study by Bentley colleagues, in which convergent validity of the frameworks for five different cancer drugs appeared high, despite different metrics used for defining clinical benefit and toxicity, according to Lowell E. Schnipper, MD, FASCO, co-chair of the ASCO Value in Cancer Care Task Force, chief of hematology and oncology at Beth Israel Deaconess Medical Center, and a HemOnc Today Editorial Board Member, and Richard L. Schilsky, MD, FACP, FASCO, chief medical officer for ASCO, wrote in a related editorial.
“The different conclusions articulated by Cheng [and colleagues] and Bentley [and colleagues] might be a function of the small number of trials evaluated in the study by Bentley [and colleagues],” Schnipper and Schilsky. “However, the discordant findings underscore an important consideration. The methodology for analyzing convergent validity of these value frameworks must be consistent or such analyses will have limited use in discerning which of the frameworks is most reliable.” – by Melinda Stevens
Disclosure: Chan reports he has no relevant financial disclosures. One researcher reports employment with Rexall and consultant/advisory roles with AstraZeneca and Novo Nordisk. Schilsky reports research funding to his institution from AstraZeneca, Bayer, Bristol-Myers Squibb, Genentech, Eli Lilly, Merck and Pfizer. Schnipper reports he holds a leadership position with Eviti; consultant/advisory role with Merck; and is the co-editor in chief for Oncology and UpToDate.
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