A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of…

By N. Cherny, R. Sullivan, U. Dafni, J. Kerst, A. Sobrero, Christoph C. Zielinski, E. D. Vries, M. Piccart. Annals of Oncology, 2015

756 citations recorded by the source corpus.

The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool 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 anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis.

Subfields: Economics and Econometrics, Oncology

View Paper: https://www.semanticscholar.org/paper/684d8b4f2ea19eaec0a18ad1a2d80d2aa0e03a79

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Citations in the corpus

• Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2017, neutral): “Given the differences in early toxicity and quality of life between surgery and SABR, as well as the growing emphasis on patient reported endpoints when evaluating new treatments [95], more attention should be given towards developing tools for shared decision-making, as it may assist operable patie”
• Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021 (2021, background): “The Panel believes it is critical that patients around the world have secure access to important, evolving molecular diagnostic assays for optimal management of breast cancer and determination of treatment value.(15) Tumor infiltrating lymphocytes (TILs) and programmed cell death protein 1/programme”