title: 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 Clinical Benefit Scale (ESMO-MCBS).
abstract: 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.
authors.affiliation: Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel mcbs@esmo.org.
authors.forename: N I
authors.initials: NI
authors.lastname: Cherny
authors.affiliation: Kings Health Partners Integrated Cancer Centre, King's College London, Institute of Cancer Policy, London, UK.
authors.forename: R
authors.initials: R
authors.lastname: Sullivan
authors.affiliation: University of Athens and Frontiers of Science Foundation-Hellas, Athens, Greece.
authors.forename: U
authors.initials: U
authors.lastname: Dafni
authors.affiliation: Department of Medical Oncology, Antoni van Leeuwenhoek Hospital.
authors.forename: J M
authors.initials: JM
authors.lastname: Kerst
authors.affiliation: Department of Medical Oncology, IRCCS San Martino IST, Genova, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Sobrero
authors.affiliation: Division of Oncology, Medical University Vienna, Vienna, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Zielinski
authors.affiliation: Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: E G E
authors.initials: EG
authors.lastname: de Vries
authors.affiliation: Jules Bordet Institute, UniversitéLibre de Bruxelles, Brussels, Belgium Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: M J
authors.initials: MJ
authors.lastname: Piccart
mesh_terms: D026683:Advisory Committees; D003362:Cost-Benefit Analysis; D005060:Europe; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D012955:Societies, Medical; D016896:Treatment Outcome
keywords: ESMO; clinical benefit; tool