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ESMO-magnitude of clinical benefit scale version 2.0 (ESMO-MCBS v2.0)

Cherny, N. I.
; 
Oosting, S. F.
; 
Dafni, U.
; 
Latino, N. J.
; 
Galotti, M.
; 
Zygoura, P.
; 
Dimopoulou, G.
; 
Amaral, T.
; 
Barriuso, J.
; 
Calles, A.
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Abstract
BACKGROUND: The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated tool to assess the magnitude of clinical benefit from new cancer therapies, with planned updates based upon recognition of new needs and shortcomings. This paper describes the development of ESMO-MCBS v2.0. METHODOLOGY: The revision process incorporates nine steps: (i) review of critiques and suggestions and identification of problems in the application of ESMO-MCBS v1.1; (ii) identification of shortcomings for revision in the upcoming version; (iii) drafting solutions addressing identified shortcomings; (iv) field-testing of solutions; (v) preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and ESMO Guidelines Committee; (vi) amendments based on peer review for reasonableness; (vii) near-final review by members of the ESMO-MCBS Working Group; (viii) final amendments; (ix) final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board. RESULTS: Seventeen issues for revision or amendment were considered, and 13 amendments were formulated to address identified shortcomings. In the curative setting, studies evaluated based on disease-free survival now credit improved time without treatment or disease even when overall survival is not significantly improved, and studies with small absolute gain in disease-free survival are credited more conservatively. Additionally, acute and persistent toxicity annotations are added. In the non-curative setting, the approach to crediting a difference in the tail of overall survival and progression-free survival curves is more statistically valid, and the toxicity evaluation has been revised. In peer review all amendments were found to be either reasonable or mostly reasonable. The amendments changed the scoring of 85/353 of evaluated studies. CONCLUSIONS: The amendments incorporated into ESMO-MCBS v2.0 change the scores of 13.6% of evaluated studies (10.5% downgraded, 3.1% upgraded) and add toxicity annotations to 45.5% of the studies in the curative setting, and improve its discriminatory capacity and utility.
Authors
Cherny, N. I.
Oosting, S. F.
Dafni, U.
Latino, N. J.
Galotti, M.
Zygoura, P.
Dimopoulou, G.
Amaral, T.
Barriuso, J.
Calles, A.
Kiesewetter, B.
Gomez-Roca, C.
Gyawali, B.
Piccart, M.
Passaro, A.
Roitberg, F.
Tarazona, N.
Trapani, D.
Curigliano, G.
Wester, R.
Zarkavelis, G.
Zielinski, C.
de Vries, E. G. E.
Affiliation
Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel. Electronic address: mcbs@esmo.org. Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Laboratory of Biostatistics, Division of Public Health, Department of Nursing, University of Athens, Athens; Frontier Science Foundation-Hellas, Athens, Greece. ESMO Head Office, European Society for Medical Oncology, Lugano, Switzerland. Frontier Science Foundation-Hellas, Athens, Greece; Athens University of Economics and Business, Athens, Greece. Frontier Science Foundation-Hellas, Athens, Greece. Skin Cancer Center, Department of Dermatology, Eberhard Karls University, Tuebingen, Germany. The Christie NHS Foundation Trust and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. Medical Oncology Department, Hospital General Universitario Gregorio Marañon, Madrid, Spain. Division of Oncology, Department of Medicine I, Medical University of Vienna, Vienna, Austria. Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole, Institut Claudius Regaud, Toulouse, France. Department of Oncology, Queen's University, Kingston, Canada. Institut Jules Bordet, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Brussels, Belgium. Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan, Italy. Rede Ebserh (Empresa Brasileira de Serviços Hospitalares), Brasilia, Brazil. Department of Medical Oncology, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain. European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. University of Ioannina, Department of Medical Oncology, Ioannina, Greece. Wiener Privat Klinik, Central European Academy Cancer Center, Vienna, Austria.
Description
Date
2025
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All Christie Publications
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Cherny NI, Oosting SF, Dafni U, Latino NJ, Galotti M, Zygoura P, et al. ESMO-Magnitude of Clinical Benefit Scale version 2.0 (ESMO-MCBS v2.0). Annals of oncology : official journal of the European Society for Medical Oncology. 2025 Aug;36(8):866-908. PubMed PMID: 40409995. Epub 2025/05/24. eng.
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https://christie.openrepository.com/handle/10541/627706
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