ESMO-magnitude of clinical benefit scale version 1.1
Open accessAbstract
Background The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified since the last review.Methods The revision process for the ESMO-MCBS incorporates a nine-step process: Careful review of critiques and suggestions, and identification of problems in the application of v1.0; Identification of shortcomings for revision in the upcoming version; Proposal and evaluation of solutions to address identified shortcomings; Field testing of solutions; Preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and Guidelines Committee; Amendments based on peer review for reasonableness; Near-final review by members of the ESMO-MCBS Working Group and the ESMO Executive Board; Final amendments; Final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board.Results Twelve issues for revision or amendment were proposed for consideration; proposed amendments were formulated for eight identified shortcomings. The proposed amendments are classified as either structural, technical, immunotherapy triggered or nuanced. All amendments were field tested in a wide range of studies comparing scores generated with ESMO-MCBS v1.0 and version 1.1 (v1.1).Conclusions ESMO-MCBS v1.1 incorporates 10 revisions and will allow for scoring of single-arm studies. Scoring remains very stable; revisions in v1.1 alter the scores of only 12 out of 118 comparative studies and facilitate scoring for single-arm studies.
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- Authors
- Cherny, N. I., Dafni, U., Bogaerts, J., Latino, N. J., Pentheroudakis, G., Douillard, J.-Y., Tabernero, J., Zielinski, C., Piccart, M. J., & de Vries, E. G. E.
- Affiliations
- Shaare Zedek Medical Center (IL)
- National and Kapodistrian University of Athens (GR)
- European Organisation for Research and Treatment of Cancer (NL)
- European Society for Medical Oncology (CH)
- University Hospital of Ioannina (GR)
- Vall d'Hebron Hospital Universitari (ES)
- Medical University of Vienna (AT)
- Université Libre de Bruxelles (BE)
- Corresponding author
- Cherny, N.I.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 28
- Issue
- 10
- Pages
- 2340-2366
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2753603515
- Cited by
- 641
- References
- 47
- Citations by year
- 2026: 30 · 2025: 54 · 2024: 84 · 2023: 83 · 2022: 77 · 2021: 99 · 2020: 79 · 2019: 74 · 2018: 47 · 2017: 11 · 2016: 1
- FWCI
- 40.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- ESMO
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- ESMO Magnitude of Clinical Benefit Scale, ESMO-MCBS, cancer therapy, scale revision, single-arm studies, immunotherapy, score stability
- MeSH terms
- Clinical Trials as Topic, Humans, Medical Oncology, Neoplasms, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Biostatistics
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