Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Practice Guideline
. 2025 Aug;36(8):866-908.
doi: 10.1016/j.annonc.2025.04.006. Epub 2025 May 22.

ESMO-Magnitude of Clinical Benefit Scale version 2.0 (ESMO-MCBS v2.0)

N I Cherny  1 , S F Oosting  2 , U Dafni  3 , N J Latino  4 , M Galotti  4 , P Zygoura  5 , G Dimopoulou  6 , T Amaral  7 , J Barriuso  8 , A Calles  9 , B Kiesewetter  10 , C Gomez-Roca  11 , B Gyawali  12 , M Piccart  13 , A Passaro  14 , F Roitberg  15 , N Tarazona  16 , D Trapani  17 , G Curigliano  17 , R Wester  18 , G Zarkavelis  19 , C Zielinski  20 , E G E de Vries  2
Affiliations
Practice Guideline

ESMO-Magnitude of Clinical Benefit Scale version 2.0 (ESMO-MCBS v2.0)

N I Cherny et al. Ann Oncol. 2025 Aug.

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.

Keywords: ESMO; ESMO-MCBS; biostatistics; research design.

PubMed Disclaimer

Publication types

LinkOut - more resources