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ESMO-Magnitude of Clinical Benefit Scale version 1.1
N I Cherny1, U Dafni2, J Bogaerts3
1Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel;.
Summary
The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) was updated to version 1.1, incorporating 10 revisions. This enhanced tool now allows scoring for single-arm studies, improving cancer therapy benefit assessment.
Area of Science:
- Oncology
- Clinical Trial Methodology
- Health Economics and Outcomes Research
Background:
- The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) v1.0 was the first validated tool for assessing clinical benefit of new cancer therapies.
- ESMO-MCBS was designed as a dynamic tool, subject to revisions based on identified needs and limitations.
Purpose of the Study:
- To revise and update the ESMO-MCBS based on user feedback and identified shortcomings of version 1.0.
- To enhance the scale's utility and applicability in evaluating cancer therapies.
Main Methods:
- A nine-step revision process was employed, including critique review, problem identification, solution proposal and testing, and multiple rounds of peer review.
- Amendments were field-tested on studies comparing ESMO-MCBS v1.0 and v1.1 scores.
Main Results:
- Twelve issues were proposed for revision, leading to amendments for eight identified shortcomings.
- Amendments were categorized as structural, technical, immunotherapy-triggered, or nuanced.
- Field testing confirmed stable scoring, with v1.1 altering scores in only 12 of 118 comparative studies.
Conclusions:
- ESMO-MCBS version 1.1 (v1.1) includes 10 revisions and now accommodates the scoring of single-arm studies.
- The revisions in v1.1 maintain scoring stability while expanding the scale's applicability.
- ESMO-MCBS v1.1 offers an improved tool for assessing the magnitude of clinical benefit from cancer therapies.

