The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 and 1.1
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 this validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS is designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified.
The revised version of the scale, ESMO-MCBS v1.1, launched in 2017, incorporates 10 revisions and allows for scoring of single-arm studies.
The 2015 and 2017 articles can both be found in Annals of Oncology and are freely downloadable.
Despite all the efforts done so far, access to essential drugs in Oncology is still asymmetric. In this podcast, Teresa Amaral, member of the ESMO YOC, interviews Professor Martine Piccart (Scientific Director of the Institut Jules Bordet, Universite Libre de Bruxelles, Belgium) that shares valuable insights on the work that has been done on this field by the ESMO Magnitude of Clinical Benefit Scale (ESMO – MCBS) group.
In January 2020, the manuscript ‘EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies’ has been published. The study presents the results of the first feasibility testing of the ESMO-MCBS v1.1 for haematological malignancies. Based on the findings of this study, ESMO and EHA are committed to develop a version of the ESMO-MCBS that is validated for haematological malignancies.
In 2017, an article addressing the methodology behind the ESMO-MCBS and providing a detailed statistical assessment was published in ESMO Open. The article is freely downloadable.
Grading is guided by a dual rule comparing the relative benefit (RB) and the absolute benefit (AB) achieved by the therapy to prespecified threshold values. The ESMO-MCBS v1.0 dual rule evaluates the RB of an experimental treatment based on the lower limit of the 95%CI (LL95%CI) for the hazard ratio (HR) along with an AB threshold.
This dual rule addresses two goals:
- Inclusiveness - not unfairly penalising experimental treatments from trials designed with adequate power targeting clinically meaningful relative benefit;
- Discernment - penalising trials designed to detect a small inconsequential benefit.