early breast cancer magnitude of clinical benefit scale ESMO-MCBS

Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies

by Shani Paluch-Shimon, Nathan I. Cherny, Elisabeth G.E. de Vries, Urania Dafni, Martine J. Piccart, Nicola Jane Latino, Fatima Cardoso

Sep 6^th 2020
20 mins
ESMO Open 2020;5:e000743

Share This Article

Summary

The ESMO-MCBS is a validated value scale for assessing solid tumour anticancer treatments, specifically for therapies with curative intent.
This document represents the first large-scale field testing of the ESMO-MCBS in early breast cancer to assess its applicability and identify any shortcomings.
Studies and meta-analyses for various adjuvant systemic therapies in breast cancer were graded using the ESMO-MCBS, and scores were reviewed by experts.
Scores generally aligned with contemporary standards, but six shortcomings were identified, particularly regarding disease-free survival (DFS) grading, and the lack of acute and long-term toxicity data.
The scale needs improvements related to grading based on DFS, annotation of grades with toxicity information, and developing a grading approach for single-arm de-escalation studies.

As the population ages, the incidence and prevalence of cancer are expected to continue to rise both in developed and developing countries. The estimated total annual economic cost of cancer was US$1.16 trillion in 2010, about 2% of global gross domestic product and is continuing to rise exponentially. Breast cancer remains the leading cause of cancer among women and the ongoing care of breast cancer patients is estimated to be one of the most significant contributors to growing cancer care expenditure.

These considerations underscore the need for validated tools to evaluate value of care, where value is recognised as a balance between clinical benefit and cost. With this in mind, both the European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) established Working Groups to address these issues and they have developed and published a platform for evaluating new anticancer therapeutics—the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the ASCO Framework for assessing value of cancer care.

The ESMO-MCBS was initially launched and published in 2015 and revised in 2017 with version 1.1. The scale aims to provide a validated and rational stratification process for oncology therapies, and its development process has been predicated on ‘accountability for reasonableness’ which incorporated extensive field testing and the peer review of results for ‘reasonableness’. Form 1 of the ESMO-MCBS, which is used to grade therapies with curative intent including adjuvant therapies, hitherto, has only been applied in a limited number of studies. Form 1 of the ESMO-MCBS grades therapies with curative intent on a three-point scale A, B and C where scores of A and B represent substantial improvement.

This is the first large-scale field testing of form 1 in early breast cancer to assess the applicability of the ESMO-MCBS in this setting, to determine whether the scoring reflected clinical practice (reasonableness) and to identify shortcomings to be addressed in future versions of the scale. It also provides an overview of the magnitude of benefit for the most common therapies/therapeutic strategies in the field of breast cancer, allowing for a critical reassessment of available options.

Click for Source Download PDF version

early breast cancer, magnitude of clinical benefit scale, ESMO-MCBS

Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies

Share This Article

Related Topics

Meet Our Innovation Partners

You May Also Like

Value assessment of PD-1/PD-L1 inhibitors in the treatment of esophageal and gastrointestinal cancers

Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020

MSL Career Options: The transition from Field Medical to Medical Director

EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies

Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

Model-Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration-Approved Antibody-Drug Conjugates?

Explore OVN