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. 2020 Sep;5(5):e000743.
doi: 10.1136/esmoopen-2020-000743.

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

Shani Paluch-Shimon  1 , Nathan I Cherny  2 , Elisabeth G E de Vries  3 , Urania Dafni  4 , Martine J Piccart  5 , Nicola Jane Latino  6 , Fatima Cardoso  7
Affiliations

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

Shani Paluch-Shimon et al. ESMO Open. 2020 Sep.

Abstract

Click here to listen to the Podcast BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated value scale for solid tumour anticancer treatments. Form 1 of the ESMO-MCBS, used to grade therapies with curative intent including adjuvant therapies, has only been evaluated for a limited number of studies. This is the first large-scale field testing in early breast cancer to assess the applicability of the scale to this data set and the reasonableness of derived scores and to identify any shortcomings to be addressed in future modifications of the scale.

Method: Representative key studies and meta-analyses of the major modalities of adjuvant systemic therapy of breast cancer were identified for each of the major clinical scenarios (HER2-positive, HER2-negative, endocrine-responsive) and were graded with form 1 of the ESMO-MCBS. These generated scores were reviewed by a panel of experts for reasonableness. Shortcomings and issues related to the application of the scale and interpretation of results were identified and critically evaluated.

Results: Sixty-five studies were eligible for evaluation: 59 individual studies and 6 meta-analyses. These studies incorporated 101 therapeutic comparisons, 61 of which were scorable. Review of the generated scores indicated that, with few exceptions, they generally reflected contemporary standards of practice. Six shortcomings were identified related to grading based on disease-free survival (DFS), lack of information regarding acute and long-term toxicity and an inability to grade single-arm de-escalation scales.

Conclusions: Form 1 of the ESMO-MCBS is a robust tool for the evaluation of the magnitude of benefit studies in early breast cancer. The scale can be further improved by addressing issues related to grading based on DFS, annotating grades with information regarding acute and long-term toxicity and developing an approach to grade single-arm de-escalation studies.

Keywords: ESMO-MCBS; early breast cancer; magnitude of clinical benefit scale.

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Conflict of interest statement

Competing interests: SP-S reports institutional financial support for her advisory role from Astra Zeneca, Pfizer, Novartis, Roche, Teva, NanoString; EGEdV reports institutional financial support for her advisory role from Daiichi Sankyo, Merck, NSABP, Pfizer, Sanofi, Synthon and institutional financial support for clinical trials or contracted research from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Synthon; MJP reports scientific board member for Oncolytics, consultant honoraria from AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Genentech, Huya, Immunomedics, Lilly, Menarini, MSD, Novartis, Odonate, Periphagen, Pfizer, Roche, Seattle Genetics, research grants to institute AstraZeneca, Lilly, MSD, Novartis, Pfizer, Radius, Roche-Genentech, Servier, Synthon; FC reports institutional financial support for her advisory role from Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline (GSK), Merck-Sharp, Merus BV, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Teva.

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References

    1. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. . Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer 2013;49:1374–403. 10.1016/j.ejca.2012.12.027 - DOI - PubMed
    1. Ferlay J, et al. GLOBOCAN 2008 v1.2, cancer incidence and mortality worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer, 2010.
    1. GBD 2015 Risk Factors Collaborators Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the global burden of disease study 2015. Lancet 2016;388:1659–724. 10.1016/S0140-6736(16)31679-8 - DOI - PMC - PubMed
    1. Mariotto AB, Yabroff KR, Shao Y, et al. . Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst 2011;103:117–28. 10.1093/jnci/djq495 - DOI - PMC - PubMed
    1. Cherny NI, Sullivan R, Dafni U, et al. . A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for medical oncology magnitude of clinical benefit scale (ESMO-MCBS). Annals of Oncology 2015;26:1547–73. 10.1093/annonc/mdv249 - DOI - PubMed