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Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
  1. Shani Paluch-Shimon1,
  2. Nathan I Cherny1,
  3. Elisabeth G E de Vries2,
  4. Urania Dafni3,4,
  5. Martine J Piccart5,
  6. Nicola Jane Latino6,
  7. Fatima Cardoso7
  1. 1Oncology, Shaare Zedek Medical Center, Jerusalem, Israel
  2. 2Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  3. 3National and Kapodistrian University of Athens, Athens, Greece
  4. 4Frontier Science Foundation-Hellas, Athens, Greece
  5. 5Université Libre de Bruxelles, Institut Jules Bordet, Bruxelles, Belgium
  6. 6ESMO-MCBS Working Group, European Society for Medical Oncology, Viganello, Switzerland
  7. 7Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal
  1. Correspondence to Dr Shani Paluch-Shimon; shani.paluch{at}gmail.com

Abstract

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.

  • early breast cancer
  • magnitude of clinical benefit scale
  • ESMO-MCBS
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Footnotes

  • Contributors Conception of the work: all authors. Funding acquisition: not applicable. Data collection and data analysis: all authors. Manuscript writing/editing: all authors. Final approval: all authors.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • 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.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data freely available.

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