Work

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

Year: 2020

Type: article

Abstract: BackgroundThe 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. MethodRepresentative 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, endocrineresponsive) 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. IntRoduCtIonAs the population ages, the incidence and prevalence of cancer are expected to continue to rise both in developed 1 and developing countries.2 The estimated total annual economic cost of cancer was US$1.16 trillion in 2010, about 2% of global gross domestic product 3 and is continuing to rise exponentially.Breast cancer remains the leading cause of cancer among women 2 and the ongoing care of breast cancer patients is estimated to be one of the most significant contributors to growing cancer care expenditure.4 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 Click here to listen to the Podcast Key questionsWhat is already known about this subject?► Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) serves to score therapies with curative intent.To date, very limited field testing has been performed to assess the scale in the curative setting.What does this study add?► We evaluated the applicability of the scale and assessed the reasonableness of the generated scores in early breast cancer.Form 1 of the ESMO-MCBS V.1.1 provided a generally robust tool for scoring of adjuvant breast cancer studies.Six shortcomings were identified including lack of information regarding acute and long-term toxicity, an inability to grade single-arm de-escalation scales and limitations related to grading based on disease-free survival.How might this impact on clinical practice?► The identified shortcomings in form 1 of the ESMO-MCBS V.1.1 will be rectified in the upcoming version 2.0 of the scale to strengthen the validity of that scale and its generated results.These developments have important implications for data interpretation, public health and clinical decision-making.

Source: ESMO Open

DOI: 10.1136/esmoopen-2020-000743