Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
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 li...
Main Authors: | , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2020-10-01
|
Series: | ESMO Open |
Online Access: | https://esmoopen.bmj.com/content/5/5/e000743.full |
id |
doaj-5ff52306a949433686bc9080ccb33158 |
---|---|
record_format |
Article |
spelling |
doaj-5ff52306a949433686bc9080ccb331582021-04-02T18:57:20ZengElsevierESMO Open2059-70292020-10-015510.1136/esmoopen-2020-000743Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapiesFatima Cardoso0Elisabeth G E de Vries1Nathan I Cherny2Urania Dafni3Nicola Jane Latino4Shani Paluch-Shimon5Martine J Piccart617Breast Unit, Champalimaud Clinical Center, Lisbon, Portugal27Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel5 Nursing, National and Kapodistrian University of Athens, Goudi-Athens, Greece 4 ESMO-MCBS Working Group, European Society for Medical Oncology, Viganello, Switzerland 1 Oncology, Shaare Zedek Medical Center, Jerusalem, Israel11 Medical Oncology Department, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium 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.https://esmoopen.bmj.com/content/5/5/e000743.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Fatima Cardoso Elisabeth G E de Vries Nathan I Cherny Urania Dafni Nicola Jane Latino Shani Paluch-Shimon Martine J Piccart |
spellingShingle |
Fatima Cardoso Elisabeth G E de Vries Nathan I Cherny Urania Dafni Nicola Jane Latino Shani Paluch-Shimon Martine J Piccart Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies ESMO Open |
author_facet |
Fatima Cardoso Elisabeth G E de Vries Nathan I Cherny Urania Dafni Nicola Jane Latino Shani Paluch-Shimon Martine J Piccart |
author_sort |
Fatima Cardoso |
title |
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies |
title_short |
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies |
title_full |
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies |
title_fullStr |
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies |
title_full_unstemmed |
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies |
title_sort |
application of the esmo-magnitude of clinical benefit scale (v.1.1) to the field of early breast cancer therapies |
publisher |
Elsevier |
series |
ESMO Open |
issn |
2059-7029 |
publishDate |
2020-10-01 |
description |
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. |
url |
https://esmoopen.bmj.com/content/5/5/e000743.full |
work_keys_str_mv |
AT fatimacardoso applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies AT elisabethgedevries applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies AT nathanicherny applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies AT uraniadafni applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies AT nicolajanelatino applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies AT shanipaluchshimon applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies AT martinejpiccart applicationoftheesmomagnitudeofclinicalbenefitscalev11tothefieldofearlybreastcancertherapies |
_version_ |
1721550372350197760 |