ESMO - Magnitude of Clinical Benefit Scale V.1.0 questions and answers

Abstract

The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a standardised, generic, validated tool to stratify the magnitude of clinical benefit that can be anticipated from anticancer therapies. The ESMO-MCBS is intended to both assist oncologists in explaining the likely benefits of a particular treatment to their patients as well as to aid public health decision makers' prioritise therapies for reimbursement. From its inception the ESMO-MCBS Working Group has invited questions and critiques to promote understanding and to address misunderstandings regarding the nuanced use of the scale, and to identify shortcomings in the scale to be addressed in future planned revisions and updates. The ESMO-MCBS V.1.0 has attracted many questions regarding its development, structure and potential applications. These questions, together with responses from the ESMO-MCBS Working Group, have been edited and collated, and are herein presented as a supplementary resource.

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

“…8 Moreover, improved standardization of endpoint definitions, as well as the analysis and presentation of PRO data would strengthen the rationale for the use of PRO endpoints and generate rigorous data needed to power future trials that could statistically test important PRO hypotheses, thereby complementing traditional radiologic and survival based endpoints. 9 What is promising is the increased awareness in the research community that this issue needs to be addressed. …”

“…Therefore, the data we gather from these trials must be exploited to the full, with statistical analyses conducted in the most rigorous and standardized fashion, and with results that clearly highlight clinical benefits (not just statistical significance). 9 …”

New Treatment Options for Advanced Gastroesophageal Tumours: Mature for the Current Practice?

“…Thus, it is important for clinical trials to evaluate the real-life benefit of novel drug regimens, so that the financial toxicity can be related to the benefits for the patient. The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCSBS) or ASCO Value Framework Net Health Benefit Score are such tools to stratify the magnitude of clinical benefit that can be anticipated from anticancer therapies [94,95]. Clinical benefit scales should be evaluated in further clinical trials and also involved in individual decision making to optimize patient care and minimize financial toxicity without benefit.…”

A case report on the long-term survival of a patient with HER2-positive metastatic gastric adenocarcinoma and a short review of the current literature

“…A recent subgroup analysis of the initial trial also demonstrated efficacy benefits of this regimen after trastuzumab-based treatment [19]. However, the European Society of Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS), a score which indicates the substantial magnitude of clinical benefit of particular novel treatment options in oncology, is only 2 for ramucirumab and paclitaxel [20]. Thus, the clinical benefit for the patient might be minimal and that is why this regimen is critically viewed and widely discussed as a second-line option.…”