First feasibility study of the ESMO-MCBS scale in rare tumor entities

October 11, 2016, European Society for Medical Oncology

The results of the first study analysing the application of the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) in a real-life context for rare tumour entities, were announced today at the ESMO 2016 Congress in Copenhagen.

The ESMO-MCBS is a new tool to quantify the clinical benefit of a certain drug for the treatment of cancer and its application in daily clinical practice. It was first evaluated on common tumour entities by one of Europe's largest cancer centres, the Medical University of Vienna (MUV), which also conducted this new study.

Dr Barbara Kiesewetter at MUV states, "We assessed data on neuroendocrine tumors (NET), glioblastoma, sarcomas, thyroid, pancreatic, ovarian, head/neck and urothelial cancers. Data was analysed in a three-step approach: we collected data on regimens in daily use at the MUV, then analysed the data with the ESMO-MCBS as our second step and finally we evaluated and discussed the data in terms of clinical feasibility and practicability in daily practice." "We noted a phenomenon whereby the ESMO-MCBS particularly highlights the clinical benefit to be expected of new immunomodulatory drugs. This was also observed in our field testing on common tumour entities and may help us to implement these treatments in daily practice in the near future. We are particularly excited that new data on check point inhibitors for rare entities is due to be available soon. For example, in head and neck cancers, the CHECKMATE141 data currently scores for an ESMO-MCBS score of 3 (field testing) based on available results2 but might improve to an even stronger recommendation with more mature survival data," she continued.

"The practicability of applying the ESMO-MCBS is somewhat limited for very rare tumours, for example sarcoma and glioblastoma, due to a lack of randomized data. However, the ESMO-MCBS was applicable in most situations where controlled trials were available such as the data on salvage treatment with pazopanib for achieving a score of 3 based on a significant progression free survival (PFS) gain of 3 months in comparison to 1.6 months in the placebo arm. "For sarcomas, practicability of ESMO-MCBS was limited due to a lack of trials in many indications. However, the ESMO-MCBS was useful whenever randomized data were available. For example, the ESMO-MCBS score of 4 clearly underlines the clinical benefit achieved by adding dacarbazine to gemcitabine in pre-treated soft tissue sarcoma. This is in line with our clinical experience and supports further use of the ESMO Magnitude of Clinical Benefit Scale," Kiesewetter explained.

The ESMO-MCBS has been designed to assess the therapeutic benefit of drugs registered for the treatment of cancer. It considers the predefined primary and secondary study endpoints: overall survival and progression-free survival in terms of absolute gain and lower end of the 95% confidence interval of the corresponding hazard ratio and quality of life or toxicity respectively. Data of the new treatment is then analysed with respect to the duration of response or survival in the control arm, which has to be entered in corresponding forms and results in a clinical benefit ranking.

"We found that the ESMO-MCBS is a helpful tool for clinical practice in rare tumours, as well as for common tumour entities, if randomized data is available. It supports treatment decisions based on the expected . It is very simple to use and we feel that it is going to prove to be a very important tool for daily clinical practice based on our study results. Clinicians can go back to the data when considering new treatments and use the ESMO-MCBS online to analyse what can be expected from a new approach," concluded Dr Kiesewetter.

Explore further: Results of first study assessing clinical impact of ESMO-MCBS

Related Stories

Results of first study assessing clinical impact of ESMO-MCBS

July 7, 2016
Details of the first study by one of Europe's largest cancer centres, the Medical University of Vienna (MUV), assessing the clinical impact and feasibility of the ESMO Magnitude of Clinical Benefit Scale (MCBS) in a real-life ...

ESMO announces scale to stratify magnitude of clinical benefit of anticancer medicines

May 30, 2015
ESMO, the European Society for Medical Oncology, has announced today the publication of the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS)(1), a tool to assist oncology clinicians in evaluating the most effective anti-cancer ...

70 percent of advanced cancer patients receive palliative care consultation at ESMO Designated Centres

October 10, 2016
Seven out of 10 patients with advanced cancer receive a palliative care consultation at ESMO Designated Centres of Integrated Oncology and Palliative Care, according to survey results reported today at the ESMO 2016 Congress ...

ESMO releases new consensus guidelines on the management of metastatic colorectal cancer

July 6, 2016
ESMO, the leading European professional organisation for medical oncology, has released new consensus guidelines for the management of metastatic colorectal cancer that reflect an increasingly personalized approach to treatment, ...

Single-arm trials improve early access to rare cancer drugs

October 11, 2016
Although randomised clinical trials (RCTs) remain the gold standard for evaluating the benefit/risk of cancer drugs, single-arm trials (SATs) can provide invaluable opportunities to speed up cancer drug development and approval, ...

Thousands of melanoma patients in Europe have no access to new life saving drugs

October 7, 2016
Over 5000 patients with metastatic melanoma in Europe are denied access to new, life saving drugs every year, according to a survey presented at the ESMO 2016 Congress in Copenhagen.

Recommended for you

Pushing closer to a new cancer-fighting strategy

December 11, 2018
A molecular pathway that's frequently mutated in many different forms of cancer becomes active when cells push parts of their membranes outward into bulging protrusions, Johns Hopkins researchers report in a new study. The ...

Scientists have identified and modelled a distinct biology for paediatric AML

December 11, 2018
Scientists have identified and modelled a distinct biology for paediatric acute myeloid leukaemia, one of the major causes of death in children.

HER2 mutations can cause treatment resistance in metastatic ER-positive breast cancer

December 11, 2018
Metastatic breast cancers treated with hormone therapy can become treatment-resistant when they acquire mutations in the human epidermal growth factor receptor 2 (HER2) that were not present in the original tumor, reports ...

Loss of two genes drives a deadly form of colorectal cancer, reveals a potential treatment

December 11, 2018
Colorectal cancers arise from earlier growths, called polyps, found on the inner surface of the colon. Scientists are now learning that polyps use two distinct molecular pathways as they progress to cancer, called the "conventional" ...

Taking uncertainty out of cancer prognosis

December 11, 2018
A cancer diagnosis tells you that you have cancer, but how that cancer will progress is a terrifying uncertainty for most patients. Researchers at Cold Spring Harbor Laboratory (CSHL) have now identified a specific class ...

Successful anti-PD-1 therapy requires interaction between CD8+ T cells and dendritic cells

December 11, 2018
A team led by a Massachusetts General Hospital (MGH) investigator has found that successful cancer immunotherapy targeting the PD-1 molecule requires interaction between cytotoxic CD8+ T cells, which have been considered ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.