First Review of ESMO’s Magnitude of Clinical Benefit Scale Offers a Thumbs-Up

First Review of ESMO’s Magnitude of Clinical Benefit Scale Offers a Thumbs-Up

The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a valuable tool to measure the importance of clinically meaningful benefits that can be expected from a new anti-cancer drug in both common and rare diseases.

Data from ESMO-MCBS on common tumors already had been obtained by researchers at Medical University of Vienna (MUV), one of Europe’s largest cancer centers, and the application of ESMO-MCBS in real-life context for rare tumors was presented recently at the ESMO 2016 Congress, held Oct. 7-11 in Denmark.

“We assessed data on neuroendocrine tumors (NET), glioblastoma, sarcomas, thyroid, pancreatic, ovarian, head/neck and urothelial cancers,” Barbara Kiesewetter, MD of MUV, said in a press release. “Data was analyzed in a three-step approach: we collected data on regimens in daily use at the MUV, then analyzed 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,” she said.

“We noted a phenomenon whereby the ESMO-MCBS particularly highlights the clinical benefit to be expected of new immunomodulatory drugs,” she said. “This was also observed in our field testing on common tumor entities and may help us to implement these treatments in daily practice in the near future. We are particularly excited that new data on checkpoint inhibitors for rare entities is due to be available soon.”

Prior to ESMO-MCBS development, no standard tool was available to grade the magnitude of clinical benefit of cancer therapies, which may range from improving median-progression free survival in only a few weeks (classified as trivial), to improving long-term survival (classified as substantial).

The problem with the lack of a standardized approach to grade the magnitude of clinical benefit is that modest incremental advances often have been presented, discussed and promoted as major advances in the treatment of a particular disease.

The ESMO-MCBS grading now allows researchers to present clear and unbiased statements regarding the magnitude of the clinical benefit from new approaches for the treatment of cancer, including ovarian cancer. However, the scale requires randomized clinical trial, preferentially from Phase 3 trials, to draw the data regarding the efficacy, benefit and safety of the new therapies, which are not very common or easy to conduct in rare diseases.

“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 said.

The scale was designed to consider studies’ primary and secondary endpoints, such as overall survival and progression-free survival in terms of absolute gain as well as safety and quality of life. That data is then compared to that of the control arm, resulting in a clinical benefit ranking.

“We found that the ESMO-MCBS is a helpful tool for clinical practice in rare tumors, as well as for common tumor entities, if randomized data is available. It supports treatment decisions based on the expected clinical benefit. 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 analyze what can be expected from a new approach,” Kiesewetter concluded.

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