Report Assesses Degree of Alignment Between ASCO, ESMO Oncology Frameworks

A joint assessment comparing the results of value frameworks created by the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) found that the frameworks produce comparable measures of the clinical benefits of new cancer therapies in roughly two-thirds of more than 100 drug comparisons examined.

The findings were published Monday in ASCO’s Journal of Clinical Oncology. The frameworks were created to provide clear, unbiased, and reliable assessments of the clinical benefits of new cancer treatments.

The 2 tools are similar but different. The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was developed to generate clear, valid, and unbiased grading of the magnitude of clinical benefit demonstrated in therapeutic studies that could be used for a number of purposes, including public health policy and health technology assessment, clinical decision making, medical publication, and journalism.

The ASCO Value Framework was developed primarily as a physician-guided tool to facilitate shared decision making by patients and oncologists in selecting a high-value therapy for an individual patient.

The ESMO version was published in 2015 and was revised in 2017. The ASCO Value Framework was published in 2015 and was revised in version 2016.

The researchers said the agreement found between the studies is more than what has been found in previous comparisons.

Of the 37 discordant studies that were identified, the authors said the major factors that contributed to the variance were different approaches to evaluation of relative and absolute gain for overall survival (OS) and progression-free survival (PFS), crediting tail of the curve gains, and assessing toxicity.

To improve convergence of the 2 frameworks, the findings recommended addressing 4 issues:

1. Future iterations of the ASCO framework should consider a more rigorous evaluation of the scoring system as it relates to absolute and relative benefit. ASCO authors have written that an ideal scale takes into consideration both absolute benefit and relative benefit gains, based on a numeric score derived from the hazard ratio. That approach is practical, but ignores the variability of the estimate and was not developed using a data-driven or statistically based approach, the study said.

2. The approach to the scoring of studies on the basis of PFS data must include adequate adjustments to ensure that the limitations of PFS as a surrogate for improved OS are fully expressed in the generated grades.

3. If long-term benefit is to be called tail of the curve, the criteria should reflect the true tail, or a different term should be used to avoid confusion.

4. Both frameworks have advantages and disadvantages with regard to toxicity penalties and the 2 approaches could consider incorporating elements from each one. The ASCO approach, which is intended to guide doctors and patients, accounts for low-grade toxicities that often affect patient activities of daily living, but the approach requires a more complicated adjudication of reported toxicities. The ESMO approach is simpler and accounts for important high-grade toxicities. But it may underestimate the effect of persistent, low-grade adverse events.

Reference

Cherny NI, de Vries EGE, Dafni U, et al. Comparative assessment of clinical benefit using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score. [published online December 17, 2018]. J Clin Oncol. doi: 10.1200/JCO.18.00729.