Assessing Clinical Value of New Treatment Strategies: ESMO-MCBS and ASCO-VF Evaluation in Phase III Trials at ASCO Annual Meeting 2022.

Abstract

Purpose: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the ASCO Value Framework (ASCO-VF) are tools designed to assess the value of anticancer therapies. International conferences are the primary venues for sharing trial outcomes, often influencing clinical practices even before full publications are available. This analysis compares the ESMO-MCBS and ASCO-VF in evaluating the benefit of all phase III trials presented at the 2022 ASCO Annual Meeting (AM) and to examine the level of agreement between these scales.

Methods: A systematic search of abstracts from the 2022 ASCO AM was conducted, focusing on phase III trial data presented. The clinical benefit of each abstract was assessed using both ESMO-MCBS and ASCO-VF, and Cohen's κ coefficients were calculated to analyze concordance between the tools.

Results: Out of 239 phase III trial abstracts, 90 trials involving 49,721 patients met the inclusion criteria. Of these, 36 (40%) could not be graded by ESMO-MCBS, mainly because of nonsignificant results. Among the 54 gradable abstracts, 61.1% (n = 33) were deemed to provide substantial clinical benefit. ASCO-VF was unable to grade 40 (44.4%) abstracts, with nonsignificant results being the leading cause. Of the 50 gradable abstracts, 20% (n = 10) were considered to offer substantial clinical benefit. Moderate agreement between ESMO-MCBS and ASCO-VF was observed (Cohen's kappa, 0.4783 [95% CI, 0.3673 to 0.6034]). No significant association was found between clinical benefit and research funding or the economic status of the trial's origin country.

Conclusion: Both frameworks showed a high rate of nongradable studies, primarily because of nonsignificant results. ESMO-MCBS identified more studies with substantial clinical benefit, and the agreement between the two tools was moderate.