Background: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS) is a validated and reproducible tool to assess the magnitude of clinical benefit from drugs for solid tumors. Here, we evaluate characteristics and outcomes of clinical trials supporting drugs used in advanced Soft Tissue Sarcomas (STS) and GIST and their association with ESMO-MCBS.Methods: We reviewed publications between January 1990 and December 2020 that support the recommendations of NCCN (National Comprehensive Cancer Network) guidelines version 1.2021 for treatment of advanced STS and GIST. We collected data on trial characteristics, efficacy, toxicity and quality of life (QoL). For each trial, ESMO-MCBS grades were applied. Substantial clinical benefit was defined as a grade 4 or 5 (in a scale from 1 to 5).Results: Among the 23 trials for which the ESMO-MCBS could be applied (23/57 -40.4%-), 13 (56.5 %) were randomized controlled trials (RCT; 8 phase III and 5 phase II trials), and 10 (43.5%) were single arm trials. Eighteen (78.2%) involved STS and 5 (21.8%) GIST. Six trials (26.1% of all trials and 46.1% of RCT) demonstrated improvement in overall survival. QoL was reported in 7 (30.4%) trials. Among these, only 3 (42.9%) showed improvement in QoL. Only 9 (39.1 %) trials met the ESMO-MCBS substantial benefit threshold (5/18 involving STS and 4/5 involving GIST). Of these 9 trials, 8 (88.8%) were RCT (4 phase III and 4 phase II). All 3 trials that demonstrated improvement in QoL showed substantial benefit according to the scale.Conclusions: Only 39.1% of trials supporting the use of drugs in patients with advanced STS and GIST meet the threshold for substantial benefit using ESMO-MCBS. These results suggest that randomized trials with QoL assessment are more likely to achieve the ESMO-MCBS substantial benefit threshold. Only a quarter of the trials showed improvement in OS.
TEAEs occurring in !15% of pts and grade 3e4 TEAEs occurring in !5% of pts are shown. TEAEs were defined as adverse events that started or worsened on or after the day of the first TAZ dose up to 30 days after the last dose. abstracts Annals of Oncology Volume 31 -Issue S4 -2020 S981
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.