Application of ASCO value framework to compare the efficacy of treatment options for hepatocellular carcinoma (HCC) found higher scores among FDA-approved therapies than those that were not (JCO Oncol Pract. 2021;OP2000558. doi:10.1200/OP.20.00558).
“Determination of the comparative efficacy of one therapy over another for [HCC] can be challenging,” explained Emerson Y Chen, MD, Division of Hematology Oncology, Oregon Health & Science University, Knight Cancer Institute (Portland), and colleagues.
“Application of a recognized value framework to published studies could objectively compare the potential benefit across available therapies,” they continued.
Dr Chen and colleagues performed an umbrella review of phase 3 trials for HCC. The primary analysis calculated ASCO Value Framework Net Health Benefit Score versions 2 scores. The secondary analysis calculated European Society of Medical Oncology Magnitude of Clinical Benefit Scale version 1.1 scores.
Both scores were used to compare drugs approved by the FDA to those that are not by the year 2020.
A total of 22 phase 3 trials for HCC therapies were identified. Of these, 9 were FDA-approved drugs, and 13 were not. The median overall survival (OS) across the studies was 9.2 months with a median gain of .35 month.
Overall, therapies approved by the FDA demonstrated longer OS (median, 10.7 vs 7.9 months; P <.01) and higher ASCO Net Health Benefit scores (+18.4 vs -5.7; P <.01). Median OS gain was 2.2 months with approved treatments versus -.3 months with unapproved drugs. No progression-free survival difference was noted between the groups.
“The nine FDA-approved therapies for HCC have higher mean [Net Health Benefit] score than those that were not FDA-approved. The application of ASCO [Net Health Benefit] v2 and other proposed value frameworks could examine data of future therapies for HCC through a patient-oriented approach,” concluded Dr Chen and colleagues.—Janelle Bradley