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Clinical Trials of High-intensity Focused Ultrasound for Cancer: Concerns Arising from Low Post-Hoc Power
- Source: Current Medicinal Chemistry, Volume 32, Issue 1, Jan 2025, p. 2 - 5
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- 12 Sep 2023
- 22 Dec 2023
- 07 Feb 2024
Abstract
Prospective controlled trials of high-intensity focused ultrasound (HIFU) for cancers were evaluated. Post-hoc power was <0.80 in 30/46 trials and in 22/38 trials with positive results, indicating low quality in most trials. Unscientific endpoints, small sample sizes, and high dropout rates led to low post-hoc power that caused inter-trial heterogeneity and overestimated the therapeutic effect. The objective response rate was not a substitute for survival time for estimating the sample size and assessing the efficacy. The present data can interpret a paradox: HIFU is considered to have slighter cytotoxicity to non-cancer tissues and no radiation but is frequently combined with chemotherapy and/or radiotherapy in practice.