College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea.
Department of Pharmacy, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Cancer Med. 2024 Apr;13(7):e7142. doi: 10.1002/cam4.7142.
This study aims to investigate the use of steroids as antiemetics in clinical trials involving immune checkpoint inhibitors with chemotherapy.
Focusing on phase III trials registered before August 2023, it evaluated the consistency of steroid use guidelines.
Out of 3452 trials screened, 44 were selected for in-depth review. The findings indicate a considerable variation: 13 trials did not specify the use of antiemetics, while 31 provided criteria for antiemetics, with 13 conforming to local standards, six to international guidelines, and five allowing either. Seven trials recommended effective antiemetics without detailed criteria. This inconsistency led to a range of steroid dosages, with only 11 trials advocating for minimizing or avoiding steroids for antiemetic purposes.
The research highlights the lack of uniformity in antiemetic steroid use in trials, reflecting diverse clinical practices and underscoring the need for further research to understand the implications on treatment outcomes.
本研究旨在调查在涉及化疗的免疫检查点抑制剂的临床试验中使用类固醇作为止吐药的情况。
本研究聚焦于 2023 年 8 月之前注册的 III 期试验，评估了类固醇使用指南的一致性。
在筛选出的 3452 项试验中，有 44 项被选作深入审查。研究结果表明存在相当大的差异：13 项试验未具体说明止吐药的使用，而 31 项提供了止吐药的标准，其中 13 项符合当地标准，6 项符合国际指南，5 项允许使用任何一种。7 项试验建议使用有效的止吐药，但没有详细的标准。这种不一致导致了类固醇剂量的差异，只有 11 项试验主张为了止吐目的最小化或避免使用类固醇。
研究结果强调了试验中抗呕吐类固醇使用缺乏统一性，反映了不同的临床实践，并强调需要进一步研究以了解其对治疗结果的影响。
