Inconsistency in steroid use as antiemetics in clinical trial protocols involving immune checkpoint inhibitors combined with chemotherapy.

Abstract

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.