The following is a summary of “Importance of Low- and Moderate-Grade Adverse Events in Patients’ Treatment Experience and Treatment Discontinuation: An Analysis of the E1912 Trial,” published in the October 2023 issue of Oncology by O’Connell, et al.

Despite the existence of defined grades (1 to 5) for adverse events (AEs) based on Common Terminology Criteria for Adverse Events criteria, mild (G1) and moderate (G2) AEs often go unreported in phase III trials, hindering our understanding of patient toxicity burden. For a study, researchers sought to explore the relationship between the grades of AEs, patient-reported side-effect bother, and treatment discontinuation.

Each additional G1 and G2 AE experienced during a treatment cycle increased the odds of heightened self-reported patient side-effect bother by 13% (95% CrI, 1.06 to 1.21) and 35% (95% CrI, 1.19 to 1.54), respectively. Notably, only symptomatic AEs were associated with increased side-effect bother, while asymptomatic AEs showed no association irrespective of grade. The count of G2 AEs raised the odds of treatment discontinuation by 59% (95% CrI, 1.32 to 1.95), with symptomatic G2 AEs exhibiting a stronger association (OR, 1.75; 95% CrI, 1.28 to 2.39) compared to asymptomatic G2 AEs (OR, 1.45; 95% CrI, 1.12 to 1.89).

Low- and moderate-grade AEs were correlated with increased odds of heightened patient side-effect bother and treatment discontinuation. Symptomatic AEs exhibit a greater magnitude of association than asymptomatic ones. The findings underscored the importance of capturing AEs of all grades, as limiting AE reporting to grade 3 and above may overlook crucial contributors to treatment side-effect bother and discontinuation.

Source: ascopubs.org/doi/10.1200/JCO.23.00377