Cumulative gastrointestinal adverse events in EMBRACE-I: comparative evaluation of CTCAE vs. MOSES methods in predicting the impact of incident vs. persistent adverse events on quality of life.

Abstract

This report describes the impact of incidence, severity, and time spent in late gastrointestinal (GI) adverse events (AEs) after radio chemotherapy on Quality of Life (QoL) in locally advanced cervical cancer patients. The Months and Severity Score (MOSES) was applied to late GI AEs (CTCAEv.3) in patients enrolled in the prospective EMBRACE-I study. MOSES scores accumulated severity and duration of diarrhea, flatulence, incontinence, proctitis, stenosis, fistula, bleeding, and MOSES scores for each endpoint were summed to cumulative MOSES (C-MOSES). Functioning (physical, role, emotional, cognitive, social) and QoL scales were assessed using EORTC C30 questionnaire. Patients were grouped according to two C-MOSES cut-offs (0.7 and 2.0). Of 1416 patients included in EMBRACE-I, 977 had both CTCAE and EORTC-C30 data available. The median follow-up was 53 months. C-MOSES ≥ 0.7 was associated with significantly lower functioning and QoL scores than C-MOSES < 0.7. Among patients with G1 AEs, 27.4% had C-MOSES ≥ 0.7, indicating that persistent low-grade symptoms can contribute substantially to burden. C-MOSES ≥ 2.0 was present in 9% of the patient population and was associated with even lower functioning and QoL scores. C-MOSES ≥ 2.0 was most often observed in patients with ≥ 4 AEs (75%). Diarrhea and flatulence had the highest contribution to C-MOSES scores. C-MOSES combined with CTCAE maximum grade method identified patients with a higher AE burden over time and worse QoL. This highlights the need to consider cumulative impact of incidence, severity, and duration of AE in assessments, reporting, and analysis.