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This report describes the impact of incidence, severity and duration of late gastrointestinal (GI) morbidity after radiochemotherapy on Quality of Life (QoL) in locally advanced cervix cancer patients using the Months and Severity Score (MOSES) method.

EMBRACE-I is a prospective, observational, multicentre cohort study (1416 patients, 2008-2015).  Physician-assessed (CTCAE v.3) and patient-reported outcomes (EORTC C30) were collected during follow-up at intervals of 3 months in the 1st year, 6 months in next 2 years, and annually thereafter. CTCAE scores were converted into MOSES score which integrates severity of symptoms over time by imputing proportionate time weightage (P) to CTCAE grade (S) by using the mathematical formula Ʃ(PxS). This score was calculated for each GI symptom (diarrhea, flatulence, incontinence, proctitis, stenosis, fistula, bleeding) and then summated to determine cumulative MOSES (C-MOSES). The EORTC C30 questionnaire was used to calculate five functioning subscales: physical, role, emotional, cognitive, social and global health/QoL by linear transformation into a continuous scale (0-100 score), according to EORTC guidelines. Different patient subgroups were identified based on: CTCAE maximum grade during follow-up (CTCAE ≥G1, ≥G2 and ≥G3) and C-MOSES ≥2.0 (90th percentile), and ≥2.5 (94th percentile) (Fig1, Table1). Inter-group comparison was carried out for the mean QoL score of each functional subscale.

Of 1416 patients, 977 patients had both CTCAE and QoL data available. The median follow-up was 48 months. The C-MOSES groups ≥2.0 and ≥2.5 include patients with CTCAE maximum G1 to G4 suggesting that these groups include both patients with severe toxicity (≥G3) as well as patients with considerably persistent moderate (G1 and G2) toxicity (Table1). Fig1 shows the mean values of QoL functional subscales for different subgroups of patients. The inter-group comparisons suggest differences in mean QoL of varying magnitude. In summary, patients with higher CTCAE maximum grades had worse QoL. Patients with C-MOSES ≥ 2.0 and C-MOSES ≥ 2.5 had in most instances worse QoL than patients with incidence of ≥G1, ≥G2 and ≥G3, respectively. The subgroup of patients with C-MOSES ≥ 2.5 and CTCAE maximum grade combined showed further deteriorating mean scores of medium to small magnitude, compared to the maximum method, indicating clinical relevance. (Cocks et al.,2012). For example, for role function, the mean QoL scores in patient groups with maximum G1, G2 and G3 were 15-22 points lower when maximum grade was also combined with C-MOSES ≥ 2.5 (Fig 1).

This analysis demonstrated that C-MOSES combined with CTCAE maximum grade method can identify specific groups of patients with worse QoL. This finding highlights the need to take into account not only the maximum severity of toxicity after treatment but also the cumulative duration of each severity grade over time.