36MO Patient-reported outcomes in primary advanced or recurrent endometrial carcinoma treated with atezolizumab or placebo in combination with carboplatin-paclitaxel in the AtTEnd/ENGOT-EN7 trial

The AtTEnd trial showed that adding atezolizumab (atezo) to carboplatin-paclitaxel chemotherapy (CP) improved progression free survival (PFS) in patients (pts) with advanced/recurrent endometrial carcinomas (EC), especially those with mismatch repair deficient tumours. Here we report the patient-reported outcomes (PROs). Pts were randomized (2:1) to receive CP plus atezo (N=360) or placebo (N=189), followed by maintenance atezo or placebo until disease progression. EORTC QLQ-C30, QLQ-EN24 and EQ-5D-5L questionnaires were analysed at baseline (BL), cycle 6 (C6) of treatment phase, and cycle 8 (M8) of maintenance phase. Mixed models were used to analyze score trends over time, with individual pts treated as random effects to account for intra-patient variability, and trial treatment and baseline values treated as fixed effects. PROs completed were evaluable for 89% pts (atezo arm, N=323; placebo arm, N=170). Although no statistically differences were detected, global health status scores decreased at C6 but improved by M8 above BL in atezo arm, remaining lower than BL in placebo arm (Table). At C6, pts reported lower scores in most functional scales except for emotional functioning. By M8, all functional scales showed improvement, with social functioning increased above BL in both arms and role functioning increased above BL in atezo arm only. No differences in symptom scales were reported between two arms, except for back/pelvic pain score where a significant reduction in severity from BL was observed in favour of atezo vs placebo arm (p=0.023). Mean scores on the EQ-5D-5L were similar at all time points in both arms.Table: 36MOAtezoPlaceboC6-BLM8-BLC6-BLM8-BLQLQ-C30Global health status-1.8 (22)3.8 (19)-5.5 (21)-2.5 (21)Functional scalesPhysical-5.1 (19)-2.8 (16)-7.3 (18)-3.5 (15)Role-6.4 (30)0.6 (24)-8.1 (33)-1.4 (27)Emotional4.6 (22)8.0 (18)3.8 (19)6.2 (18)Social-4.7 (26)2.4 (23)-5.1 (24)1.7 (22)Symptom scales*Fatigue8.6 (26)1.3 (18)9.6 (25)0.2 (21)Pain-2.5 (30)-0.6 (24)-2.6 (31)-4.4 (23)Nausea/vomiting2.6 (17)-0.2 (11)3.7 (20)1.0 (15)Dyspnoea4.9 (26)2.6 (19)8.3 (28)3.5 (22)Appetite loss-2.7 (33)-7.8 (24)1.9 (30)-3.4 (26)QLQ EN24 Symptom scales*Pain in back-pelvis-7.1 (31)-4.7 (28)-2.7 (28)-0.0 (18)Numbers are mean (SD), *lower scores indicate reduced symptom severity. Open table in a new tab Numbers are mean (SD), *lower scores indicate reduced symptom severity. Quality of life was maintained over time in both arms, even if an initially reduction could not be excluded. Coupled with the significantly improved PFS, these findings support the use of CP plus atezo in advanced/recurrent EC.