KEY TAKEAWAYS
- The AtTEnd phase III trial aimed to assess the efficacy of CP+atezo in pts with endometrial carcinomas.
- CP+atezo significantly improved PFS and QoL in endometrial carcinomas.
The AtTEnd trial demonstrated that combining atezolizumab (atezo) with carboplatin-paclitaxel chemotherapy (CP) enhanced progression-free survival (PFS) among patients (pts) with advanced or recurrent endometrial carcinomas (EC), particularly those with tumors deficient in mismatch repair. In this trial the patient-reported outcomes (PROs) were presented.
Yeh Chen Lee and the team focussed on unveiling whether combined atezo+CP improved progression-free survival (PFS) in advanced or recurrent endometrial carcinomas.
In this trial, pts were randomly assigned in a 2:1 ratio to receive CP+atezo (N=360) or placebo (PBO) (N=189). This was followed by maintenance treatment with atezo or PBO until disease progression. PROs were assessed using EORTC QLQ-C30, QLQ-EN24, and EQ-5D-5L questionnaires at baseline (BL), cycle 6 (C6) during the treatment phase, and cycle 8 (M8) during the maintenance phase.
Analysis of PROs utilized mixed models to examine score trends over time. Individual pts were treated as random effects to accommodate intra-patient variability, while trial treatment and BL values were treated as fixed effects in the statistical models.
They noted that PROs from 89% of pts (atezo arm N=323; PBO arm N=170) were analyzed. Global health status scores decreased at C6 and improved by M8 in the atezo arm, remaining lower than BL in PBO. At C6, most functional scales showed lower scores except emotional functioning. By M8, all functional scales improved, with social functioning rising above BL in both arms and role functioning improving above BL only in atezo. Symptom scales showed no differences between arms were seen except back/pelvic pain which significantly reduced from BL favoring atezo (P=0.023). EQ-5D-5L scores were similar across all time points in both arms.
Further data indicated that for global health status in the atezo arm, scores decreased by 1.8 at C6 but improved by 3.8 at M8 compared to BL, whereas, in the placebo arm, scores decreased by 5.5 at C6 and remained 2.5 points lower at M8 compared to BL. Functional scales showed varied responses: physical and role functioning improved at M8 in the atezo arm, while emotional and social functioning showed improvements in both arms by M8.
Symptom scales indicated reductions in fatigue and pain in the atezo arm at M8, particularly a significant decrease in back/pelvic pain (mean change -7.1) compared to placebo (mean change -2.7). EQ-5D-5L scores were comparable between the 2 arms across all time points, suggesting similar overall health-related quality of life outcomes.
The study concluded that preserved quality of life was demonstrated in both arms over time, irrespective of the initial decline in addition to the significant improvement in PFS, favoring the use of CP+atezo in pts with advanced or recurrent endometrial carcinomas.
The trial was sponsored by Mario Negri Institute for Pharmacological Research.
Source: https://cslide.ctimeetingtech.com/gynae24hybrid/attendee/confcal/show/session/10
Clinical Trial: https://clinicaltrials.gov/study/NCT03603184
Lee Y C, Colombo N, Harano K, et al. (2024). “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.” Presented at ESMO-GC 2024, (Abstract 36MO)
