Patient-reported Outcomes in Patients With Primary Advanced or Recurrent Endometrial Cancer Who Received Dostarlimab Plus Carboplatin-Paclitaxel vs Carboplatin-Paclitaxel in the ENGOT-EN6/GOG3031/RUBY Trial.

Background: RUBY (NCT03981796) is a phase 3, randomized, placebo-controlled trial in patients with primary advanced or recurrent endometrial cancer (pA/rEC). In RUBY, dostarlimab plus carboplatin-paclitaxel (D+CP) demonstrated clinically meaningful efficacy in patients with pA/rEC, including a significant improvement in progression-free survival (PFS), compared with placebo (PBO) plus carboplatin-paclitaxel (PBO+CP).1 Objective: To examine and report similarities and differences in patient-reported outcomes (PROs) in patients with pA/rEC who received either D+CP or PBO+CP in the phase 3 RUBY trial. Methods: A total of 494 patients with pA/rEC were randomized 1:1 to receive either D+CP or PBO+CP every 3 weeks for 6 cycles, followed by D or PBO alone every 6 weeks for up to 3 years or until disease progression. As a secondary endpoint, PRO questionnaires for patients with any cancer (ie, the European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30) and for patients with endometrial cancer (ie, EORTC QLQ-EN24) were administered on day 1 of each treatment cycle (C), at end of treatment, and at safety and survival follow-up points. Changes in patients' scores over time were calculated using mixed model for repeated measures analyses, and least-squares means (LSMs) were used to quantify the difference between treatment arms in change observed in patients' scores over time. Results are reported here for C7 (the end of chemotherapy) and C13 (the end of 1 year of study follow-up). Results: PRO scores were similar in patients who received D+CP and PBO+CP through the chemotherapy period (C7). After 1 year of study follow-up (C13), the mean change in global health status/quality-of-life (GHS/QoL) score from baseline was 3.3 (SD, 23.51) with D+CP, and -0.9 (SD, 19.25) with PBO+CP (positive score indicates improvement; ≥10-point change was considered clinically meaningful). Over the 3-year study period, no differences between the 2 treatment arms were detected (P≥.05 indicated no significant difference) based on LSMs; more specifically, GHS/QoL was 0.5 (P=.72), physical function was -0.7 (P=.63), fatigue was 0.2 (P=.91), and pain was -1.0 (P=.62). At the end of study treatment, patients who received D+CP reported improvement in back/pelvic pain compared with baseline; patients receiving PBO+CP reported worsening of GHS/QoL, social functioning, body image, and change in taste compared with baseline. Conclusions: In this study, patients with pA/rEC receiving D+CP experienced significantly improved PFS while maintaining health-related QoL. These findings further support the use of D+CP as a standard of care in treating patients with pA/rEC. Funding: This study was sponsored by GSK. Editorial support provided by ArticulateScience, LLC, and funded by GSK. [ABSTRACT FROM AUTHOR]