CONFERENCE UPDATE: ESGO 2024

Long-term HRQoL outcomes of dostarlimab + chemotherapy in patients with primary advanced or recurrent EC from the RUBY trial

OBSTETRICS & GYNECOLOGY ONCOLOGY
08 May 2024

STUDY DESIGN

Dostarlimab in conjunction with carboplatin-paclitaxel (CP) has previously been shown to significantly improve progression-free survival (PFS) and overall survival (OS) outcomes compared with CP alone in patients with primary advanced or recurrent endometrial cancer (EC).1 This has led to its approval in the first line for EC patients in the mismatch repair deficient (dMMR) microsatellite instability-high (MSI-H) population.1 However, more data are required to describe the health-related quality of life (HRQoL) of this immunotherapy CP combination over extended periods.1

Previously, the RUBY trial included 494 patients who had stage III/IV EC or first recurrent EC.1 They were randomized 1:1 to receive dostarlimab 500mg (n=245) or a matching placebo (n=249) in addition to 6 cycles of carboplatin at area under the curve (AUC) of 5mg/mL/min and paclitaxel 175mg/m2 Q3W.1 This was followed by dostarlimab 1,000mg Q6W or a matching placebo for up to 3 years.1 The primary endpoints included PFS by investigator assessment and OS outcomes.1 Secondary endpoints included PFS by blinded independent central review (BICR), PFS2, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), HRQoL outcomes, as well as safety results.1

In this post-hoc analysis, the results of time-to-deterioration (TTD) of patient-reported outcomes (PROs) on HRQoL over time were been reported, allowing longitudinal comparisons of the trial arms.1 The analysis was conducted using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) and the Endometrial Cancer Module (QLQ-EN24).1 Time to first deterioration (TTD1) was defined by the first ≥10 points deterioration from baseline while time to permanent deterioration (TTDP) was defined by a deterioration of ≥10 points sustained at all subsequent time points.1

FINDINGS

TTD1 outcomes: 
  • TTD1 was defined as the first instance of a ≥10 points loss on functional scales or a ≥10 points gain on the symptom scale compared to the baseline1
  • Most domains in the EORTC QLQ-C30 directionally favored dostarlimab and CP in the dMMR/MSI-H population including global health status quality of life (GHS/QoL) (HR=0.63; 95% CI: 0.39-1.04)1
  • Dostarlimab and CP also lengthened TTD1 across the physical (HR=0.95; 95% CI: 0.59-1.52), role (HR=0.62; 95% CI: 0.39-1.00), emotional (HR=0.86; 95% CI: 0.51-1.47), cognitive (HR=0.70; 95% CI: 0.44-1.11), and social functioning (HR=0.58; 95% CI: 0.36-0.94) domains1
  • Aside from diarrhea (HR=1.23; 95% CI: 0.76-2.01), other symptom scales also had a longer time to TTD1 compared with dostarlimab and CP in the dMMR/MSI-H population1
  • However, no clear difference in TTD1 was observed between the two arms was observed in the overall population1
TTDP outcomes:
  • TTDP was defined as a ≥10 points loss on functional scales or a ≥10 points gain on the symptom scale compared to the baseline that was sustained at all subsequent time points1
  • Most domains in the EORTC QLQ-C30 directionally favored dostarlimab and CP in the dMMR/MSI-H population including global health status quality of life (GHS/QoL) (HR=0.27; 95% CI: 0.08-1.00)1
  • Dostarlimab and CP also delayed TTDP across the physical (HR=0.30; 95% CI: 0.08-1.07), role (HR=0.22; 95% CI: 0.06-0.79), emotional (HR=0.58; 95% CI: 0.10-3.35), cognitive (HR=0.34; 95% CI: 0.09-1.25), and social functioning (HR=0.65; 95% CI: 0.19-2.23) domains1
  • Favorable TTDP outcomes in terms of EORTC QLQ-EN24 for gastrointestinal symptoms (HR=0.91; 95% CI: 0.43-1.91) were also observed in the dMMR/MSI-H population1
  • Similarly, no clear difference in TTDP was observed between the two arms in the overall population1

 

“These findings, together with the PFS benefits, further support the use of dostarlimab + CP as a standard of care in patients with primary advanced or recurrent EC.

 

Dr. Ingrid Boere
Department of Medical Oncology,
Erasmus MC Cancer Centre,
The Netherlands

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