KEY TAKEAWAYS
- The phase II trial aimed to assess RUBY part 1’s impact on patient well-being by measuring Q-TWiST.
- The results demonstrated that dostarlimab+CP extends both lifespan and symptom-free quality time.
The RUBY study investigated dostarlimab combined with standard therapy (carboplatin-paclitaxel) versus standard therapy alone in advanced or recurrent endometrial cancer patients. So, for this phase 2 study, researchers aimed to explore quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) in RUBY part 1.
The study included 494 patients (safety population, N=486); individuals were assigned in a 1:1 ratio to either receive dostarlimab+chemotherapy(CP) or placebo+CP every 3 weeks for a minimum of 6 cycles, followed by dostarlimab or placebo every 6 weeks for up to 3 years.
The Q-TWiST was computed based on the sum product of mean survival time (months) within three distinct states—Time Without Symptoms of progression or toxicity (TWiST), toxicity (duration from randomization to progression with Grade ≥3 adverse events), and relapse (period from progression to any-cause death)—utilizing the quality of life data (EQ-5D-5L) for each state.
Overall, with a median follow-up of 20.5 months, mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) patients exhibited a significantly longer restricted mean Q-TWiST in the dostarlimab+CP group compared to the CP group (P<0.001*) (difference: 5.4 months; actual restricted mean: 22.7 versus 17.2 months, respectively).
Similarly, Q-TWiST was significantly longer in the dostarlimab+CP group for MMR-proficient/microsatellite-stable (MMRp/MSS) patients (P<0.001*), with a difference of 2.6 months (actual restricted mean: 22.6 vs 20.1 months, respectively).
These findings indicate clinically meaningful improvements in Q-TWiST for both MMRp/MSS and dMMR/MSI-H populations in the dostarlimab+CP group, with mean survival gains of 2.6 and 5.4 months, respectively. Similar outcomes were observed with Grade ≥2 adverse events(AEs) included in the toxicity definition.
The results demonstrated that dostarlimab+CP extends both lifespan and symptom-free quality time.
Source: https://www.emma.events/site/programme/?sessiondetail=4534549&trackid=0&a=esgo2023#!
Clinical Trial: https://clinicaltrials.gov/study/NCT03981796
Chase, D., Bjørge, L., Coleman, R. L., et al. (2023). “Quality-Adjusted Time Without Symptoms Of Disease Or Toxicity In Patients With Primary Advanced Or Recurrent Endometrial Cancer Treated With Dostarlimab Plus Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel In The ENGOT-EN6/GOG-3031/RUBY Trial.” Presented at the ESGO Congress 2023. (Abstract 267)
