This randomized, double‑blind, placebo‑controlled trial assessed whether adding dostarlimab to standard carboplatin–paclitaxel chemotherapy improves quality‑adjusted and overall survival in primary advanced or recurrent endometrial carcinoma.
A total of 487 patients were randomized (241 dostarlimab; 246 placebo). Subjects received six 21‑day cycles of dostarlimab or placebo alongside carboplatin (AUC 5–6) and paclitaxel (175 mg/m²), followed by monotherapy every six weeks for up to 36 months. Quality of life was measured using the EuroQoL 5‑Dimensions 5‑Level (EQ‑5D‑5L) questionnaire. An interim analysis was conducted as of September 28, 2022.
The dostarlimab arm achieved a mean quality‑adjusted time without symptoms or toxicity (Q‑TWiST) of 24.75 versus 20.34 months in the placebo cohort (difference: 4.41 months; p < 0.001). Benefits persisted regardless of mismatch repair or microsatellite instability status and were primarily driven by extended symptom‑free intervals. Additionally, overall survival was superior in the dostarlimab group. Adverse event rates and severity were comparable between arms, with no novel safety concerns.
Therefore, integrating dostarlimab into platinum– taxane regimens yields significant improvements in both quality‑adjusted and overall survival. Nevertheless, longer follow‑up and comprehensive overall survival data are warranted to validate durability and guide clinical practice.
