Rigshospitalet, Copenhagen University Hospital, Nordic Society of Gynaecologic Oncology–Clinical Trial Unit, Copenhagen, Denmark
Mansoor Raza Mirza , Matthew A. Powell , Caroline Lundgren , Vladyslav Sukhin , Bhavana Pothuri , Lucy Gilbert , Sarah Gill , Graziana Ronzino , Nicole Nevadunsky , Stefan Kommoss , Lyndsay Willmott , Ingrid Boere , Cara Amanda Mathews , Joseph Buscema , Michael Teneriello , Mark S. Shahin , Oren Meyers , Jamie Garside , Robert L. Coleman , Brian M. Slomovitz
Background: In RUBY, a phase 3, global, randomized, double-blind, placebo (PBO)-controlled trial, dostarlimab+carboplatin/paclitaxel demonstrated significant and clinically meaningful improvement in PFS compared with PBO+CP in pts with pA/rEC. PROs are reported here. Methods: 494 pts with pA/rEC were randomized 1:1 to dostarlimab (D)+CP or PBO+CP Q3W for 6 cycles followed by D or PBO monotherapy Q6W ≤3 yrs or to disease progression. EORTC QLQ-C30 and EN24 were prespecified secondary endpoints. PROs were administered on Day 1 of each treatment (tx) cycle (C), end of tx (EOT), and at safety and survival follow-ups and reported here for C7, the end of chemotherapy (chemo) and C13, and the end of 1 yr of study. Change (chg) from baseline (BL) to C7/C13 was calculated for all scales assessed. Mixed model for repeated measures analysis was conducted to generate least-squares means (LSM), adjusting for correlations across multiple time point assessments within a pt and controlling for the BL value for the global, pain, fatigue, and physical function (PF) scores. Results: PRO outcomes were similar for D+CP and PBO+CP through the chemo period (C7). The table shows selected scores at C7 and C13 for mean (SD) and chg from BL. Further, no differences across the 3 yr period between the 2 arms were reported; LSM (standard error) for global QoL was 0.5 (1.42; P=0.72), PF was −0.7 (1.39; P=0.63), fatigue was 0.2 (1.75; P=0.91) and pain was −1.0 (1.99; P=0.62). Mean chg from BL to EOT showed improvement in back/pelvic pain for D+CP and deterioration in global QoL/GHS, social functioning, body image, and chg in taste for pts on PBO+CP. Conclusions: Dostarlimab + CP significantly improved PFS while maintaining HRQoL, further supporting its use as a standard of care in pA/rEC. Clinical trial information: NCT03981796.
Domain: | D + CP BL Mean (SD) | D + CP BL to C7 Mean chg (SD) | D + CP BL to C13 Mean chg (SD) | PBO + CP BL Mean (SD) | PBO + CP BL to C7 Mean chg (SD) | PBO + CP BL to C13 Mean chg (SD) |
---|---|---|---|---|---|---|
Global QoL/GHS | 67.7 (21.63) | −1.8 (22.79) | 3.3 (23.51) | 69.7 (21.15) | −2.3 (23.10) | −0.9 (19.25) |
Physical Function | 77.7 (20.83) | −6.9 (22.82) | 2.4 (20.64) | 76.2 (21.92) | −6.8 (21.09) | −0.1 (18.22) |
Role Function | 73.9 (28.77) | −6.9 (34.88) | 4.6 (33.46) | 77.5 (28.89) | −8.4 (32.94) | −0.2 (28.17) |
Emotional Function | 76.2 (18.40) | 2.0 (18.75) | 5.4 (20.16) | 78.6 (19.41) | 2.5 (22.64) | 4.0 (19.85) |
Cognitive Function | 87.4 (16.96) | −4.8 (19.78) | −3.2 (16.95) | 88.7 (16.86) | −6.8 (21.70) | −4.6 (21.73) |
Social Function | 79.7 (24.70) | −3.8 (31.55) | 3.8 (25.90) | 83.0 (23.75) | −4.5 (27.08) | 1.8 (21.93) |
Pain* | −2.4 (19.40) | −3.6 (30.85) | −2.4 (34.02) | 25.2 (27.68) | 1.1 (26.34) | 2.1 (22.52) |
Fatigue* | 31.1 (22.57) | 10.3 (26.67) | −1.2 (22.73) | 30.2 (23.84) | 9.0 (26.78) | −2.4 (19.40) |
EN24 back/pelvic pain* | 29.0 (28.81) | −10.1 (31.89) | −5.6 (35.72) | 28.6 (31.25) | −6.3 (30.62) | −3.0 (25.90) |
*Lower scores indicate reduced symptom severity.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2023 ASCO Quality Care Symposium
First Author: Mansoor Raza Mirza
2020 ASCO Virtual Scientific Program
First Author: Rebecca Sophie Kristeleit
2020 ASCO Virtual Scientific Program
First Author: Mario Javier Pineda
2023 ASCO Annual Meeting
First Author: Zhen Zeng