Rigshospitalet, Copenhagen University Hospital, Denmark, Nordic Society of Gynaecologic Oncology–Clinical Trial Unit, Copenhagen, Denmark
Mansoor Raza Mirza, Mark S. Shahin, Matthew A. Powell, Caroline Lundgren, Vladyslav Sukhin, Bhavana Pothuri, Lucy Gilbert, Sarah Gill, Graziana Ronzino, Nicole Suzanne Nevadunsky, Stefan Kommoss, Lyndsay Willmott, Ingrid Boere, Cara Amanda Mathews, Joseph Buscema, Michael Teneriello, Oren Meyers, Jamie Garside, Robert L. Coleman, Brian M. Slomovitz
Background: In RUBY (NCT03981796), a phase 3, global, randomized, double-blind trial, D+CP demonstrated significant and clinically meaningful improvement in PFS vs placebo + CP (P+CP) in pA/rEC. Methods: 494 pts with pA/rEC were randomized 1:1 to D+CP or P+CP Q3W for 6 cycles (C), followed by D or placebo monotherapy Q6W for ≤2 y. EORTC QLQ-C30 and EN24 (prespecified secondary endpoints) were administered on day 1 of each C, at end of treatment (EOT), and at safety and survival follow-ups. Change (chg) from baseline (BL) to C7 (end of chemotherapy) and C13 (1 y) was calculated in the overall and mismatch repair–deficient (dMMR)/microsatellite instability–high (MSI-H) populations. Least-squares means (LSM) were generated using mixed models for repeated measures, adjusting for correlations across multiple assessments within a pt and controlling for BL global, pain, fatigue, and physical function (PF) scores. Results: In the overall population, PROs were similar with D+CP and P+CP through C7, and no differences between arms across the 3-y period were reported; mean chg from BL to EOT showed numerical improvement with D+CP in back/pelvic pain and deterioration with P+CP in global QOL/GHS, social function (SF), body image, and chg in taste. In the dMMR/MSI-H population, at C7, nominally significant improvements in QOL, PF, role function (RF), pain, and back/pelvic pain were seen with D+CP vs P+CP (Table). Conclusions: Dostarlimab+CP significantly improved PFS and maintained HRQOL in dMMR/MSI-H and overall populations, further supporting its use as a standard of care in pA/rEC. Clinical trial information: NCT03981796.
dMMR/MSI-H | Overall | ||||||||
---|---|---|---|---|---|---|---|---|---|
C7 | C13 | C7 | C13 | ||||||
D+CP | P+CP | D+CP | P+CP | D+CP | P+CP | D+CP | P+CP | ||
GHS/QOL | 1.4 (23.33)a | −6.0 (26.12) | 9.2 (17.30) | −8.5 (15.86) | −1.8 (22.79) | −2.3 (23.10) | 3.3 (23.51) | −0.9 (19.25) | |
PF | −1.6 (15.64)a | −6.4 (22.14) | 7.7 (14.01) | −5.2 (10.26) | −6.9 (22.82) | −6.8 (21.09) | 2.4 (20.64) | −0.1 (18.22) | |
RF | 4.8 (33.12)a | −12.2 (31.87) | 10.6 (33.66) | −10.7 (23.01) | −6.9 (34.88) | −8.4 (32.94) | 4.6 (33.56) | −0.2 (28.17) | |
Emotional function | 3.6 (15.56) | 1.0 (28.66) | 5.8 (14.17) | 2.9 (20.49) | 2.0 (18.75) | 2.5 (22.64) | 5.4 (20.16) | 4.0 (19.85) | |
Cognitive function | −3.8 (17.13) | −9.1 (27.92) | −1.3 (17.64) | −7.3 (19.35) | −4.8 (19.78) | −6.8 (21.70) | −3.2 (16.95) | −4.6 (21.73) | |
SF | 0.0 (30.08) | −9.8 (25.22) | 6.1 (24.00) | −2.4 (18.34) | −3.8 (31.55) | −4.5 (27.08) | 3.8 (25.90) | 1.8 (21.39) | |
Painb | −13.6 (26.71)a | 6.6 (26.10) | −9.3 (31.24) | 8.3 (21.60) | −3.6 (30.85) | 1.1 (26.34) | −2.4 (34.02) | 2.1 (22.52) | |
Fatigueb | 5.1 (22.15) | 12.3 (26.90) | −5.4 (21.27) | 0.1 (17.36) | 10.3 (26.67) | 9.0 (26.78) | −1.2 (22.73) | −2.4 (19.40) | |
Back/pelvic painb | −17.6 (25.42)a | −5.0 (32.99) | −16.1 (29.85) | 2.5 (35.64) | −10.1 (31.89) | −6.3 (30.62) | −5.6 (35.72) | −3.0 (25.90) |
aNominally significant LSM difference between arms (P<.05). bLower scores indicate reduced symptom severity.
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Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Mansoor Raza Mirza
2020 ASCO Virtual Scientific Program
First Author: Mansoor Raza Mirza
2020 ASCO Virtual Scientific Program
First Author: Rebecca Sophie Kristeleit
2023 ASCO Annual Meeting
First Author: Bradley Corr