Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial

Authors

Shannon N Westin
Kathleen Moore
Hye Sook Chon
Jung-Yun Lee
Jessica Thomes Pepin
Michael Sundborg
Ayelet Shai
Joseph de la Garza
Shin Nishio
Michael A Gold
Ke Wang
Kristi McIntyre
Todd D Tillmanns
Stephanie V Blank
Ji-Hong Liu
Michael McCollum
Fernando Contreras Mejia
Tadaaki Nishikawa
Kathryn Pennington
Zoltan Novak
Andreia Cristina De Melo
Jalid Sehouli
Dagmara Klasa-Mazurkiewicz
Christos Papadimitriou
Marta Gil-Martin
Birute Brasiuniene
Conor Donnelly
Paula Michelle Del Rosario
Xiaochun Liu
Els Van Nieuwenhuysen
DUO-E Investigators

Publication Date

1-20-2024

Journal

Journal of Clinical Oncology

DOI

10.1200/JCO.23.02132

PMID

37864337

PMCID

PMC10824389

PubMedCentral® Posted Date

October 2023

PubMedCentral® Full Text Version

Post-print

Abstract

PURPOSE: Immunotherapy and chemotherapy combinations have shown activity in endometrial cancer, with greater benefit in mismatch repair (MMR)-deficient (dMMR) than MMR-proficient (pMMR) disease. Adding a poly(ADP-ribose) polymerase inhibitor may improve outcomes, especially in pMMR disease.

METHODS: This phase III, global, double-blind, placebo-controlled trial randomly assigned eligible patients with newly diagnosed advanced or recurrent endometrial cancer 1:1:1 to: carboplatin/paclitaxel plus durvalumab placebo followed by placebo maintenance (control arm); carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib placebo (durvalumab arm); or carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib (durvalumab + olaparib arm). The primary end points were progression-free survival (PFS) in the durvalumab arm versus control and the durvalumab + olaparib arm versus control.

RESULTS: Seven hundred eighteen patients were randomly assigned. In the intention-to-treat population, statistically significant PFS benefit was observed in the durvalumab (hazard ratio [HR], 0.71 [95% CI, 0.57 to 0.89];

CONCLUSION: Carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab with or without olaparib demonstrated a statistically significant and clinically meaningful PFS benefit in patients with advanced or recurrent endometrial cancer.

Keywords

Female, Humans, Antibodies, Monoclonal, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Endometrial Neoplasms, Neoplasm Recurrence, Local, Paclitaxel, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Double-Blind Method

Published Open-Access

yes

Recommended Citation

Westin, Shannon N; Moore, Kathleen; Chon, Hye Sook; et al., "Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial" (2024). Faculty, Staff and Student Publications. 2330.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/2330