Evidence mapPaperPMID 40590327Full record

Trial reportJournal of gynecologic oncology2025

Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer: Japan subset from the phase III DUO-E trial.

Shin Nishio, Tadaaki Nishikawa, Masahiko Mori, Shoji Kamiura, Toshiyuki Sumi, Mayu Yunokawa, Yuichi Imai, Eiji Kondo, Kazuhiro Takehara, Hirokuni Takano and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04269200 (A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04269200 phase3active not recruitingnot on this map

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)

TypeinterventionalSponsorAstraZenecaRan2020 to 2027Enrolled805ConditionsEndometrial NeoplasmsArmsolaparib, durvalumab, durvalumab placebo, olaparib placebo, Carboplatin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Shin NishioDepartment of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Japan. shinshin@med.kurume-u.ac.jp.ORCID 0000-0003-2526-630X
Tadaaki NishikawaDepartment of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-2606-4208
Masahiko MoriDepartment of Gynecologic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0003-3673-384X
Shoji KamiuraDepartment of Gynecology, Osaka International Cancer Institute, Osaka, Japan.ORCID 0000-0002-5723-8891
Toshiyuki SumiDepartment of Obstetrics and Gynecology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.ORCID 0000-0002-7734-4173
Mayu YunokawaDepartment of Gynecologic Oncology and Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0001-7354-6977
Yuichi ImaiDepartment of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, Japan.ORCID 0000-0001-7347-9719
Eiji KondoDepartment of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Japan.ORCID 0000-0001-9773-2520
Kazuhiro TakeharaDepartment of Gynecologic Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.ORCID 0000-0001-8808-3338
Hirokuni TakanoDepartment of Obstetrics and Gynecology, The Jikei University Kashiwa Hospital, Kashiwa, Japan.ORCID 0000-0002-6465-7883
Wataru KudakaDepartment of Obstetrics and Gynecology, Graduate School of Medicine, University of the Ryukyus, Nakagami, Japan.ORCID 0000-0002-7600-074X
Nobuhiro KadoDepartment of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.ORCID 0000-0002-6474-9796
Wataru YamagamiDepartment of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.ORCID 0000-0003-3925-6057
Hidenori KatoDivision of Gynecologic Oncology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.ORCID 0009-0004-1612-6027
Koji NishinoDepartment of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.ORCID 0000-0001-6218-8641
Tomoka UsamiDepartment of Obstetrics and Gynecology, Ehime University School of Medicine, Toon, Japan.ORCID 0009-0004-5742-6421
Junzo HamanishiDepartment of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-7750-0623
Masahiro NiiResearch and Development, AstraZeneca KK, Osaka, Japan.ORCID 0009-0001-8271-188X
Itsumi TakayaResearch and Development, AstraZeneca KK, Osaka, Japan.ORCID 0009-0002-0555-5542
Aikou OkamotoDepartment of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.ORCID 0000-0002-5079-0464

Funding

AstraZeneca
6 · The paper itself

Abstract

objectiveDUO-E/GOG-3041/ENGOT-EN10 (NCT04269200) demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvement with durvalumab plus carboplatin/paclitaxel, followed by durvalumab with or without olaparib, vs. carboplatin/paclitaxel alone (intention-to-treat [ITT] population) in patients with newly diagnosed advanced or recurrent endometrial cancer. We evaluated efficacy and safety in the Japan subset of DUO-E.

methodsPatients with newly diagnosed International Federation of Gynecology and Obstetrics stage III/IV or recurrent endometrial cancer were randomized 1:1:1 to control arm (carboplatin/paclitaxel + durvalumab placebo [6 cycles] followed by durvalumab placebo + olaparib placebo), durvalumab arm (carboplatin/paclitaxel + durvalumab [1,120 mg every 3 weeks] [6 cycles] followed by durvalumab [1,500 mg every 4 weeks] + olaparib placebo), or durvalumab + olaparib arm (carboplatin/paclitaxel + durvalumab [6 cycles] followed by durvalumab + olaparib [300 mg twice a day]). Dual primary endpoints were investigator-assessed PFS for durvalumab and durvalumab + olaparib arms vs. control. This prespecified exploratory analysis evaluated PFS and safety in the Japan subset.

resultsIn the Japan subset (n=88) PFS favored durvalumab (hazard ratio=0.61, 95% confidence interval [CI]=0.32-1.12) and durvalumab + olaparib (0.44, 95% CI=0.22-0.85) vs. control; median PFS was 9.9 and 15.1 vs. 9.5 months, and the 18-month PFS rate was 37.0% and 42.1% vs. 22.2%, respectively. The safety profile in the Japan subset was generally consistent with the full safety analysis set and the established profiles of the individual agents.

conclusionEfficacy and safety in the Japan subset were generally consistent with outcomes in the DUO-E ITT population. This Japanese subset analysis of DUO-E supports carboplatin/paclitaxel + durvalumab followed by durvalumab with or without olaparib as new treatment options in patients with advanced or recurrent endometrial cancer and is the first to report on these regimens in Japanese patients alone.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEndometrial NeoplasmsNeoplasm Recurrence, LocalAdultAgedAntibodies, MonoclonalCarboplatinFemaleHumansJapanMiddle AgedPaclitaxelPhthalazinesPiperazinesProgression-Free SurvivalAntibodies, MonoclonalCarboplatindurvalumabolaparibPaclitaxelPhthalazinesPiperazinesCarboplatinDurvalumabEndometrial CancerImmunotherapyJapanOlaparib

Identifiers

PMID40590327
PMCPMC12226317

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.