Evidence map›Paper›PMID 34103352›Full record

Trial reportJournal for immunotherapy of cancer2021

Clinical activity of durvalumab for patients with advanced mismatch repair-deficient and repair-proficient endometrial cancer. A nonrandomized phase 2 clinical trial.

Yoland Antill, Peey-Sei Kok, Kristy Robledo, Sonia Yip, Michelle Cummins, Deborah Smith, Amanda Spurdle, Elizabeth Barnes, Yeh Chen Lee, Michael Friedlander and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03015129 (A Phase 2 Trial of Durvalumab [MEDI4736]), which is not on this map. Cited by 64 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 7 pooled it
14.6field-weighted citation impact, top 1% of its field
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.

NCT03015129 phase2completednot on this map

A Phase 2 Trial of Durvalumab [MEDI4736](Anti-PD-L1 Antibody) With or Without Tremelimumab (Anti-CTLA-4 Antibody) in Patients With Persistent or Recurrent Endometrial Carcinoma and Endometrial Carcinosarcoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2017 to 2022Enrolled80ConditionsEndometrial Cancer, Endometrial Carcinosarcoma, Endometrial Carcinoma, Endometrial Cancer RecurrentArmsDurvalumab, Tremelimumab
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 7 syntheses or guidelines pooled it, 126 citations in OpenAlex.

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4 more citing papers are in PubMed but not listed here.

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

21 authors at 12 institutions in 1 country.

Yoland AntillMedical Oncology, Cabrini Health, Malvern, Victoria, Australia Yoland.Antill@monash.edu.ORCID 0000-0002-6366-5523
Peey-Sei KokNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Kristy RobledoNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Sonia YipNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Michelle CumminsNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Deborah SmithMater Pathology, Mater Research and University of Queensland, Brisbane, Queensland, Australia.
Amanda SpurdleMolecular Cancer Epidemiology Laboratory, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.
Elizabeth BarnesNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Yeh Chen LeeNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Michael FriedlanderDepartment of Medical Oncology, Prince of Wales Hospital Nelune Comprehensive Cancer Centre, Randwick, New South Wales, Australia.
Sally Baron-HayMedical Oncology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
Catherine ShannonMater Cancer Care Centre, Mater Hospital, South Brisbane, Queensland, Australia.
Jermaine CowardClinical Trials Unit, Icon Cancer Care, South Brisbane, Queensland, Australia.
Philip BealeChris O'Brien Lifehouse, Camperdown, New South Wales, Australia.
Geraldine GossMedical Oncology, Monash Medical Centre Clayton, Clayton, Victoria, Australia.
Tarek MeniawyDepartment of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
Janine LombardMedical Oncology, Calvary Mater Newcastle, Hunter Region Mail Centre, New South Wales, Australia.
John AndrewsNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Martin R StocklerNHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Linda MileshkinDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Parkville, Victoria, Australia.
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
The University of Sydney · AUThe University of Queensland · AUCabrini Hospital · AUCalvary Mater Newcastle Hospital · AUChris O’Brien Lifehouse · AUMater Health Services · AUMonash Medical Centre · AUPeter MacCallum Cancer Centre · AUPrince of Wales Hospital · AUQIMR Berghofer Medical Research Institute · AURoyal North Shore Hospital · AUSir Charles Gairdner Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this study, we assessed the activity of durvalumab, an antibody to programmed death ligand-1, in two cohorts of women with advanced endometrial cancers (AEC)-mismatch repair proficient (pMMR) and mismatch repair deficient (dMMR).

methodsA multicenter phase two study was performed in women with AEC with pMMR tumor progressing after one to three lines of chemotherapy and women with AEC with dMMR tumor progressing after zero to three lines of chemotherapy. Mismatch repair status was based on immunohistochemistry expression. All women received durvalumab 1500 mg given every 4 weeks until progression or unacceptable toxicity. The primary endpoint was objective tumor response by RECIST V.1.1 modified for immune-based therapeutics.

resultsSeventy-one women were recruited: 35 dMMR and 36 pMMR. Median follow-up was 19 vs 21 months in dMMR versus pMMR, respectively. Median age was 67 years. Histology in dMMR versus pMMR included endometrioid (94% vs 57%) and serous (0% vs 31%) and was high grade in 26% vs 74%. The objective tumor response rate (OTRR) in the dMMR cohort was 47% (17/36, 95% CI 32 to 63), including 6 complete responses and 11 partial responses (PRs)) vs 3% in the pMMR cohort (1/35, 95% CI 1 to 15, PR). In the dMMR cohort, durvalumab was the first-line therapy in 58% (OTRR 57%) and the second-line therapy in 39% (OTRR 38%). Median progression-free survival was 8.3 months in the dMMR cohort vs 1.8 months in the pMMR cohort. The 12-month overall survival (OS) rate was 71% in dMMR vs 51% in pMMR, with median OS not reached for dMMR vs 12 months for pMMR. Immune-related adverse events occurred in 14 women, mostly grades 1-2.

conclusionDurvalumab monotherapy showed promising activity and acceptable safety in AEC with dMMR regardless of prior lines of chemotherapy, but activity was limited in AEC with pMMR. TRIAL REGISTRATION NUMBERS: ANZGOG1601, ACTRN12617000106336, and NCT03015129.

Indexed as

AdultAgedAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalDNA Mismatch RepairDrug Administration ScheduleEndometrial NeoplasmsFemaleHumansMiddle AgedSurvival AnalysisTreatment OutcomeAntibodies, MonoclonalAntineoplastic Agents, Immunologicaldurvalumabclinical trialsimmunotherapyphase II as topicprogrammed cell death 1 receptor

Identifiers

PMID34103352
PMCPMC8190057
OpenAlexW3167167915

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 OpenQuestion graph.