Evidence map›Paper›PMID 32398324›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Combination of PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab, in Recurrent Ovarian Cancer: a Proof-of-Concept Phase II Study.

Erika J Lampert, Alexandra Zimmer, Michelle Padget, Ashley Cimino-Mathews, Jayakumar R Nair, Yingmiao Liu, Elizabeth M Swisher, James W Hodge, Andrew B Nixon, Erin Nichols and 8 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 143 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 4 pooled it
11.3field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 4 syntheses or guidelines pooled it, 215 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article

83 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

18 authors at 6 institutions in 1 country.

Erika J Lampert *Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0001-9406-5371
Alexandra Zimmer *Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0001-6789-0982
Michelle PadgetLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.
Ashley Cimino-MathewsDepartment of Pathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.ORCID 0000-0002-0638-7969
Jayakumar R NairWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.
Yingmiao LiuDepartment of Medicine, Duke University Medical Center, Durham, North Carolina.
Elizabeth M SwisherDivision of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.ORCID 0000-0003-2331-0434
James W HodgeLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0001-5282-3154
Andrew B NixonDepartment of Medicine, Duke University Medical Center, Durham, North Carolina.ORCID 0000-0003-3971-2964
Erin NicholsClinical Research Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Bethesda, Maryland.
Mohammad H BagheriDepartment of Radiology and Imaging Sciences, Clinical Center, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-9273-5359
Elliott LevyInterventional Radiology, NIH Clinical Center, Bethesda, Maryland.
Marc R RadkeDivision of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.
Stanley LipkowitzWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-6103-2255
Christina M AnnunziataWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.
Janis M TaubeDepartment of Dermatopathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.
Jung-Min LeeWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland. leej6@mail.nih.gov.
National Cancer Institute · USDuke Medical Center · USJohns Hopkins University · USUniversity of Washington · USFrederick National Laboratory for Cancer Research · USNational Institutes of Health Clinical Center · US

Funding

Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI DONNA NIEDZWIECKI · 1985 to 2026
$174.8M
Targeting DNA damage repair and related pathways in HRD-womens cancersZIABC011525 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI LEE, JUNG-MIN · 2013 to 2025
$14.8M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Vaccine and Drug Combination Therapy for Human CancersZIABC010661 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HODGE, JAMES · 2009 to 2025
$11.2M
Clinical trials in womens cancersZIABC011584 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ANNUNZIATA, CHRISTINA · 2014 to 2023
$3.1M
CCR NIH HHS HHSN261200800001CIntramural NIH HHS ZIA BC011525NCI NIH HHS HHSN261200800001ENCI NIH HHS P30 CA014236
6 · The paper itself

Abstract

purposePreclinical studies suggest PARP inhibition (PARPi) induces immunostimulatory micromilieu in ovarian cancer thus complementing activity of immune checkpoint blockade. We conducted a phase II trial of PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies and blood samples to test this hypothesis. PATIENTS AND

methodsIn a single-center, proof-of-concept phase II study, we enrolled women aged ≥18 with recurrent ovarian cancer. All patients were immune checkpoint inhibitor-naïve and had measurable disease per RECISTv1.1, ECOG performance status 0-2, and adequate organ and marrow function. Patients received olaparib 300 mg twice daily and durvalumab 1,500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Primary endpoint was overall response rate (ORR). Secondary objectives were safety and progression-free survival (PFS). Translational objectives included biomarker evaluation for relationships with clinical response and immunomodulatory effects by treatment.

resultsThirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),

conclusionsThe PARPi and anti-PD-L1 combination showed modest clinical activity in recurrent ovarian cancer. Our correlative study results suggest immunomodulatory effects by olaparib/durvalumab in patients and indicate that VEGF/VEGFR pathway blockade would be necessary for improved efficacy of the combination.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalB7-H1 AntigenChemokine CXCL10Chemokine CXCL9FemaleGene Expression Regulation, NeoplasticHumansImmune Checkpoint InhibitorsInterferon-gammaMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPhthalazinesAntibodies, MonoclonalB7-H1 AntigenCD274 protein, humanChemokine CXCL10Chemokine CXCL9CXCL10 protein, humanCXCL9 protein, humandurvalumabIFNG protein, humanImmune Checkpoint InhibitorsInterferon-gammaolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasesVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID32398324
PMCPMC7442720
OpenAlexW3025130660

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.