Evidence map›Paper›PMID 38635934›Full record

Trial reportJCO precision oncology2024

Randomized Phase II Study of Gemcitabine With or Without ATR Inhibitor Berzosertib in Platinum-Resistant Ovarian Cancer: Final Overall Survival and Biomarker Analyses.

Panagiotis A Konstantinopoulos, Su-Chun Cheng, Elizabeth K Lee, Alexandre André B A da Costa, Doga Gulhan, Andrea E Wahner Hendrickson, Bose Kochupurakkal, David L Kolin, Elise C Kohn, Joyce F Liu and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in JCO precision oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02595892 (Phase 2 Study of M6620), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
8.6field-weighted citation impact, top 2% 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.

NCT02595892 phase2active not recruitingnot on this map

Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2016 to 2026Enrolled70ConditionsOvarian Serous Tumor, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal CarcinomaArmsBerzosertib, Gemcitabine, Gemcitabine Hydrochloride
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

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

Panagiotis A KonstantinopoulosDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-1032-1479
Su-Chun ChengDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Elizabeth K LeeDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-7533-7853
Alexandre André B A da CostaDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-1631-0105
Doga GulhanDepartment of Biomedical Informatics and Ludwig Center at Harvard, Harvard Medical School, Boston, MA.ORCID 0000-0001-5419-0549
Andrea E Wahner HendricksonDepartment of Medical Oncology, Mayo Clinic, Rochester, MN.ORCID 0000-0002-4752-7104
Bose KochupurakkalDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-8929-3070
David L KolinDepartment of Pathology, Brigham and Women's Hospital, Boston, MA.ORCID 0000-0002-7631-6525
Elise C KohnCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD.
Joyce F LiuDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0003-3888-3972
Richard T PensonDepartment of Medical Oncology, Massachusetts General Hospital, Boston, MA.ORCID 0000-0002-8091-8588
Elizabeth H StoverDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-6578-3216
Jennifer CurtisDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Hannah SawyerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Madeline PolakDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-1331-3845
Dipanjan ChowdhuryDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA.
Alan D D'AndreaDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-6168-6294
Anniina FärkkiläResearch Program in Systems Oncology, FIMM and HiLife, University of Helsinki, Helsinki, Finland.
Geoffrey I ShapiroDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-3331-4095
Ursula A MatulonisDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-3103-6992
Dana-Farber Cancer Institute · USBrigham and Women's Hospital · USHarvard University · USMassachusetts General Hospital · USMayo Clinic in Arizona · USNational Cancer Institute · USUniversity of Helsinki · FI

Funding

XPO1 inhibitors Selinexor and Eltanexor in Combination with Venetoclax and Decitabine (ASTX727) in AMLUM1CA186709 · NCI · DANA-FARBER CANCER INST · PI KEITH T FLAHERTY, DONALD W. KUFE · 2014 to 2026
$25.9M
Project 2: Combined personal neoantigen-targeting cancer vaccines with immune checkpoint blockade for ovarian cancerP50CA240243 · NCI · DANA-FARBER CANCER INST · PI SHAPIRO, GEOFFREY I · 2020 to 2024
$11.5M
The roles of anti-apoptotic proteins BCL-XL and MCL1 in mediating survival of high-grade serous ovarian cancer following drug-induced DNA damageK08CA237871 · NCI · DANA-FARBER CANCER INST · PI STOVER, ELIZABETH HARMON · 2019 to 2023
$921k
NCI NIH HHS K08 CA237871NCI NIH HHS P50 CA240243NCI NIH HHS UM1 CA186709
6 · The paper itself

Abstract

purposeThe multicenter, open-label, randomized phase 2 NCI-9944 study (NCT02595892) demonstrated that addition of ATR inhibitor (ATRi) berzosertib to gemcitabine increased progression-free survival (PFS) compared to gemcitabine alone (hazard ratio [HR]=0.57, one-sided log-rank

methodsWe report here the final overall survival (OS) analysis and biomarker correlations (ATM expression by immunohistochemistry, mutational signature 3 and a genomic biomarker of replication stress) along with post-hoc exploratory analyses to adjust for crossover from gemcitabine to gemcitabine/berzosertib.

resultsAt the data cutoff of January 27, 2023 (>30 months of additional follow-up from the primary analysis), median OS was 59.4 weeks with gemcitabine/berzosertib versus 43.0 weeks with gemcitabine alone (HR 0.79, 90% CI 0.52 to 1.2, one-sided log-rank

conclusionThe results of this follow-up analysis continue to support the promise of combined gemcitabine/ATRi therapy in platinum resistant ovarian cancer, an active area of investigation with several ongoing clinical trials.

Indexed as

GemcitabineIsoxazolesOvarian NeoplasmsPyrazinesAtaxia Telangiectasia Mutated ProteinsCarcinoma, Ovarian EpithelialDeoxycytidineFemaleHumansProtein Kinase InhibitorsAtaxia Telangiectasia Mutated ProteinsATR protein, humanberzosertibDeoxycytidineGemcitabineIsoxazolesProtein Kinase InhibitorsPyrazines

Identifiers

PMID38635934
PMCPMC11095660
OpenAlexW4394908642

What OpenQuestion holds

Textmetadata
LicenceTDM
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.