Evidence map›Paper›PMID 27039845›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2016

Randomized Phase 2 Trial of the Oncolytic Virus Pelareorep (Reolysin) in Upfront Treatment of Metastatic Pancreatic Adenocarcinoma.

Anne M Noonan, Matthew R Farren, Susan M Geyer, Ying Huang, Sanaa Tahiri, Daniel Ahn, Sameh Mikhail, Kristen K Ciombor, Shubham Pant, Santiago Aparo and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01280058 (A 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel Plus Reovirus Serotype-3 Dearing Strain), which is not on this map. Cited by 107 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 5 pooled it
13.8field-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.

NCT01280058 phase2completednot on this map

A 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel Plus Reovirus Serotype-3 Dearing Strain (Reolysin) vs. Carboplatin and Paclitaxel in the First Line Treatment of Patients With Recurrent or Metastatic Pancreatic Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2010 to 2016Enrolled73ConditionsPancreatic Acinar Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage IV Pancreatic CancerArmsCarboplatin, Laboratory Biomarker Analysis, Paclitaxel, Wild-type Reovirus
3 · Its place in the literature

Who cites it

107 citing papers in PubMed, 5 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Oncolytic viruses: advanced strategies in cancer therapy.Signal transduction and targeted therapy · 2026
    Review
  17. Review
  18. Review
  19. Review
  20. Review

47 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

20 authors at 7 institutions in 1 country.

Anne M NoonanDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Matthew R FarrenDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Susan M GeyerHealth Informatics Institute, University of South Florida, Tampa, Florida, USA.
Ying HuangDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Sanaa TahiriDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Daniel AhnDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Sameh MikhailDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Kristen K CiomborDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Shubham PantDepartment of Medicine, Hematology/Oncology, Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, USA.
Santiago AparoDepartment of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Jennifer SextonDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
John L MarshallGeorgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, District of Columbia, USA.
Thomas A MaceDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Christina S WuDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Bassel El-RayesDepartment of Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Cynthia D TimmersSolid Tumor Translational Science Shared Resource, The James Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio, USA.
James ZwiebelInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, Maryland, USA.
Gregory B LesinskiDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Miguel A Villalona-CaleroDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Tanios S Bekaii-SaabDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, Ohio, USA. Electronic address: Bekaii-Saab.tanios@mayo.edu.
The Ohio State University · USAlbert Einstein College of Medicine · USEmory University · USGeorgetown University Medical Center · USNational Cancer Institute · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USUniversity of South Florida · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
Vanderbilt Clinical Oncology Research Career Development ProgramK12CA090625 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Debra L. Friedman, Paula Jill Hurley · 2001 to 2026
$16.9M
Tumor ImmunologyT32CA090223 · NCI · OHIO STATE UNIVERSITY · PI CARSON, WILLIAM E. · 2002 to 2023
$4.1M
Training Hematology and Oncology Fellows in Clinical ResearchT32CA165998 · NCI · OHIO STATE UNIVERSITY · PI CLINTON, STEVEN K, GARZON, RAMIRO · 2012 to 2016
$944k
NCI NIH HHS HHSN261201100070CNCI NIH HHS K12 CA090625NCI NIH HHS P30 CA016058NCI NIH HHS T32 CA090223NCI NIH HHS T32 CA165998NCI NIH HHS UM1 CA186712
6 · The paper itself

Abstract

Pelareorep causes oncolysis in tumor cells with activated Ras. We hypothesized that pelareorep would have efficacy and immunomodulatory activity in metastatic pancreatic adenocarcinoma (MPA) when combined with carboplatin and paclitaxel. A randomized phase 2 study (NCT01280058) was conducted in treatment-naive patients with MPA randomized to two treatment arms: paclitaxel/carboplatin + pelareorep (Arm A, n = 36 evaluable patients) versus paclitaxel/carboplatin (Arm B, n = 37 evaluable patients). There was no difference in progression-free survival (PFS) between the arms (Arm A PFS = 4.9 months, Arm B PFS = 5.2 months, P = 0.6), and Kirsten rat sarcoma viral oncogene (KRAS) status did not impact outcome. Quality-adjusted Time without Symptoms or Toxicity analysis revealed that the majority of PFS time was without toxicity or progression (4.3 months). Patient immunophenotype appeared important, as soluble immune biomarkers were associated with treatment outcome (fractalkine, interleukin (IL)-6, IL-8, regulated on activation, normal T cell expressed and secreted (RANTES), and vascular endothelial growth factor (VEGF)). Increased circulating T and natural killer (NK)-cell subsets were also significantly associated with treatment outcome. Addition of pelareorep was associated with higher levels of 14 proinflammatory plasma cytokines/chemokines and cells with an immunosuppressive phenotype (Tregs, cytotoxic T lymphocyte associated protein 4 (CTLA4)(+) T cells). Overall, pelareorep was safe but does not improve PFS when administered with carboplatin/paclitaxel, regardless of KRAS mutational status. Immunologic studies suggest that chemotherapy backbone improves immune reconstitution and that targeting remaining immunosuppressive mediators may improve oncolytic virotherapy.

Indexed as

AdultAgedAged, 80 and overCarboplatinDisease-Free SurvivalDrug Administration ScheduleFemaleGenetic VectorsHumansMaleMammalian orthoreovirus 3Middle AgedNeoplasm MetastasisOncolytic VirotherapyOncolytic VirusesPaclitaxelCarboplatinPaclitaxel

Identifiers

PMID27039845
PMCPMC4923331
OpenAlexW2336525273

What OpenQuestion holds

Textmetadata
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.