Evidence map›Paper›PMID 26334096›Full record

Trial reportOncotarget2015

A phase 1/2 study combining gemcitabine, Pegintron and p53 SLP vaccine in patients with platinum-resistant ovarian cancer.

Eveline M Dijkgraaf, Saskia J A M Santegoets, An K L Reyners, Renske Goedemans, Hans W Nijman, Mariëtte I E van Poelgeest, Arien R van Erkel, Vincent T H B M Smit, Toos A H H Daemen, Jacobus J M van der Hoeven and 4 more

Open access · diamondAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Oncotarget, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
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  5. Myeloid-derived suppressor cells modulation in the context of tumor microenvironment for gastric cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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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

14 authors at 3 institutions in 1 country.

Eveline M DijkgraafDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Saskia J A M SantegoetsDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
An K L ReynersDepartment of Clinical Oncology, University Medical Center Groningen, University of Groningen, 9713 GZ, Groningen, The Netherlands.
Renske GoedemansDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Hans W NijmanDepartment of Gynecologic Oncology, University Medical Center Groningen, University of Groningen, 9713 GZ, Groningen, The Netherlands.
Mariëtte I E van PoelgeestDepartment of Gynecology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Arien R van ErkelDepartment of Radiology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Vincent T H B M SmitDepartment of Pathology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Toos A H H DaemenDepartment of Medical Microbiology, University Medical Center Groningen, University of Groningen, 9713 GZ, Groningen, The Netherlands.
Jacobus J M van der HoevenDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Cornelis J M MeliefDepartment of Immunohematology and Blood Transfusion, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Marij J P WeltersDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Sjoerd H van der BurgDepartment of Medical Oncology, Leiden University Medical Center, 2333 ZA, Leiden, The Netherlands.
Leiden University Medical Center · NLUniversity of Groningen · NLUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePreclinical tumor models show that chemotherapy has immune modulatory properties which can be exploited in the context of immunotherapy. The purpose of this study was to determine the feasibility and immunogenicity of combinations of such an immunomodulatory chemotherapeutic agent with immunotherapy, p53 synthetic long peptide (SLP) vaccine and Pegintron (IFN-α) in patients with platinum-resistant p53-positive epithelial ovarian cancer (EOC). EXPERIMENTAL

designThis is a phase 1/2 trial in which patients sequential 6 cycles of gemcitabine (1000 mg/kg2 iv; n = 3), gemcitabine with Pegintron before and after the first gemcitabine cycle (Pegintron 1 μg/kg sc; n = 6), and gemcitabine and Pegintron combined with p53 SLP vaccine (0.3 mg/peptide, 9 peptides; n = 6). At baseline, 22 days after the 2nd and 6th cycle, blood was collected for immunomonitoring. Toxicity, CA-125, and radiologic response were evaluated after 3 and 6 cycles of chemotherapy.

resultsNone of the patients enrolled experienced dose-limiting toxicity. Predominant grade 3/4 toxicities were nausea/vomiting and dyspnea. Grade 1/2 toxicities consisted of fatigue (78%) and Pegintron-related flu-like symptoms (72%). Gemcitabine reduced myeloid-derived suppressor cells (p = 0.0005) and increased immune-supportive M1 macrophages (p = 0.04). Combination of gemcitabine and Pegintron stimulated higher frequencies of circulating proliferating CD4+ and CD8+ T-cells but not regulatory T-cells. All vaccinated patients showed strong vaccine-induced p53-specific T-cell responses.

conclusionCombination of gemcitabine, the immune modulator Pegintron and therapeutic peptide vaccination is a viable approach in the development of combined chemo-immunotherapeutic regimens to treat cancer.

Indexed as

Drug Resistance, NeoplasmAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCancer VaccinesCells, CulturedDeoxycytidineDrug Administration ScheduleFeasibility StudiesFemaleGemcitabineHumansInterferon-alphaInterferon alpha-2Lymphocytes, Tumor-InfiltratingMiddle AgedBiomarkers, TumorCancer VaccinesDeoxycytidineGemcitabineInterferon-alphaInterferon alpha-2p53 synthetic long peptide vaccinepeginterferon alfa-2bPlatinum CompoundsPolyethylene GlycolsRecombinant ProteinsTP53 protein, humanTumor Suppressor Protein p53chemoresistanceClinical Sectionimmunotherapyovarian cancerp53tumor immunity

Identifiers

PMID26334096
PMCPMC4741673
OpenAlexW1960571207

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.