Evidence map›Paper›PMID 26728480›Full record

Trial reportCancer immunology, immunotherapy : CII2016

A randomized phase II clinical trial of personalized peptide vaccination with metronomic low-dose cyclophosphamide in patients with metastatic castration-resistant prostate cancer.

Masanori Noguchi, Fukuko Moriya, Noriko Koga, Satoko Matsueda, Tetsuro Sasada, Akira Yamada, Tatsuyuki Kakuma, Kyogo Itoh

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
5.8field-weighted citation impact, top 4% 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

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
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  14. Review
  15. Review
  16. Vaccines as treatments for prostate cancer.Nature reviews. Urology · 2023
    Review
  17. Inflammation in Urological Malignancies: The Silent Killer.International journal of molecular sciences · 2023
    Review
  18. Cell-penetrating peptides enhance peptide vaccine accumulation and persistence in lymph nodes to drive immunogenicity.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  19. Review
  20. Anti-cancer peptide-based therapeutic strategies in solid tumors.Cellular & molecular biology letters · 2022
    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

8 authors at 2 institutions in 1 country.

Masanori NoguchiDivision of Clinical Research, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan. noguchi@med.kurume-u.ac.jp.
Fukuko MoriyaDepartment of Pathology, Kurume University School of Medicine, Kurume, Japan.
Noriko KogaDivision of Clinical Research, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Satoko MatsuedaCancer Vaccine Center, Kurume University School of Medicine, Kurume, Japan.
Tetsuro SasadaKanagawa Cancer Center Research Institute, Yokohama, Kanagawa, Japan.
Akira YamadaDivision of Cancer Vaccines, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Tatsuyuki KakumaBio-statistics Center, Kurume University School of Medicine, Kurume, Japan.
Kyogo ItohCancer Vaccine Center, Kurume University School of Medicine, Kurume, Japan.
Kurume University · JPKanagawa Prefectural Hospital Organization · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study investigated the effect of metronomic cyclophosphamide (CPA) in combination with personalized peptide vaccination (PPV) on regulatory T cells (Treg) and myeloid-derived suppressor cells (MDSC), and whether it could improve the antitumor effect of PPV. Seventy patients with metastatic castration-resistant prostate cancer were randomly assigned (1:1) to receive PPV plus oral low-dose CPA (50 mg/day), or PPV alone. PPV treatment used a maximum of four peptides chosen from 31 pooled peptides according to human leukocyte antigen types and antigen-specific humoral immune responses before PPV, for 8 subcutaneous weekly injections. Peptide-specific cytotoxic T lymphocyte (CTL) and immunoglobulin G responses were measured before and after PPV. The incidence of grade 3 or 4 hematologic adverse events was higher in the PPV plus CPA arm than in the PPV alone arm. Decrease in Treg and increase in MDSC were more pronounced in PPV plus CPA treatment than in PPV alone (p = 0.036 and p = 0.048, respectively). There was no correlation between the changes in Treg or MDSC and CTL response. There was no difference in positive immune responses between the two arms, although overall survival in patients with positive immune responses was longer than in those with negative immune responses (p = 0.001). Significant differences in neither progression-free survival nor overall survival were observed between the two arms. Low-dose CPA showed no change in the antitumor effect of PPV, possibly due to the simultaneous decrease in Treg and increase in MDSC, in patients under PPV.

Indexed as

Precision MedicineAdministration, MetronomicAgedAged, 80 and overCancer VaccinesCombined Modality TherapyCyclophosphamideHumansMaleMiddle AgedNeoplasm GradingNeoplasm MetastasisPeptidesProstatic Neoplasms, Castration-ResistantSurvival AnalysisT-Lymphocytes, CytotoxicCancer VaccinesCyclophosphamidePeptidesVaccines, SubunitCyclophosphamideImmunotherapyMyeloid-derived suppressor cellPeptide vaccinationPhase II trialRegulatory T cell

Identifiers

PMID26728480
PMCPMC11028889
OpenAlexW2230826027

What OpenQuestion holds

Textmetadata
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.