Evidence map›Paper›PMID 28361045›Full record

ArticleImmunoTargets and therapy2017

Phase I clinical trial of sipuleucel-T combined with escalating doses of ipilimumab in progressive metastatic castrate-resistant prostate cancer.

Mark Scholz, Sabrina Yep, Micah Chancey, Colleen Kelly, Ken Chau, Jeffrey Turner, Richard Lam, Charles G Drake

Abstract read
In one paragraph

Article in ImmunoTargets and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

44 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Metal-based nanoparticle in cancer treatment: lessons learned and challenges.Frontiers in bioengineering and biotechnology · 2024
    Review
  9. Vaccines as treatments for prostate cancer.Nature reviews. Urology · 2023
    Review
  10. Review
  11. Review
  12. Peptide-based vaccine for cancer therapies.Frontiers in immunology · 2023
    Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Targeting the spectrum of immune checkpoints in prostate cancer.Expert review of clinical pharmacology · 2021
    Review
  19. Review
  20. Review
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.

Mark ScholzProstate Oncology Specialists, Inc., Marina del Rey, CA.
Sabrina YepProstate Oncology Specialists, Inc., Marina del Rey, CA.
Micah ChanceyProstate Oncology Specialists, Inc., Marina del Rey, CA.
Colleen KellyProstate Oncology Specialists, Inc., Marina del Rey, CA.
Ken ChauProstate Oncology Specialists, Inc., Marina del Rey, CA.
Jeffrey TurnerProstate Oncology Specialists, Inc., Marina del Rey, CA.
Richard LamProstate Oncology Specialists, Inc., Marina del Rey, CA.
Charles G DrakeThe Sidney Kimmel Cancer Center; The James Buchanan Brady Urological Institute, John Hopkins Medical Institutions, Baltimore, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSipuleucel-T (SIP-T), which functions by stimulating cancer-specific dendritic cells, prolongs survival in men with prostate cancer. Ipilimumab (IPI) achieved a borderline survival advantage in a large randomized trial. SIP-T and IPI are potentially synergistic. PATIENTS AND

methodsNine men with progressive metastatic castrate-resistant prostate cancer (mCRPC) were treated prospectively with SIP-T followed immediately by IPI with one of the following doses of IPI: 1 mg/kg at 1 week after SIP-T; 1 mg/kg at 1 and 4 weeks after SIP-T; or 1 mg/kg at 1, 4, and 7 weeks after SIP-T. Three patients were evaluated at each level. Cancer-specific immunoglobulins directed at granulocyte-macrophage-colony-stimulating factor/prostatic acid phosphatase (PAP) fusion protein (PA2024) and PAP were measured prior to SIP-T, after SIP-T, 1 week after IPI, every other month for 5 months, then every 3 months for an additional 12 months.

resultsAdverse events of SIP-T were consistent with previous reports. IPI only caused a transient grade 1 rash in one patient. Median age, Gleason score, and number of previous hormonal interventions were 77 years, 8, and 3, respectively. Eight men had bone metastases and one had lymph node metastasis. Statistically significant increases in serum immunoglobulin G (IgG) and IgG-IgM specific for PA2024 and PAP occurred after SIP-T. An additional statistically significant increase in the aforementioned immunoglobulins - above the levels achieved by SIP-T - occurred after IPI. Median clinical follow-up was 36 months (range: 26-40). Three patients died from progressive disease after 9, 18, and 20 months. Out of the remaining six patients, five of them needed further treatment that included abiraterone acetate, enzalutamide, radium-223 dichloride, and spot radiation. One patient had an undetectable PSA, who did not receive any other treatment except spot radiation. Median PSA at last follow-up for the surviving patients was 3.8 (range: 0.6-7.47).

conclusionIn this small trial, the addition of IPI to SIP-T was well tolerated. IPI increased immunoglobulins specific for the PA2024 protein and PAP above the level achieved with SIP-T alone.

Indexed as

immune therapyipilimumabprostate cancersipuleucel-T

Identifiers

PMID28361045
PMCPMC5365325

What OpenQuestion holds

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LicenceCC BY-NC
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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.