Evidence map›Paper›PMID 23740935›Full record

Trial reportThe oncologist2013

Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer.

Jacqueline Vuky, John M Corman, Christopher Porter, Semra Olgac, Evan Auerbach, Kathryn Dahl

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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

16 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Advances in bio-immunotherapy for castration-resistant prostate cancer.Journal of cancer research and clinical oncology · 2023
    Review
  6. Review
  7. Review
  8. Development of Cancer Immunotherapies.Cancer treatment and research · 2022
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Immunotherapy in prostate cancer: review of the current evidence.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2015
    Review
  16. Neoadjuvant Therapy in High-Risk Prostate Cancer.Indian journal of urology : IJU : journal of the Urological Society of India
    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

6 authors.

Jacqueline VukyOregon Health and Science University, Portland, Oregon 97239-3098, USA. vukyja@ohsu.edu
John M Corman
Christopher Porter
Semra Olgac
Evan Auerbach
Kathryn Dahl

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProstate cancer (PC) is the most commonly diagnosed noncutaneous malignancy in American men. PC, which exhibits a slow growth rate and multiple potential target epitopes, is an ideal candidate for immunotherapy. GVAX for prostate cancer is a cellular immunotherapy, composed of PC-3 cells (CG1940) and LNCaP cells (CG8711). Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte-macrophage colony-stimulating factor. Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease, we initiated a phase II trial of neoadjuvant docetaxel and GVAX. For the trial, the clinical effects of GVAX were assessed in patients undergoing radical prostatectomy (RP).

methodsPatients received docetaxel administered at a dose of 75 mg/m(2) every 3 weeks for 4 cycles. GVAX was administered 2-3 days after chemotherapy preoperatively for four courses of immunotherapy. The first dose of GVAX was a prime immunotherapy of 5×10(8) cells. The subsequent boost immunotherapies consisted of 3×10(8) cells. After RP, patients received an additional six courses of immunotherapy. Pathologic complete response, toxicity, and clinical response were assessed. The primary endpoint of the trial was a pathologic state of pT0, which is defined as no evidence of cancer in the prostate.

resultsSix patients completed neoadjuvant docetaxel and GVAX therapy. No serious drug-related adverse events were observed. Median change in prostate-specific antigen (PSA) following neoadjuvant therapy was 1.47 ng/ml. One patient did not undergo RP due to the discovery of positive lymph nodes during exploration. Of the five patients completing RP, four had a downstaging of their Gleason score. Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP.

conclusionsNeoadjuvant docetaxel/GVAX is safe and well tolerated in patients with high-risk locally advanced PC. No evidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted. These results justify further study of neoadjuvant immunotherapy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCancer VaccinesCell Line, TumorDocetaxelDrug-Related Side Effects and Adverse ReactionsGranulocyte-Macrophage Colony-Stimulating FactorHumansMaleNeoadjuvant TherapyNeoplasm GradingProstatectomyProstatic NeoplasmsTaxoidsTreatment OutcomeBiomarkers, TumorCancer VaccinesDocetaxelGranulocyte-Macrophage Colony-Stimulating FactorTaxoids

Identifiers

PMID23740935
PMCPMC4063395

What OpenQuestion holds

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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.