Evidence map›Paper›PMID 31329922›Full record

Trial reportJapanese journal of clinical oncology2019

Impact of pegfilgrastim as primary prophylaxis for metastatic castration-resistant prostate cancer patients undergoing cabazitaxel treatment: an open-label study in Japan.

Takeo Kosaka, Hiroji Uemura, Makoto Sumitomo, Kenichi Harada, Mikio Sugimoto, Narihiko Hayashi, Kazuhiro Yoshimura, Satoshi Fukasawa, Evelyne Ecstein-Fraisse, Yoshinori Sunaga and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Japanese journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02441894 (Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 32% 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.

NCT02441894 phase4completednot on this map

Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

TypeinterventionalSponsorSanofiRan2015 to 2016Enrolled21ConditionsProstate CancerArmsCABAZITAXEL XRP6258, PEG-G-CSF, Prednisolone, Dexchlorpheniramine or Diphenhydramine, Ranitidine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Current Evidence on Cabazitaxel for Prostate Cancer Therapy: A Narrative Review.International journal of urology : official journal of the Japanese Urological Association · 2025
    Review
  5. Incidence, predictors, and outcomes of febrile neutropenia and neutropenia in patients with metastatic castrate-resistant prostate cancer receiving docetaxel.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. 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

11 authors at 9 institutions in 3 countries.

Takeo KosakaDepartment of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Hiroji UemuraDepartment of Urology/Renal Transplantation, Yokohama City University Medical Center, 4-57 Urafune, Minami-ku, Yokohama 232-0024, Japan.
Makoto SumitomoDepartment of Urology, Aichi Medical University Hospital, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
Kenichi HaradaDepartment of Urology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
Mikio SugimotoDepartment of Urology, Kagawa University Hospital, 1750-1 Ikenobe, Miki Kita-gun, Kagawa 761-0793, Japan.
Narihiko HayashiDepartment of Urology, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.
Kazuhiro YoshimuraDepartment of Urology, Kindai University Hospital, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan.
Satoshi FukasawaDepartment of Urology/Prostate Cancer, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba 260-0801, Japan.
Evelyne Ecstein-FraisseMedical Evidence Generation, Sanofi, 54 rue La Boétie, Paris 75008, France.
Yoshinori SunagaBiostatistics Programming, Oncology, Sanofi, 640 Memorial Drive, Cambridge MA 02142, USA.
Mototsugu OyaDepartment of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Keio University Hospital · JPYokohama City University · JPAichi Medical University Hospital · JPChiba Cancer Center · JPKagawa University Hospital · JPKindai University Hospital · JPKobe University Hospital · JPSanofi (France) · FRSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCabazitaxel is an efficacious treatment for patients with metastatic castration-resistant prostate cancer who have previously progressed on docetaxel, but febrile neutropenia during the first cycle is a frequent complication. Asian patients are at increased risk of febrile neutropenia. Although primary prophylaxis with granulocyte colony-stimulating factor can reduce the incidence, its efficacy has not been prospectively demonstrated in Japanese patients with cabazitaxel treatment.

methodsPEGAZUS, a prospective, single-arm study conducted at eight clinical sites in Japan, enrolled 21 heavily pretreated patients with metastatic castration-resistant prostate cancer. Patients received cabazitaxel 25 mg/m2 every 3 weeks, up to 10 cycles. Oral prednisolone 10 mg was taken daily. Pegfilgrastim 3.6 mg was administered at least 24 h after the cabazitaxel infusion. The primary endpoint was the incidence of febrile neutropenia in the first cycle.

resultsThe median number of treatment cycles was seven. The relative dose intensity of cabazitaxel was 67.4% (range, 53.2-91.3%). Two of 21 patients (9.5%) experienced febrile neutropenia in the first cycle. This rate was lower than the rate (43%) previously observed without prophylactic granulocyte colony-stimulating factor in a similar patient population. Six patients showed a prostate-specific antigen response (28.6%). Three of four patients evaluable for tumor response had stable disease and one had progressive disease. Grade ≥3 diarrhea was not observed. Primary prophylaxis with granulocyte colony-stimulating factor significantly reduced the incidence of febrile neutropenia in this study.

conclusionsCabazitaxel plus granulocyte colony-stimulating factor is safe and effective for Japanese patients with metastatic castration-resistant prostate cancer who have previously progressed on docetaxel. Clinical trial registration: ClinicalTrials.gov (NCT02441894).

Indexed as

AgedAged, 80 and overFilgrastimHumansJapanMaleMiddle AgedNeoplasm MetastasisPolyethylene GlycolsProspective StudiesProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantTaxoidsTreatment OutcomecabazitaxelFilgrastimpegfilgrastimPolyethylene GlycolsProstate-Specific AntigenTaxoidsAsianfebrile neutropeniapegylated granulocyte colony-stimulating factorprostate-specific antigentaxane

Identifiers

PMID31329922
PMCPMC6939836
OpenAlexW2941121520

What OpenQuestion holds

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LicenceCC BY-NC
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.