Evidence map›Paper›PMID 31361807›Full record

ArticleJapanese journal of clinical oncology2019

Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: results of a Japanese post-marketing surveillance study.

Kazuhiro Suzuki, Nobuaki Matsubara, Hirotaka Kazama, Takeshi Seto, Shoko Tsukube, Hideyasu Matsuyama

Open access · bronzeAbstract read
In one paragraph

Article 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. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
5.1field-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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Article
  5. Article
  6. Current Evidence on Cabazitaxel for Prostate Cancer Therapy: A Narrative Review.International journal of urology : official journal of the Japanese Urological Association · 2025
    Review
  7. Article
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  10. Article
  11. Observational
  12. Review
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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

6 authors at 4 institutions in 1 country.

Kazuhiro SuzukiDepartment of Urology, Gunma University, Maebashi, Japan.
Nobuaki MatsubaraDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Hirotaka KazamaOncology Medical Operations, Sanofi K.K., Tokyo, Japan.
Takeshi SetoMedical Affairs, Sanofi K.K., Tokyo, Japan.
Shoko TsukubeMedical Affairs, Sanofi K.K., Tokyo, Japan.
Hideyasu MatsuyamaDepartment of Urology, Yamaguchi University, Yamaguchi, Japan.
Sanofi (Japan) · JPGunma University · JPNational Cancer Center Hospital East · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the real-world safety and efficacy of cabazitaxel in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

methodsThis prospective multicenter observational study registered all patients with mCRPC treated with cabazitaxel following its launch in Japan in September 2014. Patient enrollment continued until at least 500 patients were enrolled. Adverse drug reactions (ADRs) were evaluated according to CTCAE ver. 4.0. Efficacy endpoints were assessed for up to 1 year, and included prostate specific antigen (PSA) response rates (defined as a decrease of ≥30% or ≥50% from baseline), overall survival (OS), and time to treatment failure (TTF).

resultsA total of 660 mCRPC patients were enrolled across 316 centers by June 2016. Frequent ADRs (any grade) were neutropenia (49.1%), febrile neutropenia (18.0%) and anemia (15.0%). Most ADRs occurred in cycle 1. Neutropenia and febrile neutropenia were significantly less frequent in patients who received prophylactic granulocyte colony-stimulating factor. The PSA response rates for decrease of ≥30% or ≥50% from baseline were 28.1% and 17.5%, respectively, in patients with baseline PSA of ≥5 ng/ml. Median OS and TTF were 319 days (95% confidence interval: 293.0-361.0) and 116 days (95% confidence interval: 108.0-135.0), respectively.

conclusionsThis study of cabazitaxel in 660 Japanese patients treated in real-world settings, the largest study of cabazitaxel to date, demonstrated a safety profile that was generally consistent with those of pivotal clinical studies. Cabazitaxel was also effective in terms of the PSA response, OS, and TTF.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsAsian PeopleDocetaxelDrug-Related Side Effects and Adverse ReactionsGranulocyte Colony-Stimulating FactorHumansKallikreinsMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantSafetyAntineoplastic AgentscabazitaxelDocetaxelGranulocyte Colony-Stimulating FactorKallikreinsKLK3 protein, humanProstate-Specific AntigenTaxoidsadverse drug reactioncabazitaxelcastration-resistant prostate cancerprostate specific antigenreal-world setting

Identifiers

PMID31361807
PMCPMC6933873
OpenAlexW2966842555

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.