Evidence map›Paper›PMID 33324967›Full record

Trial reportJapanese journal of clinical oncology2021

Efficacy and safety of abiraterone acetate plus prednisolone in patients with early metastatic castration-resistant prostate cancer who failed first-line androgen-deprivation therapy: a single-arm, phase 4 study.

K Kobayashi, N Okuno, G Arai, H Nakatsu, A Maniwa, N Kamiya, T Satoh, H Kikukawa, Y Nasu, H Uemura and 6 more

Open access · hybridAbstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-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.

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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

16 authors at 15 institutions in 1 country.

K KobayashiDepartment of Urology, Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Kyosai Hospital, Kanagawa, Japan.
N OkunoDepartment of Urology, Independent Administrative Institution National Hospital Organization Sagamihara Hospital, Kanagawa, Japan.
G AraiDepartment of Urology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.
H NakatsuDepartment of Urology, Asahi General Hospital, Chiba, Japan.
A ManiwaDepartment of Urology, Independent Administrative Institution National Hospital Organization Shizuoka Medical Center, Shizuoka, Japan.
N KamiyaDepartment of Urology, Toho University Sakura Medical Center, Chiba, Japan.
T SatohDepartment of Urology, Kitasato University School of Medicine, Kanagawa, Japan.
H KikukawaDepartment of Urology, Independent Administrative Institution National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Y NasuDepartment of Urology, Japan Organization of Occupational Health and Safety Okayama Rosai Hospital, Okayama, Japan.
H UemuraDepartment of Urology and Renal Transplantation, Yokohama City University Medical Center, Kanagawa, Japan.
T NakashimaDepartment of Urology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.
K MikamiDepartment of Urology, Chibaken Saiseikai Narashino Hospital, Chiba, Japan.
M IinumaDepartment of Urology, Independent Administrative Institution National Hospital Organization Mito Medical Center, Ibaraki, Japan.
K TanabeDepartment of Urology, Tokyo Women's Medical University Hospital, Tokyo, Japan.
J FurukawaDepartment of Urology, National University Corporation Kobe University Hospital, Hyogo, Japan.
H KobayashiJanssen Pharmaceutical K.K., Tokyo, Japan.
Asahi Hospital · JPChibaken Saiseikai Narashino Hospital · JPIshikawa Prefectural Central Hospital · JPJapan Organization of Occupational Health and Safety · JPKitasato University · JPKobe University Hospital · JPKumamoto Medical Center · JPNational Hospital Organization Mito Medical Center · JPNational Sagamihara Hospital · JPShizuoka Medical Center · JPSocial Insurance Saitama Chuo Hospital · JPToho University · JPTokyo Women's Medical University Hospital · JPYokohama City University Medical Center · JPYokosuka Kyosai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim was to evaluate the efficacy and safety of abiraterone acetate plus prednisolone in patients with chemotherapy-naïve early metastatic castration-resistant prostate cancer who failed first-line androgen deprivation therapy.

methodsPatients with early metastatic castration-resistant prostate cancer with confirmed prostate-specific antigen progression within 1-year or prostate-specific antigen progression without having normal prostate-specific antigen level (<4.0 ng/mL) during first-line androgen deprivation therapy were enrolled and administered abiraterone acetate (1000 mg) plus prednisolone (10 mg). A minimum of 48 patients were required according to Simon's minimax design. The primary endpoint was prostate-specific antigen response rate (≥50% prostate-specific antigen decline by 12 weeks), secondary endpoints included prostate-specific antigen progression-free survival and overall survival. Safety parameters were also assessed.

resultsFor efficacy, 49/50 patients were evaluable. Median age was 73 (range: 55-86) years. The median duration of initial androgen deprivation therapy was 32.4 (range: 13.4-84.1) weeks and 48 patients experienced prostate-specific antigen progression within 1-year after initiation of androgen deprivation therapy. prostate-specific antigen response rate was 55.1% (95% confidence interval: 40.2%-69.3%), median prostate-specific antigen-progression-free survival was 24.1 weeks, and median overall survival was 102.9 weeks (95% confidence interval: 64.86 not estimable [NE]). Most common adverse event was nasopharyngitis (15/50 patients, 30.0%). The most common ≥grade 3 adverse event was alanine aminotransferase increased (6/50 patients, 12.0%).

conclusionsAbiraterone acetate plus prednisolone demonstrated a high prostate-specific antigen response rate of 55.1%, suggesting tumor growth still depends on androgen synthesis in patients with early metastatic castration-resistant prostate cancer. However, prostate-specific antigen-progression-free survival was shorter than that reported in previous studies. Considering the benefit-risk profile, abiraterone acetate plus prednisolone would be a beneficial treatment option for patients with chemotherapy-naive metastatic prostate cancer who show early castration resistance.

Indexed as

Abiraterone AcetateAgedAged, 80 and overAndrogensAntineoplastic Combined Chemotherapy ProtocolsHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisPrednisoloneProgression-Free SurvivalProstatic Neoplasms, Castration-ResistantTreatment OutcomeAbiraterone AcetateAndrogensPrednisoloneabiraterone acetate; chemotherapy-naive metastatic castration-resistant prostate cancerprednisoloneprostate-specific antigen

Identifiers

PMID33324967
PMCPMC8012350
OpenAlexW3111027555

What OpenQuestion holds

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LicenceCC BY
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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.