Evidence map›Paper›PMID 32188988›Full record

Trial reportJapanese journal of clinical oncology2020

Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study.

Hiroyoshi Suzuki, Toshitaka Shin, Satoshi Fukasawa, Katsuyoshi Hashine, Sumiko Kitani, Noriyuki Ohtake, Kazuhiro Shibayama, Namphuong Tran, Suneel Mundle, Karim Fizazi and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Japanese journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 5% 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

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

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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

11 authors at 7 institutions in 3 countries.

Hiroyoshi SuzukiDepartment of Urology, Toho University Sakura Medical Center, Chiba, Japan.
Toshitaka ShinDepartment of Urology, Oita University Faculty of Medicine, Oita, Japan.
Satoshi FukasawaProstate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.
Katsuyoshi HashineNational Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Sumiko KitaniJanssen Pharmaceutical K.K., Tokyo, Japan.
Noriyuki OhtakeJanssen Pharmaceutical K.K., Tokyo, Japan.
Kazuhiro ShibayamaJanssen Pharmaceutical K.K., Tokyo, Japan.
Namphuong TranJanssen Research & Development, Los Angeles, CA, USA.
Suneel MundleJanssen Research & Development, Raritan, NJ, USA.
Karim FizaziInstitut Gustave Roussy, Paris-Sud University, Villejuif, France.
Nobuaki MatsubaraDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.
Janssen (United States) · USChiba Cancer Center · JPNational Cancer Center Hospital East · JPOita University · JPShikoku Cancer Center · JPToho University · JPUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLATITUDE was a randomized, double-blind, international and phase 3 study of abiraterone acetate plus prednisone in patients with high-risk metastatic hormone-naïve prostate cancer. In the first interim analysis of LATITUDE (clinical cutoff date: 31 October 2016), significant prolongation in overall survival and radiographic progression-free survival (co-primary endpoints) was observed when compared with placebo. The results of the Japanese subgroup analysis of LATITUDE first interim analysis were consistent with those of the overall population. In this study, overall survival and safety results from the final analysis of the Japanese subgroup of the LATITUDE study are presented (clinical cutoff date: 15 August 2018).

methodsAbiraterone acetate (1000 mg/day) and prednisone (5 mg/day) were administered orally in the abiraterone acetate plus prednisone group, and matching placebos in the placebo group.

resultsOf the 1199 patients included in LATITUDE, 70 constituted the Japanese subgroup (abiraterone acetate plus prednisone: n = 35, placebo: n = 35). Following a median (range) follow-up of 56.6 (2.5, 64.2) months, the median overall survival was not reached in both the treatment arms of the Japanese subgroup (hazard ratio: 0.61; 95% confidence interval: 0.27-1.42; nominal P = 0.2502). A total of 23 deaths (abiraterone acetate plus prednisone: 9 [25.7%], placebo group: 14 [40.0%]) were reported in Japanese subgroup. Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.

conclusionsIn this Japanese subgroup analysis, addition of abiraterone acetate plus prednisone to androgen-deprivation therapy demonstrated favorable efficacy and safety outcomes in patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer. Survival benefits observed in the Japanese subgroup first interim analysis were sustained long-term and were consistent with the overall population.

Indexed as

Abiraterone AcetateAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodHumansJapanMaleMiddle AgedNeoplasm MetastasisPrednisoneProstatic NeoplasmsSurvival AnalysisAbiraterone AcetateAntineoplastic AgentsPrednisoneabiraterone acetateJapanmetastatic hormone-naïve prostate cancer

Identifiers

PMID32188988
PMCPMC7345218
OpenAlexW2898329645

What OpenQuestion holds

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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.