Evidence map›Paper›PMID 38769191›Full record

ArticleInternational journal of clinical oncology2024

Effectiveness and safety of enzalutamide and apalutamide in the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC): a multicenter retrospective study.

Shuhei Hara, Keiichiro Mori, Wataru Fukuokaya, Naoya Tomomasa, Takahiro Oguchi, Yusuke Takahashi, Shun Saito, Jun Katami, Takayuki Sano, Soushi Kadena and 15 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
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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

25 authors.

Shuhei HaraDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan. sharahara2@gmail.com.ORCID http://orcid.org/0009-0001-9842-3612
Keiichiro MoriDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Wataru FukuokayaDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Naoya TomomasaDepartment of Urology, SUBARU Health Insurance Society Ota Memorial Hospital, Gumna, Japan.
Takahiro OguchiDepartment of Urology, Tokyo Metropolitan Hiroo General Hopital, Tokyo, Japan.
Yusuke TakahashiDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Shun SaitoDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Jun KatamiDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Takayuki SanoDepartment of Urology, Saitama Jikei Hospital, Saitama, Japan.
Soushi KadenaDepartment of Urology, Kosei Hospital, Tokyo, Japan.
Masaki HashimotoDepartment of Urology, Atsugi City Hospital, Kanagawa, Japan.
Yuji YataDepartment of Urology, JR Tokyo General Hospital, Tokyo, Japan.
Eriko NishiDepartment of Urology, Kameda Medical Center, Chiba, Japan.
Yushi SuharaDepartment of Urology, Machida City Hospital, Tokyo, Japan.
Shigeyoshi TakamizawaDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Shiro KurawakiTokyo-Kita Medical Center, Tokyo, Japan.
Hirotaka SuzukiDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Keiichiro MiyajimaDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Kosuke IwataniDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Fumihiko UrabeDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Kagenori ItoDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Takafumi YanagisawaDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Shunsuke TsuzukiDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Tatsuya ShimomuraDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Takahiro KimuraDepartment of Urology, The Jikei University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePhase III clinical trials demonstrated the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and PSA doubling time ≤10 months. Although these drugs have been shown to vary in their adverse event (AE) profiles, the differences in their efficacy profiles remain to be evaluated. Therefore, this retrospective study was conducted to evaluate the efficacy of these drugs in patients with nmCRPC.

methodsThis study evaluated 191 patients with nmCRPC treated with enzalutamide (n = 137) or apalutamide (n = 54) in the first-line setting at Jikei University Hospital or its affiliated hospitals between May 2014 and November 2022. Endpoints were defined as oncological outcomes (i.e., PSA response, PFS, PSA-PFS, MFS, CSS, and OS) and AEs.

resultsNo significant differences were noted in patient backgrounds between the two groups. Patients exhibiting a maximum PSA response of >50% and >90% accounted for 74.5% and 48.9% of patients in the enzalutamide group, and 75.9% and 42.6% of patients in the apalutamide group, respectively, with no significant difference between the groups. The median PSA-PFS was 10 months in the enzalutamide group but not in the apalutamide group, with no significant difference between the groups (P = 0.48). No significant differences were observed in MFS, CSS, or OS between the groups. Patients reporting AEs of all grades and grade 3 or higher accounted for 56.2% and 4.3% of those in the enzalutamide group and 57.4% and 7.4% of those in the apalutamide group, respectively. The most common AE was fatigue (26.3%) in the enzalutamide group and skin rash (27.8%) in the apalutamide group.

conclusionIn this retrospective study of their efficacy and safety, enzalutamide and apalutamide were shown to exhibit comparable oncological outcomes but quite different AE profiles, suggesting that their differential use may be warranted based on these findings.

Indexed as

BenzamidesNitrilesPhenylthiohydantoinProstatic Neoplasms, Castration-ResistantThiohydantoinsAgedAged, 80 and overHumansMaleMiddle AgedProstate-Specific AntigenRetrospective StudiesTreatment OutcomeapalutamideBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific AntigenThiohydantoinsApalutamideEnzalutamidenmCRPCNon-metastatic castration resistant prostate cancer

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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.