Evidence map›Paper›PMID 25698064›Full record

Trial reportEuropean urology2015

Long-term Safety and Antitumor Activity in the Phase 1-2 Study of Enzalutamide in Pre- and Post-docetaxel Castration-Resistant Prostate Cancer.

Celestia S Higano, Tomasz M Beer, Mary-Ellen Taplin, Eleni Efstathiou, Mohammad Hirmand, David Forer, Howard I Scher

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Celestia S HiganoUniversity of Washington School of Medicine, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: thigano@u.washington.edu.
Tomasz M BeerOregon Health & Science University Knight Cancer Institute, Portland, OR, USA.
Mary-Ellen TaplinDana-Farber Cancer Institute, Boston, MA, USA.
Eleni EfstathiouUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mohammad HirmandMedivation Inc., San Francisco, CA, USA.
David ForerMedivation Inc., San Francisco, CA, USA.
Howard I ScherGenitourinary Oncology Service, Department of Medicine, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundGiven that some patients with castration-resistant prostate cancer (CRPC) have shown extended responses to the androgen receptor inhibitor enzalutamide, long-term safety of this drug is of interest.

objectiveTo evaluate the long-term safety and antitumor activity of enzalutamide in CRPC patients. DESIGN, SETTING, AND

participantsThis phase 1-2 study evaluated enzalutamide in 140 CRPC patients with and without prior chemotherapy. Initial findings were published in 2010. We report updated results from an additional 17-mo follow-up for antitumor activity and >4 yr for safety.

interventionPatients received 30-600mg/d oral enzalutamide. During long-term dosing, all patients were switched first to the maximum tolerated dose of 240mg/d and then to the phase 3 dose of 160mg/d. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Safety was assessed regularly. The Kaplan-Meier method was used to estimate the distributions of time to prostate-specific antigen (PSA) progression and time to radiographic progression. RESULTS AND LIMITATIONS: The safety profile of enzalutamide was consistent over time, with little change in the rates of commonly reported adverse events (AEs) or the incidence of grade 3/4 AEs. Fatigue of any grade was the most common dose-dependent AE, experienced by 70% of patients, with 14% of patients reporting grade 3/4 fatigue. The median time to PSA progression was not reached for chemotherapy-naive patients and was 45 wk for postchemotherapy patients; the corresponding median time to radiographic progression was 56 wk and 25 wk.

conclusionsEnzalutamide showed durable antitumor activity in chemotherapy-naive and postchemotherapy patients, and was well tolerated, even in patients treated for 4 yr. PATIENT SUMMARY: Enzalutamide was active against prostate cancer and was well tolerated, even for up to 4 yr of treatment, supporting its potential for long-term use in men with prostate cancer. Fatigue was the most common side effect, occurring at varying degrees of severity in most patients.

Indexed as

AdultAgedAged, 80 and overAndrogen Receptor AntagonistsAntineoplastic AgentsAntineoplastic Agents, HormonalBenzamidesBone NeoplasmsDisease-Free SurvivalDocetaxelHumansKallikreinsLymph NodesMaleMaximum Tolerated DoseMiddle AgedAndrogen Receptor AntagonistsAntineoplastic AgentsAntineoplastic Agents, HormonalBenzamidesDocetaxelenzalutamideKallikreinsKLK3 protein, humanNitrilesPhenylthiohydantoinProstate-Specific AntigenTaxoidsAndrogen receptor inhibitorCastration-resistant prostate cancerEnzalutamideLong-term follow-upMDV3100Tolerability

Identifiers

PMID25698064
PMCPMC5013546

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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.