Evidence map›Paper›PMID 34839812›Full record

Trial reportBMC cancer2021

A prospective phase-II trial of biweekly docetaxel plus androgen deprivation therapy in patients with previously-untreated metastatic castration-naïve prostate cancer.

Seonggyu Byeon, Hongsik Kim, Hwang Gyun Jeon, Seong Il Seo, Seong Soo Jeon, Hyun Moo Lee, Soon Il Lee, Se Hoon Park

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
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

8 authors at 4 institutions in 1 country.

Seonggyu Byeon *Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
Hongsik Kim *Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.
Hwang Gyun JeonDepartment of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Seong Il SeoDepartment of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Seong Soo JeonDepartment of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Hyun Moo LeeDepartment of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Soon Il LeeInternal Medicine, Dankook University College of Medicine, Cheonan, Chungcheongnam-do, Korea.
Se Hoon ParkDivision of Hematology-Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea. hematoma@skku.edu.
Samsung Medical Center · KRSungkyunkwan University · KRChungbuk National University Hospital · KRDankook University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this prospective phase II study was to evaluate the efficacy and safety of biweekly docetaxel plus androgen-deprivation therapy (ADT) in patients with metastatic castration-naïve prostate cancer (mCNPC). PATIENTS AND

methodsPatients with histologically-proven, previously-untreated mCNPC received ADT plus docetaxel, 40 mg/m

resultsA total of 42 patients were registered and analyzed for final outcomes. Of the 42 patients, 36 (86%) completed the 12 planned cycles of docetaxel plus ADT. During a median follow up of 25 months, all but two patients (95%) achieved a PSA response with a nadir PSA level of 0.42 ng/ml (range 0.01-1280.87). The median CRPC-free survival was 26.4 months (95% confidence interval [CI] 20.9-32.0) with a one-year CRPC-free rate of 79% (33 patients, 95% CI 66-91). Multivariable analysis revealed that the performance status of the Eastern Cooperative Oncology Group 0 was independently associated with longer CRPC-free survival (hazard ratio [HR] 0.27, 95% CI 0.07-0.99). The most common adverse events of any grade were anemia (95%), followed by nail changes (33%), fatigue (29%), and oral mucositis (26%). Severe (grade 3 or higher) adverse events were infrequent: pneumonitis (n = 2), diarrhea (n = 1), and neutropenia (n = 1).

conclusionOur results suggest that biweekly docetaxel plus ADT is feasible, and clinical efficacy does not seem to be compromised compared to a standard triweekly docetaxel 75 mg/m

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAnemiaAntineoplastic AgentsDiarrheaDisease-Free SurvivalDocetaxelDrug Administration ScheduleFatigueFollow-Up StudiesHumansMaleMiddle AgedNail DiseasesNeutropeniaAndrogen AntagonistsAntineoplastic AgentsDocetaxelProstate-Specific Antigen

Identifiers

PMID34839812
PMCPMC8628395
OpenAlexW3217654032

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.