Evidence map›Paper›PMID 23294853›Full record

Trial reportThe Lancet. Oncology2013

2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial.

Pirkko-Liisa Kellokumpu-Lehtinen, Ulrika Harmenberg, Timo Joensuu, Ray McDermott, Petteri Hervonen, Claes Ginman, Marjaana Luukkaa, Paul Nyandoto, Akseli Hemminki, Sten Nilsson and 11 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 72 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 9 pooled it
16.1field-weighted citation impact, top 1% 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.

NCT00255606 phase3completednot on this map

A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial

TypeinterventionalSponsorTampere UniversityRan2005 to 2010Enrolled360ConditionsProstate CancerArmsdocetaxel, prednisone
NCT03737370 phase1completednot on this mapstarted 2018, after this paper: background citation

A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)

TypeinterventionalSponsorTufts Medical CenterRan2018 to 2025Enrolled43ConditionsMetastatic Castrate Resistant Prostate CancerArmsDocetaxel, Radium 223
NCT05471427 completednot on this mapstarted 2020, after this paper: background citation

Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer, a Prospective Observational Study (ANCHISES)

TypeobservationalSponsorAzienda Ospedaliero-Universitaria CareggiRan2020 to 2022Enrolled118ConditionsElderly Patients, Metastatic Prostate CancerArmsTaxane chemotherapy
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 9 syntheses or guidelines pooled it, 207 citations in OpenAlex.

  1. Pooled it
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  5. SEOM clinical guidelines for the treatment of metastatic prostate cancer (2017).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  6. Pooled it
  7. Pooled it
  8. SEOM clinical guidelines for the treatment of metastatic prostate cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2014
    Guideline
  9. Pooled it
  10. Trial
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  13. Article
  14. Review
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  17. 27-Hydroxycholesterol in cancer development and drug resistance.Journal of enzyme inhibition and medicinal chemistry · 2025
    Review
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  20. Article

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 11 institutions in 3 countries.

Pirkko-Liisa Kellokumpu-LehtinenDepartment of Oncology, Tampere University Hospital, Tampere, Finland. Pirkko-Liisa.Kellokumpu-Lehtinen@uta.fi
Ulrika Harmenberg
Timo Joensuu
Ray McDermott
Petteri Hervonen
Claes Ginman
Marjaana Luukkaa
Paul Nyandoto
Akseli Hemminki
Sten Nilsson
John McCaffrey
Raija Asola
Taina Turpeenniemi-Hujanen
Fredrik Laestadius
Tiina Tasmuth
Katinka Sandberg
Maccon Keane
Ilari Lehtinen
Tiina Luukkaala
Heikki Joensuu
PROSTY study group
Karolinska University Hospital · SECancer Trials Ireland · IEHelsinki University Hospital · FITampere University · FIKarlstad Central Hospital · SEOulu University Hospital · FIPäijät-Hämeen Keskussairaala · FIPirkanmaa Hospital District · FISatakunta Central Hospital · FITurku University Hospital · FIUniversity of Helsinki · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDocetaxel administered every 3 weeks is a standard treatment for castration-resistant advanced prostate cancer. We hypothesised that 2-weekly administration of docetaxel would be better tolerated than 3-weekly docetaxel in patients with castration-resistant advanced prostate cancer, and did a prospective, multicentre, randomised, phase 3 study to compare efficacy and safety.

methodsEligible patients had advanced prostate cancer (metastasis, a prostate-specific-antigen test result of more than 10·0 ng/mL, and WHO performance status score of 0-2), had received no chemotherapy (except with estramustine), had undergone surgical or chemical castration, and had been referred to a treatment centre in Finland, Ireland, or Sweden. Enrolment and treatment were done between March 1, 2004, and May 31, 2009. Randomisation was done centrally and stratified by centre and WHO performance status score of 0-1 vs 2. Patients were assigned 75 mg/m(2) docetaxel intravenously on day 1 of a 3-week cycle, or 50 mg/m(2) docetaxel intravenously on days 1 and 15 of a 4-week cycle. 10 mg oral prednisolone was administered daily to all patients. The primary endpoint was time to treatment failure (TTTF). We assessed data in the per-protocol population. This study is registered with ClinicalTrials.gov, number NCT00255606.

findings177 patients were randomly assigned to the 2-weekly docetaxel group and 184 to the 3-weekly group. 170 patients in the 2-weekly group and 176 in the 3-weekly group were included in the analysis. The 2-weekly administration was associated with significantly longer TTTF than was 3-weekly administration (5·6 months, 95% CI 5·0-6·2 vs 4·9 months, 4·5-5·4; hazard ratio 1·3, 95% CI 1·1-1·6, p=0·014). Grade 3-4 adverse events occurred more frequently in the 3-weekly than in the 2-weekly administration group, including neutropenia (93 [53%] vs 61 [36%]), leucopenia (51 [29%] vs 22 [13%]), and febrile neutropenia (25 [14%] vs six [4%]). Neutropenic infections were reported more frequently in patients who received docetaxel every 3 weeks (43 [24%] vs 11 [6%], p=0·002).

interpretationAdministration of docetaxel every 2 weeks seems to be well tolerated in patients with castration-resistant advanced prostate cancer and could be a useful option when 3-weekly single-dose administration is unlikely to be tolerated.

fundingSanofi.

Indexed as

OrchiectomyAgedAged, 80 and overAntineoplastic AgentsDocetaxelDrug Administration RoutesHumansMaleMiddle AgedProspective StudiesProstatic NeoplasmsQuality of LifeTaxoidsTreatment FailureAntineoplastic AgentsDocetaxelTaxoids

Identifiers

PMID23294853
OpenAlexW2160129915

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.