Evidence map›Paper›PMID 29059273›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy.

K Fizazi, A Ulys, L Sengeløv, M Moe, S Ladoire, A Thiery-Vuillemin, A Flechon, A Guida, J Bellmunt, M A Climent and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01732549 (A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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.

NCT01732549 phase2terminatednot on this map

A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy

TypeinterventionalSponsorIpsenRan2013 to 2015Enrolled144ConditionsMetastatic Castrate Resistant Prostate CancerArmsTasquinimod, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
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  11. Article
  12. Validation of the Brazilian Version of Functional Assessment of Cancer Therapy-Prostate-FACT-P (Version 4) in Prostate Cancer Patients.Journal of cancer education : the official journal of the American Association for Cancer Education · 2022
    Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. S100 proteins as therapeutic targets.Biophysical reviews · 2018
    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

20 authors at 16 institutions in 8 countries.

K FizaziDepartment of Cancer Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.
A UlysNational Cancer Institute, Vilnius, Lithuania.
L SengeløvDepartment of Oncology, Herlev Hospital, Herlev.
M MoeDepartment of Oncology, Aalborg University Hospital, Aalborg, Denmark.
S LadoireDepartment of Medical Oncology, Centre Georges François Leclerc, Dijon.
A Thiery-VuilleminINSERM, UMR1098, Besançon.
A FlechonMedicine, Centre Léon Bérard, Lyon, France.
A GuidaDepartment of Oncology & Hematology, Azienda University Hospital, Modena, Italy.
J BellmuntDana-Farber/Brigham and Women's Cancer Center, Boston, USA.
M A ClimentDepartment of Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain.
S ChowdhuryGuy's and St Thomas' NHS Foundation Trust, London, UK.
H DumezDepartment of General Medical Oncology, University Hospitals Leuven, Leuven; KU Leuven, Leuven, Belgium.
M MatouskovaUrocentrum, Prague, Czech Republic.
N PenelGeneral Oncology Department, Centre Oscar Lambret, Lille, France.
S LiutkauskieneLithuanian University of Health Sciences Hospital, Kaunas, Lithuania.
L StachurskiGabinet Urologiczny, Gdynia, Gdańsk, Poland.
C N SternbergDepartment of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy.
F BatonIpsen Innovation, Les Ulis, France.
N GermannIpsen Innovation, Les Ulis, France.
G DaugaardDepartment of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Ipsen (France) · FRAalborg University Hospital · DKCarlo Forlanini Hospital · ITCentre Georges François Leclerc · FRCentre Léon Bérard · FRCentre Oscar Lambret · FRDana-Farber Brigham Cancer Center · USFundación Instituto Valenciano de Oncología · ESGuy's and St Thomas' NHS Foundation Trust · GBHerlev Hospital · DKInserm · FRKU Leuven · BELithuanian University of Health Sciences · LTNational Cancer Institute · LTRigshospitalet · DKUniversité Paris-Saclay · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase II study was conducted to assess clinical efficacy of tasquinimod maintenance therapy in patients with metastatic castrate-resistant prostate cancer not progressing during first-line docetaxel-based therapy. PATIENTS AND

methodsPatients were randomly assigned (1 : 1) to receive tasquinimod (0.25-1.0 mg/day orally) or placebo. The primary end point was radiologic progression-free survival (rPFS); secondary efficacy end points included: overall survival (OS); PFS on next-line therapy (PFS 2) and symptomatic PFS, assessed using the Brief Pain Inventory (BPI) questionnaire and analgesic use. Quality of life was measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol-5 Dimension Quality of Life Instrument (EQ-5D). Adverse events were recorded.

resultsA total of 219 patients were screened and 144 patients randomized. The median duration of treatment was 18.7 weeks (range 0.6-102.7 weeks) for the tasquinimod arm and 19.2 weeks (range 0.4-80.0 weeks) for the placebo arm. Median (90% CI) rPFS was 31.7 (24.3-53.7) and 22.7 (16.1-25.9) weeks in the tasquinimod and placebo arms, respectively [HR (90% CI) 0.6 (0.4-0.9), P = 0.0162]. The median OS was not reached because only 14 deaths occurred by the cut-off date. No statistically significant differences between treatment arms were noted for symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE) was similar in the tasquinimod and placebo arms (97.2% versus 94.3%, respectively), whereas severe TEAEs (NCI-CTC Grade 3-5) incidence was higher in the tasquinimod group (50.7% versus 27.1%).

conclusionsRandomized trials testing new drugs as maintenance can be successfully conducted after chemotherapy in castrate-resistant prostate cancer. Maintenance tasquinimod therapy significantly reduced the risk of rPFS by 40%. CLINICALTRIALS: gov identifier NCT01732549.

Indexed as

Quality of LifeAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDisease ManagementDocetaxelDouble-Blind MethodFollow-Up StudiesHumansInternational AgenciesMaleMiddle AgedPrognosisProstatic Neoplasms, Castration-ResistantQuinolonesSurvival RateDocetaxelQuinolonestasquinimodTaxoidscastrate-resistantdocetaxelmaintenance therapyprostate cancertasquinimod

Identifiers

PMID29059273
PMCPMC6246397
OpenAlexW2766100008

What OpenQuestion holds

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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.