Evidence map›Paper›PMID 29454321›Full record

Trial reportBMC cancer2018

Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer.

Marina Pulido, Guilhem Roubaud, Anne-Laure Cazeau, Hakim Mahammedi, Lionel Vedrine, Florence Joly, Loic Mourey, Christian Pfister, Alejandro Goberna, Barbara Lortal and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01827943 (Phase II Trial, Evaluating Efficacy of Temsirolimus), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.4field-weighted citation impact, top 13% 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.

NCT01827943 phase2completednot on this map

Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer

TypeinterventionalSponsorInstitut BergoniéRan2009 to 2016Enrolled54ConditionsRelapsed Bladder CancerArmsTemsirolimus
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Abnormal changes in metabolites caused by mJournal of advanced research · 2025
    Review
  3. Article
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  6. Landscape of targeted therapies for advanced urothelial carcinoma.Exploration of targeted anti-tumor therapy · 2024
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 1 country.

Marina PulidoClinical and Epidemiology Department & Clinical Investigation Center INSERM CIC 1401, Bergonié Institute, Bordeaux, France.
Guilhem RoubaudMedical Oncology Department, Bergonié Institute, Bordeaux, France.
Anne-Laure CazeauNuclear Medicine Department, Bergonié Institute, Bordeaux, France.
Hakim MahammediMedical Oncology Department, Jean Perrin Cancer Center, Clermont-Ferrand, France.
Lionel VedrineHartmann Oncology Radiotherapy Group, Levallois-Peret, France.
Florence JolyMedical Oncology Department, François Baclesse Cancer Center, Caen, France.
Loic MoureyMedical Oncology Department, IUCT Oncopole, Toulouse, France.
Christian PfisterUrology Department, Rouen University Hospital & Clinical Investigation Center INSERM CIC 1404, Rouen, France.
Alejandro GobernaClinical and Epidemiology Department & Clinical Investigation Center INSERM CIC 1401, Bergonié Institute, Bordeaux, France.
Barbara LortalMedical Oncology Department, Bergonié Institute, Bordeaux, France.
Carine BelleraClinical and Epidemiology Department & Clinical Investigation Center INSERM CIC 1401, Bergonié Institute, Bordeaux, France.
Philippe PourquierINSERM U1194, Montpellier Cancer Research Institute, Montpellier, France.
Nadine HouédéINSERM U1194, Montpellier Cancer Research Institute, Montpellier, France. nadine.houede@chu-nimes.fr.ORCID 0000-0002-8852-5754
Inserm · FRInstitut Bergonié · FRCentre François Baclesse · FRCentre Jean Perrin · FRClinique Hartmann · FRInstitut universitaire du cancer de Toulouse Oncopole · FR

Funding

Pfizer WS979392
6 · The paper itself

Abstract

backgroundBladder cancer is the 7th cause of death from cancer in men and 10th in women. Metastatic patients have a poor prognosis with a median overall survival of 14 months. Until recently, vinflunine was the only second-line chemotherapy available for patients who relapse. Deregulation of the PI3K/AKT/mTOR pathway was observed in more than 40% of bladder tumors and suggested the use of mTOR as a target for the treatment of urothelial cancers.

methodsThis trial assessed the efficacy of temsirolimus in a homogenous cohort of patients with recurrent or metastatic bladder cancer following first-line chemotherapy. Efficacy was measured in terms of non-progression at two months according to the RECIST v1.1 criteria. Based on a two-stage optimal Simon's design, 15 non-progressions out of 51 evaluable patients were required to claim efficacy. Patients were treated at a weekly dose of 25 mg IV until progression, unacceptable toxicities or withdrawal.

resultsAmong the 54 patients enrolled in the study between November 2009 and July 2014, 45 were assessable for the primary efficacy endpoint. A total of 22 (48.9%) non-progressions were observed at 2 months with 3 partial responses and 19 stable diseases. Remarkably, 4 patients were treated for more than 30 weeks. Fifty patients experienced at least a related grade1/2 (94%) and twenty-eight patients (52.8%) a related grade 3/4 adverse event. Eleven patients had to stop treatment for toxicity. This led to recruitment being halted by an independent data monitoring committee with regard to the risk-benefit balance and the fact that the primary objective was already met.

conclusionsWhile the positivity of this trial indicates a potential benefit of temsirolimus for a subset of bladder cancer patients who are refractory to first line platinum-based chemotherapy, the risk of adverse events associated with the use of this mTOR inhibitor would need to be considered when such an option is envisaged in this frail population of patients. It also remains to identify patients who will benefit the most from this targeted therapy.

trial registrationClinicalTrials.gov Identifier: NCT01827943 (trial registration date: October 29, 2012); Retrospectively registered.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingPositron Emission Tomography Computed TomographyProtein Kinase InhibitorsRetreatmentSirolimusAntineoplastic AgentsProtein Kinase InhibitorsSirolimustemsirolimusClinical trialMetastatic bladder cancermTORTemsirolimus

Identifiers

PMID29454321
PMCPMC5816357
OpenAlexW2789045296

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.