Evidence map›Paper›PMID 25938001›Full record

ArticleExperimental hematology & oncology2015

Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis.

Georg Hess, Bertrand Coiffier, Michael Crump, Christian Gisselbrecht, Fritz Offner, Jorge Romaguera, Lisa Kang, Pádraig J Moran

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Experimental hematology & oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00117598 (An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT00117598 phase3completednot on this map

An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

TypeinterventionalSponsorPfizerRan2005 to 2011Enrolled169ConditionsLymphomaArmsTemsirolimus (CCI-779), Investigator's choice
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
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 5 institutions in 3 countries.

Georg HessDepartment of Hematology/Oncology, Johannes Gutenberg University, Langenbeckstr. 1, Mainz, DE 55101 Germany.
Bertrand CoiffierCentre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.
Michael CrumpPrincess Margaret Hospital, Toronto, ON Canada.
Christian GisselbrechtHôpital Saint-Louis, Paris, France.
Fritz OffnerGhent University Hospital, Ghent, Belgium.
Jorge RomagueraThe University of Texas MD Anderson Cancer Center, Houston, TX USA.
Lisa KangPfizer Inc, Cambridge, MA USA.
Pádraig J MoranPrizer Inc, Dublin, Ireland.
Ghent University Hospital · BEHôpital Saint-Louis · FRHospices Civils de Lyon · FRPfizer (United States) · USThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTemsirolimus, a selective inhibitor of the mammalian target of rapamycin, has demonstrated clinical benefit versus investigator's choice (INV) of therapy in patients with relapsed/refractory mantle cell lymphoma (MCL).

methodsThis post hoc study retrospectively assigned simplified Mantle Cell Lymphoma International Prognostic Index (MIPI) scores (ie, secondary MIPI) based on parameters at the time of randomization in patients with MCL (N = 162) who received temsirolimus 175 mg once weekly for 3 weeks followed by once-weekly 75 mg or 25 mg or the INV of active therapy. Outcomes were analyzed according to the low-, intermediate- or high-risk category.

resultsPatient distribution by MIPI risk category was 31%, 39%, and 30% in the low-, intermediate-, and high-risk groups, respectively. Among patients in all categories, objective response rate (complete response + partial response) was higher in patients in the temsirolimus 175/75-mg group versus the INV group, respectively: 42% versus 0% (low-risk); 33% versus 5% (intermediate-risk); 10% versus 0% (high-risk). Median progression-free survival was significantly longer with temsirolimus 175/75 mg versus INV, respectively, in patients with intermediate (4.3 vs 1.9 months; P = 0.035) or high (4.5 vs 1.6 months; P = 0.0025) risk, and a trend toward improvement was observed in patients with low risk (5.3 vs 2.6 months; P = 0.091). Improvement in median overall survival was observed with temsirolimus 175/75 mg versus INV in low-risk patients (18.0 vs 10.5 months, respectively; P = 0.069).

conclusionsThis analysis suggests that, compared with INV, temsirolimus demonstrated benefit in all MIPI risk categories in patients with MCL. In all treatment groups, patients with high secondary MIPI scores at baseline faced a dismal prognosis.

trial registrationClinicalTrials.gov NCT00117598.

Indexed as

EfficacyMantle cell lymphomaPrognosticRiskSafetyTemsirolimus

Identifiers

PMID25938001
PMCPMC4416347
OpenAlexW2108822735

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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.