Evidence map›Paper›PMID 27118109›Full record

Trial reportBritish journal of haematology2016

Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial.

Ruth Pettengell, Catherine Sebban, Pier Luigi Zinzani, Hans Gunter Derigs, Sergey Kravchenko, Jack W Singer, Panteli Theocharous, Lixia Wang, Mariya Pavlyuk, Kahina M Makhloufi and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

8 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Pixantrone beyond monotherapy: a review.Annals of hematology · 2019
    Review
  7. Review
  8. 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

11 authors.

Ruth PettengellSt George's University of London, London, UK.
Catherine SebbanLeon Bérard Cancer Centre, Lyon, France.
Pier Luigi ZinzaniInstitute of Haematology "Le A Seràgnoli", University of Bologna, Bologna, Italy.
Hans Gunter DerigsStädt Klinikum, Frankfurt-Hoeschest, Klinik für Innere Medizin III, Frankfurt am Main, Germany.
Sergey KravchenkoChemotherapy and Intensive Treatment of Haematology Diseases, Haematology Scientific Centre Ministry of Health RF, Moscow, Russia.
Jack W SingerCell Therapeutics Inc Life Sciences, London, UK.
Panteli TheocharousCell Therapeutics Inc, Seattle, WA, USA.
Lixia WangCell Therapeutics Inc, Seattle, WA, USA.
Mariya PavlyukInstitut de Recherches Internationales Servier, Suresnes, France.
Kahina M MakhloufiInstitut de Recherches Internationales Servier, Suresnes, France.
Bertrand CoiffierCentre Hospitalier Lyon Sud, Pierre-Benite, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This post hoc analysis of a phase 3 trial explored the effect of pixantrone in patients (50 pixantrone, 47 comparator) with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) confirmed by centralized histological review. Patients received 28-d cycles of 85 mg/m(2) pixantrone dimaleate (equivalent to 50 mg/m(2) in the approved formulation) on days 1, 8 and 15, or comparator. The population was subdivided according to previous rituximab use and whether they received the study treatment as 3rd or 4th line. Median number of cycles was 4 (range, 2-6) with pixantrone and 3 (2-6) with comparator. In 3rd or 4th line, pixantrone was associated with higher complete response (CR) (23·1% vs. 5·1% comparator, P = 0·047) and overall response rate (ORR, 43·6% vs. 12·8%, P = 0·005). In 3rd or 4th line with previous rituximab (20 pixantrone, 18 comparator), pixantrone produced better ORR (45·0% vs. 11·1%, P = 0·033), CR (30·0% vs. 5·6%, P = 0·093) and progression-free survival (median 5·4 vs. 2·8 months, hazard ratio 0·52, 95% confidence interval 0·26-1·04) than the comparator. Similar results were found in patients without previous rituximab. There were no unexpected safety issues. Pixantrone monotherapy is more effective than comparator in relapsed or refractory aggressive B-cell NHL in the 3rd or 4th line setting, independently of previous rituximab.

Indexed as

AdultAgedAged, 80 and overDisease-Free SurvivalFemaleHumansIsoquinolinesLymphoma, B-CellMaleMiddle AgedRemission InductionRituximabSalvage TherapyTopoisomerase II InhibitorsIsoquinolinespixantroneRituximabTopoisomerase II InhibitorsB-cell non-Hodgkin lymphomapixantronepost hoc studyrituximabsalvage therapy

Identifiers

PMID27118109
PMCPMC5074333

What OpenQuestion holds

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Registered trials

None linked

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.