Evidence map›Paper›PMID 23091101›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma.

Christian Gisselbrecht, Norbert Schmitz, Nicolas Mounier, Devinder Singh Gill, David C Linch, Marek Trneny, Andre Bosly, Noel J Milpied, John Radford, Nicolas Ketterer and 10 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03016000 (A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma), which is not on this map. Cited by 128 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
128citing papers in PubMed, 6 pooled it
15.9field-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.

NCT03016000 phase3unknown statusnot on this mapstarted 2017, after this paper: background citation

A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2017 to 2023Enrolled226ConditionsLymphoma, Large B-Cell, DiffuseArmsThalidomide, Observation
3 · Its place in the literature

Who cites it

128 citing papers in PubMed, 6 syntheses or guidelines pooled it, 269 citations in OpenAlex.

  1. Guideline
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  5. Meta-analysis of cardiovascular toxicity risks in cancer patients on selected targeted agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
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  15. Cytochrome P450 2B6*5 Increases Relapse after Cyclophosphamide-Containing Conditioning and Autologous Transplantation for Lymphoma.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2015
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  18. Article
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68 more citing papers are in PubMed but not listed here.

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 7 institutions in 7 countries.

Christian GisselbrechtHôpital Saint Louis, Paris, France. christian.gisselbrecht@sls.aphp.fr
Norbert Schmitz
Nicolas Mounier
Devinder Singh Gill
David C Linch
Marek Trneny
Andre Bosly
Noel J Milpied
John Radford
Nicolas Ketterer
Ofer Shpilberg
Ulrich Dührsen
Hans Hagberg
David D Ma
Andreas Viardot
Ray Lowenthal
Josette Brière
Gilles Salles
Craig H Moskowitz
Bertram Glass
Charles University · CZHirslanden Clinique Bois-Cerf · CHMemorial Sloan Kettering Cancer Center · USRabin Medical Center · ILUCL Australia · AUUCLouvain · BEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL) is salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT). The impact of maintenance rituximab after ASCT is not known. PATIENTS AND

methodsIn total, 477 patients with CD20(+) DLBCL who were in their first relapse or refractory to initial therapy were randomly assigned to one of two salvage regimens. After three cycles of salvage chemotherapy, the responding patients received high-dose chemotherapy followed by ASCT. Then, 242 patients were randomly assigned to either rituximab every 2 months for 1 year or observation.

resultsAfter ASCT, 122 patients received rituximab, and 120 patients were observed only. The median follow-up time was 44 months. The 4-year event-free survival (EFS) rates after ASCT were 52% and 53% for the rituximab and observation groups, respectively (P = .7). Treatment with rituximab was associated with a 15% attributable risk of serious adverse events after day 100, with more deaths (six deaths v three deaths in the observation arm). Several factors affected EFS after ASCT (P < .05), including relapsed disease within 12 months (EFS: 46% v 56% for relapsed disease after 12 months), secondary age-adjusted International Prognostic Index (saaIPI) more than 1 (EFS: 37% v 61% for saaIPI < 1), and prior treatment with rituximab (EFS: 47% v 59% for no prior rituximab). A significant difference in EFS between women (63%) and men (46%) was also observed in the rituximab group. In the Cox model for maintenance, the saaIPI was a significant prognostic factor (P < .001), as was male sex (P = .01).

conclusionIn relapsed DLBCL, we observed no difference between the control group and the rituximab maintenance group and do not recommend rituximab after ASCT.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntigens, CD20Antineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyDisease ProgressionFemaleHematopoietic Stem Cell TransplantationHumansLymphoma, Large B-Cell, DiffuseMaintenance ChemotherapyMaleMiddle AgedRecurrenceRemission InductionAntibodies, Monoclonal, Murine-DerivedAntigens, CD20Rituximab

Identifiers

PMID23091101
PMCPMC3646314
OpenAlexW2130997237

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.