Evidence map›Paper›PMID 25921098›Full record

Trial reportBritish journal of haematology2015

Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial.

Andre Goy, Sevgi Kalayoglu Besisik, Johannes Drach, Radhakrishnan Ramchandren, Michael J Robertson, Irit Avivi, Jacob M Rowe, Raoul Herbrecht, Achiel Van Hoof, Lei Zhang and 3 more

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

Trial report in British journal of haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00737529 (A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.4field-weighted citation impact, top 12% 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.

NCT00737529 phase2completednot on this map

A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

TypeinterventionalSponsorCelgeneRan2008 to 2017Enrolled134ConditionsMantle Cell LymphomaArmslenalidomide
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 41 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Pirtobrutinib in Covalent Bruton Tyrosine Kinase Inhibitor Pretreated Mantle-Cell Lymphoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  7. Article
  8. Article
  9. Immunomodulatory Drugs for the Treatment of B Cell Malignancies.International journal of molecular sciences · 2021
    Review
  10. Article
  11. Review
  12. Review
  13. Molecular profiling and management of mantle cell lymphoma.Hematology. American Society of Hematology. Education Program · 2019
    Article
  14. IMiDs New and Old.Current hematologic malignancy reports · 2019
    Review
  15. Review
  16. Optimizing therapy for mantle cell lymphoma.Hematology. American Society of Hematology. Education Program · 2017
    Review
  17. 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

13 authors at 10 institutions in 6 countries.

Andre GoyJohn Theurer Cancer Center at HUMC, Hackensack, NJ, USA.
Sevgi Kalayoglu BesisikIstanbul University Faculty of Medicine, Istanbul, Turkey.
Johannes DrachMedical University of Vienna, Vienna, Austria.
Radhakrishnan RamchandrenKarmanos Cancer Institute, Detroit, MI, USA.
Michael J RobertsonIndiana University Medical Center, Indianapolis, IN, USA.
Irit AviviRambam Health Care Campus, Haifa, Israel.
Jacob M RoweShaare Zedek Medical Centre, Jerusalem, Israel.
Raoul HerbrechtHôpital de Hautepierre, Strasbourg, France.
Achiel Van HoofGeneral Hospital St-Jan, Brugge, Belgium.
Lei ZhangCelgene Corporation, Summit, NJ, USA.
Sherri CiceroCelgene Corporation, Summit, NJ, USA.
Tommy FuCelgene Corporation, Summit, NJ, USA.
Thomas WitzigMayo Clinic, Rochester, MN, USA.
AZ Sint-Jan · BEHackensack University Medical Center · USHôpital d'Hautepierre · FRIndiana University – Purdue University Indianapolis · USIstanbul University · TRMayo Clinic in Arizona · USMedical University of Vienna · ATRambam Health Care Campus · ILShaare Zedek Medical Center · ILThe Barbara Ann Karmanos Cancer Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with mantle cell lymphoma (MCL) generally respond to first-line immunochemotherapy, but often show chemoresistance upon subsequent relapses, with poor outcome. Several studies of the immunomodulator, lenalidomide, have demonstrated its activity in MCL including the MCL-001 study in relapsed/refractory patients who had failed defined prior therapies of anthracyclines or mitoxantrone, cyclophosphamide, rituximab and also bortezomib. We present here the long-term efficacy follow-up of the prospective phase II MCL-001 study (N = 134), including new exploratory analyses with baseline Ki-67 (MIB1), a biological marker of tumour proliferation. With longer follow-up, lenalidomide showed a 28% overall response rate [ORR; 8% complete response (CR)/CR unconfirmed (CRu)]. Median duration of response (DOR), progression-free survival and overall survival were 16·6, 4·0 and 20·9 months, respectively. Myelosuppression continued to be the most common grade 3/4 toxicity. Several studies of MCL patients treated with chemotherapy, rituximab and bortezomib have shown an inverse association between survival and Ki-67. Ki-67 data in 81/134 MCL-001 patients showed similar ORRs in both low (<30% or <50%) versus high (≥30% or ≥50%) Ki-67-expressing groups, yet lower Ki-67 levels demonstrated superior CR/CRu, DOR and survival outcomes. Overall, lenalidomide showed durable efficacy with a consistent safety profile in heavily pretreated, relapsed/refractory MCL post-bortezomib.

Indexed as

Lymphoma, Mantle-CellAdultAgedAged, 80 and overAngiogenesis InhibitorsBiomarkers, TumorCell ProliferationDisease-Free SurvivalFemaleFollow-Up StudiesHumansKi-67 AntigenLenalidomideMaleMiddle AgedSurvival RateAngiogenesis InhibitorsBiomarkers, TumorKi-67 AntigenLenalidomideThalidomideefficacyKi-67lenalidomidemantle cell lymphomasafety

Identifiers

PMID25921098
PMCPMC5029780
OpenAlexW2014489070

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.