Evidence map›Paper›PMID 35963941›Full record

Trial reportLeukemia2022

Molecular determinants of outcomes in relapsed or refractory mantle cell lymphoma treated with ibrutinib or temsirolimus in the MCL3001 (RAY) trial.

Ciara L Freeman, Prasath Pararajalingam, Ling Jin, Sriram Balasubramanian, Aixiang Jiang, Wendan Xu, Michael Grau, Myroslav Zapukhlyak, Merrill Boyle, Brendan Hodkinson and 8 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. 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

18 authors at 7 institutions in 4 countries.

Ciara L FreemanCentre for Lymphoid Cancer, BC Cancer, Vancouver, BC, Canada. ciara.freeman@moffitt.org.ORCID http://orcid.org/0000-0002-0662-6480
Prasath PararajalingamDepartment of Molecular Biology and Biochemistry, Simon Fraser University, Burnaby, BC, Canada.
Ling JinMedical Department A for Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany.
Sriram BalasubramanianOncology Translational Research, Janssen Research & Development, San Diego, CA, USA.
Aixiang JiangCentre for Lymphoid Cancer, BC Cancer, Vancouver, BC, Canada.ORCID http://orcid.org/0000-0002-6153-7595
Wendan XuMedical Department A for Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany.
Michael GrauMedical Department A for Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany.
Myroslav ZapukhlyakMedical Department A for Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany.
Merrill BoyleCentre for Lymphoid Cancer, BC Cancer, Vancouver, BC, Canada.
Brendan HodkinsonOncology Translational Research, Janssen Research & Development, Spring House, PA, USA.
Michael SchafferOncology Translational Research, Janssen Research & Development, Spring House, PA, USA.
Christopher EnnyClinical Oncology, Janssen Research & Development, Raritan, NJ, USA.
Sanjay DeshpandeClinical Oncology, Janssen Research & Development, Raritan, NJ, USA.
Steven SunClinical Biostats, Janssen Research & Development, Raritan, NJ, USA.
Jessica VermeulenClinical Oncology, Janssen Research & Development, Leiden, The Netherlands.
Ryan D Morin *Department of Molecular Biology and Biochemistry, Simon Fraser University, Burnaby, BC, Canada.ORCID http://orcid.org/0000-0003-2932-7800
David W Scott *Centre for Lymphoid Cancer, BC Cancer, Vancouver, BC, Canada.
Georg Lenz *Medical Department A for Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany.ORCID http://orcid.org/0000-0002-4728-1693
Janssen (United States) · USUniversity Hospital Münster · DESimon Fraser University · CASpinal Cord Injury BC · CAJanssen (Netherlands) · NLUniversity of British Columbia · CAUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mantle cell lymphoma (MCL) is a rare, incurable lymphoma subtype characterized by heterogeneous outcomes. To better understand the clinical behavior and response to treatment, predictive biomarkers are needed. Using residual archived material from patients enrolled in the MCL3001 (RAY) study, we performed detailed analyses of gene expression and targeted genetic sequencing. This phase III clinical trial randomized patients with relapsed or refractory MCL to treatment with either ibrutinib or temsirolimus. We confirmed the prognostic capability of the gene expression proliferation assay MCL35 in this cohort treated with novel agents; it outperformed the simplified MCL International Prognostic Index in discriminating patients with different outcomes. Regardless of treatment arm, our data demonstrated that this assay captures the risk conferred by known biological factors, including increased MYC expression, blastoid morphology, aberrations of TP53, and truncated CCND1 3' untranslated region. We showed the negative impact of BIRC3 mutations/deletions on outcomes in this cohort and identified that deletion of chromosome 8p23.3 also negatively impacts survival. Restricted to patients with deletions/alterations in TP53, ibrutinib appeared to abrogate the deleterious impact on outcome. These data illustrate the potential to perform a molecular analysis of predictive biomarkers on routine patient samples that can meaningfully inform clinical practice.

Indexed as

Lymphoma, Mantle-Cell3' Untranslated RegionsAdenineAdultBiological FactorsHumansNeoplasm Recurrence, LocalPiperidinesPyrazolesPyrimidinesSirolimus3' Untranslated RegionsAdenineBiological FactorsibrutinibPiperidinesPyrazolesPyrimidinesSirolimustemsirolimus

Identifiers

PMID35963941
OpenAlexW4291227654

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.