Evidence map›Paper›PMID 24048792›Full record

Trial reportCancer2011

Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma.

Robert A Baiocchi, Lapo Alinari, Mark E Lustberg, Thomas S Lin, Pierluigi Porcu, Xiaobai Li, Jeffrey S Johnston, John C Byrd, Kristie A Blum

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00201877 (A Phase II Study of Velcade), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 9% 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.

NCT00201877 phase2completednot on this map

A Phase II Study of Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma

TypeinterventionalSponsorOhio State University Comprehensive Cancer CenterRan2004 to 2012Enrolled25ConditionsNon-Hodgkin's Lymphoma, Mantle Cell LymphomaArmsVelcade, Rituximab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Non-Hodgkin's lymphomas, version 4.2014.Journal of the National Comprehensive Cancer Network : JNCCN · 2014
    Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Review
  11. Bortezomib in mantle cell lymphoma: comparative therapeutic outcomes.Therapeutics and clinical risk management · 2015
    Review
  12. Article
  13. Bortezomib for the treatment of non-Hodgkin's lymphoma.Expert opinion on pharmacotherapy · 2014
    Review
  14. Review
  15. Review
  16. 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

9 authors at 1 institution in 1 country.

Robert A BaiocchiDivision of Hematology, Ohio State University, Columbus, Ohio.
Lapo Alinari
Mark E Lustberg
Thomas S Lin
Pierluigi Porcu
Xiaobai Li
Jeffrey S Johnston
John C Byrd
Kristie A Blum
The Ohio State University · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
TWO SIGNAL REQUIREMENT FOR NATURAL KILLER IMMUNITYP01CA095426 · NCI · OHIO STATE UNIVERSITY · PI CARSON, WILLIAM E. · 2002 to 2016
$29.6M
University of Iowa Clinical and Translational Science Program (TL1)UL1RR025755 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$26.3M
Targeting Transcriptional Repression in CLLK23CA109004 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A · 2005 to 2009
$675k
NCI NIH HHS K23 CA109004NCI NIH HHS NCI K23 CA109004-01A1NCI NIH HHS NCI P01 CA095426NCI NIH HHS P01 CA095426NCI NIH HHS P30 CA016058NCI NIH HHS P30 CA16058NCRR NIH HHS UL1 RR025755
6 · The paper itself

Abstract

backgroundIn vitro studies in mantle cell lymphoma (MCL) cell lines and patient-derived cells have demonstrated synergistic apoptosis with combined rituximab and bortezomib (R-bortezomib) compared with single-agent bortezomib. Therefore, the authors of this report evaluated R-bortezomib in a preclinical model and in a phase 2 clinical trial.

methodsA Hu-MCL-severe combined immunodeficiency (SCID) model engrafted with the Jeko cell line was treated with R-bortezomib, bortezomib, or rituximab. Twenty-five patients with relapsed follicular lymphoma (n = 11) and MCL (n = 14) received 375 mg/m(2) rituximab on Days 1 and 8 and 1.3 to 1.5 mg/m(2) bortezomib on Days 1, 4, 8, and 11 every 21 days for a median of 3 cycles (range, 1-5 cycles).

resultsR-bortezomib resulted in a statistically significant improvement in overall survival in Hu-MCL-SCID mice. In the clinical trial, the overall response rate was 40% in all 25 patients, 55% in patients with follicular lymphoma, and 29% in patients with MCL. The estimated 2-year progression-free survival (PFS) rate was 24% (95% confidence interval [CI], 10%-53%) in all patients and 60% (95% CI, 20%-85%) in responding patients. Thirteen patients (52%) developed grade 3 neurotoxicity, which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension. Patients who were heterozygous for the CD32a (Fcγ receptor IIa) 131 histidine (H) to arginine (R) polymorphism had a significantly decreased PFS (P = .009) after R-bortezomib compared with HH and RR homozygotes.

conclusionsR-bortezomib had significant activity in patients with relapsed or refractory follicular lymphoma and MCL, although an unexpectedly high incidence of grade 3 neurologic toxicity was a potential limiting factor with this combination.

Indexed as

AdultAgedAged, 80 and overAnimalsAntibodies, Monoclonal, Murine-DerivedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibDisease Models, AnimalDrug Evaluation, PreclinicalFemaleHumansLymphoma, FollicularLymphoma, Mantle-CellMaleAntibodies, Monoclonal, Murine-DerivedAntineoplastic AgentsBoronic AcidsBortezomibProteasome InhibitorsPyrazinesReceptors, IgGRituximabbortezomibfollicular lymphomamantle cell lymphomaneuropathyrituximab

Identifiers

PMID24048792
PMCPMC3116936
OpenAlexW1988855108

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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.