Evidence map›Paper›PMID 24244687›Full record

Trial reportPloS one2013

Immunomodulatory effects in a phase II study of lenalidomide combined with cetuximab in refractory KRAS-mutant metastatic colorectal cancer patients.

Anita K Gandhi, Tao Shi, Mingyu Li, Ulf Jungnelius, Alfredo Romano, Josep Tabernero, Salvatore Siena, Peter H Schafer, Rajesh Chopra

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01032291 (A Phase 2, Open-Label Study To Evaluate The Efficacy And Safety Of Lenalidomide In Combination With Cetuximab In Pretreated Subjects With K-Ras Mutant Metastatic Colorectal Cancer), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

NCT01032291 phase2terminatednot on this map

A Phase 2, Open-Label Study To Evaluate The Efficacy And Safety Of Lenalidomide In Combination With Cetuximab In Pretreated Subjects With K-Ras Mutant Metastatic Colorectal Cancer

TypeinterventionalSponsorCelgene CorporationRan2009 to 2011Enrolled51ConditionsColorectal CancerArmscetuximab, lenalidomide
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 32 citations in OpenAlex.

  1. Article
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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 2 institutions in 2 countries.

Anita K GandhiDepartment of Translational Development, Celgene Corporation, Summit, New Jersey, United States of America.
Tao Shi
Mingyu Li
Ulf Jungnelius
Alfredo Romano
Josep Tabernero
Salvatore Siena
Peter H Schafer
Rajesh Chopra
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITUniversitat Autònoma de Barcelona · ES

Funding

Cancer Research UK 11566
6 · The paper itself

Abstract

unlabelledThis study assessed the immunomodulatory effects in previously treated KRAS-mutant metastatic colorectal cancer patients participating in a phase II multicenter, open-label clinical trial receiving lenalidomide alone or lenalidomide plus cetuximab. The main findings show the T cell immunostimulatory properties of lenalidomide as the drug induced a decrease in the percentage CD45RA(+) naïve T cells 3-fold while increasing the percentage HLA-DR(+) activated T helper cells and percentage total CD45RO(+) CD8(+) memory T cytotoxic cells, 2.6- and 2.1-fold respectively (p<0.0001). In addition, lenalidomide decreased the percentage of circulating CD19(+) B cells 2.6-fold (p<0.0001). Lenalidomide increased a modest, yet significant, 1.4-fold change in the percentage of circulating natural killer cells. Our findings indicate that lenalidomide significantly activates T cells, suggestive of an immunotherapeutic role for this drug in settings of maintenance therapy and tumor immunity. Furthermore, reported for the first time is the effect of lenalidomide in combination with cetuximab on T cell function, including increases in circulating naïve and central memory T cells. In summary, lenalidomide and cetuximab have significant effects on circulating immune cells in patients with colorectal carcinoma.

trial registrationClinicalTrials.gov NCT01032291.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabColorectal NeoplasmsHumansLenalidomideMutationProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)ras ProteinsThalidomideAntibodies, Monoclonal, HumanizedCetuximabKRAS protein, humanLenalidomideProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)ras ProteinsThalidomide

Identifiers

PMID24244687
PMCPMC3823649
OpenAlexW2034454074

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.