Evidence map›Paper›PMID 29284010›Full record

ArticlePloS one2017

Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced colorectal carcinoma.

Bert H O'Neil, John M Wallmark, David Lorente, Elena Elez, Judith Raimbourg, Carlos Gomez-Roca, Samuel Ejadi, Sarina A Piha-Paul, Mark N Stein, Albiruni R Abdul Razak and 7 more

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 161 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
161citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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.

NCT02054806 phase1completednot on this map

Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2021Enrolled477ConditionsSolid TumorArmsPembrolizumab
NCT06930118 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

An Exploratory Study Investigating the Combination of Chidamide, Regorafenib, Plus Iparomlimab and Tuvonralimab for the Treatment of Drug-esistant and Efractory Dvanced Colorectal Cancer

TypeinterventionalSponsorShanghai Changzheng HospitalRan2025 to 2027Enrolled60ConditionsAdvanced Colorectal Cancer in the Third-line Treatment and Beyond, pMMR/MSS Advanced Colorectal CancerArmschidamide, regorafenib, and iparomlimab/tuvonralimab
3 · Its place in the literature

Who cites it

161 citing papers in PubMed, 13 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

101 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

17 authors.

Bert H O'NeilDepartment of Hematology/Oncology, Indiana University Simon Cancer Center, Indianapolis, Indiana, United States of America.ORCID 0000-0001-7032-7453
John M WallmarkDepartment of Hematology/Oncology, Maryland Hematology Oncology, Rockville, Maryland, United States of America.
David LorenteProstate Cancer Targeted Therapy Group, The Royal Marsden, Sutton, United Kingdom.
Elena ElezVall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Judith RaimbourgDepartment of Oncology Medical, Institut de Cancérologie de l'Ouest, Nantes, France.
Carlos Gomez-RocaDepartment of Oncology Medical, Institut Claudius Regaud and IUCT-Oncopole, Toulouse, France.
Samuel EjadiDepartment of Oncology, Scottsdale Healthcare, Virginia G. Piper Cancer Center, Scottsdale, Arizona, United States of America.
Sarina A Piha-PaulDepartment of Investigational Clinical Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Mark N SteinDepartment of Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States of America.
Albiruni R Abdul RazakClinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, Canada.
Katia DottiDepartment of Medical Oncology, Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori, Milan, Italy.
Armando SantoroHumanitas Cancer Center, Humanitas Research Hospital, Rozzano, Italy.
Roger B CohenDivision of Hematology-Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
Marlena GouldDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, United States of America.
Sanatan SarafDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, United States of America.
Karen SteinDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, United States of America.
Sae-Won HanDivision of Hematology and Medical Oncology, Seoul National University Hospital, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColorectal cancers (CRCs) expressing programmed death ligand 1 (PD-L1) have poor prognosis. In the multicohort KEYNOTE-028 trial, the anti-PD-1 antibody pembrolizumab was evaluated in 20 PD-L1-positive advanced solid tumors. Herein, we report results for the advanced CRC cohort.

methodsPatients with advanced, treatment-resistant PD-L1-positive carcinoma of the colon or rectum were enrolled, regardless of microsatellite instability (MSI) status. Pembrolizumab 10 mg/kg was administered every 2 weeks for up to 2 years or until disease progression/unacceptable toxicity. Response was assessed every 8 weeks for the first 6 months and every 12 weeks thereafter. Primary end points were safety and overall response rate by investigator review per Response Evaluation Criteria in Solid Tumors version 1.1. Data cutoff was June 20, 2016.

resultsOf 137 patients with CRC and samples evaluable for PD-L1 expression, 33 (24%) had PD-L1-positive tumors, of which 23 were enrolled. Median follow-up was 5.3 months, and 8 patients (35%) reported treatment-related adverse events (AEs), most commonly fatigue (n = 3, 13%), stomatitis (n = 2, 9%), and asthenia (n = 2, 9%). One patient (4%) experienced grade 4 treatment-related increased blood bilirubin. No grade 3 AEs, discontinuations, or deaths were attributed to treatment. Most patients (n = 15, 65%) experienced progressive disease. One partial response occurred in a patient (4%) with MSI-high CRC.

conclusionPembrolizumab demonstrated a favorable safety profile in advanced PD-L1-positive CRC. Antitumor activity was observed in a single patient with MSI-high CRC, warranting further evaluation in this patient population. (Clinicaltrials.gov registration: NCT02054806).

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCohort StudiesColorectal NeoplasmsFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanpembrolizumab

Identifiers

PMID29284010
PMCPMC5746232

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.