Evidence map›Paper›PMID 24403266›Full record

Trial reportCancer medicine2013

Phase 2, multicenter, open-label study of tigatuzumab (CS-1008), a humanized monoclonal antibody targeting death receptor 5, in combination with gemcitabine in chemotherapy-naive patients with unresectable or metastatic pancreatic cancer.

Andres Forero-Torres, Jeffrey R Infante, David Waterhouse, Lucas Wong, Selwyn Vickers, Edward Arrowsmith, Aiwu Ruth He, Lowell Hart, David Trent, James Wade and 8 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 6% 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

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Pharmacological targeting of caspase-8/c-FLIPCommunications biology · 2025
    Article
  5. Review
  6. Advances in the study of death receptor 5.Frontiers in pharmacology · 2025
    Review
  7. Clinical immunotherapy in pancreatic cancer.Cancer immunology, immunotherapy : CII · 2024
    Review
  8. Article
  9. Review
  10. Heparan sulfate promotes TRAIL-induced tumor cell apoptosis.bioRxiv : the preprint server for biology · 2023
    Article
  11. Therapeutic targeting of TRAIL death receptors.Biochemical Society transactions · 2023
    Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. 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

18 authors at 12 institutions in 2 countries.

Andres Forero-TorresUniversity of Alabama at Birmingham, Birmingham, Alabama.
Jeffrey R Infante
David Waterhouse
Lucas Wong
Selwyn Vickers
Edward Arrowsmith
Aiwu Ruth He
Lowell Hart
David Trent
James Wade
Xiaoping Jin
Qiang Wang
Tashara Austin
Michael Rosen
Robert Beckman
Reinhard von Roemeling
Jonathan Greenberg
Mansoor Saleh
Daiichi Sankyo (Germany) · DEDaiichi Sankyo (United States) · USDecatur Memorial Hospital · USFlorida Cancer Specialists & Research Institute · USGeorgetown University · USGeorgia Cancer Specialists · USOncology Hematology Care · USSarah Cannon · USScott & White Memorial Hospital · USUniversity of Alabama at Birmingham · USUniversity of Minnesota System · USVirginia Cancer Institute · US

Funding

UAB / UMN SPORE in Pancreatic CancerP50CA101955 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BUCHSBAUM, DONALD J · 2010 to 2014
$11.1M
6 · The paper itself

Abstract

Tigatuzumab is the humanized version of the agonistic murine monoclonal antibody TRA-8 that binds to the death receptor 5 and induces apoptosis of human cancer cell lines via the caspase cascade. The combination of tigatuzumab and gemcitabine inhibits tumor growth in murine pancreatic xenografts. This phase 2 trial evaluated the efficacy of tigatuzumab combined with gemcitabine in 62 chemotherapy-naive patients with histologically or cytologically confirmed unresectable or metastatic pancreatic cancer. Patients received intravenous tigatuzumab (8 mg/kg loading dose followed by 3 mg/kg weekly) and gemcitabine (1000 mg/m(2) once weekly for 3 weeks followed by 1 week of rest) until progressive disease (PD) or unacceptable toxicity occurred. The primary end point was progression-free survival (PFS) at 16 weeks. Secondary end points included objective response rate (ORR) (complete responses plus partial responses), duration of response, and overall survival (OS). Safety of the combination was also evaluated. Mean duration of treatment was 18.48 weeks for tigatuzumab and 17.73 weeks for gemcitabine. The PFS rate at 16 weeks was 52.5% (95% confidence interval [CI], 39.3-64.1%). The ORR was 13.1%; 28 (45.9%) patients had stable disease and 14 (23%) patients had PD. Median PFS was 3.9 months (95% CI, 2.2-5.4 months). Median OS was 8.2 months (95% CI, 5.1-9.6 months). The most common adverse events related to tigatuzumab were nausea (35.5%), fatigue (32.3%), and peripheral edema (19.4%). Tigatuzumab combined with gemcitabine was well tolerated and may be clinically active for the treatment of chemotherapy-naive patients with unresectable or metastatic pancreatic cancer.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedNeoplasm MetastasisPancreatic NeoplasmsReceptors, TNF-Related Apoptosis-Inducing LigandAntibodies, Monoclonal, HumanizedDeoxycytidineGemcitabineReceptors, TNF-Related Apoptosis-Inducing LigandtigatuzumabMonoclonal antibodiespancreatic cancerphase 2tigatuzumabTNF-related apoptosis-inducing ligand

Identifiers

PMID24403266
PMCPMC3892397
OpenAlexW1972473939

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.