Evidence map›Paper›PMID 23448807›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2013

Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer.

B M Wolpin, E M O'Reilly, Y J Ko, L S Blaszkowsky, M Rarick, C M Rocha-Lima, P Ritch, E Chan, J Spratlin, T Macarulla and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00902291 (A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 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.

NCT00902291 phase2completednot on this map

A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

TypeinterventionalSponsorAstellas Pharma IncRan2009 to 2012Enrolled205ConditionsCarcinoma, Pancreatic Ductal, Pancreatic Cancer, Pancreatic DiseaseArmsAGS-1C4D4, Gemcitabine
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. A phase I/IIA study of AGS-PSCA for castration-resistant prostate cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2012
    Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

20 authors.

B M WolpinDana-Farber Cancer Institute, Boston. Electronic address: bwolpin@partners.org.
E M O'ReillyMemorial Sloan Kettering Cancer Center, New York, USA.
Y J KoSunnybrook Health Science Center, Toronto, Canada.
L S BlaszkowskyMassachusettes General Hospital, Boston.
M RarickKaiser Permanente Northwest Region Oncology Hematology, Portland.
C M Rocha-LimaSylvester Comprehensive Cancer Center, University of Miami, Miami.
P RitchMedical College of Wisconsin, Milwaukee.
E ChanVanderbilt University Medical Center, Nashville, USA.
J SpratlinCross Cancer Institute, Edmonton, Alberta, Canada.
T MacarullaHospital Vall d'Hebrón, Servicio de Oncología, Barcelona, Spain.
E McWhirterJuravinski Cancer Centre, Hamilton, Ontario, Canada.
D PezetInserm U1071, Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, France.
M LichinitserState Institution 'Blokhin Cancer Research Centre RAMS', Moscow.
L RomanState Healthcare Institution 'Leningrad Regional Oncologic Dispensary', Saint Petersburg, Russia.
A HartfordAgensys, Inc., Santa Monica, USA.
K MorrisonAgensys, Inc., Santa Monica, USA.
L JacksonAgensys, Inc., Santa Monica, USA.
M VincentAgensys, Inc., Santa Monica, USA.
L ReynoAgensys, Inc., Santa Monica, USA.
M HidalgoCentro Integral Oncológico 'Clara Campal', Madrid; Centro Nacional de Investigaciones Oncologicas, Madrid, Spain.

Funding

Cohort Study of Biochemical and Genetic Risk Factors for Pancreatic CancerK07CA140790 · NCI · DANA-FARBER CANCER INST · PI WOLPIN, BRIAN MATTHEW · 2009 to 2013
$890k
NCI NIH HHS K07 CA140790
6 · The paper itself

Abstract

backgroundWe evaluated AGS-1C4D4, a fully human monoclonal antibody to prostate stem cell antigen (PSCA), with gemcitabine in a randomized, phase II study of metastatic pancreatic cancer. PATIENTS AND

methodsPatients with Eastern Cooperative Oncology Group (ECOG) performance status 0/1 and previously untreated, metastatic pancreatic adenocarcinoma were randomly assigned 1:2 to gemcitabine (1000 mg/m(2) weekly seven times, 1 week rest, weekly three times q4weeks) or gemcitabine plus AGS-1C4D4 (48 mg/kg loading dose, then 24 mg/kg q3weeks IV). The primary end point was 6-month survival rate (SR). Archived tumor samples were collected for pre-planned analyses by PSCA expression.

resultsBetween April 2009 and May 2010, 196 patients were randomly assigned to gemcitabine (n = 63) or gemcitabine plus AGS-1C4D4 (n = 133). The 6-month SR was 44.4% (95% CI, 31.9-57.5) in the gemcitabine arm and 60.9% (95% CI, 52.1-69.2) in the gemcitabine plus AGS-1C4D4 arm (P = 0.03), while the median survival was 5.5 versus 7.6 months and the response rate was 13.1% versus 21.6% in the two arms, respectively. The 6-month SR was 57.1% in the gemcitabine arm versus 79.5% in the gemcitabine plus AGS-1C4D4 arm among the PSCA-positive subgroup and 31.6% versus 46.2% among the PSCA-negative subgroup.

conclusionsThis randomized, phase II study achieved its primary end point, demonstrating an improved 6-month SR with addition of AGS-1C4D4 to gemcitabine among patients with previously untreated, metastatic pancreatic adenocarcinoma. ClinicalTrials.gov identifier: NCT00902291.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDisease-Free SurvivalFemaleGemcitabineGPI-Linked ProteinsHumansKaplan-Meier EstimateLiver NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntigens, NeoplasmDeoxycytidineGemcitabineGPI-Linked ProteinsMK-4721Neoplasm ProteinsPSCA protein, humanchemotherapyclinical trialgemcitabinemetastatic diseasepancreatic cancerprostate stem cell antigen

Identifiers

PMID23448807
PMCPMC3716216

What OpenQuestion holds

Textmetadata
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.