Evidence map›Paper›PMID 24960403›Full record

Trial reportBritish journal of cancer2014

Phase II study of gemcitabine, oxaliplatin in combination with panitumumab in KRAS wild-type unresectable or metastatic biliary tract and gallbladder cancer.

A F Hezel, M S Noel, J N Allen, T A Abrams, M Yurgelun, J E Faris, L Goyal, J W Clark, L S Blaszkowsky, J E Murphy and 15 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 2% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Article
  4. Article
  5. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Overview of current targeted therapy in gallbladder cancer.Signal transduction and targeted therapy · 2020
    Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Immunotherapeutic Approaches to Biliary Cancer.Current treatment options in oncology · 2017
    Review
  19. Current biologics for treatment of biliary tract cancers.Journal of gastrointestinal oncology · 2017
    Review
  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

25 authors at 6 institutions in 1 country.

A F HezelDivision of Hematology/Oncology, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
M S NoelDivision of Hematology/Oncology, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
J N AllenDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
T A AbramsDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
M YurgelunDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
J E FarisDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
L GoyalDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
J W ClarkDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
L S BlaszkowskyDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
J E MurphyDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
H ZhengBiostatistics Center, Massachusetts General Hospital, Boston, MA, USA.
A A KhoranaTaussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
G C ConnollyDivision of Hematology/Oncology, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
O HyrienDepartment of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA.
A BaranDepartment of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA.
M HerrDepartment of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, USA.
K NgDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
S SheehanDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
D J HarrisDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
E ReganDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
D R BorgerDepartment of Pathology, Massachusetts General Hospital, Boston, MA, USA.
A J IafrateDepartment of Pathology, Massachusetts General Hospital, Boston, MA, USA.
C FuchsDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
D P RyanDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
A X ZhuDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
Harvard University · USDana-Farber Cancer Institute · USMassachusetts General Hospital · USUniversity of Rochester · USUniversity of Rochester Medical Center · USCleveland Clinic · US

Funding

Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI EL-BARDEESY, NABEEL, SELLERS, WILLIAM R · 2007 to 2023
$33.2M
Role of Vitamin D, Inflammation, and Energy Balance in Colorectal Cancer SurvivalK07CA148894 · NCI · DANA-FARBER CANCER INST · PI NG, KIMMIE · 2011 to 2015
$889k
NCI NIH HHS K07 CA148894NCI NIH HHS P50 CA127003
6 · The paper itself

Abstract

backgroundCurrent data suggest that platinum-based combination therapy is the standard first-line treatment for biliary tract cancer. EGFR inhibition has proven beneficial across a number of gastrointestinal malignancies; and has shown specific advantages among KRAS wild-type genetic subtypes of colon cancer. We report the combination of panitumumab with gemcitabine (GEM) and oxaliplatin (OX) as first-line therapy for KRAS wild-type biliary tract cancer.

methodsPatients with histologically confirmed, previously untreated, unresectable or metastatic KRAS wild-type biliary tract or gallbladder adenocarcinoma with ECOG performance status 0-2 were treated with panitumumab 6 mg kg(-1), GEM 1000 mg m(-2) (10 mg m(-2) min(-1)) and OX 85 mg m(-2) on days 1 and 15 of each 28-day cycle. The primary objective was to determine the objective response rate by RECIST criteria v.1.1. Secondary objectives were to evaluate toxicity, progression-free survival (PFS), and overall survival.

resultsThirty-one patients received at least one cycle of treatment across three institutions, 28 had measurable disease. Response rate was 45% and disease control rate was 90%. Median PFS was 10.6 months (95% CI 5-24 months) and median overall survival 20.3 months (95% CI 9-25 months). The most common grade 3/4 adverse events were anaemia 26%, leukopenia 23%, fatigue 23%, neuropathy 16% and rash 10%.

conclusionsThe combination of gemcitabine, oxaliplatin and panitumumab in KRAS wild type metastatic biliary tract cancer showed encouraging efficacy, additional efforts of genetic stratification and targeted therapy is warranted in biliary tract cancer.

Indexed as

AdenocarcinomaAdultAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineDisease-Free SurvivalFemaleGallbladder NeoplasmsGemcitabineHumansKaplan-Meier EstimateLymphatic MetastasisMaleMiddle AgedAntibodies, MonoclonalDeoxycytidineGemcitabineKRAS protein, humanOrganoplatinum CompoundsOxaliplatinPanitumumabProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)ras Proteins

Identifiers

PMID24960403
PMCPMC4119993
OpenAlexW1996138775

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.