Evidence map›Paper›PMID 21424698›Full record

Trial reportInvestigational new drugs2012

A randomized phase II of gemcitabine and sorafenib versus sorafenib alone in patients with metastatic pancreatic cancer.

A B El-Khoueiry, R K Ramanathan, D Y Yang, W Zhang, S Shibata, J J Wright, D Gandara, H J Lenz

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 6 pooled it
2.5field-weighted citation impact, top 10% 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

25 citing papers in PubMed, 6 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  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. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Review
  8. Systemic treatment for advanced pancreatic cancer.World journal of gastrointestinal oncology · 2023
    Review
  9. Review
  10. Review
  11. Targeting protein kinase CK2 in the treatment of cholangiocarcinoma.Exploration of targeted anti-tumor therapy · 2021
    Review
  12. Review
  13. Review
  14. Article
  15. Article
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  17. Review
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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

8 authors at 5 institutions in 1 country.

A B El-KhoueiryDivision of Medical Oncology, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, 1441 Eastlake Ave, Suite 3440, Los Angeles, CA 90033, USA. elkhouei@usc.edu
R K Ramanathan
D Y Yang
W Zhang
S Shibata
J J Wright
D Gandara
H J Lenz
University of Southern California · USCity Of Hope National Medical Center · USNational Cancer Institute · USUniversity of California Davis Medical Center · USUPMC Hillman Cancer Center · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
REGULATION OF RADIATION-INDUCED APOPTOTIC CELL DEATHR29CA062209 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI STORY, MICHAEL D · 1994 to 1998
–
NCI NIH HHS N01 CM062209NCI NIH HHS N01 CM-62209NCI NIH HHS P30 CA014089NCI NIH HHS P30 CA033572NCI NIH HHS P30CA033572NCI NIH HHS P30CA14089
6 · The paper itself

Abstract

purposePatients with metastatic pancreatic cancer have limited therapeutic options. The role of the Ras-Raf-MAPK pathway and of vascular endothelial growth factor in pancreatic carcinogenesis provided the rational to evaluate the efficacy of sorafenib with or without gemcitabine in a randomized phase II study.

methodsPatients with metastatic pancreatic cancer were randomized to sorafenib alone (arm A) or sorafenib with gemcitabine (arm B).

resultsArm A was closed to accrual at interim analysis due to the lack of objective response. Median PFS and OS were 2.3 and 4.3 months respectively. There was one partial response among the 37 patients in arm B. Median PFS and OS were 2.9 and 6.5 months respectively. There were more grade 3 and 4 toxicities in arm B with the most common being neutropenia (17%), thrombocytopenia (8%), alkaline phosphatase elevation (14%), venous thromboembolism (8%), diarrhea, hypokalemia and ALT elevation (5%) each. Several associations were noted between single nucleotide polymorphisms in ribonucleotide reductase, Cox-2, vascular endothelial growth factor and survival in patients treated with gemcitabine and sorafenib.

conclusionsNeither sorafenib alone or sorafenib in combination with gemcitabine manifested promising activity in metastatic pancreatic cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzenesulfonatesCyclooxygenase 2Cytidine DeaminaseDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansMaleMiddle AgedNeoplasm MetastasisNiacinamideBenzenesulfonatesCyclooxygenase 2Cytidine DeaminaseDeoxycytidinedeoxycytidine deaminaseGemcitabineNiacinamideNucleoside DeaminasesPhenylurea CompoundsPTGS2 protein, humanPyridinesRibonucleoside Diphosphate ReductaseRRM1 protein, humanSorafenibTumor Suppressor Proteins

Identifiers

PMID21424698
PMCPMC3745766
OpenAlexW2051719959

What OpenQuestion holds

Textmetadata
LicenceTDM
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.