Evidence map›Paper›PMID 34101295›Full record

Trial reportThe oncologist2021

Phase II Study of 5-Fluorouracil, Oxaliplatin plus Dasatinib (FOLFOX-D) in First-Line Metastatic Pancreatic Adenocarcinoma.

Thomas J George, Azka Ali, Yu Wang, Ji-Hyun Lee, Alison M Ivey, David DeRemer, Karen C Daily, Carmen J Allegra, Steven J Hughes, Z Hugh Fan and 3 more

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Pancreatic Cancer: Beyond Brca Mutations.Journal of personalized medicine · 2022
    Review
  8. Article
  9. Review
  10. 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

13 authors at 3 institutions in 1 country.

Thomas J GeorgeDivision of Hematology Oncology, Department of Medicine, University of Florida, Gainesville, Florida, USA.ORCID 0000-0002-6249-9180
Azka AliDivision of Hematology Oncology, Department of Medicine, University of Florida, Gainesville, Florida, USA.ORCID 0000-0001-7476-6664
Yu WangDivision of Quantitative  Sciences, University of Florida Health Cancer Center, Gainesville, Florida, USA.
Ji-Hyun LeeDepartment of Biostatistics, University of Florida, Gainesville, Florida, USA.ORCID 0000-0001-6420-5150
Alison M IveyUniversity of Florida Health  Cancer Center, Gainesville, Florida, USA.
David DeRemerUniversity of Florida Health  Cancer Center, Gainesville, Florida, USA.ORCID 0000-0002-2207-9552
Karen C DailyDivision of Hematology Oncology, Department of Medicine, University of Florida, Gainesville, Florida, USA.
Carmen J AllegraDivision of Hematology Oncology, Department of Medicine, University of Florida, Gainesville, Florida, USA.
Steven J HughesDepartment of Surgery, University of Florida, Gainesville, Florida, USA.
Z Hugh FanDepartment of Mechanical and Aerospace Engineering, University of Florida, Gainesville, FL, USA.
Miles E CameronCollege of Medicine, University of Florida, Gainesville, Florida, USA.
Andrew R JudgeDepartment of Physical Therapy, University of Florida, Gainesville, Florida, USA.
Jose G TrevinoDepartment of Surgery, Virginia Commonwealth University, Richmond, Virginia, USA.
University of Florida Health · USUniversity of Florida · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPreclinical studies have demonstrated that Src inhibition through dasatinib synergistically enhances the antitumor effects of oxaliplatin. In this phase II, single-arm study, FOLFOX with dasatinib in previously untreated patients with mPC only showed only modest clinical activity, with a progressive-free survival of 4 months and overall survival of 10.6 months. Continued investigation is ongoing to better understand the role of Src inhibition with concurrent 5-fluorouracil and oxaliplatin in a subset of exceptional responders.

backgroundSrc tyrosine kinase activity is overexpressed in many human cancers, including metastatic pancreatic cancer (mPC). Dasatinib is a potent inhibitor of Src family of tyrosine kinases. This study was designed to investigate whether dasatinib can synergistically enhance antitumor effects of FOLFOX regimen (FOLFOX-D).

methodsIn this single-arm, phase II study, previously untreated patients received dasatinib 150 mg oral daily on days 1-14, oxaliplatin 85 mg/m

resultsForty-four patients enrolled with an estimated median PFS of 4.0 (95% confidence interval [CI], 2.3-8.5) months and overall survival (OS) of 10.6 (95% CI, 6.9-12.7) months. Overall response rate (ORR) was 22.7% (n = 10): one patient (2.3%) with complete response (CR) and nine patients (20.5%) with partial response (PR). Fifteen patients (34.1%) had stable disease (SD). Nausea was the most common adverse event (AE) seen in 35 patients (79.5%).

conclusionThe addition of dasatinib did not appear to add incremental clinical benefit to FOLFOX in untreated patients with mPC.

Indexed as

AdenocarcinomaColorectal NeoplasmsPancreatic NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDasatinibFluorouracilHumansLeucovorinOxaliplatinTreatment OutcomeDasatinibFluorouracilLeucovorinOxaliplatinDasatinibFOLFOXMetastatic pancreatic cancerSrc

Identifiers

PMID34101295
PMCPMC8488773
OpenAlexW3167128222

What OpenQuestion holds

Textmetadata
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.