Evidence map›Paper›PMID 36807743›Full record

ArticleThe oncologist2023

Phase Ib and Expansion Study of Gemcitabine, Nab-Paclitaxel, and Ficlatuzumab in Patients With Metastatic Pancreatic Cancer.

Kimberly Perez, Anna M Chiarella, James M Cleary, Nora Horick, Colin Weekes, Thomas Abrams, Lawrence Blaszkowsky, Peter Enzinger, Marios Giannakis, Lipika Goyal and 16 more

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

Article in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. The role of molecular testing in pancreatic cancer.Therapeutic advances in gastroenterology · 2023
    Review
  6. 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

26 authors at 7 institutions in 1 country.

Kimberly PerezDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0002-5745-2994
Anna M ChiarellaHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.
James M ClearyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Nora HorickBiostatistics Center, Massachusetts General Hospital, Boston, MA, USA.
Colin WeekesHarvard Medical School, Boston, MA, USA.
Thomas AbramsDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Lawrence BlaszkowskyHarvard Medical School, Boston, MA, USA.
Peter EnzingerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Marios GiannakisDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Lipika GoyalHarvard Medical School, Boston, MA, USA.
Jeffrey A MeyerhardtDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Douglas RubinsonDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Matthew B YurgelunDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Wolfram GoesslingDepartment of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Bruce J GiantonioDepartment of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Lauren BraisDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Victoria GermonDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Danielle StonelyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Srivatsan RaghavanDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Basil BakirHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.
Koushik DasDivision of Gastroenterology, Washington University School of Medicine, St. Louis, MO, USA.
Jason R PitarresiPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Andrew J AguirreDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Michael NeedleAVEO Oncology, Cambridge, MA, USA.
Anil K RustgiHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.
Brian M WolpinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Harvard University · USColumbia University Irving Medical Center · USDana-Farber Cancer Institute · USMassachusetts General Hospital · USAVEO Oncology (United States) · USUniversity of Pennsylvania · USWashington University in St. Louis · US

Funding

Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI BASS, ADAM JOEL · 2007 to 2023
$33.2M
Circulating Biomarker Consortium for Pancreatic Cancer Early DetectionU01CA210171 · NCI · DANA-FARBER CANCER INST · PI Michael H. Rosenthal, Brian Matthew Wolpin · 2016 to 2026
$8.7M
The Prrx-1 transcription factor in pancreatic ductal biologyR01DK060694 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI CHANDWANI, ROHIT, RUSTGI, ANIL K · 2002 to 2025
$8.3M
NCI NIH HHS P50 CA127003NCI NIH HHS U01 CA210171NIDDK NIH HHS R01 DK060694
6 · The paper itself

Abstract

backgroundIn preclinical pancreatic ductal adenocarcinoma (PDAC) models, inhibition of hepatocyte growth factor (HGF) signaling using ficlatuzumab, a recombinant humanized anti-HGF antibody, and gemcitabine reduced tumor burden.

methodsPatients with previously untreated metastatic PDAC enrolled in a phase Ib dose escalation study with 3 + 3 design of 2 dose cohorts of ficlatuzumab 10 and 20 mg/kg administered intravenously every other week with gemcitabine 1000 mg/m2 and albumin-bound paclitaxel 125 mg/m2 given 3 weeks on and 1 week off. This was followed by an expansion phase at the maximally tolerated dose of the combination.

resultsTwenty-six patients (sex, 12 male:14 female; median age, 68 years [range, 49-83 years]) were enrolled, 22 patients were evaluable. No dose-limiting toxicities were identified (N = 7 pts) and ficlatuzumab at 20 mg/kg was chosen as the maximum tolerated dose. Among the 21 patients treated at the MTD, best response by RECISTv1.1: 6 (29%) partial response, 12 (57%) stable disease, 1 (5%) progressive disease, and 2 (9%) not evaluable. Median progression-free survival and overall survival times were 11.0 months (95% CI, 7.6-11.4 months) and 16.2 months (95% CI, 9.1 months to not reached), respectively. Toxicities attributed to ficlatuzumab included hypoalbuminemia (grade 3, 16%; any grade, 52%) and edema (grade 3, 8%; any grade, 48%). Immunohistochemistry for c-Met pathway activation demonstrated higher tumor cell p-Met levels in patients who experienced response to therapy.

conclusionIn this phase Ib trial, ficlatuzumab, gemcitabine, and albumin-bound paclitaxel were associated with durable treatment responses and increased rates of hypoalbuminemia and edema.

Indexed as

HypoalbuminemiaPancreatic NeoplasmsAgedAlbumin-Bound PaclitaxelAlbuminsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsEdemaFemaleGemcitabineHumansMalePaclitaxel130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelAlbuminsAntibodies, MonoclonalficlatuzumabGemcitabinePaclitaxelficlatuzumabgemcitabinemetastatic pancreatic cancernab-paclitaxelphase Ib clinical trial

Identifiers

PMID36807743
PMCPMC10166179
OpenAlexW4321324719

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.