Evidence map›Paper›PMID 36970055›Full record

ArticleCancer research communications2022

A Preclinical and Phase Ib Study of Palbociclib plus Nab-Paclitaxel in Patients with Metastatic Adenocarcinoma of the Pancreas.

Manuel Hidalgo, Rocio Garcia-Carbonero, Kian-Huat Lim, Wells A Messersmith, Ignacio Garrido-Laguna, Erkut Borazanci, Andrew M Lowy, Laura Medina Rodriguez, Daniel Laheru, Beatriz Salvador-Barbero and 9 more

Registry-linked trialOpen access · goldFull text readClinical Trial, Phase I
In one paragraph

Article in Cancer research communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02501902 (AN OPEN-LABEL PHASE IB STUDY OF PALBOCICLIB), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

NCT02501902 phase1completednot on this map

An open-label phase ib study of palbociclib (oral cdk 4/6 inhibitor) plus abraxane (registered) (nab-paclitaxel) in patients with metastatic pancreatic ductal adenocarcinoma

TypeinterventionalSponsorPfizerRan2015 to 2018Enrolled76ConditionsMetastatic Pancreatic Ductal AdenocarcinomaArmsPalbociclib, Nab-Paclitaxel
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. 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

19 authors at 15 institutions in 4 countries.

Manuel HidalgoHematology and Medical Oncology, Weill Cornell Medicine, New York, New York.ORCID 0000-0002-3765-3318
Rocio Garcia-CarboneroOncology Department, Hospital Universitario 12 de Octubre, Imas12, UCM, CNIO, CIBERONC, Madrid, Spain.ORCID 0000-0002-3342-397X
Kian-Huat LimDepartment of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, Missouri.ORCID 0000-0002-2766-200X
Wells A MessersmithSchool of Medicine, University of Colorado Cancer Center, Aurora, Colorado.
Ignacio Garrido-LagunaDepartment of Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.ORCID 0000-0003-2273-9028
Erkut BorazanciHonorHealth/TGen, Scottsdale, Arizona.ORCID 0000-0001-5136-5462
Andrew M LowyDepartment of Surgery, UC San Diego Moores Cancer Center, San Diego, California.ORCID 0000-0002-7106-0735
Laura Medina RodriguezHospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.ORCID 0000-0002-8041-3547
Daniel LaheruDepartment of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.ORCID 0000-0001-6646-0200
Beatriz Salvador-BarberoSchool of Biosciences, European Cancer Stem Cell Research Institute, Cardiff University, Cardiff, United Kingdom.ORCID 0000-0003-3842-2383
Marcos MalumbresCell Division and Cancer Group, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.ORCID 0000-0002-0829-6315
David J ShieldsCenters for Therapeutic Innovation, Pfizer Inc, New York, New York.
Joseph E GrossmanDepartment of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.ORCID 0000-0002-2130-2783
Xin HuangPfizer Oncology, San Diego, California.ORCID 0000-0003-3285-365X
Meggan TammaroPfizer Oncology, San Diego, California.
Jean-François MartiniPfizer Oncology, San Diego, California.ORCID 0000-0001-8570-1401
Yanke YuPfizer Oncology, San Diego, California.
Kenneth KernPfizer Oncology, San Diego, California.
Teresa MacarullaGastrointestinal Cancer Unit, Vall d´Hebrón University Hospital and Vall d´Hebrón Institute of Oncology (VHIO), IOB Quirón, Barcelona, Spain.
The Fertilizer Institute · USBeth Israel Deaconess Medical Center · USCardiff University · GBCornell University · USHebron University · PSHonorHealth · USHospital Universitario 12 De Octubre · ESHospital Universitario de Fuenlabrada · ESHuntsman Cancer Institute · USPfizer (United States) · USSidney Kimmel Comprehensive Cancer Center · USSpanish National Cancer Research Centre · ESUC San Diego Health System · USUniversity of Colorado Cancer Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To assess the preclinical efficacy, clinical safety and efficacy, and MTD of palbociclib plus nab-paclitaxel in patients with advanced pancreatic ductal adenocarcinoma (PDAC). Experimental Design: Preclinical activity was tested in patient-derived xenograft (PDX) models of PDAC. In the open-label, phase I clinical study, the dose-escalation cohort received oral palbociclib initially at 75 mg/day (range, 50‒125 mg/day; modified 3+3 design; 3/1 schedule); intravenous nab-paclitaxel was administered weekly for 3 weeks/28-day cycle at 100‒125 mg/m Results: Palbociclib plus nab-paclitaxel was more effective than gemcitabine plus nab-paclitaxel in three of four PDX models tested; the combination was not inferior to paclitaxel plus gemcitabine. In the clinical trial, 76 patients (80% received prior treatment for advanced disease) were enrolled. Four dose-limiting toxicities were observed [mucositis ( Conclusions: This study showed the tolerability and antitumor activity of palbociclib plus nab-paclitaxel treatment in patients with PDAC; however, the prespecified efficacy threshold was not met. Trial Registration: Pfizer Inc (NCT02501902). Significance: In this article, the combination of palbociclib, a CDK4/6 inhibitor, and nab-paclitaxel in advanced pancreatic cancer evaluates an important drug combination using translational science. In addition, the work presented combines preclinical and clinical data along with pharmacokinetic and pharmacodynamic assessments to find alternative treatments for this patient population.

Indexed as

Carcinoma, Pancreatic DuctalNeutropeniaPancreatic NeoplasmsAlbuminsDeoxycytidineHumansPaclitaxelPancreasPiperazinesPyridines130-nm albumin-bound paclitaxelAlbuminsDeoxycytidinePaclitaxelpalbociclibPiperazinesPyridines

Identifiers

PMID36970055
PMCPMC10035387
OpenAlexW4296213398

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read108
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.