Evidence map›Paper›PMID 32706635›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma.

Eric Van Cutsem, Margaret A Tempero, Darren Sigal, Do-Youn Oh, Nicola Fazio, Teresa Macarulla, Erika Hitre, Pascal Hammel, Andrew E Hendifar, Susan E Bates and 18 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 335 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
335citing papers in PubMed, 3 pooled it
21.5field-weighted citation impact, top 1% 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

335 citing papers in PubMed, 3 syntheses or guidelines pooled it, 416 citations in OpenAlex.

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  14. Understanding and targeting the tumour matrisome.Nature reviews. Clinical oncology · 2026
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  20. Aortic Stenosis Hyalectan Remodeling Revealed by Proteomics and Glycoproteomics.Arteriosclerosis, thrombosis, and vascular biology · 2026
    Article

275 more citing papers are in PubMed but not listed here.

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

28 authors at 20 institutions in 10 countries.

Eric Van CutsemDigestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.
Margaret A TemperoDivision of Hematology and Oncology, Department of Medicine, UCSF Medical Center, San Francisco, CA.
Darren SigalDivision of Hematology/Oncology, Scripps Clinic and Scripps MD Anderson Cancer Center, La Jolla, CA.
Do-Youn OhSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Nicola FazioDivision of Gastrointestinal Medical Oncology & Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy.
Teresa MacarullaVall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Erika HitreDepartment of Medical Oncology and Clinical Pharmacology "B," National Institute of Oncology, Budapest, Hungary.
Pascal HammelHôpital Beaujon (AP-HP), Clichy, and Université de Paris, Paris, France.
Andrew E HendifarDepartment of Gastrointestinal Malignancies, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.
Susan E BatesDivision of Hematology/Oncology, Columbia University Irving Medical Center, New York, NY.
Chung-Pin LiDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Sunil R HingoraniFred Hutchinson Cancer Research Center and Division of Medical Oncology, University of Washington, Seattle, WA.
Christelle de la FouchardiereDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.
Anup KasiUniversity of Kansas Medical Center, Kansas City, KS.
Volker HeinemannDepartment of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany.
Anthony MaraveyasJoint Centre for Cancer Studies, Hull York Medical School, Castle Hill Hospital, Cottingham, United Kingdom.
Nathan BaharyDepartment of Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.
Laura LayosMedical Oncology Service, Catalan Institute of Oncology (ICO), Hospital Germans Trias i Pujol, Badalona, Barcelona, Catalonia, Spain.
Vaibhav SahaiDivision of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.
Lei ZhengThe Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Jill LacyDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, New Haven, CT.
Joon Oh ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Fabienne PortalesInstitut du Cancer de Montpellier, Montpellier, France.
Paul ObersteinPerlmutter Cancer Center, NYU Langone Health, New York, NY.
Wilson WuHalozyme Therapeutics, Inc, San Diego, CA.
Dimitrios ChondrosHalozyme Therapeutics, Inc, San Diego, CA.
Andrea J BullockDivision of Medical Oncology, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
HALO 109-301 Investigators
Halozyme Therapeutics (United States) · USAssistance Publique – Hôpitaux de Paris · FRBeth Israel Deaconess Medical Center · USCedars-Sinai Medical Center · USCentre Léon Bérard · FRColumbia University Irving Medical Center · USEuropean Institute of Oncology · ITFred Hutch Cancer Center · USHull York Medical School · GBInstitut Català d'Oncologia · ESInstitut de Recherche en Cancérologie de Montpellier · FRJohns Hopkins University · USKU Leuven · BELudwig-Maximilians-Universität München · DENational Institute of Oncology · HUNYU Langone Health · USScripps Clinic · USSeoul National University Hospital · KRSungkyunkwan University · KRTaipei Veterans General Hospital · TW

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Tumor Antigens for Individual Signatures and TherapyP50CA062924 · NCI · JOHNS HOPKINS UNIVERSITY · PI JAFFEE, ELIZABETH M. · 1993 to 2022
$54.6M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P50 CA062924
6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel/gemcitabine (AG) in patients with hyaluronan-high metastatic pancreatic ductal adenocarcinoma (PDA). PATIENTS AND

methodsHALO 109-301 was a phase III, randomized, double-blind, placebo-controlled study. Patients ≥ 18 years of age with untreated, metastatic, hyaluronan-high PDA were randomly assigned 2:1 to PEGPH20 plus AG or placebo plus AG. Treatment was administered intravenously in 4-week cycles (3 weeks on, 1 week off) until progression or intolerable adverse events: PEGPH20 3.0 µg/kg twice per week for cycle 1 and once per week thereafter; nab-paclitaxel 125 mg/m

resultsAt data cutoff, 494 patients were randomly assigned, with 492 (327 for PEGPH20 and 165 for placebo) included in intention-to-treat analyses. Baseline characteristics were balanced for PEGPH20 plus AG versus placebo plus AG. There were 330 deaths, with a median OS of 11.2 months for PEGPH20 plus AG versus 11.5 months for placebo plus AG (hazard ratio [HR], 1.00; 95% CI, 0.80 to 1.27;

conclusionThe addition of PEGPH20 to AG increased the ORR but did not improve OS or PFS. The safety profile of PEGPH20 plus AG was consistent with that found in previous studies. These results do not support additional development of PEGPH20 in metastatic PDA.

Indexed as

AgedAlbuminsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalDeoxycytidineDisease ProgressionDouble-Blind MethodFatigueFemaleGemcitabineHumansHyaluronic AcidHyaluronoglucosaminidaseHyponatremiaMaleMiddle Aged130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabineHyaluronic AcidHyaluronoglucosaminidasePaclitaxelPEGPH20

Identifiers

PMID32706635
PMCPMC7499614
OpenAlexW3044807317

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.