Evidence map›Paper›PMID 34841717›Full record

ArticleCancer medicine2022

Phase 1 trial of ADI-PEG 20 and liposomal doxorubicin in patients with metastatic solid tumors.

Shuyang Yao, Filip Janku, Kimberly Koenig, Apostolia Maria Tsimberidou, Sarina Anne Piha-Paul, Nai Shi, John Stewart, Amanda Johnston, John Bomalaski, Funda Meric-Bernstam and 1 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.6field-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

16 citing papers in PubMed, 24 citations in OpenAlex.

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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

11 authors at 3 institutions in 3 countries.

Shuyang YaoDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.
Filip JankuDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.
Kimberly KoenigDepartment of Breast Medical Oncology, Houston, Texas, USA.
Apostolia Maria TsimberidouDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.ORCID 0000-0003-2713-233X
Sarina Anne Piha-PaulDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.
Nai ShiDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.
John StewartDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Amanda JohnstonPolaris Pharmaceuticals, Inc., San Diego, California, USA.
John BomalaskiPolaris Pharmaceuticals, Inc., San Diego, California, USA.
Funda Meric-BernstamDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.
Siqing FuDepartment of Investigational Cancer Therapeutics, Houston, Texas, USA.ORCID 0000-0002-1933-0419
The University of Texas MD Anderson Cancer Center · USPolaris (United States) · USTexas Medical Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI/NIH P30CA016672NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundArginine depletion interferes with pyrimidine metabolism and DNA damage repair pathways. Preclinical data demonstrated that depletion of arginine by PEGylated arginine deiminase (ADI-PEG 20) enhanced liposomal doxorubicin (PLD) cytotoxicity in cancer cells with argininosuccinate synthase 1 (ASS1) deficiency. The objective of this study was to assess safety and tolerability of ADI-PEG 20 and PLD in patients with metastatic solid tumors.

methodsPatients with advanced ASS1-deficient solid tumors were enrolled in this phase 1 trial of ADI-PEG 20 and PLD following a 3 + 3 design. Eligible patients were given intravenous PLD biweekly and intramuscular (IM) ADI-PEG 20 weekly. Toxicity and efficacy were evaluated according to the Common Terminology Criteria for Adverse Events (version 4.0) and Response Evaluation Criteria in Solid Tumors (version 1.1), respectively.

resultsOf 15 enrolled patients, 9 had metastatic HER2-negative breast carcinoma. We observed no dose-limiting toxicities or treatment-related deaths. One patient safely received 880 mg/m

conclusionConcurrent IM injection of ADI-PEG 20 at 36 mg/m

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsArgininosuccinate SynthaseDoxorubicinFemaleHumansHydrolasesKaplan-Meier EstimateMaleMiddle AgedNeoplasmsPolyethylene GlycolsProgression-Free SurvivalSurvival RateADI PEG20Argininosuccinate SynthaseDoxorubicinHydrolasesliposomal doxorubicinPolyethylene GlycolsADI-PEG 20advanced solid tumorarginine deprivationargininosuccinate synthetasebreast carcinomaliposomal doxorubicin

Identifiers

PMID34841717
PMCPMC8729058
OpenAlexW3215861896

What OpenQuestion holds

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LicenceCC BY
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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.