Evidence map›Paper›PMID 30519122›Full record

ArticleClinical pharmacology : advances and applications2018

Species difference in paclitaxel disposition correlated with poor pharmacological efficacy translation from mice to humans.

Ying Fei Li, Chengyue Zhang, Simon Zhou, Miao He, Huixia Zhang, Nianhang Chen, Feng Li, Xin Luan, Manjunath Pai, Hebao Yuan and 2 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Clinical pharmacology : advances and applications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are 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
0.2field-weighted citation impact, top 41% 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.

NCT02027428 phase3completednot on this map

A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorCelgeneRan2014 to 2019Enrolled427ConditionsSquamous Cell Carcinoma, Non-Small-Cell LungArmsAbraxane (Induction), Carboplatin (Induction), Abraxane (Maintenance), Best Supportive Care (Maintenance)
NCT02250326 phase2completednot on this map

A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+

TypeinterventionalSponsorCelgeneRan2015 to 2023Enrolled240ConditionsCarcinoma, Non-Small-Cell LungArmsnab-paclitaxel IV, CC-486, Duravalumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 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

12 authors at 2 institutions in 2 countries.

Ying Fei LiTranslational Development and Clinical Pharmacology, Celgene Corporation, Summit, NJ 07901, USA, yali@celgene.com.
Chengyue ZhangTranslational Development and Clinical Pharmacology, Celgene Corporation, Summit, NJ 07901, USA, yali@celgene.com.
Simon ZhouTranslational Development and Clinical Pharmacology, Celgene Corporation, Summit, NJ 07901, USA, yali@celgene.com.
Miao HeDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Huixia ZhangDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Nianhang ChenTranslational Development and Clinical Pharmacology, Celgene Corporation, Summit, NJ 07901, USA, yali@celgene.com.
Feng LiDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Xin LuanDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Manjunath PaiDepartment of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Hebao YuanDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Duxin SunDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.
Yan LiTranslational Development and Clinical Pharmacology, Celgene Corporation, Summit, NJ 07901, USA, yali@celgene.com.
University of Michigan · USBristol-Myers Squibb (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPaclitaxel (PTX) products currently approved by the Food and Drug Administration include Kolliphor EL-paclitaxel micelles (KoEL-paclitaxel, Taxol) and nanoparticle albumin-bound paclitaxel ( MATERIALS AND

methodsA 10 mg/kg IV dose of KoEL-paclitaxel or

resultsOur pharmacokinetic modeling results suggested that elimination predominates over distribution in driving PTX disposition in mice, hence restricting the PTX tissue accumulation. Moreover, the rapid elimination of PTX in mice minimized the different formulation effects on PTX tissue distribution, which is believed to link to the superior efficacy of

conclusionThis species difference in PTX distribution and elimination hinders a simple direct extrapolation from animals to humans. Therefore, species difference in drug distribution and elimination should be carefully assessed during translational drug development.

Indexed as

dispositiondrug eliminationpaclitaxelpharmacokineticsspecies differencetissue distribution

Identifiers

PMID30519122
PMCPMC6235005
OpenAlexW2899621985

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.