Evidence map›Paper›PMID 31432461›Full record

ArticleAdvances in therapy2019

Pharmacokinetics of Total and Unbound Paclitaxel After Administration of Paclitaxel Micellar or Nab-Paclitaxel: An Open, Randomized, Cross-Over, Explorative Study in Breast Cancer Patients.

Olof Borgå, Elsa Lilienberg, Helena Bjermo, Fredrik Hansson, Nina Heldring, Renata Dediu

Abstract readComparative Study
In one paragraph

Article in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
–field-weighted citation impact
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

28 citing papers in PubMed.

  1. Article
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  15. YAP Signaling Regulates the Cellular Uptake and Therapeutic Effect of Nanoparticles.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024
    Article
  16. Article
  17. Pharmacokinetic behaviors of soft nanoparticulate formulations of chemotherapeutics.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2023
    Review
  18. Natural Taxanes: From Plant Composition to Human Pharmacology and Toxicity.International journal of molecular sciences · 2022
    Review
  19. Article
  20. 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

6 authors.

Olof BorgåBorgå PK Consulting, Stockholm, Sweden.
Elsa LilienbergOasmia Pharmaceutical AB, Uppsala, Sweden.
Helena BjermoOasmia Pharmaceutical AB, Uppsala, Sweden.
Fredrik HanssonCTC Clinical Trial Consultants AB, Uppsala, Sweden.
Nina HeldringOasmia Pharmaceutical AB, Uppsala, Sweden. nina.heldring@oasmia.com.
Renata DediuArensia Exploratory Medicine in Collaboration with Institutul de Pneumoftiziologie "Marius Nasta", Bucharest, Romania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPaclitaxel micellar is a novel formulation of paclitaxel in which retinoic acid derivates solubilize paclitaxel. The aim of the present study was to compare the unbound and total plasma pharmacokinetics of the new formulation with those of nanoparticle albumin-bound (nab)-paclitaxel and to further assess its safety.

methodsIn this open, randomized, cross-over study, 28 female patients with breast cancer were given paclitaxel micellar and nab-paclitaxel as a 1-h intravenous infusion at a dose of 260 mg/m

resultsNo difference in fu of paclitaxel between the two formulations was observed. Statistical comparison of AUC

conclusionThe two formulations, paclitaxel micellar and nab-paclitaxel, behaved similarly following infusion. Probably, both formulations dissociate immediately in the blood, whereupon released paclitaxel rapidly distributes into tissue. Judged from the bioequivalence demonstrated for unbound paclitaxel, the two formulations are considered clinically equivalent.

trial registrationEudraCT no.: 2010-019838-27.

fundingOasmia Pharmaceutical AB.

Indexed as

MicellesAdultAgedAged, 80 and overAlbuminsAntineoplastic Agents, PhytogenicBreast NeoplasmsCross-Over StudiesFemaleHumansMiddle AgedPaclitaxelRandom AllocationRomaniaTherapeutic EquivalencyAlbuminsAntineoplastic Agents, PhytogenicMicellesPaclitaxelApealeaBioequivalenceCancerCross-overNab-paclitaxelPaclitaxel micellarPharmacokinetics

Identifiers

PMID31432461
PMCPMC6822820

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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.