Evidence map›Paper›PMID 19018756›Full record

ArticleCancer science2009

Population pharmacokinetics of docetaxel in patients with hepatic dysfunction treated in an oncology practice.

Hironobu Minami, Kenji Kawada, Yasutsuna Sasaki, Makoto Tahara, Tadahiko Igarashi, Kuniaki Itoh, Hirofumi Fujii, Toshiaki Saeki, Kazuhiro Ozawa, Hitoshi Sato

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Cancer science, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01891123 (An Open-label Randomized Clinical Trial to Compare the Toxicities and Efficacy of Pharmacokinetically-guided and BSA Fixed Dosing Strategy of Docetaxel and Paclitaxel in Chinese Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma, and Breast Cancer Patients.), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% 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.

NCT01891123 naunknown statusnot on this mapstarted 2013, after this paper: background citation

An Open-label Randomized Clinical Trial to Compare the Toxicities and Efficacy of Pharmacokinetically-guided and BSA Fixed Dosing Strategy of Docetaxel and Paclitaxel in Chinese Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma, and Breast Cancer Patients.

TypeinterventionalSponsorSun Yat-sen UniversityRan2013 to 2016Enrolled300ConditionsNon-small Cell Lung Cancer, Breast Cancer, Nasal CancerArmsPK guided arm, PTX 175mg/m2, DOC 75mg/m2
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

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  13. The effects of advanced age and serum αBritish journal of clinical pharmacology · 2017
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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

10 authors at 3 institutions in 1 country.

Hironobu MinamiMedical Oncology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine, Hyogo 650-0017, Japan. hminami@med.kobe-u.ac.jp
Kenji Kawada
Yasutsuna Sasaki
Makoto Tahara
Tadahiko Igarashi
Kuniaki Itoh
Hirofumi Fujii
Toshiaki Saeki
Kazuhiro Ozawa
Hitoshi Sato
National Cancer Center Hospital East · JPShowa University · JPKobe University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To investigate the relationship between the degree of liver dysfunction and the pharmacokinetics of docetaxel, a population pharmacokinetic model was developed in an oncology practice without excluding patients with moderate to severe liver dysfunction. Two hundred patients were treated with docetaxel as a single agent or in combination chemotherapy. The plasma concentration-time course data were analyzed using a three-compartment open model with zero-order administration and first-order elimination on the NONMEM program. Sixty-one had elevated transaminase levels, and alkaline phosphatase was elevated in 40. Body surface area, albumin, alpha1-acid glycoprotein, and liver function were found to be significant covariates for the systemic clearance of docetaxel. Compared to patients with normal or minimal impairment of liver function, patients with grade 2 and 3 elevations of transaminases at baseline in conjunction with elevation of alkaline phosphatase had 22 and 38% lower clearances, respectively. Goodness-of-fit plots indicated that the model was fitted well with the observed data, and the bootstrap method guaranteed robustness of the model. We developed a population pharmacokinetic model for docetaxel, which can be used in the setting of an oncology practice. Based on the model, dose reduction by approximately 20 and 40% should be considered for patients with grade 2 and 3 elevations of transaminases at baseline in conjunction with elevation of alkaline phosphatase, respectively.

Indexed as

AdultAgedAged, 80 and overAlanine TransaminaseAntineoplastic AgentsAspartate AminotransferasesDocetaxelFemaleHumansLiver DiseasesMaleMiddle AgedNeoplasmsTaxoidsAlanine TransaminaseAntineoplastic AgentsAspartate AminotransferasesDocetaxelTaxoids

Identifiers

PMID19018756
PMCPMC11158642
OpenAlexW1977094521

What OpenQuestion holds

Textmetadata
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.