Evidence map›Paper›PMID 32185579›Full record

ArticleThe AAPS journal2020

Optimal Sampling Strategies for Irinotecan (CPT-11) and its Active Metabolite (SN-38) in Cancer Patients.

Spinel Karas, Amy S Etheridge, Eleftheria Tsakalozou, Jacqueline Ramírez, Erika Cecchin, Ron H N van Schaik, Giuseppe Toffoli, Mark J Ratain, Ron H J Mathijssen, Alan Forrest and 2 more

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Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 47% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. 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

12 authors at 6 institutions in 3 countries.

Spinel KarasDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Amy S EtheridgeDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Eleftheria TsakalozouDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Jacqueline RamírezDepartment of Medicine, University of Chicago, Chicago, IL, USA.
Erika CecchinCentro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
Ron H N van SchaikDepartment of Clinical Chemistry, Erasmus MC, Rotterdam, Netherlands.
Giuseppe ToffoliCentro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
Mark J RatainDepartment of Medicine, University of Chicago, Chicago, IL, USA.
Ron H J MathijssenDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
Alan ForrestDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Robert R BiesDepartment of Pharmaceutical Sciences, University at Buffalo School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA. robertbi@buffalo.edu.
Federico InnocentiDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. innocent@email.unc.edu.ORCID http://orcid.org/0000-0001-9247-979X
University of North Carolina at Chapel Hill · USCentro di Riferimento Oncologico · ITUniversity of Chicago · USErasmus MC · NLErasmus MC Cancer Institute · NLUniversity at Buffalo, State University of New York · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Irinotecan (CPT-11) is an anticancer agent widely used in the treatment of a variety of adult solid tumors. The objective of this study was to develop an optimal sampling strategy model that accurately estimates pharmacokinetic parameters of CPT-11 and its active metabolite, SN-38. This study included 221 patients with advanced solid tumors or lymphoma receiving CPT-11 single or combination therapy with 5-fluorouracil (5-FU)/leucovorin (LV) (FOLFIRI) plus bevacizumab from 4 separate clinical trials. Population pharmacokinetic analysis of CPT-11 and SN-38 was performed by non-linear mixed effects modeling. The optimal sampling strategy model was developed using D-optimality with expected distribution approach. The pharmacokinetic profiles of CPT-11 and SN-38 were best described by a 3- and 2-compartment model, respectively, with first-order elimination. Body surface area and co-administration with 5-FU/LV plus bevacizumab were significant covariates (p < 0.01) for volumes of the central compartment of CPT-11 and SN-38, and clearance of CPT-11. Pre-treatment total bilirubin and co-administration with 5-FU/LV and bevacizumab were significant covariates (p < 0.01) for clearance of SN-38. Accurate and precise predictive performance (r

Indexed as

AdultAgedClinical Trials as TopicFemaleHumansIrinotecanMaleMiddle AgedModels, StatisticalTopoisomerase I InhibitorsIrinotecanTopoisomerase I Inhibitorsirinotecan (CPT-11)limited samplingoptimal sampling strategypopulation pharmacokineticsSN-38

Identifiers

PMID32185579
OpenAlexW3010949728

What OpenQuestion holds

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Read underepoch 390

Registered trials

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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.