Evidence map›Paper›PMID 27557783›Full record

Trial reportInvestigational new drugs2016

Clinical, pharmacodynamic and pharmacokinetic results of a prospective phase II study on oral metronomic vinorelbine and dexamethasone in castration-resistant prostate cancer patients.

Teresa Di Desidero, Lisa Derosa, Luca Galli, Paola Orlandi, Andrea Fontana, Anna Fioravanti, Riccardo Marconcini, Mario Giorgi, Beatrice Campi, Alessandro Saba and 7 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.8field-weighted citation impact, top 9% 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

12 citing papers in PubMed, 29 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

17 authors at 4 institutions in 2 countries.

Teresa Di DesideroDivision of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 55, I-56126, Pisa, Italy.
Lisa DerosaOncology Unit 2, University Hospital of Pisa, Pisa, Italy.
Luca GalliOncology Unit 2, University Hospital of Pisa, Pisa, Italy.
Paola OrlandiDivision of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 55, I-56126, Pisa, Italy.
Andrea FontanaOncology Unit 2, University Hospital of Pisa, Pisa, Italy.
Anna FioravantiDivision of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 55, I-56126, Pisa, Italy.
Riccardo MarconciniOncology Unit 2, University Hospital of Pisa, Pisa, Italy.
Mario GiorgiDepartment of Veterinary Sciences, University of Pisa, Pisa, Italy.
Beatrice CampiDepartment of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.
Alessandro SabaDepartment of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.
Sara LucchesiOncology Unit, Azienda USL Toscana Nord Ovest, Civil Hospital of Pontedera, Pisa, Italy.
Renato FelipettoUrology Unit, Civil Hospital of Pontedera, Azienda USL Toscana Nord Ovest, Pisa, Italy.
Romano DanesiDivision of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 55, I-56126, Pisa, Italy.
Giulio FranciaBorder Biomedical Research Center, University of Texas at El Paso, El Paso, TX, USA.
Giacomo AllegriniOncology Unit, Azienda USL Toscana Nord Ovest, Civil Hospital of Pontedera, Pisa, Italy.
Alfredo FalconeOncology Unit 2, University Hospital of Pisa, Pisa, Italy.
Guido BocciDivision of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma, 55, I-56126, Pisa, Italy. guido.bocci@med.unipi.it.
University of Pisa · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Usl Toscana Centro · ITThe University of Texas at El Paso · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the present study was to evaluate clinical activity, and the pharmacodynamic and pharmacokinetic profiles, of oral metronomic vinorelbine (VNR) plus dexamethasone (DEX) in metastatic castration-resistant prostate cancer (mCRPC) patients. Fourty-one patients (92 % chemotherapy-resistant) received 30 mg/day VNR p.o. thrice a week plus 1 mg/day DEX p.o. until disease progression. Plasma soluble B cell antigen 7 homolog 3 (sB7-H3), vascular endothelial growth factor (VEGF), and thrombospondin-1 (TSP-1), were measured by ELISA. Plasma VNR was detected using a LC-MS-MS system. The fraction of patients free of progression, defined by criteria of the Prostate Cancer Clinical Trials Working Group 2, at 3 months was 61 %. PSA decrease ≥50 % from baseline was observed in 35 % of patients. Median PFS and OS were 4 months (95 % CI, 2.8-6.9) and 17.5 months (95 % CI, 10.8-24.5), respectively. Toxicity was mild, and no grade 4 toxicities were found. The mean plasma VNR C

Indexed as

Administration, OralAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsDexamethasoneFollow-Up StudiesHumansLung NeoplasmsLymphatic MetastasisMaleMiddle AgedNeoplasm GradingNeoplasm StagingPrognosisProspective StudiesDexamethasoneVinblastineVinorelbineB7-H3Metronomic chemotherapyPharmacodynamic markersPharmacokineticsProstate cancerTSP-1VEGFVinorelbine

Identifiers

PMID27557783
OpenAlexW2517964430

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.