Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/9880
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dc.contributor.authorDavis, Ian Den
dc.contributor.authorKiers, Lynetteen
dc.contributor.authorMacGregor, Lachlanen
dc.contributor.authorQuinn, Michaelen
dc.contributor.authorArezzo, Josephen
dc.contributor.authorGreen, Michaelen
dc.contributor.authorRosenthal, Mark Aen
dc.contributor.authorChia, Michaelen
dc.contributor.authorMichael, Michaelen
dc.contributor.authorBartley, Peteren
dc.contributor.authorHarrison, Leonieen
dc.contributor.authorDaly, Michaelen
dc.date.accessioned2015-05-15T23:09:11Z
dc.date.available2015-05-15T23:09:11Z
dc.date.issued2005-03-01en
dc.identifier.citationClinical Cancer Research; 11(5): 1890-8en
dc.identifier.govdoc15756015en
dc.identifier.otherPUBMEDen
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/9880en
dc.description.abstractTo determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m(2) over 3 hours).Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 microg/kg), high-dose rhuLIF (4 microg/kg), or placebo.Patients (n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 microg/kg), 39 received high dose rhuLIF (4 microg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables.rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.en
dc.language.isoenen
dc.subject.otherAdulten
dc.subject.otherAgeden
dc.subject.otherAntineoplastic Combined Chemotherapy Protocols.adverse effects.therapeutic useen
dc.subject.otherCarboplatin.administration & dosage.adverse effectsen
dc.subject.otherCytokinesen
dc.subject.otherDose-Response Relationship, Drugen
dc.subject.otherDouble-Blind Methoden
dc.subject.otherFemaleen
dc.subject.otherHumansen
dc.subject.otherInterleukin-6en
dc.subject.otherLeukemia Inhibitory Factoren
dc.subject.otherLipaseen
dc.subject.otherMaleen
dc.subject.otherMiddle Ageden
dc.subject.otherNeoplasms.drug therapyen
dc.subject.otherNeural Conductionen
dc.subject.otherPaclitaxel.administration & dosage.adverse effectsen
dc.subject.otherPeripheral Nervous System Diseases.chemically induced.prevention & controlen
dc.subject.otherPlacebosen
dc.subject.otherProspective Studiesen
dc.subject.otherProteins.administration & dosage.therapeutic useen
dc.titleA randomized, double-blinded, placebo-controlled phase II trial of recombinant human leukemia inhibitory factor (rhuLIF, emfilermin, AM424) to prevent chemotherapy-induced peripheral neuropathy.en
dc.typeJournal Articleen
dc.identifier.journaltitleClinical Cancer Researchen
dc.identifier.affiliationAustin Health, Studley Road, Heidelberg, Victoria 3084, Australiaen
dc.identifier.doi10.1158/1078-0432.CCR-04-1655en
dc.description.pages1890-8en
dc.relation.urlhttps://pubmed.ncbi.nlm.nih.gov/15756015en
dc.type.austinJournal Articleen
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
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