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dc.contributor.authorKENNEDY, MICHAEL
dc.date.accessioned2015-06-15T14:08:03Z
dc.date.available2015-06-15T14:08:03Z
dc.date.issued2013en
dc.date.submitted2013en
dc.identifier.citationMICHAEL KENNEDY, 'Optimally tolerated dose of lapatinib in combinationwith docetaxel plus trastuzumab in first-line treatmentof HER2-positive metastatic breast cancer', Annals of Oncology;, 24;, 8;, 2013en
dc.identifier.otherY
dc.identifier.urihttp://hdl.handle.net/2262/74148
dc.descriptionPUBLISHEDen
dc.description.abstractBackground: This phase IB, open-label, dose-escalation study evaluated the safety, tolerability, and optimally tolerated regimen (OTR) of lapatinib in combination with docetaxel and trastuzumab in patients with previously untreated stage IV metastatic breast cancer (MBC) tumors overexpressing human epidermal growth factor receptor 2 (HER2). Patients and methods: Evaluated dose regimens included lapatinib (500 – 1500 mg/day), docetaxel (triweekly; 60 – 100 mg/m²), and trastuzumab (weekly; 2 mg/kg fi xed dose); prophylactic granulocyte colony-stimulating factor was included with regimens with ≥ 750 mg/day lapatinib. End points included OTR and safety/tolerability (primary), overall response rate (ORR), and pharmacokinetics (secondary). Results: None of the patients ( N = 53) experienced dose-limiting toxic effects (DLTs) at the highest dose level; thus, the OTR of lapatinib with 100 mg/m 2 docetaxel was not determined. Common adverse events included diarrhea, nausea, alopecia, fatigue, and rash; grade 3/4 ( ≥ 2 patients) were neutropenia, diarrhea, leukopenia, peripheral neuropathy, and rash. Seven patients had DLTs (cycle 1). In 45 patients with measurable disease con fi rmed by bone scan, investigator- assessed ORR was 31%; without bone scan, con fi rmation was 64%; 8 patients without measurable disease were evaluated as stable. Lapatinib/docetaxel plasma concentrations were positively associated with complete response. Conclusions: Lapatinib/docetaxel/trastuzumab is a feasible and well-tolerated treatment of untreated HER2-positive stage IV MBC. Two lapatinib/docetaxel OTR doses were recommended (1250 mg/75 mg/m²; 1000 mg/100 mg/m²en
dc.description.sponsorshipFunding for this study was provided by GlaxoSmithKline, Uxbridge, United Kingdom. The number NCT00251433 is a clinical trial number in the US the EudraCT number is 2005- 000846-35.en
dc.format.extent2005en
dc.format.extent2011en
dc.language.isoenen
dc.relation.ispartofseriesAnnals of Oncology;
dc.relation.ispartofseries24;
dc.relation.ispartofseries8;
dc.rightsYen
dc.subjectHER2/ERBB2, lapatinib, metastatic breast cancer, trastuzumab, tyrosine kinase inhibitoen
dc.subject.lcshHER2/ERBB2, lapatinib, metastatic breast cancer, trastuzumab, tyrosine kinase inhibitoen
dc.titleOptimally tolerated dose of lapatinib in combinationwith docetaxel plus trastuzumab in first-line treatmentof HER2-positive metastatic breast canceren
dc.typeJournal Articleen
dc.type.supercollectionscholarly_publicationsen
dc.type.supercollectionrefereed_publicationsen
dc.identifier.peoplefinderurlhttp://people.tcd.ie/kennedmi
dc.identifier.rssinternalid103874
dc.identifier.doihttp://dx.doi.org/10.1093/annonc/mdt222
dc.rights.ecaccessrightsopenAccess
dc.identifier.rssurihttp://www.scopus.com/inward/record.url?eid=2-s2.0-84881237946&partnerID=40&md5=2e0024ad2a936f11495a4ecd0ac5c325


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