2014
Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer
Tolaney S, Burris H, Gartner E, Mayer IA, Saura C, Maurer M, Ciruelos E, Garcia AA, Campana F, Wu B, Xu Y, Jiang J, Winer E, Krop I. Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2014, 149: 151-161. PMID: 25537644, DOI: 10.1007/s10549-014-3248-4.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerAdverse eventsBreast cancerArm 2Arm 1Phase I/II dose-escalation studyMetastatic HER2-positive breast cancerPhase I/II studyTreatment-related adverse eventsHER2-positive breast cancerTreatment-related gradeAcceptable safety profileDose-escalation studyDose-limiting toxicityDose-escalation designPan-class IEvaluable patientsPaclitaxel armPrior taxanePrior trastuzumabErythematous rashII studyPartial responsePeripheral neuropathyPolygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance)
Chhibber A, Mefford J, Stahl EA, Pendergrass SA, Baldwin RM, Owzar K, Li M, Winer EP, Hudis CA, Zembutsu H, Kubo M, Nakamura Y, McLeod HL, Ratain MJ, Shulman LN, Ritchie MD, Plenge RM, Witte JS, Kroetz DL. Polygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance). The Pharmacogenomics Journal 2014, 14: 336-342. PMID: 24513692, PMCID: PMC4111770, DOI: 10.1038/tpj.2014.2.Peer-Reviewed Original ResearchConceptsSensory peripheral neuropathyPaclitaxel-induced peripheral neuropathyPeripheral neuropathyCALGB 40101Common dose-limiting toxicityPhase III clinical trialsPaclitaxel-induced neuropathyDose-limiting toxicityAxon outgrowthPaclitaxel armAdjuvant therapyAdverse eventsSusceptible patientsRisk factorsClinical trialsBreast cancerNeuropathyPaclitaxel treatmentClinical decisionPatientsPatient informationMaximum gradeHeritable componentMost individualsTreatment
2012
A Genome-Wide Association Study Identifies Novel Loci for Paclitaxel-Induced Sensory Peripheral Neuropathy in CALGB 40101
Baldwin RM, Owzar K, Zembutsu H, Chhibber A, Kubo M, Jiang C, Watson D, Eclov RJ, Mefford J, McLeod HL, Friedman PN, Hudis CA, Winer EP, Jorgenson EM, Witte JS, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL. A Genome-Wide Association Study Identifies Novel Loci for Paclitaxel-Induced Sensory Peripheral Neuropathy in CALGB 40101. Clinical Cancer Research 2012, 18: 5099-5109. PMID: 22843789, PMCID: PMC3445665, DOI: 10.1158/1078-0432.ccr-12-1590.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsFemaleGenetic LociGenetic Predisposition to DiseaseGenome-Wide Association StudyGenotypeHumansIncidenceMicrofilament ProteinsMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPolymorphism, Single NucleotideReceptor, EphA5Sensory Receptor CellsConceptsSensory peripheral neuropathyWide association studyPeripheral neuropathyCALGB 40101Genome-wide association study identifies novel lociAssociation studiesPrimary breast cancerIdentification of patientsNovel genetic markersGenetic risk factorsAfrican American subjectsSingle nucleotide polymorphismsAdditional EuropeanNovel lociPaclitaxel armAdditional genesGenetic variationPaclitaxel therapyClinical managementRisk factorsBreast cancerDiscovery cohortPharmacogenetic analysisNeuropathyGenetic markers