2011
Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases
Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. Journal Of Neuro-Oncology 2011, 105: 613-620. PMID: 21706359, DOI: 10.1007/s11060-011-0629-y.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerProgressive brain metastasesObjective response rateBrain metastasesTopotecan armBreast cancerHER2-positive breast cancer brain metastasesCentral nervous system progressionBreast cancer brain metastasesRandomized phase II studyCombination of lapatinibPhase II studyCancer brain metastasesEfficacy of lapatinibStandard radiation therapyLack of efficacyNon-CNS lesionsExcess toxicityCapecitabine armRefractory settingCranial radiotherapyPrimary endpointSteroid requirementsII studyObjective response
2009
Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer
Lin N, Diéras V, Paul D, Lossignol D, Christodoulou C, Stemmler H, Roché H, Liu M, Greil R, Ciruelos E, Loibl S, Gori S, Wardley A, Yardley D, Brufsky A, Blum J, Rubin S, Dharan B, Steplewski K, Zembryki D, Oliva C, Roychowdhury D, Paoletti P, Winer E. Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer. Clinical Cancer Research 2009, 15: 1452-1459. PMID: 19228746, DOI: 10.1158/1078-0432.ccr-08-1080.Peer-Reviewed Original ResearchConceptsBrain metastasesBreast cancerObjective responseVolumetric reductionCNS lesionsNeurologic signsCentral nervous system progressionMulticenter phase II studySmall phase 2 trialHER2-positive breast cancerCombination of lapatinibExtra-CNS diseaseProgressive brain metastasesPhase II studyPrimary end pointPhase 2 trialProgression-free survivalThird of patientsProgressive neurologic signsMajor clinical challengeCNS metastasesCranial radiationEligible patientsEvaluable patientsPrior trastuzumab