Phase I and II study of exisulind in combination with capecitabine in patients with metastatic breast cancer.
Pusztai L, Zhen JH, Arun B, Rivera E, Whitehead C, Thompson WJ, Nealy KM, Gibbs A, Symmans WF, Esteva FJ, Booser D, Murray JL, Valero V, Smith TL, Hortobagyi GN. Phase I and II study of exisulind in combination with capecitabine in patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 3454-61. PMID: 12972520, DOI: 10.1200/jco.2003.02.114.Peer-Reviewed Original ResearchMeSH Keywords3',5'-Cyclic-GMP PhosphodiesterasesAdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCyclic Nucleotide Phosphodiesterases, Type 2Cyclic Nucleotide Phosphodiesterases, Type 5DeoxycytidineFemaleFluorouracilHumansImmunohistochemistryMiddle AgedNeoplasm MetastasisPhosphoric Diester HydrolasesProdrugsSulindacConceptsMetastatic breast cancerHand-foot syndromeAdverse eventsBreast cancerGrade 2Strong stainingPhase IContinuous daily therapyFrequent grade 2Dose-limiting toxicityOverall clinical benefitPercent of tumorsUnexpected adverse eventsPhase II testingBID dosePrevious anthracyclineStable diseaseDaily therapyTaxane chemotherapyLaboratory abnormalitiesMedian durationPartial responseClinical benefitTumor responseImmunohistochemical assessmentPhase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.
Rivera E, Valero V, Arun B, Royce M, Adinin R, Hoelzer K, Walters R, Wade JL, Pusztai L, Hortobagyi GN. Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 3249-54. PMID: 12947059, DOI: 10.1200/jco.2003.03.111.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerLiposomal doxorubicinBreast cancerOverall survivalDay 1Median cumulative anthracycline doseLeft ventricular ejection fractionPhase II clinical trialCommon grade 3Cumulative anthracycline doseFrequent nonhematologic toxicitiesPrevious anthracycline exposureHand-foot syndromeMedian overall survivalMedian response durationPhase II studyFront-line therapyVentricular ejection fractionOverall response rateAdjuvant chemotherapyAnthracycline doseAssessable patientsMeasurable diseaseNeutropenic complicationsNonhematologic toxicity