2016
Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study
Nanda R, Chow LQ, Dees EC, Berger R, Gupta S, Geva R, Pusztai L, Pathiraja K, Aktan G, Cheng JD, Karantza V, Buisseret L. Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study. Journal Of Clinical Oncology 2016, 34: 2460-2467. PMID: 27138582, PMCID: PMC6816000, DOI: 10.1200/jco.2015.64.8931.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerAdvanced triple-negative breast cancerPD-L1Antitumor activityBreast cancerCell death protein 1 (PD-1) inhibitorsSingle-agent phase II studyAdvanced PD-L1Single-agent pembrolizumabStudy of immunotherapyTreatment-related deathsImmune checkpoint inhibitionPhase Ib studyPhase Ib trialPhase II studyAcceptable safety profilePD-L1 expressionOverall response rateProtein 1 inhibitorCommon toxicitiesIb trialKEYNOTE-012TNBC cohortII studyMedian duration
2003
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 assessment
1998
Daily Oral Etoposide in Patients With Heavily Pretreated Metastatic Breast Cancer
Pusztai L, Walters R, Valero V, Theriault R, Hortobagyi G. Daily Oral Etoposide in Patients With Heavily Pretreated Metastatic Breast Cancer. American Journal Of Clinical Oncology 1998, 21: 442-446. PMID: 9781596, DOI: 10.1097/00000421-199810000-00004.Peer-Reviewed Original ResearchConceptsGrade 4 toxicityMetastatic breast cancerSignificant hematologic toxicityOral etoposideBreast cancerGrade 2Hematologic toxicityDaily oral etoposideFourth-line agentZubrod performance statusPercent of patientsPhase II studyMajority of patientsGreater thrombocytopeniaNeutropenic feverStable diseasePrevious therapyRadiologic evidenceII studyMedian durationPartial responsePerformance statusMedian ageMore regimensSevere anemia