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
2000
Novel marine-derived anticancer agents: a phase I clinical, pharmacological, and pharmacodynamic study of dolastatin 10 (NSC 376128) in patients with advanced solid tumors.
Madden T, Tran H, Beck D, Huie R, Newman R, Pusztai L, Wright J, Abbruzzese J. Novel marine-derived anticancer agents: a phase I clinical, pharmacological, and pharmacodynamic study of dolastatin 10 (NSC 376128) in patients with advanced solid tumors. Clinical Cancer Research 2000, 6: 1293-301. PMID: 10778954.Peer-Reviewed Original ResearchConceptsConcentration-time curveDose levelsPhase IMajor nonhematological toxicityAntitumor activityAdvanced solid tumorsDose-limiting toxicityPlasma concentration-time dataEpisodes of thrombocytopeniaRapid distribution phaseParent drug concentrationsConcentration-time dataPercentage of declineVivo tumor modelsNonhematological toxicitiesObjective responseTwo-compartment modelSevere anemiaClinical PharmacokineticsCytokine supportPlasma levelsIntrapatient variabilityClinical dataNovel agentsPharmacodynamic studies