2017
Safety of MEDI4736 (anti-PD-L1 antibody) administered concomitant with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) as neoadjuvant chemotherapy for stage I-III triple negative breast cancer (TNBC): A Phase I/II trial.
Pusztai L, Silber A, Hofstatter E, Chung G, Horowitz N, Lannin D, Killelea B, Chagpar A, Szekely B, Frederick C, Rispoli L, DiGiovanna M. Safety of MEDI4736 (anti-PD-L1 antibody) administered concomitant with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) as neoadjuvant chemotherapy for stage I-III triple negative breast cancer (TNBC): A Phase I/II trial. Journal Of Clinical Oncology 2017, 35: 572-572. DOI: 10.1200/jco.2017.35.15_suppl.572.Peer-Reviewed Original ResearchImmune related adverse eventsTriple-negative breast cancerWeekly nab-paclitaxelWeeks of therapyNeoadjuvant chemotherapyDose levelsNab-paclitaxelPhase I/II trialPathologic complete response rateChest X-ray abnormalitiesDoxorubicin/cyclophosphamidePhase I toxicityComplete response rateImmune checkpoint inhibitorsPhase I portionRelated adverse eventsPhase II portionPhase I partX-ray abnormalitiesNegative breast cancerSequential taxaneAnthracycline chemotherapyCheckpoint inhibitorsII trialAdverse events
2006
Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC)
Green M, Pusztai L, Theriault R, Adinin R, Hofweber M, Fukushima M, Mita A, Bindra N, Hortobagyi G. Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC). Journal Of Clinical Oncology 2006, 24: 10576-10576. DOI: 10.1200/jco.2006.24.18_suppl.10576.Peer-Reviewed Original ResearchMetastatic breast cancerPhase II doseBID days 1TAS-102Dose levelsBreast cancerDay 1Grade 3 non-hematologic toxicityEvaluable metastatic breast cancerInitial starting doseNon-hematologic toxicitiesInitial dose levelAdditional dose levelsHighest dose levelEvaluation of responseMinimal alopeciaHematologic toxicityStarting doseDaily dosingStandard therapyOral combinationStudy doseClinical activityOral administrationGrade 3
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