2024
TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Loriot Y. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. Journal Of Clinical Oncology 2024, 42: 3410-3420. PMID: 39186707, PMCID: PMC11458109, DOI: 10.1200/jco.23.01720.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerClinical benefit rateProgression-free survivalDuration of responseCisplatin-ineligible patientsCheckpoint inhibitor therapyPhase II studyCheckpoint inhibitorsSacituzumab govitecanCohort 2Central reviewOpen-label phase II studyPlatinum (Pt)-based chemotherapyMedian duration of responseMedian progression-free survivalTreatment-emergent adverse eventsMedian overall survivalSN-38 payloadUrothelial cancer progressionSecondary end pointsAntibody-drug conjugatesCisplatin-ineligibleInhibitor therapyOverall survivalII studySacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.
Loriot Y, Balar A, Petrylak D, Kalebasty A, Grivas P, Fléchon A, Jain R, Swami U, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zavodovskaya M, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer. Clinical Cancer Research 2024, 30: 3179-3188. PMID: 39086310, DOI: 10.1158/1078-0432.ccr-23-3924.Peer-Reviewed Original ResearchConceptsTrop-2 expressionTrop-2Positive tumor cellsUrothelial cancerMetastatic UCSacituzumab govitecanTumor cellsTumor samplesOpen-label phase II studyTrophoblast cell surface antigen 2Human trophoblast cell-surface antigen 2Advanced urothelial cancerSN-38 payloadPhase II studyC1-3Archival tumor samplesExpression levelsCohorts 1 to 3Surface antigen 2Antibody drug conjugatesOS benefitII studyExamined tumorsH-scoreMembrane expression
2000
Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point.
Small E, Lew D, Redman B, Petrylak D, Hammond N, Gross H, Eastham J, Crawford E. Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point. Journal Of Clinical Oncology 2000, 18: 2537-44. PMID: 10893284, DOI: 10.1200/jco.2000.18.13.2537.Peer-Reviewed Original ResearchConceptsAdvanced transitional cell carcinomaTransitional cell carcinomaCombination of paclitaxelSurvival timeMedian progression-free survival timeNeoadjuvant platinum-based therapySouthwest Oncology Group studyProgression-free survival timeClinical trial end pointsGrade 4 toxicityPoor prognostic featuresTrial end pointsEnrollment of patientsMedian survival timeOverall survival timeCooperative group settingPlatinum-based therapyResponse proportionsAcceptable toxicityExtranodal diseaseNeoadjuvant therapyNeurologic toxicityComplete responsePartial responsePrognostic features
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