2021
Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristics
2018
Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study
Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O’Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncology 2018, 4: 537-544. PMID: 29423515, PMCID: PMC5885219, DOI: 10.1001/jamaoncol.2017.5440.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellCohort StudiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisSurvival AnalysisTime FactorsUrinary Bladder NeoplasmsUrotheliumConceptsDeath ligand 1 (PD-L1) expressionMedian overall survivalMetastatic urothelial carcinomaLigand 1 expressionProgression-free survivalPhase 1 studyOverall survivalAdverse eventsClinical benefitUrothelial carcinomaImmune cellsEastern Cooperative Oncology Group performance status 0Long-term clinical profilesMedian progression-free survivalSerious related adverse eventsSolid Tumors version 1.1Treatment-related adverse eventsLong-term clinical outcomesTumor-infiltrating immune cellsPerformance status 0Treatment-related deathsUnacceptable toxic effectsMetastatic urothelial cancerObjective response rateThird-line therapy
2016
Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial
Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. The Lancet Oncology 2016, 17: 1590-1598. PMID: 27733243, PMCID: PMC5648054, DOI: 10.1016/s1470-2045(16)30496-x.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaTreatment-related adverse eventsAdvanced urothelial carcinomaSerious adverse eventsPlatinum-based chemotherapyUrothelial carcinomaAdverse eventsNivolumab monotherapyObjective responseInvestigator-assessed objective responsePrevious platinum-based chemotherapyProtocol-defined reasonsSafety of nivolumabManageable safety profileOpen-label studyPD-L1 expressionDurable clinical responsesDose of treatmentBristol-Myers SquibbCheckMate 032Data cutoffElevated lipaseMonotherapy groupPrimary endpointStudy drug
2015
Emerging immunotherapies for bladder cancer
Kim JW, Tomita Y, Trepel J, Apolo AB. Emerging immunotherapies for bladder cancer. Current Opinion In Oncology 2015, 27: 191-200. PMID: 25811346, PMCID: PMC7709951, DOI: 10.1097/cco.0000000000000177.Peer-Reviewed Original ResearchConceptsUrothelial carcinomaImmune escapeImmune systemTumor antigen presentationAdvanced urothelial carcinomaBenefit of immunotherapyImmune escape mechanismsFraction of patientsHigh mutational burdenImmune-mediated cytotoxicityMultiple tumor typesDurable responsesImmune checkpointsBladder cancerClinical trialsT cellsCombinatorial regimensTumor antigensMutational burdenImmunotherapyClinical developmentCarcinomaTumor typesTumor cellsEscape mechanisms
2014
Examining the management of muscle-invasive bladder cancer by medical oncologists in the United States11Funding source: The US Office of Management and Budget (0925-0046).
Apolo AB, Kim JW, Bochner BH, Steinberg SM, Bajorin DF, Kelly K, Agarwal PK, Koppie TM, Kaag MG, Quinn DI, Vogelzang NJ, Sridhar SS. Examining the management of muscle-invasive bladder cancer by medical oncologists in the United States11Funding source: The US Office of Management and Budget (0925-0046). Urologic Oncology Seminars And Original Investigations 2014, 32: 637-644. PMID: 24840869, PMCID: PMC6771274, DOI: 10.1016/j.urolonc.2013.12.012.Peer-Reviewed Original ResearchConceptsMuscle-invasive bladder cancerTreatment of MIBCUpper tract urothelial carcinomaNeoadjuvant chemotherapyMedical oncologistsUrothelial carcinomaBladder cancerEastern Cooperative Oncology Group performance statusHigh grade upper tract urothelial carcinomaBladder Cancer Advocacy NetworkUse of NACDose-dense methotrexateGemcitabine/carboplatinGemcitabine/cisplatinGlomerular filtration rateAdjuvant chemotherapyPerioperative chemotherapyChemotherapy regimensLymphovascular invasionPerformance statusT2 lesionsStandardization of practiceMost referralsFiltration rateChemotherapy management