2020
Cabozantinib plus docetaxel and prednisone in metastatic castration‐resistant prostate cancer
Madan RA, Karzai FH, Al Harthy M, Petrylak DP, Kim JW, Arlen PM, Rosner I, Theoret MR, Cordes L, Bilusic M, Peer CJ, Dawson NA, Couvillon A, Hankin A, Williams M, Chun G, Owens H, Marte JL, Lee M, Tomita Y, Yuno A, Trepel JB, Lee S, Steinberg SM, Gulley JL, Figg WD, Dahut WL. Cabozantinib plus docetaxel and prednisone in metastatic castration‐resistant prostate cancer. BJU International 2020, 127: 435-444. PMID: 32969563, PMCID: PMC8265825, DOI: 10.1111/bju.15227.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerDocetaxel/prednisoneCastration-resistant prostate cancerPhase 1 studyProstate cancerDose of cabozantinibEfficacy of cabozantinibPalmar-plantar erythrodysesthesiaPhase 1/2 trialPhase 2 studyOverall survival timeDocetaxel/Median TTPNeutropenic feverPoor accrualThromboembolic eventsMore patientsRandomized studyMedian timeMulticentre studyGrade 3Survival timeCabozantinibPrednisonePatients
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
2017
Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge”, Napoli, November 30th 2016
Ascierto PA, Daniele B, Hammers H, Hirsh V, Kim J, Licitra L, Nanda R, Pignata S. Perspectives in immunotherapy: meeting report from the “Immunotherapy Bridge”, Napoli, November 30th 2016. Journal Of Translational Medicine 2017, 15: 205. PMID: 29020960, PMCID: PMC5637331, DOI: 10.1186/s12967-017-1309-2.Peer-Reviewed Original ResearchConceptsTypes of cancerAnti-PD-1/PD-L1 monotherapyPlatinum-refractory metastatic urothelial carcinomaResponse rateImmune systemPD-L1/PDFirst-line monotherapyImmunotherapy-responsive diseasePD-L1 monotherapyPre-treated NSCLCAddition of chemotherapyDiscontinuation of therapyMetastatic urothelial carcinomaMetastatic breast cancerUse of nivolumabMetastatic renal carcinomaImmune checkpoint receptorsModest response ratesHigh response rateLess side effectsMultiple oncogenic pathwaysImmunotherapy BridgeLine monotherapyAdvanced NSCLCMetastatic NSCLC
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