2023
Optimization of Radium-223 Treatment of Castration-resistant Prostate Cancer Based on the Burden of Skeletal Metastasis and Clinical Parameters
Shariftabrizi A, Kothari S, George S, Attwood K, Levine E, Lamonica D. Optimization of Radium-223 Treatment of Castration-resistant Prostate Cancer Based on the Burden of Skeletal Metastasis and Clinical Parameters. The Oncologist 2023, 28: 246-251. PMID: 36651837, PMCID: PMC10020806, DOI: 10.1093/oncolo/oyac245.Peer-Reviewed Original ResearchConceptsBaseline BSIBone scan indexMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerProstate cancerOverall survivalSkeletal metastasesRa-223 therapyRa-223 treatmentRadium-223 treatmentTreatment-associated reductionChemotherapy-naïve patientsMedian overall survivalAbsolute neutrophil countRadium-223 dichlorideHigh serum PSANovel treatment modalitiesAlkaline phosphatase levelsChemotherapy-naïveTreatment tolerabilityNeutrophil countSerum PSABone scanLaboratory parametersPatient selection
2020
Overall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis
Schettini F, Giudici F, Giuliano M, Cristofanilli M, Arpino G, Del Mastro L, Puglisi F, De Placido S, Paris I, De Placido P, Venturini S, De Laurentis M, Conte P, Juric D, Llombart-Cussac A, Pusztai L, Prat A, Jerusalem G, Di Leo A, Generali D. Overall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis. Journal Of The National Cancer Institute 2020, 112: 1089-1097. PMID: 32407488, PMCID: PMC7669227, DOI: 10.1093/jnci/djaa071.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FemaleHumansLetrozoleNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsPyridinesRandomized Controlled Trials as TopicConceptsSecond-line therapyMetastatic breast cancerEndocrine therapyCDK4/6 inhibitorsVisceral involvementBreast cancerPostmenopausal metastatic breast cancerAvailable phase IIChemotherapy-naïve patientsClear OS benefitSpecific clinical subgroupsProgression-free survivalOverall survival dataBreast cancer prognosisStudy-level factorsCyclin-dependent kinase 4Random-effects modelSystematic literature searchEndocrine monotherapyOS benefitOS independentOverall survivalUpfront therapyMenopausal statusMetastatic sites
2017
Phase 2 Trial of Gemcitabine, Cisplatin, plus Ipilimumab in Patients with Metastatic Urothelial Cancer and Impact of DNA Damage Response Gene Mutations on Outcomes
Galsky M, Wang H, Hahn N, Twardowski P, Pal S, Albany C, Fleming M, Starodub A, Hauke R, Yu M, Zhao Q, Sonpavde G, Donovan M, Patel V, Sfakianos J, Domingo-Domenech J, Oh W, Akers N, Losic B, Gnjatic S, Schadt E, Chen R, Kim-Schulze S, Bhardwaj N, Uzilov A. Phase 2 Trial of Gemcitabine, Cisplatin, plus Ipilimumab in Patients with Metastatic Urothelial Cancer and Impact of DNA Damage Response Gene Mutations on Outcomes. European Urology 2017, 73: 751-759. PMID: 29248319, DOI: 10.1016/j.eururo.2017.12.001.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellCisplatinDeoxycytidineDisease-Free SurvivalDNA DamageDNA Mutational AnalysisFemaleGemcitabineHumansIpilimumabKaplan-Meier EstimateMaleMiddle AgedMolecular Targeted TherapyMutationNeoplasm InvasivenessNeoplasm MetastasisNeoplasm StagingPrognosisProspective StudiesRisk AssessmentSurvival AnalysisTreatment OutcomeUrologic NeoplasmsConceptsMetastatic urothelial cancerCycles of GCObjective response rateImmune checkpoint blockadePotential predictive biomarkersUrothelial cancerResponse ratePrimary endpointCheckpoint blockadeOverall survivalImmunomodulatory effectsPredictive biomarkersSingle-arm phase 2 studyPeripheral blood flow cytometryAddition of ipilimumabBlood flow cytometryChemotherapy-naïve patientsPhase 2 studyPhase 2 trialProgression-free survivalSingle-arm trialDNA damage response gene alterationsSingle-arm designArchival tumor tissueSmall single-arm trials
2015
355TiP Phase III clinical trials of atezolizumab compared with standard chemotherapy in PD-L1–selected chemotherapy-naïve patients with advanced NSCLC
Herbst R, de Marinis F, Jassem J, Spigel D, Shankar G, Mocci S, Sandler A, Lopez-Chavez A, Li S, Giaccone G. 355TiP Phase III clinical trials of atezolizumab compared with standard chemotherapy in PD-L1–selected chemotherapy-naïve patients with advanced NSCLC. Annals Of Oncology 2015, 26: ix103. DOI: 10.1093/annonc/mdv528.12.Peer-Reviewed Original Research
2012
LBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial
Petrylak D, Fizazi K, Sternberg C, Budnik N, De Wit R, Wiechno P, Bellmunt J, Barton D, Fandi A, Jungnelius U, Li S, Vogelzang N. LBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial. Annals Of Oncology 2012, 23: ixe15. DOI: 10.1016/s0923-7534(20)34329-5.Peer-Reviewed Original ResearchCastrate-resistant prostate cancerProgression-free survivalDP armOverall survivalProgressive metastatic castrate-resistant prostate cancerMetastatic castrate-resistant prostate cancerMethods Chemotherapy-naïve patientsAddition of lenalidomideLower dose intensitySafety of docetaxelSafety of lenalidomideChemotherapy-naïve patientsEarly treatment discontinuationMedian overall survivalObjective response rateECOG PS scoreFirst-line treatmentPhase 1/2 trialShorter treatment durationPhase 3Lack of benefitFebrile neutropeniaMAINSAIL trialNeutropenic sepsisPrimary endpoint
2009
Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial
Halabi S, Sartor O, Petrylak D, Sternberg C, Witjes J, Noursalehi M, McKearn T, George M. Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial. Journal Of Clinical Oncology 2009, 27: 5150-5150. DOI: 10.1200/jco.2009.27.15_suppl.5150.Peer-Reviewed Original ResearchProgression-free survivalCastration-resistant prostate cancerFirst-line chemotherapyOverall survivalMetastatic castration-resistant prostate cancerChemotherapy-naïve patientsDouble-blind trialDate of randomizationMedian survival timePredictors of OSProportional hazards modelType of progressionSPARC trialLine chemotherapyCRPC patientsNaïve patientsFirst progressionTau measuresProstate cancerLandmark analysisSurvival timeTreatment groupsHazards modelStratification factorsClinical relevance
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