2019
Ramucirumab (RAM) exposure-response (ER) relationship in RANGE: A randomized phase III trial of RAM plus docetaxel (DOC) versus placebo (P) plus DOC in advanced platinum-refractory urothelial carcinoma (UC) patients (pts).
De Wit R, Powles T, Castellano D, Necchi A, Lee J, Van Der Heijden M, Matsubara N, Bamias A, Flechon A, Sternberg C, Drakaki A, Yu E, Hamid O, Zimmermann A, Gao L, Long A, Walgren R, Bell-McGuinn K, Petrylak D. Ramucirumab (RAM) exposure-response (ER) relationship in RANGE: A randomized phase III trial of RAM plus docetaxel (DOC) versus placebo (P) plus DOC in advanced platinum-refractory urothelial carcinoma (UC) patients (pts). Journal Of Clinical Oncology 2019, 37: 353-353. DOI: 10.1200/jco.2019.37.7_suppl.353.Peer-Reviewed Original ResearchRandomized phase III trialFavorable prognostic featuresMultivariate Cox regressionPhase III trialsPoor prognostic factorUrothelial carcinoma patientsPopulation pharmacokinetic analysisCase-control analysisExposure-response relationshipHigh exposureWarrants further explorationFirst doseIII trialsPrognostic factorsCarcinoma patientsPrognostic featuresCox regressionDiscontinuation criteriaAcceptable safetyLonger survivalRisk factorsRam exposureORR benefitPharmacokinetic analysisDocetaxelClinical outcomes in Caucasian (C), African American (AA) and Asian men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, N. K, Tangen C, Petrylak D, Araujo J, Fizazi K, Quinn D, Higano C, Tannock I, Small E, Kelly W. Clinical outcomes in Caucasian (C), African American (AA) and Asian men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2019, 37: 186-186. DOI: 10.1200/jco.2019.37.7_suppl.186.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA progression-free survivalProgression-free survivalCastration-resistant prostate cancerPooled hazard ratioMultivariable analysisAsian menHazard ratioProstate cancerMedian PSA progression-free survivalAfrican AmericansMedian progression-free survivalPhase III clinical trialsPhase III trialsResistant prostate cancerIndividual patient dataProportional hazards modelAfrican American menIII trialsPFS outcomesPrognostic factorsClinical outcomesPrognostic importanceTreatment armsCaucasian man
2018
901P Impact of prognostic factors and risk groups on overall survival (OS) in patients treated with pembrolizumab vs investigator’s choice chemotherapy for advanced urothelial cancer (UC): Post hoc analysis of KEYNOTE-045
Bellmunt J, de Wit R, Vaughn D, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Jensen E, Frenkl T, Perini R, Bajorin D. 901P Impact of prognostic factors and risk groups on overall survival (OS) in patients treated with pembrolizumab vs investigator’s choice chemotherapy for advanced urothelial cancer (UC): Post hoc analysis of KEYNOTE-045. Annals Of Oncology 2018, 29: viii320-viii321. DOI: 10.1093/annonc/mdy283.110.Peer-Reviewed Original Research
2016
IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC).
Hoffman-Censits J, Grivas P, Van Der Heijden M, Dreicer R, Loriot Y, Retz M, Vogelzang N, Perez-Gracia J, Rezazadeh A, Bracarda S, Yu E, Hoimes C, Bellmunt J, Quinn D, Petrylak D, Hussain S, Cui N, Mariathasan S, Abidoye O, Rosenberg J. IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2016, 34: 355-355. DOI: 10.1200/jco.2016.34.2_suppl.355.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPoor prognostic factorPrognostic factorsPD-L1Prognostic subgroupsPD-L1/PDImmune cell statusMedian treatment durationPD-L1 subgroupsTreatment-related AEsPD-L1 expressionPD-L1 statusPhase II trialPlatinum-based chemotherapyCo-primary endpointsPoor prognostic subgroupMUC patientsRECIST v1.1Data cutoffDurable responsesII trialAntitumor immunityG3-4Median ageHistoric controls
2015
2637 Baseline circulating tumor cells (CTC) and serum heat shock protein 27 (Hsp27) levels are increased in advanced bladder cancer (BC) patients with poor prognostic factors: Results from the randomized phase 2 Borealis-1™ trial of first-line gemcitabine/cisplatin plus apatorsen or placebo
Petrylak D, Eigl B, Senkus E, Loriot Y, Twardowski P, Castellano D, Blais N, Sridhar S, Sternberg C, Retz M, Blumenstein B, Jacobs C, Stewart P, Bellmunt J. 2637 Baseline circulating tumor cells (CTC) and serum heat shock protein 27 (Hsp27) levels are increased in advanced bladder cancer (BC) patients with poor prognostic factors: Results from the randomized phase 2 Borealis-1™ trial of first-line gemcitabine/cisplatin plus apatorsen or placebo. European Journal Of Cancer 2015, 51: s525. DOI: 10.1016/s0959-8049(16)31454-x.Peer-Reviewed Original Research
2013
A prognostic model for predicting overall survival in metastatic castrate-resistant prostate cancer (mCRPC) men treated with second-line chemotherapy.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A prognostic model for predicting overall survival in metastatic castrate-resistant prostate cancer (mCRPC) men treated with second-line chemotherapy. Journal Of Clinical Oncology 2013, 31: 5011-5011. DOI: 10.1200/jco.2013.31.15_suppl.5011.Peer-Reviewed Original ResearchMedian overall survivalSecond-line chemotherapyFirst-line chemotherapyOverall survivalPrognostic modelRisk groupsECOG performance statusPhase III trialsBaseline prognostic factorsLow-risk groupProstate cancer menProstate-specific antigenDocetaxel useLine chemotherapyMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trialsProspective validationPrognostic variablesA model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed. Journal Of Clinical Oncology 2013, 31: 24-24. DOI: 10.1200/jco.2013.31.6_suppl.24.Peer-Reviewed Original ResearchFirst-line chemotherapyCastrate-resistant prostate cancerMedian overall survivalOverall survivalLow-risk groupRisk groupsPrognostic modelHazard ratioMetastatic castrate-resistant prostate cancerECOG performance statusPhase III trialsImportant prognostic factorProstate-specific antigenTime-dependent areaTime-dependent AUCDocetaxel useMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trials
2012
Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy.
Pond G, Sonpavde G, Choueiri T, Qu A, Vaughn D, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Beer T, Stadler W, O'Donnell P, Sternberg C, Rosenberg J, Molins J. Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy. Journal Of Clinical Oncology 2012, 30: 4522-4522. DOI: 10.1200/jco.2012.30.15_suppl.4522.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaMedian overall survivalOverall survivalPrior chemotherapyUrothelial carcinomaLiver metastasesPerformance statusPrognostic factorsSecond-line systemic therapyOptimal cutpointSignificant negative prognostic impactECOG performance statusFirst study treatmentSecond-line chemotherapyPhase II trialKaplan-Meier methodNegative prognostic impactProportional hazards regressionLikelihood ratio χBaseline HbII trialMetastatic diseaseOS independentPrognostic impact