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 analysisDocetaxel
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
2014
808O Inhibition of Pd-L1 By Mpdl3280A Leads to Clinical Activity in Pts with Metastatic Urothelial Bladder Cancer (Ubc)
Bellmunt J, Petrylak D, Powles T, Braiteh F, Vogelzang N, Cruz C, Burris H, Eder J, Fine G, Teng M, Shen X, Bruey J, Boyd Z, Hegde P, Chen D, Loriot Y. 808O Inhibition of Pd-L1 By Mpdl3280A Leads to Clinical Activity in Pts with Metastatic Urothelial Bladder Cancer (Ubc). Annals Of Oncology 2014, 25: iv280. DOI: 10.1093/annonc/mdu337.1.Peer-Reviewed Original ResearchMedian durationPD-L1Metastatic urothelial bladder cancerCaris Life SciencesClinical cutoff dateDrug-related AEsECOG PS 1Employees of GenentechPD-L1 statusPD-L1 expressionPoor prognostic factorReceptor PD-1Urothelial bladder cancerPD-L1 IHCPD-L1 bindingEvaluable ptsIHC 0/1Median DoRPrior chemoPrior cisplatinPrior therapyRECIST v1.1Visceral metastasesLiver metastasesObjective response
2000
THE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER
ENNIS R, PETRYLAK D, SINGH P, BAGIELLA E, O’TOOLE K, BENSON M, OLSSON C. THE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER. Journal Of Urology 2000, 163: 1413-1418. DOI: 10.1097/00005392-200005000-00004.Peer-Reviewed Original ResearchRelapse-free survivalMuscle-invasive bladder cancerM-VAC chemotherapyLow-risk patientsInvasive bladder cancerRisk patientsPelvic failurePelvic relapseCisplatin chemotherapyBladder cancerMultivariate analysisIndependent poor prognostic factorCox proportional hazards modelMUSCLE INVASIVE BLADDERBenefit of chemotherapyHigh-risk featuresHigh-risk patientsPatterns of relapsePelvic lymph nodesKaplan-Meier methodPoor prognostic factorAmerican Joint CommitteePathological stage T3Proportional hazards modelExcellent disease controlTHE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER
ENNIS R, PETRYLAK D, SINGH P, BAGIELLA E, O’TOOLE K, BENSON M, OLSSON C. THE EFFECT OF CYSTECTOMY, AND PERIOPERATIVE METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN CHEMOTHERAPY ON THE RISK AND PATTERN OF RELAPSE IN PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER. Journal Of Urology 2000, 163: 1413-1418. PMID: 10751847, DOI: 10.1016/s0022-5347(05)67632-x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinCombined Modality TherapyCystectomyDisease-Free SurvivalDoxorubicinFemaleHumansMaleMethotrexateMiddle AgedMuscle NeoplasmsMuscle, SmoothNeoplasm InvasivenessNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingRetrospective StudiesRisk FactorsTreatment FailureUrinary Bladder NeoplasmsVinblastineConceptsRelapse-free survivalMuscle-invasive bladder cancerM-VAC chemotherapyLow-risk patientsInvasive bladder cancerRisk patientsPelvic failurePelvic relapseCisplatin chemotherapyBladder cancerMultivariate analysisIndependent poor prognostic factorCox proportional hazards modelMUSCLE INVASIVE BLADDERBenefit of chemotherapyHigh-risk featuresHigh-risk patientsPatterns of relapsePelvic lymph nodesKaplan-Meier methodPoor prognostic factorAmerican Joint CommitteePathological stage T3Proportional hazards modelExcellent disease control