2024
1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up
Aggarwal R, Tagawa S, Monk P, Zhu X, Jones R, Linch M, Costin D, de Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Zhang J. 1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up. Annals Of Oncology 2024, 35: s979. DOI: 10.1016/j.annonc.2024.08.1703.Peer-Reviewed Original ResearchSacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.
Loriot Y, Balar A, Petrylak D, Kalebasty A, Grivas P, Fléchon A, Jain R, Swami U, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zavodovskaya M, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer. Clinical Cancer Research 2024, 30: 3179-3188. PMID: 39086310, DOI: 10.1158/1078-0432.ccr-23-3924.Peer-Reviewed Original ResearchConceptsTrop-2 expressionTrop-2Positive tumor cellsUrothelial cancerMetastatic UCSacituzumab govitecanTumor cellsTumor samplesOpen-label phase II studyTrophoblast cell surface antigen 2Human trophoblast cell-surface antigen 2Advanced urothelial cancerSN-38 payloadPhase II studyC1-3Archival tumor samplesExpression levelsCohorts 1 to 3Surface antigen 2Antibody drug conjugatesOS benefitII studyExamined tumorsH-scoreMembrane expressionSWOG S2210: A phase II study of neoadjuvant carboplatin for localized, high-risk prostate cancer with germline BRCA1/2 mutations.
Cheng H, Callis S, Lin D, Yu E, Dorff T, Kase A, Tangen C, Petrylak D, Lerner S. SWOG S2210: A phase II study of neoadjuvant carboplatin for localized, high-risk prostate cancer with germline BRCA1/2 mutations. Journal Of Clinical Oncology 2024, 42: tps354-tps354. DOI: 10.1200/jco.2024.42.4_suppl.tps354.Peer-Reviewed Original ResearchPathological complete responseHigh-risk diseaseNeoadjuvant carboplatinRadical prostatectomyProstate cancerComplete responseCarriers of germline pathogenic variantsRate of pathological complete responseHigh-risk prostate cancerGermline BRCA1/2 mutationsPlatinum-based regimensBiochemical recurrence-freeMetastatic prostate cancerPhase II studyCurative intent treatmentGermline genetic testingGermline pathogenic variantsMonitoring of recurrenceFDA-approved optionsLate-stage diseaseGBRCA1/2mRecurrence-freeBRCA1/2 mutationsMetastasis-freeOverall survivalSacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Fléchon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. Journal Of Clinical Oncology 2024, 42: 1415-1425. PMID: 38261969, PMCID: PMC11095901, DOI: 10.1200/jco.22.02835.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based chemotherapyClinical benefit rateProgression-free survivalDuration of responseSacituzumab govitecanCheckpoint inhibitorsCohort 3Central reviewUrothelial cancerFirst-line platinum-based chemotherapyOpen-label phase II studyDay 1Median duration of responseMedian progression-free survivalTreatment-related adverse eventsMedian overall survivalMedian follow-upPhase II studySecondary end pointsAntibody-drug conjugatesMetastatic settingOverall survivalStandard therapyII study
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
2020
TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI)
Loriot Y, Balar A, Petrylak D, Tagawa S, Rezazadeh A, Fléchon A, Jain R, Agarwal N, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Hong Q, Goswami T, Itri L, Grivas P. TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI). Annals Of Oncology 2020, 31: s1156. DOI: 10.1016/j.annonc.2020.08.2253.Peer-Reviewed Original Research
2019
LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD
Fizazi K, Mella P, Castellano D, Minatta J, Kalebasty A, Shaffer D, Limon J, Armstrong A, Lopez H, Sharkey B, Saci A, Li J, Wang X, Ciprotti M, Sathyanarayana P, Saad F, Petrylak D, Retz M, Pachynski R, Drake C. LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD. Annals Of Oncology 2019, 30: v885-v886. DOI: 10.1093/annonc/mdz394.045.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerRadiographic progression-free survivalObjective response rateCastration-resistant prostate cancerBristol-Myers SquibbGenentech/RocheAssociation of biomarkersPersonal feesMeasurable diseaseProstate cancerGrade 3/4 treatment-related adverse eventsMedian radiographic progression-free survivalProstate-specific antigen (PSA) response rateResponse rateOngoing androgen deprivation therapyTreatment-related adverse eventsSafety of nivolumabAndrogen deprivation therapyPhase II studyPhase III trialsProgression-free survivalSanofi-AventisInterim analysis resultsMedical writing assistanceNon-financial support
2018
793PD Preliminary results from TRITON2: A phase II study of rucaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination repair (HRR) gene alterations
Abida W, Bryce A, Vogelzang N, Amato R, Percent I, Shapiro J, McDermott R, Hussain A, Patnaik A, Petrylak D, Ryan C, Stanton T, Zhang J, Simmons A, Despain D, Collins M, Golsorskhi T, Scher H, Chowdhury S. 793PD Preliminary results from TRITON2: A phase II study of rucaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination repair (HRR) gene alterations. Annals Of Oncology 2018, 29: viii272. DOI: 10.1093/annonc/mdy284.002.Peer-Reviewed Original ResearchTRITON2: An international, multicenter, open-label, phase II study of the PARP inhibitor rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination deficiency (HRD).
Abida W, Bryce A, Balar A, Chatta G, Dawson N, Guancial E, Hussain A, Jha G, Lipsitz D, Patnaik A, Petrylak D, Ryan C, Stanton T, Vogelzang N, Zhang J, Simmons A, Go J, Golsorkhi T, Chowdhury S, Scher H. TRITON2: An international, multicenter, open-label, phase II study of the PARP inhibitor rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination deficiency (HRD). Journal Of Clinical Oncology 2018, 36: tps388-tps388. DOI: 10.1200/jco.2018.36.6_suppl.tps388.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerHomologous recombination deficiencyNodal diseaseDeleterious germlineProstate cancerProstate-specific antigen (PSA) responseRadiographic progression-free survivalCastration-resistant prostate cancerDNA repair genesClinical benefit rateObjective response ratePhase 2 studyPhase II studyProgression-free survivalTaxane-based chemotherapyHomologous recombination (HR) DNA repair genesPlatinum-based chemotherapyPretreatment blood samplesAdvanced prostate cancerDuration of responseSoft tissue diseaseRepair genesPrimary endpointSecondary endpointsII study
2015
21LBA Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210)
Rosenberg J, Petrylak D, Abidoye O, Van der Heijden M, Hofman-Censits J, Necchi A, O'Donnell P, Balmanoukian A, Loriot Y, Retz M, Perez-Gracia J, Dawson N, Balar A, Galsky M, Fleming M, Powles T, Cui N, Mariathasan S, Fine G, Dreicer R. 21LBA Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210). European Journal Of Cancer 2015, 51: s720. DOI: 10.1016/s0959-8049(16)31942-6.Peer-Reviewed Original ResearchFirst-line randomized phase II study of gemcitabine/cisplatin plus apatorsen or placebo in patients with advanced bladder cancer: The International Borealis-1 trial.
Bellmunt J, Eigl B, Senkus-Konefka E, Loriot Y, Twardowski P, Castellano D, Blais N, Sridhar S, Sternberg C, Retz M, Blumenstein B, Jacobs C, Stewart P, Petrylak D. First-line randomized phase II study of gemcitabine/cisplatin plus apatorsen or placebo in patients with advanced bladder cancer: The International Borealis-1 trial. Journal Of Clinical Oncology 2015, 33: 4503-4503. DOI: 10.1200/jco.2015.33.15_suppl.4503.Peer-Reviewed Original Research
2012
Randomized phase II study of docetaxel with or without ramucirumab (IMC-1121B) or icrucumab (IMC-18F1) in patients with urothelial transitional cell carcinoma (TCC) following progression on first-line platinum-based therapy.
Petrylak D, Chi K, Vogelzang N, Sonpavde G, Rutstein M, Schwartz J, Fox F, Wang W, Abad L, Cosaert J, Grebennik D. Randomized phase II study of docetaxel with or without ramucirumab (IMC-1121B) or icrucumab (IMC-18F1) in patients with urothelial transitional cell carcinoma (TCC) following progression on first-line platinum-based therapy. Journal Of Clinical Oncology 2012, 30: tps4675-tps4675. DOI: 10.1200/jco.2012.30.15_suppl.tps4675.Peer-Reviewed Original ResearchProgression-free survivalTransitional cell carcinomaHuman IgG1 monoclonal antibodyVEGF receptor 2Platinum-based therapyDay 1VEGFR-1IgG1 monoclonal antibodyMonoclonal antibodiesFirst-line platinum-based therapyMedian progression-free survivalPrior platinum-based therapyRandomized phase II studyVascular endothelial growth factor (VEGF) pathwayEndothelial growth factor pathwayPrior antiangiogenic therapyUrothelial transitional cell carcinomaOpen-label treatmentPhase II studySecondary outcome measuresDuration of responseLevels of PlGFPlacental growth factorOne-sided alphaSoluble VEGFR-2
2008
Efficacy and safety of docetaxel in the elderly
Mohile S, Berenji F, Sahasrabudhe D, Morrow G, Petrylak D. Efficacy and safety of docetaxel in the elderly. Aging Health 2008, 4: 113-127. DOI: 10.2217/1745509x.4.2.113.Peer-Reviewed Original ResearchElderly patientsWeekly dosingSide effectsSafety of docetaxelPhase II studyCommon side effectsElderly cancer patientsIncidence of myelosuppressionMost side effectsSolid tumor malignanciesEffective chemotherapeutic agentSignificant age-related effectsDermatologic toxicitiesII studyAdverse eventsDosing schedulesHypersensitivity reactionsCancer patientsFluid retentionAge-related effectsDose reductionTreatment planCancer subtypesTumor malignancyChemotherapeutic agents
2007
4534 POSTER Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
George C, Vaughn D, Petrylak D, Srinivas S, Pili R, Stadler W, De Marco S, Smith D, Nason S, DeWit E. 4534 POSTER Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). European Journal Of Cancer Supplements 2007, 5: 309. DOI: 10.1016/s1359-6349(07)71165-5.Peer-Reviewed Original ResearchPhase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
Vaughn D, Srinivas S, Stadler W, Pili R, Petrylak D, De Marco S, Smith D, Nason S, De Wit E, George C. Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). Journal Of Clinical Oncology 2007, 25: 15543-15543. DOI: 10.1200/jco.2007.25.18_suppl.15543.Peer-Reviewed Original ResearchInitial doseResponse rateManageable toxicity profileObjective response ratePlatinum-containing regimenPoor performance statusPrior pelvic irradiationPhase II studySingle-arm studyTransitional cell carcinomaVinca alkaloid classNew microtubule inhibitorMales 78Febrile neutropeniaMeasurable lesionsRenal impairmentCreatinine clearanceEfficacy endpointII studyLast doseMain toxicityPelvic irradiationPerformance statusPeripheral neuropathyCell carcinoma
2005
A pilot multicenter phase II study of adjuvant docetaxel (D) for high risk prostate cancer (PC) patients (pts) after radical prostatectomy (RP): Preliminary data
Rosenbaum E, Kibel A, Roth B, Wilding G, Dreicer R, Chatta G, Petrylak D, Dipaula R, Beer T, Eisenberger M. A pilot multicenter phase II study of adjuvant docetaxel (D) for high risk prostate cancer (PC) patients (pts) after radical prostatectomy (RP): Preliminary data. Journal Of Clinical Oncology 2005, 23: 4565-4565. DOI: 10.1200/jco.2005.23.16_suppl.4565.Peer-Reviewed Original Research
2004
Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC)
Bellet R, Carducci M, Petrylak D, Kasimis B, Irwin D, Modiano M, Mansour R, Axelrod R, Doukas M. Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2004, 22: 4657-4657. DOI: 10.1200/jco.2004.22.14_suppl.4657.Peer-Reviewed Original ResearchPhase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC)
Bellet R, Carducci M, Petrylak D, Kasimis B, Irwin D, Modiano M, Mansour R, Axelrod R, Doukas M. Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2004, 22: 4657-4657. DOI: 10.1200/jco.2004.22.90140.4657.Peer-Reviewed Original Research