2024
Sacituzumab 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 expression
2023
Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma
Petrylak D, Eigl B, George S, Heath E, Hotte S, Chism D, Nabell L, Picus J, Cheng S, Appleman L, Sonpavde G, Morgans A, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu E. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clinical Cancer Research 2023, 30: of1-of11. PMID: 37861407, PMCID: PMC10767306, DOI: 10.1158/1078-0432.ccr-22-3627.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaObjective response rateDose-limiting toxicityAntibody-drug conjugatesUrothelial carcinomaCommon treatment-emergent adverse eventsInvestigational antibody-drug conjugateTreatment-emergent adverse eventsI dose-escalation studyDose-expansion cohortsCheckpoint inhibitor therapyPhase II doseDose-escalation studyDose-proportional mannerMultiple-dose administrationBest overall responseMonomethyl auristatin ECytotoxic drug monomethyl auristatin EPrior chemotherapyAdverse eventsDose escalationInhibitor therapyPeripheral neuropathyOcular toxicityExpansion trialEV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefitMaster transcription factor reprograming unleashes selective translation promoting castration resistance and immune evasion in lethal prostate cancer.
Santasusagna S, Zhu S, Jawalagatti V, Carceles-Cordon M, Ertel A, Garcia-Longarte S, Song W, Fujiwara N, Li P, Mendizabal I, Petrylak D, Kelly W, Reddy E, Wang L, Schiewer M, Lujambio A, Karnes J, Knudsen K, Cordon-Cardo C, Dong H, Huang H, Carracedo A, Hoshida Y, Rodriguez-Bravo V, Domingo-Domenech J. Master transcription factor reprograming unleashes selective translation promoting castration resistance and immune evasion in lethal prostate cancer. Cancer Discovery 2023, 13: 2584-2609. PMID: 37676710, PMCID: PMC10714140, DOI: 10.1158/2159-8290.cd-23-0306.Peer-Reviewed Original ResearchConceptsLethal prostate cancerProstate cancerCastration resistanceImmune evasionPharmacologic targetingAnti-PD-1 therapyMajor histocompatibility complex IDeprivation therapyMicrophthalmia transcription factorAndrogen receptorPreclinical modelsTherapeutic strategiesCancerTherapyDruggable mechanismMaster transcription factorTranscription factorsKey mRNAsSpecific mRNAsMRNAFactor 3bEvasionSelected ArticlesTargetingTumorsEnfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
O'Donnell P, Milowsky M, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, Friedlander T, McKay R, Bilen M, Srinivas S, Burgess E, Ramamurthy C, George S, Geynisman D, Bracarda S, Borchiellini D, Geoffrois L, Rey J, Ferrario C, Carret A, Yu Y, Guseva M, Moreno B, Rosenberg J. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. Journal Of Clinical Oncology 2023, 41: 4107-4117. PMID: 37369081, PMCID: PMC10852367, DOI: 10.1200/jco.22.02887.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCisplatin-ineligible patientsDuration of responseMetastatic urothelial cancerUrothelial cancerAdverse eventsHigher treatment-related adverse eventsPhase Ib/II studyMedian DORFirst-line treatment optionEnd pointBlinded independent central reviewCommon grade 3Objective response ratePrimary end pointSecondary end pointsNew safety signalsCisplatin-based therapyIndependent central reviewUntreated LACombination armDurable responsesII studyMaculopapular rashSurvival benefitCrisis of the Clinical Trials Staff Attrition After the COVID-19 Pandemic
Sun G, Dizon D, Szczepanek C, Petrylak D, Sparks D, Tangen C, Lara P, Thompson I, Blanke C. Crisis of the Clinical Trials Staff Attrition After the COVID-19 Pandemic. JCO Oncology Practice 2023, 19: 533-535. PMID: 37285550, PMCID: PMC10424897, DOI: 10.1200/op.23.00152.Peer-Reviewed Original ResearchThe Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgiotti G, El-Chaar N, Stenzl A. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES. European Urology 2023, 84: 229-241. PMID: 37179240, DOI: 10.1016/j.eururo.2023.04.002.Peer-Reviewed Original ResearchConceptsHormone-sensitive prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalMetastatic hormone-sensitive prostate cancerOligometastatic hormone-sensitive prostate cancerOverall survivalProstate cancerDeprivation therapyHazard ratioAndrogen receptor inhibitionEarly treatment intensificationEfficacy of enzalutamideRisk of undertreatmentSystemic treatment strategiesSecondary efficacy endpointsPhase 3 studyProgression-free survivalNumber of metastasesConfidence intervalsProportional hazards modelPost Hoc AnalysisEfficacy endpointOligometastatic diseaseSecondary endpointsTreatment intensificationAvelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial
Grivas P, Park S, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullén A, Loriot Y, Sridhar S, Yamamoto Y, Petrylak D, Sternberg C, Gupta S, Huang B, Costa N, Laliberte R, di Pietro A, Valderrama B, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. European Urology 2023, 84: 95-108. PMID: 37121850, DOI: 10.1016/j.eururo.2023.03.030.Peer-Reviewed Original ResearchConceptsBest supportive careProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyOverall survivalHazard ratioUrothelial carcinomaAnalysis of OSFirst-line maintenance therapyRelevant subgroupsCox proportional hazards modelClinical subgroup analysisPhase 3 trialKaplan-Meier methodProportional hazards modelFirst-line maintenanceMetastatic UCMaintenance therapyStable diseaseSupportive careComplete responsePartial responseAdvanced cancerPD-L1Maintenance treatmentCell-free DNA Methylation as a Predictive Biomarker of Response to Neoadjuvant Chemotherapy for Patients with Muscle-invasive Bladder Cancer in SWOG S1314
Lu Y, Plets M, Morrison G, Cunha A, Cen S, Rhie S, Siegmund K, Daneshmand S, Quinn D, Meeks J, Lerner S, Petrylak D, McConkey D, Flaig T, Thompson I, Goldkorn A. Cell-free DNA Methylation as a Predictive Biomarker of Response to Neoadjuvant Chemotherapy for Patients with Muscle-invasive Bladder Cancer in SWOG S1314. European Urology Oncology 2023, 6: 516-524. PMID: 37087309, PMCID: PMC10587361, DOI: 10.1016/j.euo.2023.03.008.Peer-Reviewed Original ResearchConceptsMuscle-invasive bladder cancerNeoadjuvant chemotherapyCooperative group trialsCell-free DNA methylationProspective cooperative group trialsPathologic responseBladder cancerRadical cystectomyNAC responseChemotherapy responseTreatment responseGroup trialsCycles of chemotherapyNeoadjuvant chemotherapy responseAdvanced bladder cancerStandard of careBladder cancer patientsIndependent predictive abilityGene expression signaturesMetastatic diseaseCancer patientsPredictive biomarkersPathologic respondersCurrent exploratory analysisInvasive approachCombination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials
Antonarakis E, Subudhi S, Pieczonka C, Karsh L, Quinn D, Hafron J, Wilfehrt H, Harmon M, Sheikh N, Shore N, Petrylak D. Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials. Clinical Cancer Research 2023, 29: 2426-2434. PMID: 37058234, PMCID: PMC10320463, DOI: 10.1158/1078-0432.ccr-22-3832.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAndrogen receptor-targeted agentsMedian overall survivalCastration-resistant prostate cancerOverall survivalNational Death IndexConcurrent administrationProstate cancerAntigen-presenting cell activationCurrent prescribing informationNew safety signalsKaplan-Meier methodologyLong-term outcomesConfidence intervalsReceptor-targeted agentsProstatic acid phosphataseAbiraterone acetateFirst infusionDeath IndexPrescribing informationHumoral responseSubsequent infusionSequential administrationSafety signalsImmune responseExternal Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
Halabi S, Yang Q, Roy A, Luo B, Araujo J, Logothetis C, Sternberg C, Armstrong A, Carducci M, N. K, de Bono J, Petrylak D, Fizazi K, Higano C, Morris M, Rathkopf D, Saad F, Ryan C, Small E, Kelly W. External Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer. Journal Of Clinical Oncology 2023, 41: 2736-2746. PMID: 37040594, PMCID: PMC10414709, DOI: 10.1200/jco.22.02661.Peer-Reviewed Original ResearchConceptsOverall survivalPrognostic modelPrognostic groupsRisk groupsProstate cancerChemotherapy-Naïve Metastatic CastrationLow-risk prognostic groupsCastration-resistant prostate cancerPrognostic risk groupingsIntermediate-risk groupMedian overall survivalPhase III trialsGroup of patientsPrognostic risk groupsResistant prostate cancerRandomized clinical trialsTime-dependent areaDifferent treatment classesIII trialsInhibitor trialsRisk groupingClinical trialsTreatment subgroupsSpecific subgroupsTrial statusFirst-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC)
Autio K, Higano C, Nordquist L, Appleman L, Zhang T, Zhu X, Babiker H, Vogelzang N, Prasad S, Schweizer M, Madan R, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang I, Zheng J, Tang S, Hollingsworth R, Kern K, Petrylak D. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). Journal For ImmunoTherapy Of Cancer 2023, 11: e005702. PMID: 36948505, PMCID: PMC10040068, DOI: 10.1136/jitc-2022-005702.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalCastration-resistant prostate cancerPhase 1 studyBiochemical recurrenceProstate cancerImmunotherapy regimenMedian durationDose escalationMedian radiographic progression-free survivalAntigen-specific T cell responsesImmune-related adverse eventsRecommended phase 2 doseSpecific T cell responsesPhase 2 doseImmune checkpoint inhibitorsModest antitumor activityObjective response rateProgression-free survivalAntigen-specific immunityT cell responsesInfluenza-like illnessSignificant side effectsDeprivation therapy
2022
Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆
Balar A, Castellano D, Grivas P, Vaughn D, Powles T, Vuky J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Necchi A, Petrylak D, Plimack E, Xu J, Imai K, Moreno B, Bellmunt J, de Wit R, O’Donnell P. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆. Annals Of Oncology 2022, 34: 289-299. PMID: 36494006, DOI: 10.1016/j.annonc.2022.11.012.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaBlinded independent central reviewCisplatin-ineligible patientsObjective response rateRECIST version 1.1Years of followUrothelial carcinomaKEYNOTE-045KEYNOTE-052Primary endpointMost treatment-related adverse eventsResponse rateSurvival rateConfirmed objective response rateTreatment-related adverse eventsProgression-free survival ratesFurther safety concernsPlatinum-containing chemotherapyFirst-line therapyImmune checkpoint inhibitorsNew safety signalsProgression-free survivalDurability of responseFirst-line pembrolizumabOverall survival rateEffect of Androgen–Androgen Receptor Directed Therapy on COVID-19 Outcome in Prostate Cancer Patients
Ünlü S, Shin J, Par-Young J, Simonov M, Vinetz J, Petrylak D, Kang I, Kim J. Effect of Androgen–Androgen Receptor Directed Therapy on COVID-19 Outcome in Prostate Cancer Patients. Cancer Investigation 2022, 41: 77-83. PMID: 36373994, DOI: 10.1080/07357907.2022.2139839.Peer-Reviewed Original ResearchConceptsProstate cancer patientsCOVID-19 outcomesCancer patientsPoor COVID-19 outcomesAndrogen-androgen receptorExpression of TMPRSS2COVID-19 infectionSARS-CoV-2Directed therapyMean hospitalizationPCa patientsHospitalization ratesPCa casesRetrospective analysisOutcome differencesPatientsDefinitive conclusionsStatistical significanceData generate hypothesesHospitalizationTherapyTMPRSS2Cellular entryOutcomesARDTFORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. Journal Of Clinical Oncology 2022, 41: 629-639. PMID: 36240478, PMCID: PMC9870218, DOI: 10.1200/jco.21.02303.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaUrothelial carcinomaOverall survivalComparable efficacyPan-fibroblast growth factor receptor inhibitorPhase II/III studyPrior platinum-containing regimenPhase II/IIIMRNA overexpressionGrowth factor receptor inhibitorsFGFR-directed therapiesGrade 3/4 eventsMedian overall survivalPlatinum-containing regimenPrimary end pointAdvanced urothelial carcinomaOpen-label trialDNA alterationsVersus ChemotherapyIII studyManageable safetyPlatinum chemotherapyResponse rate analysisReceptor inhibitorsInterim analysis
2018
Antigen-Specific CD8 Lytic Phenotype Induced by Sipuleucel-T in Hormone-Sensitive or Castration-Resistant Prostate Cancer and Association with Overall Survival
Antonarakis ES, Small EJ, Petrylak D, Quinn DI, Kibel AS, Chang NN, Dearstyne E, Harmon M, Campogan D, Haynes H, Vu T, Sheikh NA, Drake CG. Antigen-Specific CD8 Lytic Phenotype Induced by Sipuleucel-T in Hormone-Sensitive or Castration-Resistant Prostate Cancer and Association with Overall Survival. Clinical Cancer Research 2018, 24: 4662-4671. PMID: 29858218, PMCID: PMC6481607, DOI: 10.1158/1078-0432.ccr-18-0638.Peer-Reviewed Original ResearchMeSH KeywordsAcid PhosphataseCD8-Positive T-LymphocytesCell Line, TumorCell ProliferationClinical Trials as TopicGene Expression Regulation, NeoplasticGranulocyte-Macrophage Colony-Stimulating FactorHumansLysosomal-Associated Membrane Protein 1MaleNeoplasm MetastasisNeoplasms, Hormone-DependentProstatic Neoplasms, Castration-ResistantRecombinant Fusion ProteinsT-Lymphocytes, CytotoxicTissue ExtractsConceptsSipuleucel-T treatmentMetastatic castration-resistant prostate cancerProstatic acid phosphataseOverall survivalCTL activityWeek 26Immune responseWeek 6Peripheral cellular immune responsesCytotoxic T lymphocyte activityCastration-resistant prostate cancerEfficacy of sipuleucelImproved overall survivalMedian overall survivalT lymphocyte activityT cell responsesCellular immune responsesT cell proliferationClin Cancer ResHealthy volunteer samplesCD107a expressionLonger OSLymphocyte activityCytolytic responsesTertile analysis
2006
Quality of Life and Pain in Advanced Stage Prostate Cancer: Results of a Southwest Oncology Group Randomized Trial Comparing Docetaxel and Estramustine to Mitoxantrone and Prednisone
Berry D, Moinpour C, Jiang C, Ankerst D, Petrylak D, Vinson L, Lara P, Jones S, Taplin M, Burch P, Hussain M, Crawford E. Quality of Life and Pain in Advanced Stage Prostate Cancer: Results of a Southwest Oncology Group Randomized Trial Comparing Docetaxel and Estramustine to Mitoxantrone and Prednisone. Journal Of Clinical Oncology 2006, 24: 2828-2835. PMID: 16782921, DOI: 10.1200/jco.2005.04.8207.Peer-Reviewed Original ResearchConceptsPain palliationMP armProstate cancerMcGill Pain Questionnaire-Short FormPrimary patient-reported outcomesPain Questionnaire-Short FormPresent Pain Intensity scaleAndrogen-independent prostate cancerAdvanced stage prostate cancerProstate cancer moduleMedian overall survivalLife Questionnaire C30Cancer Core QualityPatient-reported outcomesSuperior clinical efficacyDisease-related symptomsStage prostate cancerPain intensity scaleQuality of lifeRandom assignmentQuestionnaire-Short FormBone painDE armAnalgesic useEligible patients
2001
Transitional cell carcinoma of the bladder: New approaches to the treatment of advanced disease
Petrylak D. Transitional cell carcinoma of the bladder: New approaches to the treatment of advanced disease. Current Oncology Reports 2001, 3: 285-286. PMID: 11389810, DOI: 10.1007/s11912-001-0076-6.Peer-Reviewed Original Research
2000
Which patients with newly diagnosed prostate cancer need a radionuclide bone scan? An analysis based on 631 patients
Lee N, Fawaaz R, Olsson C, Benson M, Petrylak D, Schiff P, Bagiella E, Singh A, Ennis R. Which patients with newly diagnosed prostate cancer need a radionuclide bone scan? An analysis based on 631 patients. International Journal Of Radiation Oncology • Biology • Physics 2000, 48: 1443-1446. PMID: 11121646, DOI: 10.1016/s0360-3016(00)00785-9.Peer-Reviewed Original ResearchConceptsProstate-specific antigenPositive bone scanRadionuclide bone scanBone scanClinical stageLow-risk groupGleason scorePositive BSIndependent predictorsProstate cancerNegative bone scanSignificant independent predictorsProstate cancer patientsSame risk groupProstate cancer biopsiesPathologic reviewStaging evaluationConsecutive patientsGleason 2Cancer patientsVs. 0Odds ratioRisk groupsPatientsCancer biopsiesSouthwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point.
Small E, Lew D, Redman B, Petrylak D, Hammond N, Gross H, Eastham J, Crawford E. Southwest Oncology Group Study of paclitaxel and carboplatin for advanced transitional-cell carcinoma: the importance of survival as a clinical trial end point. Journal Of Clinical Oncology 2000, 18: 2537-44. PMID: 10893284, DOI: 10.1200/jco.2000.18.13.2537.Peer-Reviewed Original ResearchConceptsAdvanced transitional cell carcinomaTransitional cell carcinomaCombination of paclitaxelSurvival timeMedian progression-free survival timeNeoadjuvant platinum-based therapySouthwest Oncology Group studyProgression-free survival timeClinical trial end pointsGrade 4 toxicityPoor prognostic featuresTrial end pointsEnrollment of patientsMedian survival timeOverall survival timeCooperative group settingPlatinum-based therapyResponse proportionsAcceptable toxicityExtranodal diseaseNeoadjuvant therapyNeurologic toxicityComplete responsePartial responsePrognostic features