Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma.
Barata P, Tangen C, Plets M, Thompson I, Narayan V, George D, Heng D, Shuch B, Stein M, Gulati S, Tretiakova M, Tripathi A, Bjarnason G, Humphrey P, Adeniran A, Vaishampayan U, Alva A, Zhang T, Cole S, Lara P, Lerner S, Balzer-Haas N, Pal S. Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma. Journal Of Clinical Oncology 2024, jco2400767. PMID: 39255440, DOI: 10.1200/jco.24.00767.Peer-Reviewed Original ResearchAdvanced papillary renal cell carcinomaPapillary renal cell carcinomaRenal cell carcinomaOverall survivalCell carcinomaProlonged progression-free survivalLack of survival benefitProgression-free survivalRandomized phase IIMedian follow-upPrimary end pointOpen-label trialOverall survival analysisCrizotinib armMedian OSSurvival benefitClinical trial updateNo significant differenceCabozantinibTreatment armsSunitinibFollow-upClinical trialsSavolitinibCrizotinibLong‐term outcomes of bladder‐sparing therapy vs radical cystectomy in BCG‐unresponsive non‐muscle‐invasive bladder cancer
Taylor J, Kamat A, O'Donnell M, Annapureddy D, Howard J, Tan W, McElree I, Davaro F, Yim K, Harrington S, Dyer E, Black A, Kanabur P, Roumiguié M, Lerner S, Black P, Raman J, Preston M, Steinberg G, Huang W, Li R, Packiam V, Woldu S, Lotan Y. Long‐term outcomes of bladder‐sparing therapy vs radical cystectomy in BCG‐unresponsive non‐muscle‐invasive bladder cancer. BJU International 2024 PMID: 39183466, DOI: 10.1111/bju.16509.Peer-Reviewed Original ResearchNon-muscle-invasive bladder cancerBladder-sparing therapyUpfront RCRadical cystectomyCohort of patientsBladder cancerBCG-unresponsive NMIBCRetrospective cohort of patientsProgression to MIBCUpfront radical cystectomyCancer-specific survivalInstitutional review board approvalMetastasis-free survivalFood and Drug Administration criteriaRate of recurrenceReview board approvalLong-term outcomesStatistically significant differenceNodal diseaseRe-resectionSystemic immunotherapyIntravesical chemotherapyOncological outcomesOverall survivalOncological riskAdjuvant Everolimus in Non–Clear Cell Renal Cell Carcinoma
Gulati S, Tangen C, Ryan C, Vaishampayan U, Shuch B, Barata P, Pruthi D, Bergerot C, Tripathi A, Lerner S, Thompson I, Lara P, Pal S. Adjuvant Everolimus in Non–Clear Cell Renal Cell Carcinoma. JAMA Network Open 2024, 7: e2425288. PMID: 39106067, PMCID: PMC11304111, DOI: 10.1001/jamanetworkopen.2024.25288.Peer-Reviewed Original ResearchConceptsChromophobe renal cell carcinomaRecurrence-free survivalPapillary renal cell carcinomaRenal cell carcinomaNon-clear cell renal cell carcinomaResected renal cell carcinomaCell renal cell carcinomaOverall survivalWeeks of treatmentCell carcinomaAdverse eventsClinical trialsHazard ratioPhase 3 randomized clinical trialWeeks of everolimusHigher adverse eventsRate of adverse eventsIntermediate-high riskIntervention groupVery-high-riskCox regression modelsPotential treatment benefitsClinical trial dataTreatment-naivePartial nephrectomyBone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer
Gebrael G, Jo Y, Swami U, Plets M, Chehade C, Narang A, Gupta S, Myint Z, Sayegh N, Tangen C, Hussain M, Dorff T, Lara P, Lerner S, Thompson I, Agarwal N. Bone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer. JAMA Network Open 2024, 7: e2419966. PMID: 38980676, PMCID: PMC11234233, DOI: 10.1001/jamanetworkopen.2024.19966.Peer-Reviewed Original ResearchConceptsProgression-free survivalAndrogen deprivation therapyProstate-specific antigenHormone-sensitive prostate cancerBone painOverall survivalPost hoc secondary analysisProstate cancerSurvival outcomesPain statusAssociated with shorter progression-free survivalClinical trialsPresence of bone painProstate-specific antigen levelAssociated with worse overall survivalCastration-resistant prostate cancerShorter progression-free survivalIntention-to-treat populationSecondary analysisZubrod performance statusHigh-volume diseaseCompare survival outcomesCox proportional hazards regression modelsSecondary end pointsProportional hazards regression modelsCorrelation of body mass index (BMI) with survival outcomes in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC): Analysis of patient (pt)-level data from SWOG 1216 study.
Swami U, Jo Y, Narang A, Plets M, Hage Chehade C, Gebrael G, Gupta S, Myint Z, Tangen C, Lara P, Thompson I, Hussain M, Dorff T, Lerner S, Agarwal N. Correlation of body mass index (BMI) with survival outcomes in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC): Analysis of patient (pt)-level data from SWOG 1216 study. Journal Of Clinical Oncology 2024, 42: 5081-5081. DOI: 10.1200/jco.2024.42.16_suppl.5081.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerBody mass indexBody mass index cohortZubrod performance statusCorrelation of body mass indexPhase III studyOverall survivalSurvival outcomesGleason scoreIII studiesPerformance statusProstate cancerMetastatic hormone-sensitive prostate cancer settingAssociated with improved survival outcomesMetastatic castration-resistant prostate cancerMultivariate analysisHormone-sensitive prostate cancerAssociated with better OSRandomized phase III studyCastration-resistant prostate cancerNormal body mass indexCategorized body mass indexPrognostication of patientsAssociation of obesityDisease burdenA phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design.
Sadeghi S, Plets M, Lara P, Tangen C, Berg S, Brown J, Bangs R, Nakagawa D, Daneshmand S, Ian M. Jr., Flaig T, Petrylak D, Lerner S. A phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design. Journal Of Clinical Oncology 2024, 42: tps4617-tps4617. DOI: 10.1200/jco.2024.42.16_suppl.tps4617.Peer-Reviewed Original ResearchProgression free survivalMetastatic urothelial carcinomaMedian progression free survivalStandard of careOverall survivalEnfortumab vedotinSacituzumab govitecanFree survivalCisplatin-ineligible metastatic urothelial carcinomaPhase III randomized trialMedian overall survivalStudies of eribulinEndpoint of OSFGFR alterationsLiver metastasesSystemic therapyEligible ptsUrothelial carcinomaPrimary endpointGenitourinary cancersTreatment changesEribulinResponse rateActivity of EORRAdjuvant Everolimus in Patients with Completely Resected, Very High-risk Renal Cell Carcinoma of Clear Cell Histology: Results from the Phase 3 Placebo-controlled SWOG S0931 (EVEREST) Trial
Lara P, Tangen C, Heath E, Gulati S, Stein M, Meng M, Alva A, Pal S, Puzanov I, Clark J, Choueiri T, Agarwal N, Uzzo R, Haas N, Synold T, Plets M, Vaishampayan U, Shuch B, Lerner S, Thompson I, Ryan C. Adjuvant Everolimus in Patients with Completely Resected, Very High-risk Renal Cell Carcinoma of Clear Cell Histology: Results from the Phase 3 Placebo-controlled SWOG S0931 (EVEREST) Trial. European Urology 2024 PMID: 38811313, DOI: 10.1016/j.eururo.2024.05.012.Peer-Reviewed Original ResearchRecurrence-free survivalHigh-risk diseaseRenal cell cancerPhase 3 trialOverall survivalEverolimus armCell histologyPlacebo armDiscontinuation rate due to adverse eventsHigh-risk renal cell carcinomaCompare recurrence-free survivalPatients treated with everolimusPositive phase 3 trialClear cell renal cell cancerCell renal cell cancerRate of side effectsClear cell histologyComparison to placeboComplete surgical removalNode-positive statusRisk of recurrenceRisk stratification toolCox regression modelsAdjuvant sunitinibAdjuvant trialsEfficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin–Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial
Narayan V, Boorjian S, Alemozaffar M, Konety B, Shore N, Gomella L, Kamat A, Bivalacqua T, Montgomery J, Lerner S, Busby J, Poch M, Crispen P, Steinberg G, Schuckman A, Downs T, Mashni J, Lane B, Guzzo T, Bratslavsky G, Karsh L, Woods M, Brown G, Canter D, Luchey A, Lotan Y, Inman B, Williams M, Cookson M, Chang S, Sankin A, O’Donnell M, Sawutz D, Philipson R, Parker N, Yla-Herttuala S, Rehm D, Jakobsen J, Juul K, Dinney C. Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin–Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial. Journal Of Urology 2024, 212: 74-86. PMID: 38704840, DOI: 10.1097/ju.0000000000004020.Peer-Reviewed Original ResearchConceptsNonmuscle-invasive bladder cancerPhase 3 trialBladder cancerFollow-upAdenoviral vector-based gene therapyProgression to muscle-invasive diseaseOpen-label phase 3 trialVector-based gene therapyCystectomy-free survivalMuscle-invasive diseaseMedian follow-upCarcinoma in situBladder preservationNadofaragene firadenovecOverall survivalGene therapyCytological assessmentTa/T1PatientsUS sitesCohortReceiving treatmentMonthsCancerHGRFThree- and Seven-month Prostate-specific Antigen Levels as Prognostic Markers for Overall Survival in Metastatic Hormone-sensitive Prostate Cancer: Results from SWOG S1216, a Phase 3 Randomized Trial of Androgen Deprivation Plus Orteronel or Bicalutamide
Parikh M, Tangen C, Hussain M, Gupta S, Callis S, Jo Y, Harzstark A, Paller C, George S, Zibelman M, Cheng H, Maughan B, Zhang J, Pachynski R, Bryce A, Lin D, Quinn D, Lerner S, Thompson I, Dorff T, Lara P, Agarwal N. Three- and Seven-month Prostate-specific Antigen Levels as Prognostic Markers for Overall Survival in Metastatic Hormone-sensitive Prostate Cancer: Results from SWOG S1216, a Phase 3 Randomized Trial of Androgen Deprivation Plus Orteronel or Bicalutamide. European Urology Oncology 2024 PMID: 38523017, DOI: 10.1016/j.euo.2024.03.001.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerHormone-sensitive prostate cancerProstate-specific antigenAndrogen deprivation therapyProstate-specific antigen levelOverall survivalProstate cancerDeprivation therapyComplete responseAntigen levelsNo responseTreatment of metastatic hormone-sensitive prostate cancerLow prostate-specific antigen levelsResponse to androgen deprivation therapyAssociated with improved OSPSA responsePhase 3 randomized trialPhase 3 clinical trialsEarly identification of patientsAssociated with OSHigher risk of deathIdentification of patientsResponse to treatmentRisk of deathOS associationBaseline bone pain as a prognostic marker for survival for men with metastatic hormone-sensitive prostate cancer (mHSPC): Patient-level analysis of SWOG 1216 trial.
Gebrael G, Jo Y, Swami U, Plets M, Hage Chehade C, Narang A, Gupta S, Myint Z, Sayegh N, Tangen C, Hussain M, Dorff T, Lara P, Lerner S, Thompson I, Agarwal N. Baseline bone pain as a prognostic marker for survival for men with metastatic hormone-sensitive prostate cancer (mHSPC): Patient-level analysis of SWOG 1216 trial. Journal Of Clinical Oncology 2024, 42: 188-188. DOI: 10.1200/jco.2024.42.4_suppl.188.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerProgression-free survivalAndrogen deprivation therapyBone painOverall survivalGleason scoreProstate cancerPrognostic markerAssociated with decreased PFSDisease burdenMedian progression-free survivalHormone-sensitive prostate cancerCastration-resistant prostate cancerCox proportional hazards modelsConfidence intervalsPatient-level analysisProportional hazards modelDeprivation therapyHigher disease burdenBone metastasesPain statusSurvival outcomesPatient-level dataTreatment intensificationPrognostic variablesInfigratinib versus placebo in patients with resected urothelial cancer (UC) bearing FGFR3 mutation or fusion: Primary DFS analysis from the phase 3, randomized PROOF302 study.
Pal S, Grivas P, Gupta S, Valderrama B, Rodriguez-Vida A, Roghmann F, Sevillano E, Matin S, Loriot Y, Sridhar S, Sonpavde G, Fleming M, Lerner S, Bellmunt J, Master V, Tripathi A, Davis K, Van Veenhuyzen D, Weng R, Daneshmand S. Infigratinib versus placebo in patients with resected urothelial cancer (UC) bearing FGFR3 mutation or fusion: Primary DFS analysis from the phase 3, randomized PROOF302 study. Journal Of Clinical Oncology 2024, 42: 629-629. DOI: 10.1200/jco.2024.42.4_suppl.629.Peer-Reviewed Original ResearchDisease-free survivalMetastasis-free survivalOverall survivalUrothelial cancerFibroblast growth factor 3FGFR3 alterationsAdjuvant therapyAdverse eventsInvestigator-assessed disease-free survivalMulticenter phase III clinical trialAssessed disease-free survivalPhase III clinical trialsLower tract UCUpper tract UCDays of randomizationFatal adverse eventsIII clinical trialsPrecision oncology trialsDFS analysisMetastatic settingOral infigratinibRadical surgeryDisease recurrenceFrequent gradeInvasive UCSWOG S2200 (PAPMET2): A phase II randomized trial of cabozantinib with or without atezolizumab in patients with advanced papillary renal cell carcinoma (PRCC).
Maughan B, Plets M, Pal S, Ged Y, Tangen C, Vaishampayan U, Lerner S, Thompson I. SWOG S2200 (PAPMET2): A phase II randomized trial of cabozantinib with or without atezolizumab in patients with advanced papillary renal cell carcinoma (PRCC). Journal Of Clinical Oncology 2024, 42: tps493-tps493. DOI: 10.1200/jco.2024.42.4_suppl.tps493.Peer-Reviewed Original ResearchPapillary renal cell carcinomaProgression free survivalMedian progression free survivalImmune therapyAdvanced papillary renal cell carcinomaComparison of progression free survivalClinical trialsPhase II randomized trialObjective response rateLines of therapyPresence of metastasesRenal cell carcinomaSignificant autoimmune diseaseSingle arm trialRandomized clinical trialsStandard of careAdjuvant pembrolizumabFree survivalMetastatic diseaseOverall survivalCell carcinomaPrimary endpointPathological confirmationSecondary endpointsTargeted therapySWOG 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 survival