2025
A randomized phase 2 study of neratinib with or without fulvestrant for patients with HER2-positive, estrogen receptor-positive metastatic breast cancer
Morganti S, Chu X, Ballinger T, Unni N, Sinclair S, Wesolowski R, Pereslete A, Lange P, Tayob N, Lin N, Leone J, Krop I, Tolaney S, Parsons H. A randomized phase 2 study of neratinib with or without fulvestrant for patients with HER2-positive, estrogen receptor-positive metastatic breast cancer. Clinical Breast Cancer 2025 PMID: 40484776, DOI: 10.1016/j.clbc.2025.05.009.Peer-Reviewed Original ResearchProgression-free survivalCirculating tumor DNAMetastatic breast cancerOverall survivalEstrogen receptorBreast cancerClearance of circulating tumor DNAHER2-positive metastatic breast cancerAssociated with progression-free survivalEstrogen receptor-positive metastatic breast cancerGrade 3 adverse eventsMedian progression-free survivalRandomized phase 2 studyIdentification of predictive biomarkersPhase 2 clinical trialCombination of neratinibDuration of responseOverall response rateER signaling pathwayCtDNA dynamicsMedian OSHER2-positiveER-positiveOpen-labelSlow accrual
2024
Intensification of ADT with enzalutamide in high-risk patients with biochemical relapse following radical prostatectomy undergoing salvage radiation: Initial results from RTOG 3506 (STEEL).
Posadas E, Gay H, Rodgers J, Morgan T, Xiao Y, Yu J, Michalski J, Bouchard M, Desai N, Funk R, Boike T, Jurgens D, Wong A, Shen X, Miyawaki L, Bland C, Hairston J, Sandler H, Pugh S, Feng F. Intensification of ADT with enzalutamide in high-risk patients with biochemical relapse following radical prostatectomy undergoing salvage radiation: Initial results from RTOG 3506 (STEEL). Journal Of Clinical Oncology 2024, 42: 131-131. DOI: 10.1200/jco.2024.42.4_suppl.131.Peer-Reviewed Original ResearchAndrogen deprivation therapyProgression free survivalSalvage radiotherapyHigh-risk featuresBiochemical relapseHigh-risk patientsRadical prostatectomyLHRH analogsDecreased lymphocytesAndrogen receptorMonths of androgen deprivation therapyGrade 3 adverse eventsProgression free survival benefitStandard androgen deprivation therapyMedian follow-up timeGrade 4 AEsPara-aortic radiotherapyProstate cancer patientsEnzalutamide armGleason 9Salvage radiationDeprivation therapyNodal involvementFree survivalRT boost
2023
A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1
Weiss S, Sznol M, Shaheen M, Berciano-Guerrero M, Couselo E, Rodríguez-Abreu D, Boni V, Schuchter L, Gonzalez-Cao M, Arance A, Wei W, Ganti A, Hauke R, Berrocal A, Iannotti N, Hsu F, Kluger H. A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1. Clinical Cancer Research 2023, 30: 74-81. PMID: 37535056, PMCID: PMC10767304, DOI: 10.1158/1078-0432.ccr-23-0475.Peer-Reviewed Original ResearchConceptsObjective response ratePhase II trialAdverse eventsPartial responseDisease progressionII trialGrade 3 adverse eventsAnti PD-1CD40 agonist antibodyElevated liver functionTreatment-related SAEsCommon adverse eventsActivation of CD40Subset of patientsFavorable safety profileAntigen presenting cellsStable diseaseMedian durationAdvanced melanomaAdditional patientsLiver functionSafety profileMetastatic melanomaPreclinical dataPresenting cells
2022
A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161
Rajdev L, Lee JW, Libutti SK, Benson AB, Fisher GA, Kunz PL, Hendifar AE, Catalano P, O’Dwyer P. A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161. Investigational New Drugs 2022, 40: 1306-1314. PMID: 36264382, PMCID: PMC9795724, DOI: 10.1007/s10637-022-01311-w.Peer-Reviewed Original ResearchConceptsPancreatic neuroendocrine tumorsNeuroendocrine tumorsTreatment-related grade 3 adverse eventsGrade 3 adverse eventsAdvanced pancreatic neuroendocrine tumorsTwo-stage phase II trialObjective tumor responsePhase II studyPhase II trialContinuous dosing scheduleStage 1Lack of responseEligible patientsMedian OSMedian PFSII trialAdverse eventsII studyObjective responseDosing schedulesTumor responseClinical activityPatientsMTOR pathwayMTORC1/2 inhibitorsPhase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer
Waks AG, Keenan TE, Li T, Tayob N, Wulf GM, Richardson ET, Attaya V, Anderson L, Mittendorf EA, Overmoyer B, Winer EP, Krop IE, Agudo J, Van Allen EM, Tolaney SM. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Journal For ImmunoTherapy Of Cancer 2022, 10: e005119. PMID: 36252998, PMCID: PMC9577940, DOI: 10.1136/jitc-2022-005119.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMetastatic breast cancerAdverse eventsBreast cancerT-DM1Immune biomarkersTrastuzumab emtansineHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerGrade 3 adverse eventsMedian progression-free survivalTreatment-related adverse eventsHuman epidermal growth factor receptor 2Cell death ligand 1HER2-positive breast cancerEpidermal growth factor receptor 2Dose-finding cohortPhase 2 dosePhase Ib studyPhase Ib trialAnti-HER2 therapyDose-limiting toxicityGrowth factor receptor 2Immune checkpoint blockadeA phase 1 study of the safety, pharmacokinetics and pharmacodynamics of escalating doses followed by dose expansion of the selective inhibitor of nuclear export (SINE) selinexor in Asian patients with advanced or metastatic malignancies
Ho J, Heong V, Yong W, Soo R, Chee C, Wong A, Sundar R, Thian Y, Gopinathan A, Pang M, Koe P, Jeraj S, Soe P, Soe M, Tang T, Ng M, Tai D, Tan T, Xu H, Chang H, Landesman Y, Shah J, Shacham S, Lee S, Tan D, Goh B, Tan D. A phase 1 study of the safety, pharmacokinetics and pharmacodynamics of escalating doses followed by dose expansion of the selective inhibitor of nuclear export (SINE) selinexor in Asian patients with advanced or metastatic malignancies. Therapeutic Advances In Medical Oncology 2022, 14: 17588359221087555. PMID: 35432603, PMCID: PMC9008867, DOI: 10.1177/17588359221087555.Peer-Reviewed Original ResearchPhase 1 studyAsian patientsMetastatic malignancyMedian t<sub>max</sub> wasGrade 3 adverse eventsNCI Common Terminology CriteriaRecommended phase 2 doseAsian patient cohortContinuous dosing regimensGrade 3 fatiguePhase 2 doseThymic carcinoma patientsDose-escalation designCommon Terminology CriteriaInhibitor of nuclear exportCytoplasmic localization of p27Dose expansionComplete responseHodgkin lymphomaExpansion cohortLymphoma patientsPartial responseDrug holidayEscalation designPharmacodynamic assessments
2021
Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial
Pusztai L, Yau C, Wolf DM, Han HS, Du L, Wallace AM, String-Reasor E, Boughey JC, Chien AJ, Elias AD, Beckwith H, Nanda R, Albain KS, Clark AS, Kemmer K, Kalinsky K, Isaacs C, Thomas A, Shatsky R, Helsten TL, Forero-Torres A, Liu MC, Brown-Swigart L, Petricoin EF, Wulfkuhle JD, Asare SM, Wilson A, Singhrao R, Sit L, Hirst GL, Berry S, Sanil A, Asare AL, Matthews JB, Perlmutter J, Melisko M, Rugo HS, Schwab RB, Symmans WF, Yee D, Van't Veer LJ, Hylton NM, DeMichele AM, Berry DA, Esserman LJ. Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial. Cancer Cell 2021, 39: 989-998.e5. PMID: 34143979, PMCID: PMC11064785, DOI: 10.1016/j.ccell.2021.05.009.Peer-Reviewed Original ResearchConceptsHER2-negative breast cancerTriple-negative breast cancerI-SPY2 trialBreast cancerNeoadjuvant chemotherapyStage II/III HER2-negative breast cancerStage II/III breast cancerGrade 3 adverse eventsPathologic complete response ratePD-L1 inhibitor durvalumabMast cell signaturePaclitaxel neoadjuvant chemotherapyComplete response rateHER2-negative patientsStandard neoadjuvant chemotherapyHER2-negative cancersPARP inhibitor olaparibAdverse eventsGene expression signaturesCare controlSuperior efficacyImmune responseResponse rateCancerInhibitor olaparibThe 30 ROC trial: Precision intra-treatment imaging guiding major radiation reduction in human papillomavirus related oropharyngeal cancer.
Lee N, Sherman E, Schöder H, McBride S, Yu Y, Kang J, Tsai C, Gelblum D, Boyle J, Singh B, Cohen M, Cracchiolo J, Ganly I, Dunn L, Kriplani A, Fetten J, Michel L, Wong R, Pfister D, Riaz N. The 30 ROC trial: Precision intra-treatment imaging guiding major radiation reduction in human papillomavirus related oropharyngeal cancer. Journal Of Clinical Oncology 2021, 39: 6019-6019. DOI: 10.1200/jco.2021.39.15_suppl.6019.Peer-Reviewed Original ResearchPositron emission tomographyGrade 1Locoregional controlNodal diseaseOropharyngeal carcinomaOPC patientsGrade 2Primary siteGrade 3 adverse eventsWeight lossDe-escalated patientsGross nodal diseaseRecurrent nodal diseaseResolution of hypoxiaSuccessful salvage surgeryExcellent locoregional controlOverall survival rateSpecific treatment responsesPatient-specific treatment responsesConcurrent chemotherapyDefinitive doseMucositis ratesAdditional therapySalvage surgeryAdverse events
2020
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer.
Klotz L, Pavlovich CP, Chin J, Hatiboglu G, Koch M, Penson D, Raman S, Oto A, Fütterer J, Serrallach M, Relle J, Lotan Y, Heidenreich A, Bonekamp D, Haider M, Tirkes T, Arora S, Macura KJ, Costa DN, Persigehl T, Pantuck AJ, Bomers J, Burtnyk M, Staruch R, Eggener S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer. Journal Of Urology 2020, 205: 769-779. PMID: 33021440, DOI: 10.1097/ju.0000000000001362.Peer-Reviewed Original ResearchConceptsGrade Group 2 diseaseProstate-specific antigen reductionGrade group 2Whole gland ablationTransurethral ultrasound ablationAntigen reductionMagnetic resonance imagingProstate cancerGroup 2Gland ablationMagnetic resonance imaging-guided transurethral ultrasound ablationGrade 3 adverse eventsResonance imagingTarget volumeEvidence of cancerUltrasound ablationIntermediate-risk diseaseRisk prostate cancerProspective multicenter trialMedian prostate volumeLocalized prostate cancerMedian treatment delivery timeTreatment delivery timeMagnetic resonancePrimary endpointSafety and tolerability of oxaliplatin based pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal carcinomatosis: A phase I dose-finding study in Asian patients.
Sundar R, Kim G, Tan H, Wang L, Chue K, Tai C, Teo S, Jang C, Chee C, Lieske B, Chee C, Shabbir A, So J, Yong W. Safety and tolerability of oxaliplatin based pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal carcinomatosis: A phase I dose-finding study in Asian patients. Journal Of Clinical Oncology 2020, 38: 360-360. DOI: 10.1200/jco.2020.38.4_suppl.360.Peer-Reviewed Original ResearchPressurized intraperitoneal aerosol chemotherapyPeritoneal carcinomatosis indexDose-limiting toxicityHyperthermic intraperitoneal chemotherapyPhase 1 studyDose cohortsAsian patientsDose-escalation phase 1 studyPIPAC administrationsGrade 3 adverse eventsMedian peritoneal carcinomatosis indexPeritoneal carcinomatosis index scoreRecommended phase 2 dosePressurized intraperitoneal aerosolized chemotherapy proceduresFailure of standard therapyPhase I dose-finding studyGastrointestinal primary tumorsHighest dose cohortPhase 2 doseDose-escalation studyIntraperitoneal chemotherapyPeritoneal carcinomatosisEscalation studyPeritoneal metastasisOxaliplatin chemotherapy
2019
Outcomes of multimodal therapy in a large series of patients with anaplastic thyroid cancer
Fan D, Ma J, Bell AC, Groen AH, Olsen KS, Lok BH, Leeman JE, Anderson E, Riaz N, McBride S, Ganly I, Shaha AR, Sherman EJ, Tsai CJ, Kang JJ, Lee NY. Outcomes of multimodal therapy in a large series of patients with anaplastic thyroid cancer. Cancer 2019, 126: 444-452. PMID: 31593317, PMCID: PMC7302673, DOI: 10.1002/cncr.32548.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapy, AdjuvantDose-Response Relationship, RadiationDoxorubicinFemaleFollow-Up StudiesHumansIndazolesMaleMiddle AgedPaclitaxelProgression-Free SurvivalPyrimidinesRadiotherapy DosageRadiotherapy, Intensity-ModulatedRetrospective StudiesSulfonamidesThyroid Carcinoma, AnaplasticThyroid GlandThyroid NeoplasmsThyroidectomyTumor BurdenConceptsLocoregional progression-free survivalRole of radiotherapyAnaplastic thyroid cancerTreatment of patientsOverall survivalAdverse eventsMetastatic diseaseTrimodal therapyThyroid cancerAcute grade 3 adverse eventsAdvanced anaplastic thyroid cancerGrade 3 adverse eventsPostoperative RTDistant metastasis-free survivalTrimodal treatment approachAcceptable toxicity profileProgression-free survivalLate adverse eventsLocal tumor controlMetastasis-free survivalLong-term outcomesLPFS ratesOS benefitConcurrent chemoradiationSystemic agentsSWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)
Aggarwal C, Redman MW, Lara PN, Borghaei H, Hoffman P, Bradley JD, Newman AJ, Feldman MJ, Minichiello K, Miao J, Mack PC, Papadimitrakopoulou VA, Herbst RS, Kelly K, Gandara DR. SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal Of Thoracic Oncology 2019, 14: 1847-1852. PMID: 31195180, PMCID: PMC6901020, DOI: 10.1016/j.jtho.2019.05.041.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBenzamidesBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPiperazinesPyrazolesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 3Salvage TherapySurvival RateConceptsProgression-free survivalFGFR3 S249CFGFR alterationsOverall survivalPartial responseFGFR1 amplificationLung-MAPGrade 3 adverse eventsMedian progression-free survivalPlatinum-based systemic therapySolid Tumors version 1.1Squamous cell lung cancerMedian age 66 yearsFibroblast growth factor receptor inhibitorGrowth factor receptor inhibitorsFirst phase II trialGrade 4 sepsisResponse-evaluable patientsSquamous cell NSCLCUnconfirmed partial responsePhase II studyAcceptable safety profilePhase II trialResponse Evaluation CriteriaAge 66 yearsSWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
Langer CJ, Redman MW, Wade JL, Aggarwal C, Bradley JD, Crawford J, Stella PJ, Knapp MH, Miao J, Minichiello K, Herbst RS, Kelly K, Gandara DR, Papadimitrakopoulou VA. SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study). Journal Of Thoracic Oncology 2019, 14: 1839-1846. PMID: 31158500, PMCID: PMC7017958, DOI: 10.1016/j.jtho.2019.05.029.Peer-Reviewed Original ResearchConceptsPrimary analysis populationProgression-free survivalPrimary endpointOverall survivalStage IV squamous cell lung cancerGrade 3 adverse eventsMedian progression-free survivalSolid Tumors version 1.1Squamous cell lung cancerTreatment-related deathsPhase II studyResponse Evaluation CriteriaSubset of patientsCell lung cancerDuration of responsePlatinum-based therapyInterim futility analysisPI3K inhibitorsEligible patientsEvaluable populationSquamous NSCLCSecondary endpointsAdverse eventsII studyMedian ageRibociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial
Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clinical Breast Cancer 2019, 19: 399-404. PMID: 31235441, DOI: 10.1016/j.clbc.2019.05.010.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerAdvanced HER2-positive breast cancerProgression-free survivalBreast cancerAdverse eventsObjective responseGrade 3 adverse eventsGrade 4/5 adverse eventsHormone receptor-positive diseaseMedian progression-free survivalAnti-HER2 combinationClinical benefit rateHER2-negative diseasePhase 1b/2 studyPhase 1b/2 trialPrior therapy linesReceptor-positive diseaseAnti-HER2 therapyNew safety concernsCyclin-dependent kinase 4Stable diseaseExpansion cohortMetastatic settingPrior linesQTc prolongationLentiglobin Gene Therapy in Patients with Sickle Cell Disease: Updated Interim Results from Hgb-206
Mapara M, Tisdale J, Kanter J, Kwiatkowski J, Krishnamurti L, Schmidt M, Miller A, Pierciey F, Shi W, Ribeil J, Asmal M, Thompson A, Walters M. Lentiglobin Gene Therapy in Patients with Sickle Cell Disease: Updated Interim Results from Hgb-206. Transplantation And Cellular Therapy 2019, 25: s64-s65. DOI: 10.1016/j.bbmt.2018.12.147.Peer-Reviewed Original ResearchSickle cell diseaseGrade 3 adverse eventsAdverse eventsHematopoietic stem cellsGrp BC patientsCell diseaseSevere sickle cell diseaseGene therapyNon-hematologic gradeVaso-occlusive painPhase 1 studyLentiviral vectorsAutologous hematopoietic stem cellsGrp CFebrile neutropeniaMyeloablative conditioningClinical effectsHb levelsLast visitBusulfan conditioningAutologous CD34Treatment characteristicsMethods AdultsPatients
2017
Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.
Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.Peer-Reviewed Original ResearchAdverse eventsTarget engagementPK dataCD4 T effector cellsGrade 3 adverse eventsGrade 1Inducible Co-StimulatorPhase 1 SafetyPrior systemic therapyAdvanced solid tumorsDose limiting toxicitiesT effector cellsPhase 1 studyHours post infusionAgonist monoclonal antibodyNon-tumor tissuesTriple-negative breastQuantitative systems pharmacology modelExposure increasesPreclinical potencyQ21 daysNeck painInfusion reactionsRegulatory cellsSystemic therapy
2016
Interim Results from a Phase 1/2 Clinical Study of Lentiglobin Gene Therapy for Severe Sickle Cell Disease
Kanter J, Walters M, Hsieh M, Krishnamurti L, Kwiatkowski J, Kamble R, von Kalle C, Kuypers F, Cavazzana M, Leboulch P, Joseney-Antoine M, Asmal M, Thompson A, Tisdale J. Interim Results from a Phase 1/2 Clinical Study of Lentiglobin Gene Therapy for Severe Sickle Cell Disease. Blood 2016, 128: 1176. DOI: 10.1182/blood.v128.22.1176.1176.Peer-Reviewed Original ResearchSevere sickle cell diseaseSevere SCDBone marrow harvestAdverse eventsSickle cell diseaseCell doseBluebird BioReplication-competent lentivirusHematopoietic stem cellsMyeloablative conditioningPeripheral bloodCell diseaseGrade 3 adverse eventsAdvisory CommitteeMedical directorsPhase 1/2 clinical studyTransfusion-dependent β-thalassemiaSerious adverse eventsLong-term complicationsVector copy numberStart of conditioningSymptoms 1 yearIntegration site analysisGene therapyDP infusion
2015
Phase II trial of dasatinib for recurrent or metastatic c-KIT expressing adenoid cystic carcinoma and for nonadenoid cystic malignant salivary tumors
Wong SJ, Karrison T, Hayes DN, Kies MS, Cullen KJ, Tanvetyanon T, Argiris A, Takebe N, Lim D, Saba NF, Worden FP, Gilbert J, Lenz HJ, Razak AR, Roberts JD, Vokes EE, Cohen EE. Phase II trial of dasatinib for recurrent or metastatic c-KIT expressing adenoid cystic carcinoma and for nonadenoid cystic malignant salivary tumors. Annals Of Oncology 2015, 27: 318-323. PMID: 26598548, PMCID: PMC4722891, DOI: 10.1093/annonc/mdv537.Peer-Reviewed Original ResearchConceptsMalignant salivary gland tumorsAdverse eventsStable diseaseObjective responseACC patientsCystic carcinomaECOG performance status 0Grade 3 adverse eventsMedian age 56 yearsGrade 4 adverse eventsMedian progression-free survivalFrequent adverse eventsMedian overall survivalNon-ACC patientsPerformance status 0Noncardiac chest painPhase II studyPhase II trialProgression-free survivalAge 56 yearsMalignant salivary tumorsAdenoid cystic carcinomaSalivary gland tumorsCycle 2Prior chemotherapyPreliminary Safety, Pharmacokinetics, and Efficacy of Regorafenib, Cisplatin, and Pemetrexed in Patients With Advanced Nonsquamous Non–Small-Cell Lung Cancers
Hellmann MD, Sturm I, Trnkova ZJ, Lettieri J, Diefenbach K, Rizvi NA, Gettinger SN. Preliminary Safety, Pharmacokinetics, and Efficacy of Regorafenib, Cisplatin, and Pemetrexed in Patients With Advanced Nonsquamous Non–Small-Cell Lung Cancers. Clinical Lung Cancer 2015, 16: 514-522. PMID: 26003007, PMCID: PMC4750397, DOI: 10.1016/j.cllc.2015.04.003.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungCisplatinContraindicationsDrug InteractionsFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingNeovascularization, PathologicPemetrexedPhenylurea CompoundsPyridinesSurvival AnalysisTreatment OutcomeConceptsEfficacy of regorafenibMedian progression-free survivalChemotherapy-naive patientsProgression-free survivalPhase I trialCell lung cancerLung cancerAcceptable tolerabilityPartial responsePotent antiangiogenic activityI trialStandard dosesPK interactionsAdvanced nonsquamous non-small cell lung cancerNonsquamous non-small cell lung cancerTreatment-related grade 3 adverse eventsNon-small cell lung cancerGrade 3 adverse eventsKinase inhibitorsAntiangiogenic activityMinor pharmacokinetic interactionCombination of bevacizumabAdvanced colorectal cancerGastrointestinal stromal tumorsAdverse eventsPhase II trial of abiraterone acetate (AA) treatment for metastatic prostate cancer (PC) patients with a PSA of more than four following initial androgen deprivation therapy: SWOG S1014.
Flaig T, Tangen C, Hussain M, Agarwal N, Mitsiades N, Deshpande H, Vaishampayan U, Thompson I. Phase II trial of abiraterone acetate (AA) treatment for metastatic prostate cancer (PC) patients with a PSA of more than four following initial androgen deprivation therapy: SWOG S1014. Journal Of Clinical Oncology 2015, 33: 152-152. DOI: 10.1200/jco.2015.33.7_suppl.152.Peer-Reviewed Original ResearchAndrogen deprivation therapyProgression-free survivalMonths of ADTInitial androgen deprivation therapyTime of enrollmentDeprivation therapyPSA responsePoor prognosisGrade 3 adverse eventsMedian progression-free survivalMetastatic prostate cancer patientsAbiraterone acetate treatmentMetastatic PC patientsSecondary hormonal therapySubsequent median survivalPhase II trialProstate cancer patientsEligible patientsUndetectable PSAALT elevationEfficacy of AAHormonal therapyII trialPrimary endpointRectal bleeding
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply