2020
P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for adult and pediatric male and female patients with intermediate and poor-risk metastatic germ cell tumors (GCTs).
Subramaniam S, Toner G, Stockler M, Martin A, Pashankar F, Frazier A, Mazhar D, Ford K, Walpole E, Stevanovic A, Wyld D, Troon S, Hanning F, Birtle A, Wheater M, Huddart R, White J, Spunt S, Grimison P. P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for adult and pediatric male and female patients with intermediate and poor-risk metastatic germ cell tumors (GCTs). Journal Of Clinical Oncology 2020, 38: tps425-tps425. DOI: 10.1200/jco.2020.38.6_suppl.tps425.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression-free survivalPoor-risk metastatic germ cell tumoursStandard BEPLine chemotherapyInternational randomized phase III trialExtracranial germ cell tumorsRandomized phase III trialCisplatin 20mg/Standard BEP chemotherapyFavorable response ratePhase 3 trialPhase III trialsD1-5Age group malesArchival tumor tissueFormal interim analysisShorter cycle lengthsTranslational substudyBEP chemotherapyOpen labelPrimary endpointStandard regimenBaseline blood
2018
P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumors (GCTs).
Nayar N, Lawrence N, Stockler M, Martin A, Yip S, Wong N, Yeung A, Friedlander M, Mazhar D, Pashankar F, Quinn D, McDermott R, Walker R, Winstanley M, Hanning F, Weickhardt A, Stevanovic A, Davis I, Toner G, Grimison P. P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumors (GCTs). Journal Of Clinical Oncology 2018, 36: tps574-tps574. DOI: 10.1200/jco.2018.36.6_suppl.tps574.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression-free survivalPoor-risk metastatic germ cell tumoursPhase 3 trialResponse rateLine chemotherapyStandard BEPExtracranial germ cell tumorsRandomized phase 3 trialCisplatin 20mg/Complete response rateStandard BEP chemotherapyAge group malesArchival tumor tissuePEG-G-CSFShorter cycle lengthsTranslational substudyBEP chemotherapyOpen labelPrimary endpointStandard regimenBaseline bloodFree survivalWeekly doses
2016
Paediatric extracranial germ-cell tumours
Shaikh F, Murray MJ, Amatruda JF, Coleman N, Nicholson JC, Hale JP, Pashankar F, Stoneham SJ, Poynter JN, Olson TA, Billmire DF, Stark D, Rodriguez-Galindo C, Frazier AL. Paediatric extracranial germ-cell tumours. The Lancet Oncology 2016, 17: e149-e162. PMID: 27300675, DOI: 10.1016/s1470-2045(15)00545-8.Peer-Reviewed Original ResearchConceptsGerm cell tumorsPediatric extracranial germ cell tumorExtracranial germ cell tumorsPediatric germ cell tumorsSignificant long-term toxicityPoor-risk patientsLow-risk patientsPlatinum-resistant diseaseGroup of patientsHigh tumor markersEvidence-based careRisk stratification systemLong-term toxicityCooperative Research GroupExtragonadal tumorsRisk stratificationFuture trialsClinical behaviorPatient outcomesClinical dataAdult diseaseWide age rangeTumor markersTreatment approachesPatients
2015
Pediatric and Adolescent Extracranial Germ Cell Tumors: The Road to Collaboration
Olson TA, Murray MJ, Rodriguez-Galindo C, Nicholson JC, Billmire DF, Krailo MD, Dang HM, Amatruda JF, Thornton CM, Arul GS, Stoneham SJ, Pashankar F, Stark D, Shaikh F, Gershenson DM, Covens A, Hurteau J, Stenning SP, Feldman DR, Grimison PS, Huddart RA, Sweeney C, Powles T, Lopes LF, dos Santos Agular S, Chinnaswamy G, Khaleel S, Abouelnaga S, Hale JP, Frazier AL. Pediatric and Adolescent Extracranial Germ Cell Tumors: The Road to Collaboration. Journal Of Clinical Oncology 2015, 33: 3018-3028. PMID: 26304902, PMCID: PMC4979195, DOI: 10.1200/jco.2014.60.5337.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAge of OnsetChildCooperative BehaviorDiffusion of InnovationFemaleHistory, 20th CenturyHistory, 21st CenturyHumansInterdisciplinary CommunicationInternational CooperationMaleMedical OncologyNeoplasms, Germ Cell and EmbryonalPediatricsSurvivorsTime FactorsTreatment OutcomeYoung AdultConceptsGerm cell tumorsPrimary tumor siteCell tumorsExtracranial malignant germ cell tumorsExtracranial germ cell tumorsTumor siteMalignant germ cell tumorsSignificant long-term morbidityDifferent risk stratificationLong-term morbidityPlatinum-based chemotherapyPediatric cancer patientsTreatment-related effectsDifferent cooperative groupsCisplatin dosingVariety of specialistsMedical oncologistsGynecologic oncologistsRisk stratificationTherapeutic dilemmaHistologic featuresPediatric oncologistsExcellent outcomesStaging systemCancer patients
2014
Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States
Frazier AL, Hale JP, Rodriguez-Galindo C, Dang H, Olson T, Murray MJ, Amatruda JF, Thornton C, Arul GS, Billmire D, Shaikh F, Pashankar F, Stoneham S, Krailo M, Nicholson JC. Revised Risk Classification for Pediatric Extracranial Germ Cell Tumors Based on 25 Years of Clinical Trial Data From the United Kingdom and United States. Journal Of Clinical Oncology 2014, 33: 195-201. PMID: 25452439, PMCID: PMC4279239, DOI: 10.1200/jco.2014.58.3369.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAge FactorsAlpha-FetoproteinsBiomarkers, TumorChildChild, PreschoolClinical Trials as TopicDisease-Free SurvivalEndodermal Sinus TumorEvidence-Based MedicineFemaleHumansMaleModels, StatisticalNeoplasm StagingNeoplasms, Germ Cell and EmbryonalPredictive Value of TestsPrognosisRetrospective StudiesRisk AssessmentRisk FactorsUnited KingdomUnited StatesConceptsGerm cell tumorsYolk sac tumorPediatric germ cell tumorsClinical trial dataAlpha-fetoproteinTumor siteOncology GroupCell tumorsMalignant pediatric germ cell tumorsPediatric extracranial germ cell tumorLong-term disease-free survivalEvidence-based risk stratificationExtracranial germ cell tumorsTrial dataPure yolk sac tumorPoor-risk groupStage IV diseaseDisease-free survivalPercentage of patientsChildren's Oncology GroupElevated alpha-fetoproteinPlatinum-based therapyClinical trial organizationsParametric cure modelsLeukemia group