2024
P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for individuals aged 11-45 years with intermediate and poor-risk metastatic germ cell tumours (GCTs).
Mak B, Tran B, Pashankar F, Mazhar D, Huddart R, Wheater M, Walpole E, Feldman D, Dunwoodie E, Lawrence N, Birtle A, Wyld D, Stevanovic A, Balagtas J, Stockler M, Davis I. P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for individuals aged 11-45 years with intermediate and poor-risk metastatic germ cell tumours (GCTs). Journal Of Clinical Oncology 2024, 42: tps524-tps524. DOI: 10.1200/jco.2024.42.4_suppl.tps524.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsPhase 3 trialTwo-sided type I error rateRandomized trials of chemotherapyRandomized phase 3 trialResponse rateProgression free survivalFirst-line chemotherapyStandard chemotherapy regimensFavorable response rateImprove cure ratesTrials of chemotherapyBaseline blood samplesPost-chemotherapy treatmentStage 1BEP chemotherapyStandard BEPTranslational substudyFree survivalChemotherapy regimensOpen-labelStage 2Primary endpointCell tumors
2023
P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs).
Zebic D, Stockler M, Martin A, Pashankar F, Tran B, Mazhar D, Huddart R, Wheater M, Walpole E, Dunwoodie E, Feldman D, Birtle A, Stevanovic A, Wyld D, Hanning F, Grimison P, Group A. P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs). Journal Of Clinical Oncology 2023, 41: tps431-tps431. DOI: 10.1200/jco.2023.41.6_suppl.tps431.Peer-Reviewed Original ResearchPoor-risk metastatic germ cell tumoursMetastatic germ cell tumorsGerm cell tumorsPhase 3 trialStandard BEPComplete responseStage ITwo-sided type IRandomized phase 3 trialCisplatin 20mg/Standard BEP chemotherapyBaseline blood samplesProgression-free survivalTrial of chemotherapyImproved cure ratesD1-5Post-chemotherapy treatmentTranslational substudyBEP chemotherapyLine chemotherapyOpen labelPrimary endpointStandard regimensFree survivalCR rate
2021
P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs).
Subramaniam S, Toner G, Stockler M, Martin A, Pashankar F, Tran B, Jeffery M, Mazhar D, Huddart R, Walpole E, Stevanovic A, Wyld D, Hanning F, Wheater M, Balagtas J, Troon S, Birtle A, White J, Grimison P. P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs). Journal Of Clinical Oncology 2021, 39: tps390-tps390. DOI: 10.1200/jco.2021.39.6_suppl.tps390.Peer-Reviewed Original ResearchMetastatic germ cell tumorsPoor-risk metastatic germ cell tumoursGerm cell tumorsStandard BEPComplete responseStage IInternational randomized phase III trialRandomized phase III trialStandard first-line chemotherapyCisplatin 20mg/Standard BEP chemotherapyBaseline blood samplesFirst-line chemotherapyPhase III trialsProgression-free survivalTrial of chemotherapyD1-5Post-chemotherapy treatmentClinical trial informationTranslational substudyBEP chemotherapyOpen labelPrimary endpointStandard regimensFree survival
2020
Outcomes of adolescent males with extracranial metastatic germ cell tumors: A report from the Malignant Germ Cell Tumor International Consortium
Shaikh F, Stark D, Fonseca A, Dang H, Xia C, Krailo M, Pashankar F, Rodriguez‐Galindo C, Olson TA, Nicholson JC, Murray MJ, Amatruda JF, Billmire D, Stoneham S, Frazier AL. Outcomes of adolescent males with extracranial metastatic germ cell tumors: A report from the Malignant Germ Cell Tumor International Consortium. Cancer 2020, 127: 193-202. PMID: 33079404, DOI: 10.1002/cncr.33273.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolHumansInfantInfant, NewbornLymphatic MetastasisMaleMediastinal NeoplasmsNeoplasms, Germ Cell and EmbryonalProgression-Free SurvivalRetroperitoneal NeoplasmsRetrospective StudiesTesticular NeoplasmsYoung AdultConceptsMetastatic germ cell tumorsEvent-free survivalGerm cell tumorsCell tumorsRisk groupsYoung adultsAge groupsMale patientsAdolescent patientsAdolescent malesCox proportional hazards analysisMalignant germ cell tumorsIndividual patient databasePlatinum-based chemotherapyProportional hazards analysisYoung adult patientsClinical trial organizationsAdolescent age groupPediatric cooperative groupsTreatment of adolescentsDifferent age groupsAdult patientsClinical characteristicsEFS rateInclusion criteriaP3BEP (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
2019
GCT-10 Outcomes of adolescent males with extracranial metastatic germ cell tumours compared with children and young adults: A report from the Malignant Germ Cell Tumour International Consortium (MaGIC) group
Shaikh F, Stark D, Dang H, Xia C, Krailo M, Stenning S, Pashankar F, Rodriguez-Galindo C, Olson T, Depani S, Stoneham S, Nicholson J, Murray M, Amatruda J, Billmire D, Fonseca A, Frazier A. GCT-10 Outcomes of adolescent males with extracranial metastatic germ cell tumours compared with children and young adults: A report from the Malignant Germ Cell Tumour International Consortium (MaGIC) group. European Urology Open Science 2019, 18: 9. DOI: 10.1016/s1569-9056(19)32477-7.Peer-Reviewed Original Research
2018
Protocol for the P3BEP trial (ANZUP 1302): an international randomised 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 tumours
Lawrence NJ, Chan H, Toner G, Stockler MR, Martin A, Yip S, Wong N, Yeung A, Mazhar D, Pashankar F, Frazier L, McDermott R, Walker R, Tan H, Davis ID, Grimison P, on behalf of ANZUP. Protocol for the P3BEP trial (ANZUP 1302): an international randomised 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 tumours. BMC Cancer 2018, 18: 854. PMID: 30157803, PMCID: PMC6114870, DOI: 10.1186/s12885-018-4745-3.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBleomycinChildChild, PreschoolCisplatinClinical ProtocolsClinical Trials, Phase III as TopicEtoposideFemaleHumansInfantInfant, NewbornMaleMulticenter Studies as TopicNeoplasms, Germ Cell and EmbryonalRandomized Controlled Trials as TopicResearch DesignYoung AdultConceptsPoor-risk metastatic germ cell tumoursMetastatic germ cell tumorsGerm cell tumorsStandard BEP chemotherapyFirst-line chemotherapyCell tumorsLine chemotherapyBEP chemotherapyCure rateClinical trialsPoor-risk germ cell tumorsMulticentre phase 2 trialRandomised phase 3 trialStandard first-line treatmentPhase 3 clinical trialsComplete response rateFirst-line treatmentPhase 2 trialPhase 3 trialProgression-free survivalHealth-related qualityPediatric age groupFemale participantsInternational multicentreStandard BEPP3BEP (ANZUP 1302): An international randomised 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 tumours (GCTs).
Grimison P, 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. P3BEP (ANZUP 1302): An international randomised 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 tumours (GCTs). Journal Of Clinical Oncology 2018, 36: tps4596-tps4596. DOI: 10.1200/jco.2018.36.15_suppl.tps4596.Peer-Reviewed Original ResearchP3BEP (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
2017
P3BEP (ANZUP 1302): An international randomised 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 tumours (GCTs).
Grimison P, Lawrence N, Stockler M, Martin A, Yip S, Wong N, Yeung A, Friedlander M, Mazhar D, Pashankar F, Quinn D, Walker R, Winstanley M, Hanning F, Weickhardt A, Stevanovic A, Davis I, Toner G. P3BEP (ANZUP 1302): An international randomised 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 tumours (GCTs). Journal Of Clinical Oncology 2017, 35: tps4592-tps4592. DOI: 10.1200/jco.2017.35.15_suppl.tps4592.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression-free survivalPoor-risk metastatic germ cell tumoursPhase 3 trialResponse rateStandard BEPLine chemotherapyCancer AustraliaDay 1Randomised phase 3 trialStandard BEP chemotherapyComplete response ratePediatric age groupArchival tumor tissueCancer Council AustraliaTranslational substudyBaseline bloodBEP chemotherapyFree survivalPrimary endpointWeekly dosesFemale patientsCure rateCell tumors