2025
The MATRiX trial: A multicenter, randomized, phase II study of ATR inhibition (via tuvusertib) with or without avelumab in patients with advanced anti-PD-(L)1–refractory Merkel cell carcinoma.
Bhakuni R, Hall E, Ansstas G, Bhatia S, Brohl A, Burgess M, Dimitrova M, Gao L, Ishizuka J, Lipson E, Lutzky J, Silk A, Yun J, Brownell I, Murray J, Mowery Y, Gooley T, Gore S, Topalian S, Nghiem P. The MATRiX trial: A multicenter, randomized, phase II study of ATR inhibition (via tuvusertib) with or without avelumab in patients with advanced anti-PD-(L)1–refractory Merkel cell carcinoma. Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps9598.Peer-Reviewed Original ResearchMerkel cell carcinomaProgression-free survivalCell carcinomaProgressive diseaseATR inhibitionDay 1PD-1 pathway inhibitorsRare neuroendocrine skin cancerRecommended phase II doseAnti-tumor immune responseTreatment-emergent adverse eventsKi-67 proliferative indexPD-(L)1 blockadePhase II doseResponse Evaluation CriteriaPhase II studySolid tumor immunotherapyInduce tumor regressionNeuroendocrine skin cancerPhase I trialLog-rank testMerkel cell polyomavirusHigh response rateCell cycle checkpoint regulationII doseSafety and efficacy of immune checkpoint therapy for the treatment of patients with cardiac metastasis: a multicenter international retrospective study
Nassar A, Alaiwi S, Zarif T, Denu R, Macaron W, Abdel-Wahab N, Freeman D, Vasbinder A, Hayeck S, Anderson E, Goodman R, Johnson D, Grynberg S, Shapira R, Kwan J, Woodford R, Long G, Haykal T, Dent S, Kojima Y, Yonemor K, Tandon A, Trevino A, Akhter N, Yang E, Hui G, Drakaki A, El-Am E, Kozaily E, Al-Hader A, Farhat E, Babu P, Mittra A, Li M, Jones N, Baena J, Herrera M, Foderaro S, Nana F, Kim C, Sackstein P, Parikh K, Desai A, Smith C, Cortellini A, Pinato D, Korolewicz J, Lopetegui-Lia N, Funchain P, Choudhary A, Asnani A, Navani V, Meyers D, Stukalin I, Gallegos J, Trent J, Nusrat S, Malvar C, McKay R, Neilan T, Choueiri T, Naqash A. Safety and efficacy of immune checkpoint therapy for the treatment of patients with cardiac metastasis: a multicenter international retrospective study. Journal For ImmunoTherapy Of Cancer 2025, 13: e009364. PMID: 40032601, PMCID: PMC11877189, DOI: 10.1136/jitc-2024-009364.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitor initiationImmune checkpoint inhibitorsTreatment-related adverse eventsObjective response rateProgression-free survivalCardiac metastasisOverall survivalRetrospective studyAnti-cytotoxic T-lymphocyte antigen 4Dose of immune checkpoint inhibitorsEfficacy of immune checkpoint therapyAnti-programmed death-1International multicenter retrospective studyMulticenter international retrospective studyT-lymphocyte antigen-4Non-small cell lung cancerMedian follow-up timeClinical outcomes of patientsICI-based regimensMultiple cardiac metastasesSolid Tumors V.1.1Immune checkpoint therapyResponse Evaluation CriteriaInternational retrospective studyMulticenter retrospective studyTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-upPhase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03
Dowlati A, Chiang A, Cervantes A, Babu S, Hamilton E, Wong S, Tazbirkova A, Sullivan I, van Marcke C, Italiano A, Patel J, Mekan S, Wu T, Waqar S. Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. Journal Of Thoracic Oncology 2025, 20: 799-808. PMID: 39755168, DOI: 10.1016/j.jtho.2024.12.028.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsInvestigator-assessed objective response rateExtensive-stage SCLCObjective response rateProgression-free survivalPlatinum-sensitive diseaseSecond-line treatmentSacituzumab govitecanOverall survivalTreatment-related treatment-emergent adverse eventsExtensive-stage small cell lung cancerBlinded independent central review assessmentPhase 2 open-label studySmall cell lung cancerPlatinum-resistant diseaseSolid Tumors versionResponse Evaluation CriteriaPlatinum-based chemotherapySecond-line therapyCell lung cancerStudy of solid tumorsPartial responsePlatinum-sensitiveNeutropenic sepsisSecond-line
2024
Deep learning for oncologic treatment outcomes and endpoints evaluation from CT scans in liver cancer
Xia Y, Zhou J, Xun X, Johnston L, Wei T, Gao R, Zhang Y, Reddy B, Liu C, Kim G, Zhang J, Zhao S, Yu Z. Deep learning for oncologic treatment outcomes and endpoints evaluation from CT scans in liver cancer. Npj Precision Oncology 2024, 8: 263. PMID: 39551847, PMCID: PMC11570623, DOI: 10.1038/s41698-024-00754-z.Peer-Reviewed Original ResearchProgression-free survivalCT scanLiver cancerAccurate treatment response assessmentResponse evaluationMetastatic organ sitesOncological treatment outcomesResponse Evaluation CriteriaLow-risk patientsTreatment response assessmentTreatment response evaluationTreatment response classificationAdvanced liver cancerStratify high-riskMultifocal hepatic lesionsTreatment outcome assessmentEvaluation of responseOverall survivalEvaluation CriteriaInternal five-fold cross-validationOncology clinical trialsResponse assessmentSolid tumorsClinical trialsTreatment outcomesImpact of Prior Chemotherapy on Response to Second-line Pembrolizumab in Urothelial Cancer: Exploratory Analysis of the Phase 3 KEYNOTE-045 Trial
de Wit R, Vaughn D, Fradet Y, Fong L, Climent M, Necchi A, Petrylak D, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Bajorin D, Choueiri T, Xu J, Imai K, Homet Moreno B, Bellmunt J, Lee J. Impact of Prior Chemotherapy on Response to Second-line Pembrolizumab in Urothelial Cancer: Exploratory Analysis of the Phase 3 KEYNOTE-045 Trial. European Urology 2024 PMID: 39174409, DOI: 10.1016/j.eururo.2024.07.015.Peer-Reviewed Original ResearchPlatinum-based chemotherapyDuration of responseFirst-line platinum-based chemotherapySecond-line pembrolizumabUrothelial carcinomaProgressive diseaseOverall survivalResponse to first-line platinum-based chemotherapyMedian duration of responsePlatinum-based combination chemotherapyStandard first-line treatmentStandard-of-care treatmentAdvanced urothelial carcinomaAvelumab maintenance therapyResponse to pembrolizumabSolid Tumors versionResponse Evaluation CriteriaEfficacy of pembrolizumabSecond-line treatmentFirst-line treatmentPost hoc analysisAdvanced UCMedian OSPembrolizumab monotherapyPrior chemotherapyPhase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design
Groarke J, Crawford J, Collins S, Lubaczewski S, Breen D, Harrington M, Jacobs I, Qiu R, Revkin J, Rossulek M, Saxena A. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design. Journal Of Cachexia Sarcopenia And Muscle 2024, 15: 1054-1061. PMID: 38500292, PMCID: PMC11154777, DOI: 10.1002/jcsm.13435.Peer-Reviewed Original ResearchPhysical activityPhysical functionPhase 2 studyCancer cachexiaGDF-15 concentrationsGDF-15Unintentional loss of weightLumbar skeletal muscle indexQuality of lifeSkeletal muscle indexBiomarker of cancer cachexiaNon-small-cell lungIncidence of adverse eventsResponse Evaluation CriteriaGrowth differentiation factor 15Safety laboratory testsOpen-label treatmentPlacebo-controlled studyCharacteristics of cachexiaCancer-related cachexiaMetabolic wasting syndromeHuman monoclonal antibodyCancer-relatedDifferentiation factor 15Phase 1 dataFirst-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial
Ren S, Wang X, Han B, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial. Journal For ImmunoTherapy Of Cancer 2024, 12: e007227. PMID: 38388167, PMCID: PMC10882294, DOI: 10.1136/jitc-2023-007227.Peer-Reviewed Original ResearchConceptsMetastatic NSCLC patientsDisease control rateProgression-free survivalFirst-line treatmentNSCLC patientsOS ratesPD-L1Overall survivalOpen-labelSafety profileTreatment-related adverse events of grade 3Adverse events of grade 3Combination of immune-checkpoint inhibitorsEvents of grade 3Median progression-free survivalPhase 2 basket trialProgrammed death-ligand 1Treatment-related adverse eventsGrade 5 hemoptysisImmune-checkpoint inhibitorsPD-L1 TPSSafety of camrelizumabSolid Tumors V.1.1Death-ligand 1Response Evaluation CriteriaClinical Outcomes Among Immunotherapy-Treated Patients With Primary Cardiac Soft Tissue Sarcomas A Multicenter Retrospective Study
Nassar A, El-Am E, Denu R, Alaiwi S, Zarif T, Macaron W, Abdel-Wahab N, Desai A, Smith C, Parikh K, Abbasi M, Farhat E, Williams J, Collins J, Al-Hader A, McKay R, Malvar C, Sabra M, Zhong C, Alam R, Chehab O, Lima J, Phan M, Pria H, Trevino A, Neilan T, Kwan J, Ravi V, Deshpande H, Demetri G, Choueiri T, Naqash A. Clinical Outcomes Among Immunotherapy-Treated Patients With Primary Cardiac Soft Tissue Sarcomas A Multicenter Retrospective Study. JACC CardioOncology 2024, 6: 71-79. PMID: 38510282, PMCID: PMC10950431, DOI: 10.1016/j.jaccao.2023.11.007.Peer-Reviewed Original ResearchMedian progression-free survivalProgression-free survivalImmune checkpoint inhibitorsSoft tissue sarcomasOverall survivalMedian OSTissue sarcomasClinical outcomesCommon Terminology Criteria for Adverse Events versionTreatment-related adverse eventsClinical outcomes of patientsMulti-institutional cohort studyResponse rateICI-based regimensObjective response rateSolid Tumors versionAdverse Events versionLocally advanced diseaseResponse Evaluation CriteriaImmunotherapy-treated patientsSecond-line therapyEstimate overall survivalFirst-line therapyMulticenter retrospective studyKaplan-Meier method
2023
Atezolizumab for Advanced Alveolar Soft Part Sarcoma
Chen A, Sharon E, O'Sullivan-Coyne G, Moore N, Foster J, Hu J, Van Tine B, Conley A, Read W, Riedel R, Burgess M, Glod J, Davis E, Merriam P, Naqash A, Fino K, Miller B, Wilsker D, Begum A, Ferry-Galow K, Deshpande H, Schwartz G, Ladle B, Okuno S, Beck J, Chen J, Takebe N, Fogli L, Rosenberger C, Parchment R, Doroshow J. Atezolizumab for Advanced Alveolar Soft Part Sarcoma. New England Journal Of Medicine 2023, 389: 911-921. PMID: 37672694, PMCID: PMC10729808, DOI: 10.1056/nejmoa2303383.Peer-Reviewed Original ResearchConceptsAdvanced alveolar soft part sarcomaAlveolar soft part sarcomaProgression-free survivalSoft part sarcomaObjective responsePart sarcomaMedian progression-free survivalTreatment-related grade 4Rare soft tissue sarcomaData cutoff dateImmune checkpoint inhibitorsPhase 2 studyResponse Evaluation CriteriaThird of patientsDuration of responseSoft tissue sarcomasYears of treatmentCheckpoint inhibitorsAdverse eventsMedian durationPartial responseComplete responseDeath-1PD-L1Pediatric patientsA pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial
Malarkey M, Toscano A, Bagheri M, Solomon J, Machado L, LoRusso P, Chen A, Folio L, Goncalves P. A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial. Heliyon 2023, 9: e18680. PMID: 37593628, PMCID: PMC10428039, DOI: 10.1016/j.heliyon.2023.e18680.Peer-Reviewed Original ResearchACC patientsClinical trialsTarget lesionsSolid tumorsPhase II clinical trialPilot studyPhase 2 trialResponse Evaluation CriteriaSalivary gland cancerRare salivary gland cancerSystemic therapy efficacyStable diseaseGland cancerLung lesionsComputed tomography (CT) examsCystic carcinomaTherapy responseBlinded observersTomography examsTherapy efficacyLesionsInter-observer variationPatientsAppropriate evaluationTrialsBiomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Finocchiaro G, Ahn M, Luft A, Landers G, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst R. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. Nature Medicine 2023, 29: 1718-1727. PMID: 37429923, DOI: 10.1038/s41591-023-02385-6.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerObjective response rateAdvanced non-small cell lung cancerCell lung cancerSafety profileCombination therapyLung cancerInvestigator-assessed objective response rateRandomized phase 2 studySolid Tumors version 1.1T-cell-inflamed gene expression profileGroup IIIBiomarker-defined subgroupsFirst-line pembrolizumabPhase 2 studyProgression-free survivalResponse Evaluation CriteriaSubset of patientsHeterogenous tumor microenvironmentData cutoffOverall survivalSecondary outcomesPrimary outcomeTreatment armsTMB assessmentBrief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1–Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial
Garon E, Spira A, Goldberg S, Chaft J, Papadimitrakopoulou V, Cascone T, Antonia S, Brahmer J, Camidge D, Powderly J, Wozniak A, Felip E, Wu S, Ascierto M, Elgeioushi N, Awad M. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1–Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial. Journal Of Thoracic Oncology 2023, 18: 1094-1102. PMID: 37146752, DOI: 10.1016/j.jtho.2023.04.020.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerObjective response rateAdvanced non-small cell lung cancerTreatment-related adverse eventsBlinded independent central reviewIndependent central reviewRECIST v1.1Refractory patientsAdverse eventsCentral reviewRefractory non-small cell lung cancerCommon treatment-related adverse eventsSolid Tumors version 1.1Cell death protein 1End pointPhase 1b clinical trialEfficacy of durvalumabPhase 1b studyManageable safety profilePrimary end pointSecondary end pointsProgression-free survivalResponse Evaluation CriteriaMonths of treatmentDeath protein 1A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies
Chee C, Ooi M, Lee S, Sundar R, Heong V, Yong W, Ng C, Wong A, Lim J, Tan D, Soo R, Tan J, Yang S, Thura M, Al-Aidaroos A, Chng W, Zeng Q, Goh B. A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies. Targeted Oncology 2023, 18: 391-402. PMID: 37060431, PMCID: PMC10192144, DOI: 10.1007/s11523-023-00962-w.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaAdvanced solid tumorsFirst-in-human studyEuropean Leukemia NetworkSolid tumorsHematologic malignanciesTreatment-emergent adverse eventsHuman antibodiesDose-escalation cohortsDose-limiting toxicityGrade 2 vomitingPRL-3Refractory solid tumorsResponse Evaluation CriteriaSolid tumor patientsDose-expansion cohortReduced tumor growthFirst-in-humanPhase IStable diseaseStoma outputEvaluation CriteriaMyeloid leukemiaPharmacodynamic relationshipsAdverse eventsTrial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations.
Tolcher A, Park W, Wang J, Spira A, Janne P, Lee H, Gill S, LoRusso P, Herzberg B, Goldman J, Morgensztern D, Berlin J, Kasi A, Fujii H, Pelster M. Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations. Journal Of Clinical Oncology 2023, 41: tps764-tps764. DOI: 10.1200/jco.2023.41.4_suppl.tps764.Peer-Reviewed Original ResearchKRAS G12DAdverse eventsLung cancerKRAS G12D mutationCancer cellsEastern Cooperative Oncology Group performance statusSolid tumorsNon-small cell lung cancerMetastatic solid tumor malignanciesSolid Tumors version 1.1Dose-escalation cohortsDose-expansion studyPhase 2 doseDisease control rateObjective response rateSerious adverse eventsAdvanced solid tumorsResponse Evaluation CriteriaDose-limiting toxicityPancreatic ductal cancerPhase 1 studyCell lung cancerDuration of responseSolid tumor malignanciesG12D mutation
2022
Response assessment methods for patients with hepatic metastasis from rare tumor primaries undergoing transarterial chemoembolization
Adam LC, Savic LJ, Chapiro J, Letzen B, Lin M, Georgiades C, Hong KK, Nezami N. Response assessment methods for patients with hepatic metastasis from rare tumor primaries undergoing transarterial chemoembolization. Clinical Imaging 2022, 89: 112-119. PMID: 35777239, PMCID: PMC9470015, DOI: 10.1016/j.clinimag.2022.06.013.Peer-Reviewed Original ResearchConceptsConventional transarterial chemoembolizationLipiodol depositionHepatic metastasesResponse assessment methodsPartial responseTransarterial chemoembolizationResponse assessmentTumor primaryStratification of responseRare primary tumorResponse Evaluation CriteriaRetrospective bicentric studyAssessment of responseQuantitative European AssociationLiver metastasesMajor complicationsBicentric studyPrimary tumorRare tumorEarly surrogateTreatment responseCT scanPatientsRECISTSolid tumorsSelective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial
Chan S, Chotipanich C, Choo S, Kwang S, Mo F, Worakitsitisatorn A, Tai D, Sundar R, Ng D, Loke K, Li L, Ng K, Peng Y, Yu S. Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial. Liver Cancer 2022, 11: 451-459. PMID: 36158588, PMCID: PMC9485918, DOI: 10.1159/000525489.Peer-Reviewed Original ResearchUnresectable intrahepatic cholangiocarcinomaProgression-free survivalSelective internal radiation therapyInternal radiation therapyIntrahepatic cholangiocarcinomaMedian OSRadiation therapyOverall survivalClinical trialsMedian cycle of chemotherapyMedian progression-free survivalResin yttrium-90 microspheresYttrium-90 resin microspheresTreatment-related adverse eventsIntent-to-treat populationResponse rateDisease control rateResponse Evaluation CriteriaYttrium-90 microspheresCycles of chemotherapyWithdrawal of consentMulticenter clinical trialInvestigator-initiated clinical trialStandard gemcitabineStandard chemotherapyImaging Response to Contemporary Immuno-oncology Combination Therapies in Patients With Metastatic Renal Cell Carcinoma
Navani V, Ernst M, Wells J, Yuasa T, Takemura K, Donskov F, Basappa N, Schmidt A, Pal S, Meza L, Wood L, Ernst D, Szabados B, Powles T, McKay R, Weickhardt A, Suarez C, Kapoor A, Lee J, Choueiri T, Heng D. Imaging Response to Contemporary Immuno-oncology Combination Therapies in Patients With Metastatic Renal Cell Carcinoma. JAMA Network Open 2022, 5: e2216379. PMID: 35687336, PMCID: PMC9187954, DOI: 10.1001/jamanetworkopen.2022.16379.Peer-Reviewed Original ResearchConceptsInternational Metastatic Renal Cell Carcinoma Database ConsortiumMetastatic renal cell carcinomaIO combination therapyInternational Metastatic Renal Cell Carcinoma Database Consortium riskPresence of lung metastasesCombination therapyCytoreductive nephrectomyComplete responseStable diseasePartial responseOverall survivalLung metastasesProgressive diseaseImmuno-oncologyImaging responseDiagnosis of metastatic renal cell carcinomaVascular endothelial growth factor inhibitorsIncreased likelihood of responseMedian overall survivalResponse Evaluation CriteriaGrowth factor inhibitorsMulticenter international cohort studyRenal cell carcinomaLikelihood of responseInternational cohort studyRandomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. CardioVascular And Interventional Radiology 2022, 45: 405-412. PMID: 35119481, PMCID: PMC8940827, DOI: 10.1007/s00270-021-03031-9.Peer-Reviewed Original ResearchConceptsBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseHepatocellular carcinomaCurative treatmentRECIST 1.1Primary endpointClinical benefitControl rateEastern Cooperative Oncology Group performance status 0Response rateChild-Pugh class ARandomized phase 3 studyDual primary endpointsOverall survival eventsPerformance status 0Previous systemic treatmentPD-1 inhibitorsPortal vein thrombosisPhase 3 studyResponse Evaluation CriteriaSolid Tumors 1.1Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. New England Journal Of Medicine 2022, 386: 437-448. PMID: 35045221, PMCID: PMC11651366, DOI: 10.1056/nejmoa2108330.Peer-Reviewed Original ResearchConceptsAdvanced endometrial cancerProgression-free survivalEndometrial cancerOverall survivalMedian progression-free survivalPlatinum-based chemotherapy regimenLonger progression-free survivalEnd pointBlinded independent central reviewMedian overall survivalPrimary end pointPhase 3 trialResponse Evaluation CriteriaPlatinum-based chemotherapyIndependent central reviewChemotherapy regimenAdverse eventsStandard therapyCentral reviewPembrolizumabGrade 3LenvatinibChemotherapyPhysician's choicePatients
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