2025
Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer
Ignatiadis M, Bailey A, McArthur H, El-abed S, de Azambuja E, Metzger O, Chui S, Dieterich M, Perretti T, Shearer-Kang E, Molinero L, Steger G, Jassem J, Lee S, Higgins M, Zarba J, Schmidt M, Gomez H, Zotano A, Moscetti L, Chiu J, Munzone E, Ben-Baruch N, Bajetta E, Ohno S, Im S, Werutsky G, Gal-Yam E, Farre X, Tseng L, Jacot W, Gluz O, Shao Z, Shparyk Y, Zimina A, Winer E, Cameron D, Viale G, Saji S, Gelber R, Piccart M. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer. JAMA 2025, 333: 1150-1160. PMID: 39883436, PMCID: PMC11783246, DOI: 10.1001/jama.2024.26886.Peer-Reviewed Original ResearchTriple-negative breast cancerBreast cancerAdverse eventsEarly-stage triple-negative breast cancerInvasive disease-free survival eventsTriple-negative breast cancer subtypeDisease-free survival hazard ratioInvasive disease-free survivalTreatment-related grade 3Disease-free survival eventsRandomized phase 3 trialIncidence of fatal adverse eventsRisk of recurrent diseaseIndependent data monitoring committeeAtezolizumab to chemotherapyDisease-free survivalNon-Hispanic black womenSurvival hazard ratioBreast cancer subtypesPhase 3 trialFatal adverse eventsPatient follow-upAdjuvant atezolizumabPostsurgery chemotherapyStandard chemotherapyContinued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON
Wuyts W, Bonella F, Chaudhuri N, Varone F, Antin-Ozerkis D, Song J, Miede C, Dumistracel M, Coeck C, Cottin V. Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON. Lung 2025, 203: 25. PMID: 39789408, PMCID: PMC11717875, DOI: 10.1007/s00408-024-00778-z.Peer-Reviewed Original ResearchConceptsProgressive pulmonary fibrosisForced Vital CapacityAdverse eventsSafety profilePulmonary fibrosisConclusionThe safety profileDiscontinuation of nintedanibExposure to nintedanibSafety of nintedanibOpen-label extensionBaseline to weekFrequent adverse eventsFatal adverse eventsLong-term treatmentLonger-term treatmentNintedanib groupGastrointestinal eventsINBUILD trialNintedanibMethodsAdverse eventsModerate severityPatientsContinuous treatmentVital capacityINBUILD
2024
Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study.
Kunz P, Ferone D, Halperin D, Myrehaug S, Herrmann K, Pavel M, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, de Herder W, Singh S. Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study. Journal Of Clinical Oncology 2024, 42: 4131-4131. DOI: 10.1200/jco.2024.42.16_suppl.4131.Peer-Reviewed Original ResearchTime to responseObjective response rateGastroenteropancreatic neuroendocrine tumorsLu-DOTATATEGEP-NETsAdverse eventsHematologic toxicityNeuroendocrine tumorsSafety profileSub-analysisMedian time to responseCases of myelodysplastic syndromeOctreotide long-actingHematologic adverse eventsProgression-free survivalTime to first occurrenceRandomized treatment periodFatal adverse eventsInfection rateDose interruptionCTCAE gradeRadioligand therapyMyelodysplastic syndromeEligible ptsLaboratory abnormalitiesInfigratinib 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 UC
2023
Sabatolimab in Combination with Hypomethylating Agents (HMAs) Was Safe in Patients (Pts) with Intermediate-, High-, or Very-High-Risk Myelodysplastic Syndrome (MDS)
Garcia-Manero G, Lyons R, Nandal S, Ashraf M, Thellaboina R, Ruckel-Kumar J, Menssen H, Zeidan A. Sabatolimab in Combination with Hypomethylating Agents (HMAs) Was Safe in Patients (Pts) with Intermediate-, High-, or Very-High-Risk Myelodysplastic Syndrome (MDS). Blood 2023, 142: 4606. DOI: 10.1182/blood-2023-186490.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeAdverse eventsHematologic improvementPartial remissionMyelodysplastic syndromeHypomethylating agentMarrow CRInterim analysisStable diseaseData cutoffLast doseInternational Prognostic Scoring System criteriaResponse rateCount decreaseCycle 1 day 1Second-line treatment optionExtension phaseHematologic adverse eventsNeutrophil count decreaseOral hypomethylating agentPhase Ib studySerious adverse eventsFatal adverse eventsMonths of treatmentSingle-arm study
2021
A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results.
Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.Peer-Reviewed Original ResearchRefractory solid tumorsAdverse eventsCell lung cancerSolid tumorsLymphocyte countLung cancerNon-small cell lung cancerSmall cell lung cancerMedian age 62 yearsCommon adverse eventsDose-expansion phasePhase 2 dosePrior systemic therapyTolerable safety profileFatal adverse eventsFatal cardiac arrestOverall response rateAge 62 yearsDose-escalation resultsAnti-tumor activityECOG 0ECOG 1RECIST v1.1Taxane therapyMedian duration
2019
Continued Beneficial Effects of Burosumab in Adults with X-Linked Hypophosphatemia: Results from a 24-Week Treatment Continuation Period After a 24-Week Double-Blind Placebo-Controlled Period
Portale AA, Carpenter TO, Brandi ML, Briot K, Cheong HI, Cohen-Solal M, Crowley R, Jan De Beur S, Eastell R, Imanishi Y, Imel EA, Ing S, Ito N, Javaid M, Kamenicky P, Keen R, Kubota T, Lachmann R, Perwad F, Pitukcheewanont P, Ralston SH, Takeuchi Y, Tanaka H, Weber TJ, Yoo HW, Zhang L, Theodore-Oklota C, Mealiffe M, San Martin J, Insogna K. Continued Beneficial Effects of Burosumab in Adults with X-Linked Hypophosphatemia: Results from a 24-Week Treatment Continuation Period After a 24-Week Double-Blind Placebo-Controlled Period. Calcified Tissue International 2019, 105: 271-284. PMID: 31165191, DOI: 10.1007/s00223-019-00568-3.Peer-Reviewed Original ResearchConceptsWeek 48Adverse eventsWeek 24Sustained improvementTreatment-related serious adverse eventsOpen-label treatment periodSafety of burosumabDouble-blind placeboFatal adverse eventsSerious adverse eventsSerum phosphorus levelsPatient-reported outcomesSerum phosphorus concentrationRenal phosphate wastingHuman monoclonal antibodyContinued beneficial effectsHealing of fracturesRare genetic disorderMusculoskeletal morbidityPhysical functionContinuation periodMusculoskeletal impairmentsPhosphate wastingTreatment periodBurosumab
2014
Treatment‐Related Mortality With Everolimus in Cancer Patients
Wesolowski R, Abdel‐Rasoul M, Lustberg M, Paskell M, Shapiro C, Macrae E. Treatment‐Related Mortality With Everolimus in Cancer Patients. The Oncologist 2014, 19: 661-668. PMID: 24794158, PMCID: PMC4041666, DOI: 10.1634/theoncologist.2013-0355.Peer-Reviewed Original ResearchConceptsFatal adverse eventsTreatment-related mortalityCancer patientsAdverse eventsOverall incidenceSan Antonio Breast Cancer SymposiumRole of everolimusControl group patientsMultiple solid tumorsEverolimus administrationGroup patientsCancer SymposiumSubgroup analysisControl armOdds ratioEverolimusFatal eventsClinical OncologyPatientsSolid tumorsPubMed databaseTumor typesIncidenceAmerican SocietySignificant differences
2013
Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC).
Tannock I, Fizazi K, Ivanov S, Thellenberg-Karlsson C, Flechon A, Skoneczna I, Orlandi F, Gravis G, Matveev V, Bavbek S, Gil T, Viana L, Aren O, Karyakin O, Elliott T, Birtle A, Magherini E, Petrylak D, Tombal B, Rosenthal M. Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2013, 31: 5002-5002. DOI: 10.1200/jco.2013.31.15_suppl.5002.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDocetaxel/prednisoneFirst-line chemotherapyAflibercept armPlacebo armHazard ratioMedian relative dose intensityRecombinant human fusion proteinStandard first-line chemotherapyCastration-resistant prostate cancerGrowth factorAdequate organ functionCycles of therapyPSA response rateRelative dose intensityFatal adverse eventsProgression-free survivalVascular endothelial growth factorClinical trial informationEndothelial growth factorHuman fusion proteinTrial-specific modulesOral prednisonePrimary endpointPrior chemotherapy
2012
Treatment-related mortality with vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy in patients with advanced solid tumors: A meta-analysis
Sivendran S, Liu Z, Portas L, Yu M, Hahn N, Sonpavde, Oh W, Galsky M. Treatment-related mortality with vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy in patients with advanced solid tumors: A meta-analysis. Cancer Treatment Reviews 2012, 38: 919-925. PMID: 22651902, DOI: 10.1016/j.ctrv.2012.05.001.Peer-Reviewed Original ResearchConceptsRisk of fatal adverse eventsFatal adverse eventsAdvanced solid tumorsVEGFR-TKIsSolid tumorsVascular endothelial growth factor receptor-tyrosine kinase inhibitor therapyIncreased risk of FAEsVascular endothelial growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsSubgroup analysisReceptor-tyrosine kinase inhibitor therapyTyrosine kinase inhibitor therapyTreatment of solid tumor malignanciesReceptor tyrosine kinase inhibitorsVEGFR-TKI treatmentKinase inhibitor therapyTreatment-related mortalityTyrosine kinase inhibitorsSolid tumor malignanciesMeta-analysisRenal cell carcinomaExploratory subgroup analysisRandom-effects modelRandomized Controlled TrialsTKI treatment
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