2024
Phase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in JAKi-naïve myelofibrosis.
Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Wang X, Kye S, Harrison C. Phase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in JAKi-naïve myelofibrosis. Journal Of Clinical Oncology 2024, 42: tps6594-tps6594. DOI: 10.1200/jco.2024.42.16_suppl.tps6594.Peer-Reviewed Original ResearchXPO1 inhibitorsIntent-to-treat populationCo-primary study endpointsBaseline platelet countTreatment-related AEsPlacebo-controlled studyStem cell transplantationPhase 1 portionPhase 3 trialYears of ageNausea prophylaxisOral selinexorIntermediate-1Intermediate-2Anemia responseMF patientsTreatment discontinuationDouble-blindCell transplantationMyeloproliferative neoplasmsSecondary endpointsPlatelet countSpleen volumeRuxolitinib treatmentIWG-MRT
2020
Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia
Badar T, Szabo A, Dinner S, Liedtke M, Burkart M, Shallis RM, Yurkiewicz IR, Kuo E, Khan MA, Balasubramanian S, Yang J, Hefazi M, Podoltsev N, Patel A, Curran E, Wang A, Arslan S, Aldoss I, Siebenaller C, Mattison RJ, Litzow MR, Wadleigh M, Advani AS, Atallah E. Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia. Cancer 2020, 127: 1039-1048. PMID: 33259056, DOI: 10.1002/cncr.33340.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntibodies, BispecificAntineoplastic Agents, ImmunologicalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematopoietic Stem Cell TransplantationHumansInotuzumab OzogamicinMaleMiddle AgedPrecursor Cell Lymphoblastic Leukemia-LymphomaRemission InductionRetrospective StudiesTreatment OutcomeWithholding TreatmentYoung AdultConceptsAcute lymphoblastic leukemiaRefractory B-cell acute lymphoblastic leukemiaB-cell acute lymphoblastic leukemiaMedian overall survivalINO groupNovel agentsOverall survivalLymphoblastic leukemiaComplete remissionInotuzumab ozogamicinNA therapyComparable efficacyRelapsed/refractory (r/r) B-cell acute lymphoblastic leukemiaAllogeneic hematopoietic stem cell transplantationCR/CRi rateIncomplete count recovery (CRi) ratesRefractory acute lymphoblastic leukemiaHematopoietic stem cell transplantationNovel agent therapyOutcomes of patientsStem cell transplantationBlinatumomab groupCRi rateTreatment discontinuationAdverse eventsInterferon alpha therapy in essential thrombocythemia and polycythemia vera—a systematic review and meta-analysis
Bewersdorf JP, Giri S, Wang R, Podoltsev N, Williams RT, Tallman MS, Rampal RK, Zeidan AM, Stahl M. Interferon alpha therapy in essential thrombocythemia and polycythemia vera—a systematic review and meta-analysis. Leukemia 2020, 35: 1643-1660. PMID: 32868875, PMCID: PMC7917159, DOI: 10.1038/s41375-020-01020-4.Peer-Reviewed Original ResearchConceptsOverall response ratePEG-IFNPolycythemia veraEssential thrombocythemiaHematologic responsePV patientsResponse rateSystematic reviewMeta-regression analysis resultsSafe long-term treatmentPartial hematologic responseSafety of interferonInterferon-alpha therapyLong-term treatmentRandom-effects modelMeta-regression analysisWeb of ScienceTreatment discontinuationCochrane RegistryAdverse eventsComplete responsePartial responsePrimary outcomeThromboembolic complicationsClinical trialsInterferon Therapy in Myelofibrosis: Systematic Review and Meta-analysis
Bewersdorf JP, Giri S, Wang R, Podoltsev N, Williams RT, Rampal RK, Tallman MS, Zeidan AM, Stahl M. Interferon Therapy in Myelofibrosis: Systematic Review and Meta-analysis. Clinical Lymphoma Myeloma & Leukemia 2020, 20: e712-e723. PMID: 32669244, PMCID: PMC7541411, DOI: 10.1016/j.clml.2020.05.018.Peer-Reviewed Original ResearchConceptsOverall response rateTreatment of myelofibrosisPEG-IFNMF patientsResponse rateHematologic responseSystematic reviewFormulations of interferonPartial hematologic responseCochrane Central RegisterComplete hematologic responseRisk of progressionRole of interferonAcute myeloid leukemiaPhiladelphia chromosome-negative myeloproliferative neoplasmsRandom-effects modelBone marrow failureWeb of ScienceTreatment discontinuationCentral RegisterConstitutional symptomsHematologic improvementInterferon therapyAdverse eventsComplete response
2019
Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration
Savona M, Kantarjian H, Roboz G, O'Connell C, Walsh K, Tibes R, Yee K, Stock W, Griffiths E, Jabbour E, Lunin S, Rosenblat T, Podoltsev N, Issa J, Su X, Azab M, Garcia-Manero G. Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration. Blood 2019, 134: 2957. DOI: 10.1182/blood-2019-129962.Peer-Reviewed Original ResearchMDS/CMML patientsMDS/CMMLPhase 2 studyObjective responseCMML patientsSurvival benefitClinical trialsMedian OSMyelodysplastic syndromeAstex PharmaceuticalsSurvival analysisTreatment discontinuationHematological improvementPartial responseComplete responseEarly progressionOtsuka PharmaceuticalDaiichi SankyoLandmark analysisHMA treatmentLandmark responsesCycle 4Prospective phase 2 studyBoehringer IngelheimAdvisory Committee