2023
Multicenter, Real-World Study in Patients with R/R Large B-Cell Lymphoma (LBCL) Who Received Lisocabtagene Maraleucel (liso-cel) in the United States (US)
Crombie J, Nastoupil L, Andreadis C, Isufi I, Hunter B, Winter A, Hess B, Barta S, Frigault M, Palomba M, Grover N, Jain M, Moyo T, Patel S, Pophali P, Bernasconi D, Parrilla C, Kitali A, Liu F, Gharibo M, Pasquini M. Multicenter, Real-World Study in Patients with R/R Large B-Cell Lymphoma (LBCL) Who Received Lisocabtagene Maraleucel (liso-cel) in the United States (US). Blood 2023, 142: 104. DOI: 10.1182/blood-2023-180242.Peer-Reviewed Original ResearchImmune effector cell-associated neurotoxicity syndromeR LBCLLarge B-cell lymphomaCytokine release syndromeProgression-free survivalDuration of responseReal-world clinical effectivenessHigh-grade B-cell lymphomaLiso-celInternational Prognostic IndexB-cell lymphomaOverall survivalSystemic therapyReal-world studyData cutoffPostmarketing studyMedian timeClinical effectivenessClinical studiesFavorable benefit/risk profileReal-world settingMedian DORMedian progression-free survivalBenefit/risk profileCAR T-cell productsLong-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Strober B, Coates L, Lebwohl M, Deodhar A, Leibowitz E, Rowland K, Kollmeier A, Miller M, Wang Y, Li S, Chakravarty S, Chan D, Shawi M, Yang Y, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Safety 2023, 47: 39-57. PMID: 37906417, PMCID: PMC10764399, DOI: 10.1007/s40264-023-01361-w.Peer-Reviewed Original ResearchConceptsGuselkumab-treated patientsPlacebo-controlled periodBody mass indexPrior biologic usePsoriatic diseaseAE ratesSerious AEsBiologic usePsoriatic arthritisOpportunistic infectionsSerious infectionsPsoriasis studiesWeeks 0Clinical studiesWeek 4Phase II/III studyPhase II/III clinical studiesMajor adverse cardiovascular eventsLong-term safety profileBenefit/risk profileFavorable AE profilePlacebo-treated patientsAdverse cardiovascular eventsActive psoriatic arthritisSubgroup of patientsHealth-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician’s Choice
Lorusso D, Colombo N, Herraez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Kim Y, McCormack M, Massaad R, Nguyen A, Zhao Q, McKenzie J, Prabhu V, Makker V. Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician’s Choice. European Journal Of Cancer 2023, 186: 172-184. PMID: 37086595, PMCID: PMC11003310, DOI: 10.1016/j.ejca.2023.03.015.Peer-Reviewed Original ResearchConceptsAdvanced endometrial cancerEndometrial cancerWeek 12Life QuestionnaireDefinitive deteriorationFunctional scalesPhysician's choiceGlobal health status/qualityFavorable benefit/risk profileHealth status/qualityBenefit/risk profileEuroQol-5 DimensionsHealth-related qualityTreatment of patientsTingling/numbnessImpact of treatmentQuality of lifeRate of completionHRQOL endpointsAppetite lossPoor body imageCancer QualityLife scoresMuscular painSafety results
2021
Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC).
Lorusso D, Colombo N, Herraez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Kim Y, McCormack M, Bird S, Prabhu V, Nguyen A, Zhao Q, Dutta L, Makker V. Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC). Journal Of Clinical Oncology 2021, 39: 5570-5570. DOI: 10.1200/jco.2021.39.15_suppl.5570.Peer-Reviewed Original ResearchGlobal health statusEORTC QLQ-C30QLQ-C30QOL scoresEORTC QLQ-C30 global health statusDay 1QLQ-C30 global health statusFavorable benefit/risk profileCompliance rateWk 12Advanced endometrial cancer patientsCycle 1 day 1GHS/QoL scoresPlatinum-based systemic therapyBenefit/risk profileEndometrial cancer patientsHealth-related qualityStandard treatment approachPlatinum-based therapyTime of discontinuationBetween-group differencesWorse symptom severityGHS/HRQOL endpointsQd po
2019
O1-8-4 [Encore] Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancer
Takahashi S, Modi S, Tsurutani J, Krop I, Iwata H, Wada R, Yin O, Garimella T, Sugihara M, Zhang L, Lee C, Saito K, Kawasaki Y, Yver A, Tamura K. O1-8-4 [Encore] Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancer. Annals Of Oncology 2019, 30: vi84. DOI: 10.1093/annonc/mdz339.009.Peer-Reviewed Original ResearchObjective response rateInterstitial lung diseaseTrastuzumab deruxtecanOngoing phase 1 studiesImproved progression-free survivalCox proportional hazard modelingHER2-positive breast cancerBenefit/risk profileLogistic regressionProgression-free survivalPhase 1 studyProportional hazard modelingPopulation PK modelDose-finding stageIndividual PK parametersAvailable PK dataILD riskSafety endpointLung diseasePPK modelBC subjectsBreast cancerDose justificationPK parametersPK data
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