2023
Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study
Schmid P, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia J, Zhou X, Haiderali A, Nguyen A, Cortes J, Winer E. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. European Journal Of Cancer 2023, 195: 113393. PMID: 37976633, DOI: 10.1016/j.ejca.2023.113393.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerCombined positive scoreMetastatic triple-negative breast cancerPD-L1 combined positive scoreHealth-related qualityBreast cancerQLQ-C30 functional scalesTumor PD-L1 expressionGHS/QoLNausea/vomitingPD-L1 expressionStart of treatmentHRQoL resultsEligible patientsHRQoL analysisOverall survivalSystemic therapyClinical outcomesFunctional scalesPhysician's choicePatientsChemotherapyFirst onsetCountry guidelinesMedian TTD
2021
Saci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC).
Garrido-Castro A, Keenan T, Li T, Lange P, Callahan C, Guerriero J, Tayob N, Anderson L, Stover D, Gogineni K, Carey L, Nanda R, Winer E, Mittendorf E, Tolaney S. Saci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC). Journal Of Clinical Oncology 2021, 39: tps1102-tps1102. DOI: 10.1200/jco.2021.39.15_suppl.tps1102.Peer-Reviewed Original ResearchProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalRandomized phase II trialCombined positive scorePhase II trialSacituzumab govitecanII trialPD-L1Anti-PD-1/L1 antibodyPD-1/L1 inhibitorsHER2- metastatic breast cancerAntibody-dependent cellular cytotoxicityT cell effector functionPrior hormonal therapyPD-L1 expressionAntitumor immune responseChronic antigen stimulationHealth-related qualityKey eligibility criteriaRegulatory T cellsT cell dysfunctionCell effector functionsOne-sided alphaImmune cell receptorsSaci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC).
Garrido-Castro A, Keenan T, Li T, Lange P, Callahan C, Guerriero J, Tayob N, Anderson L, Yam C, Daniel B, Carey L, Nanda R, Winer E, Mittendorf E, Tolaney S. Saci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2021, 39: tps1106-tps1106. DOI: 10.1200/jco.2021.39.15_suppl.tps1106.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalRandomized phase II trialPhase II trialSacituzumab govitecanPD-L1II trialImmune cellsBreast cancerAnti-PD-1/L1 antibodyPD-1/L1 inhibitorsAntibody-dependent cellular cytotoxicityT cell effector functionTriple-negative breast cancerPrior systemic therapyPD-L1 expressionAntitumor immune responseChronic antigen stimulationHealth-related qualityKey eligibility criteriaRegulatory T cellsT cell dysfunctionCell effector functions
2020
141P Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer
Schmid P, Haiderali A, Mejia J, Guo Z, Zhou X, Martin-Nguyen A, Cortés J, Winer E. 141P Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer. Annals Of Oncology 2020, 31: s65-s66. DOI: 10.1016/j.annonc.2020.03.242.Peer-Reviewed Original ResearchPatient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer
Adams S, Diéras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Annals Of Oncology 2020, 31: 582-589. PMID: 32178964, DOI: 10.1016/j.annonc.2020.02.003.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPatient-reported outcomesTriple-negative breast cancerFirst-line treatmentHealth-related qualityNab-paclitaxelPD-L1Treatment symptomsBreast cancerBaseline scoresDay 1Progression-free survival benefitPatients' health-related qualityEnd pointBreast cancer moduleExploratory end pointsSecondary end pointsTreatment-related symptomsEnd of treatmentKey treatment goalMean baseline scoreCourse of treatmentITT patientsMeaningful worseningMTNBC patients
2014
TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases
Anders C, Deal AM, Abramson V, Liu MC, Storniolo AM, Carpenter JT, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin NU, Kelly Marcom P, Van Poznak C, Stearns V, Melisko M, Smith JK, Karginova O, Parker J, Berg J, Winer EP, Peterman A, Prat A, Perou CM, Wolff AC, Carey LA. TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases. Breast Cancer Research And Treatment 2014, 146: 557-566. PMID: 25001612, PMCID: PMC4112043, DOI: 10.1007/s10549-014-3039-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBrain NeoplasmsCamptothecinDrug-Related Side Effects and Adverse ReactionsFemaleHumansIrinotecanMiddle AgedNeoplasm StagingReceptor, ErbB-2Survival AnalysisTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor AConceptsTriple-negative breast cancerClinical benefit rateBrain metastasesOverall survivalResponse rateTriple negative breast cancer brain metastasisCommon grade 3/4 adverse eventsAdvanced triple-negative breast cancerGrade 3/4 adverse eventsIntracranial clinical benefit rateBreast cancer brain metastasesGrade 3/4 diarrheaIntracranial response ratesProgressive brain metastasesMedian overall survivalPhase II studyPrimary end pointCancer brain metastasesHalf of patientsHealth-related qualityBRCA germline mutationsTreatment-refractory diseaseBlood-brain barrierNegative breast cancerGermline BRCA1/2 status
2011
P4-19-03: Physical and Psychological Sequelae of Breast Cancer in Men.
Ruddy K, Giobbie-Hurder A, Giordano S, Goldfarb S, Kereakoglow S, Winer E, Partridge A. P4-19-03: Physical and Psychological Sequelae of Breast Cancer in Men. Cancer Research 2011, 71: p4-19-03-p4-19-03. DOI: 10.1158/0008-5472.sabcs11-p4-19-03.Peer-Reviewed Original ResearchExpanded Prostate Cancer Index CompositeBreast cancerMale breast cancer survivorsSexual functioningProstate Cancer Index CompositeSupportive care needsCancer Therapy-BreastHealth-related qualityMale breast cancerBreast cancer survivorsHormonal symptomsFertility counselingCancer survivorsSexual symptomsHealth perceptionSubstantial symptomsDepression ScaleCare needsFunctional assessmentSymptomsLarger studyCancer ResHospitalized AnxietyPsychological sequelaeCancer
2008
Applying a conceptual model for examining health‐related quality of life in long‐term breast cancer survivors: CALGB study 79804
Paskett ED, Herndon JE, Day JM, Stark NN, Winer EP, Grubbs SS, Pavy MD, Shapiro CL, List MA, Hensley ML, Naughton MA, Kornblith AB, Habin KR, Fleming GF, Bittoni MA. Applying a conceptual model for examining health‐related quality of life in long‐term breast cancer survivors: CALGB study 79804. Psycho-Oncology 2008, 17: 1108-1120. PMID: 18314912, PMCID: PMC3930158, DOI: 10.1002/pon.1329.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantClimactericCombined Modality TherapyComorbidityDisease-Free SurvivalFemaleFollow-Up StudiesHealth BehaviorHumansLife StyleMiddle AgedNeoplasm StagingQuality of LifeRandomized Controlled Trials as TopicSick RoleSocial SupportSocioeconomic FactorsSpiritualitySurvivorsConceptsLong-term breast cancer survivorsHealth-related qualityBreast cancer survivorsHealth-oriented behaviorGlobal HRQLCancer survivorsGlobal health-related qualityBreast cancer patientsLow social supportCALGB 8541Vaginal drynessRegression modelsHot flashesMenopausal symptomsSurvivors' healthCancer patientsHeart diseaseHRQLLifestyle changesPsychosocial concernsPrevalence of problemsSurvivorsCancer diagnosisPrevalent problemSocial support