2021
Corrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; 32: 983-993
Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, Rugo HS, Schneeweiss A, Winer EP, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Patel S, Chui SY, Schmid P. Corrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; 32: 983-993. Annals Of Oncology 2021, 32: 1650. PMID: 34740469, DOI: 10.1016/j.annonc.2021.10.002.Peer-Reviewed Original ResearchCorrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable locally advanced or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; volume 32: 983–993
Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, Rugo HS, Schneeweiss A, Winer EP, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Patel S, Chui SY, Schmid P. Corrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable locally advanced or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; volume 32: 983–993. Annals Of Oncology 2021, 32: 1308. PMID: 34353668, DOI: 10.1016/j.annonc.2021.07.013.Peer-Reviewed Original ResearchFirst-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis
Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, Rugo HS, Schneeweiss A, Winer EP, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Patel S, Chui SY, Schmid P. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. Annals Of Oncology 2021, 32: 983-993. PMID: 34272041, DOI: 10.1016/j.annonc.2021.05.355.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPD-L1 (+) immune cellsTriple-negative breast cancerOverall survivalImmune cellsITT populationOS benefitNab-paclitaxelBreast cancerFinal overall survival analysisTumor-infiltrating immune cellsFinal overall survivalFirst-line atezolizumabMedian overall survivalFirst-line treatmentProgression-free survivalOverall survival analysisPrespecified analysis planMedian OSCoprimary endpointsAdverse eventsPositive patientsUnacceptable toxicitySafety outcomesToxicity profilePD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer
Rugo HS, Loi S, Adams S, Schmid P, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Winer EP, Kockx MM, Peeters D, Chui SY, Lin JC, Nguyen-Duc A, Viale G, Molinero L, Emens LA. PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer. Journal Of The National Cancer Institute 2021, 113: 1733-1743. PMID: 34097070, PMCID: PMC8634452, DOI: 10.1093/jnci/djab108.Peer-Reviewed Original ResearchConceptsNab-paclitaxelPD-L1Metastatic triple-negative breast cancer patientsAdvanced triple-negative breast cancerAnalytical concordanceTriple-negative breast cancer patientsTriple-negative breast cancerDouble-positive casesCombined positive scorePD-L1 statusPD-L1 assaysBreast cancer patientsSingle positive caseMore patientsSP263 assaysClinical outcomesClinical benefitCancer patientsClinical activityBreast cancerSP142SP263PatientsPhase IIIPositive scoreAtezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study
Emens LA, Molinero L, Loi S, Rugo HS, Schneeweiss A, Diéras V, Iwata H, Barrios CH, Nechaeva M, Nguyen-Duc A, Chui SY, Husain A, Winer EP, Adams S, Schmid P. Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study. Journal Of The National Cancer Institute 2021, 113: 1005-1016. PMID: 33523233, PMCID: PMC8328980, DOI: 10.1093/jnci/djab004.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerMetastatic triple-negative breast cancerProgression-free survivalPD-L1Tumor immune microenvironmentBreast cancerIntratumoral CD8Nab-paclitaxelClinical benefitImmune microenvironmentImmune cellsBRCA1/2 mutationsAdvanced triple-negative breast cancerStromal tumor-infiltrating lymphocytesNab-paclitaxel 100Immune checkpoint inhibitorsOverall survival benefitTumor-infiltrating lymphocytesMetastatic tumor tissueBRCA1/2 mutation statusCheckpoint inhibitorsOverall survivalSurvival benefitImmune biomarkersClinical activity
2020
49MO IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer
Iwata H, Emens L, Adams S, Barrios C, Diéras V, Loi S, Rugo H, Schneeweiss A, Winer E, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Chui S, Schmid P. 49MO IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer. Annals Of Oncology 2020, 31: s1261-s1262. DOI: 10.1016/j.annonc.2020.10.069.Peer-Reviewed Original ResearchIMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer
Emens L, Adams S, Barrios C, Dieras V, Iwata H, Loi S, Rugo H, Schneeweiss A, Winer E, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Chui S, Schmid P. IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer. Annals Of Oncology 2020, 31: s1148. PMCID: PMC7506448, DOI: 10.1016/j.annonc.2020.08.2244.Peer-Reviewed Original ResearchTumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial
Emens L, Molinero L, Adams S, Rugo H, Schneeweiss A, Diéras V, Iwata H, Barrios C, Nechaeva M, Winer E, Chang C, Chui S, Schmid P, Loi S. Tumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial. Annals Of Oncology 2020, 31: s360-s361. DOI: 10.1016/j.annonc.2020.08.398.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
2019
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cellsIMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Henschel V, Molinero L, Chui S, Husain A, Winer E, Loi S, Emens L. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1003-1003. DOI: 10.1200/jco.2019.37.15_suppl.1003.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerOverall survivalPD-L1OS analysisTriple-negative breast cancerECOG PS 0Median overall survivalPrimary PFS analysisPD-L1 testingPhase III studyCo-primary endpointsEligible ptsOS benefitData cutoffIII studyNab-paclitaxelPS 0AtezoBreast cancerPFS analysisPlaceboNP armTumor tissueSafety updateOS dataIMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schneeweiss A, Rugo H, Winer E, Barrios C, Iwata H, Dieras V, Loi S, Maiya V, Bond J, Lei G, Chui S, Adams S, Emens L, Schmid P. IMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1068-1068. DOI: 10.1200/jco.2019.37.15_suppl.1068.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTriple-negative breast cancerTolerable safety profileCauses of withdrawalMonotherapy trialsPFS benefitSerious AEsSystemic corticosteroidsMedian FUSecondary endpointsNab-paclitaxelAdverse eventsPD-L1Peripheral neuropathyMedian timeSafety profileLonger FUSafety signalsBreast cancerSafety dataCumulative toxicityData cutAESIP3 studiesGr 3
2018
Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. New England Journal Of Medicine 2018, 379: 2108-2121. PMID: 30345906, DOI: 10.1056/nejmoa1809615.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerProgression-free survivalMedian progression-free survivalMedian overall survivalNab-paclitaxelBreast cancerOverall survivalPD-L1Adverse eventsTreat analysisPositive tumorsAdvanced triple-negative breast cancerDeath ligand 1 (PD-L1) expressionAdjuvant taxane therapyPrimary end pointLigand 1 expressionPhase 3 trialNew adverse effectsTreat populationTaxane therapyLiver metastasesAggressive diseasePoor outcomeSafety profileLBA1_PR IMpassion130: Results from a global, randomised, double-blind, phase III study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC)
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Hegg R, Im S, Wright G, Henschel V, Molinero L, Chui S, Funke R, Husain A, Winer E, Loi S, Emens L. LBA1_PR IMpassion130: Results from a global, randomised, double-blind, phase III study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC). Annals Of Oncology 2018, 29: viii707-viii708. DOI: 10.1093/annonc/mdy424.008.Peer-Reviewed Original Research
2017
Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance)
Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV. Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). The AAPS Journal 2017, 19: 1411-1423. PMID: 28620884, PMCID: PMC5711539, DOI: 10.1208/s12248-017-0101-9.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyProportion of patientsMetastatic breast cancerKinetic-pharmacodynamic modelIndirect response modelNab-paclitaxelDose modificationPeripheral neuropathyBreast cancerDrug effectsRandomized phase III trialLinear drug effectFirst-line chemotherapyPhase III trialsTime pointsDose-limiting toxicityLater time pointsEarly time pointsCALGB 40502Neurotoxicity ScaleIII trialsFunctional assessmentChemotherapeutic agentsPatientsCancer
2016
136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC
Emens L, Adams S, Loi S, Schneeweiss A, Rugo H, Winer E, Barrios C, Dieras V, de la Haba-Rodriguez J, Gianni L, Kusuma N, Chui S, Schmid P. 136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC. Annals Of Oncology 2016, 27 DOI: 10.1093/annonc/mdw577.019.Peer-Reviewed Original Research136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC
Emens L, Adams S, Loi S, Schneeweiss A, Rugo H, Winer E, Barrios C, Dieras V, de la Haba-Rodriguez J, Gianni L, Kusuma N, Chui S, Schmid P. 136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC. Annals Of Oncology 2016, 27: ix40. DOI: 10.1016/s0923-7534(21)00294-5.Peer-Reviewed Original ResearchImmune Signatures Following Single Dose Trastuzumab Predict Pathologic Response to PreoperativeTrastuzumab and Chemotherapy in HER2-Positive Early Breast Cancer
Varadan V, Gilmore H, Miskimen KL, Tuck D, Parsai S, Awadallah A, Krop IE, Winer EP, Bossuyt V, Somlo G, Abu-Khalaf MM, Fenton MA, Sikov W, Harris L. Immune Signatures Following Single Dose Trastuzumab Predict Pathologic Response to PreoperativeTrastuzumab and Chemotherapy in HER2-Positive Early Breast Cancer. Clinical Cancer Research 2016, 22: 3249-3259. PMID: 26842237, PMCID: PMC5439498, DOI: 10.1158/1078-0432.ccr-15-2021.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAntineoplastic Agents, ImmunologicalBiomarkers, TumorB-LymphocytesBreast NeoplasmsFemaleGene Expression ProfilingHumansImmunity, InnateLymphocyte ActivationMacrophagesMiddle AgedNeoadjuvant TherapyPaclitaxelProgrammed Cell Death 1 ReceptorReceptor, ErbB-2T-Lymphocytes, Helper-InducerTrastuzumabTreatment OutcomeConceptsPathologic complete responseBreast cancerImmune indicesBrief exposureFollicular helper T (Tfh) cell signatureHER2-positive breast cancerPD-1 positivitySingle-agent trastuzumabTrastuzumab-based therapyT cell activityT-cell signatureImmune cell infiltrationTumor core biopsiesImmune cell activationPreoperative trastuzumabNab-paclitaxelAntitumor immunityImmune signaturesPCR rateComplete responseMulticenter trialPD-1Cell infiltrationCore biopsyIntrinsic subtypesIMpassion130: a Phase III randomized trial of atezolizumab with nab-paclitaxel for first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC).
Emens L, Adams S, Loi S, Schneeweiss A, Rugo H, Winer E, Barrios C, Dieras V, de la Haba-Rodriguez J, Gianni L, Chui S, Schmid P. IMpassion130: a Phase III randomized trial of atezolizumab with nab-paclitaxel for first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2016, 34: tps1104-tps1104. DOI: 10.1200/jco.2016.34.15_suppl.tps1104.Peer-Reviewed Original Research
2015
Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). Journal Of Clinical Oncology 2015, 33: 2361-2369. PMID: 26056183, PMCID: PMC4500830, DOI: 10.1200/jco.2014.59.5298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDrug Administration ScheduleEpothilonesFemaleHumansMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeConceptsAdvanced breast cancerProgression-free survivalNab-paclitaxelBreast cancerInterim analysisMedian progression-free survivalRandomized phase III trialEarly dose reductionSecond interim analysisFirst-line therapyPhase III trialsMetastatic breast cancerFirst interim analysisEligible patientsLine chemotherapyNonhematologic toxicityPalliative chemotherapyHazard ratioIII trialsOverall survivalPeripheral neuropathyTreatment failureExperimental armLocally RecurrentArm C