2024
Incidence and time to onset of immunotherapy-related adrenal insufficiency in the I-SPY2 trial.
Nanda R, Cohen R, Quandt Z, Basu A, Yau C, Chien A, Pusztai L, Han H, Stringer-Reasor E, Isaacs C, Hershman D, Shatsky R, Perlmutter J, Yee D, DeMichele A, van 't Veer L, Hylton N, Esserman L, Rugo H. Incidence and time to onset of immunotherapy-related adrenal insufficiency in the I-SPY2 trial. Journal Of Clinical Oncology 2024, 42: 584-584. DOI: 10.1200/jco.2024.42.16_suppl.584.Peer-Reviewed Original ResearchImmune-related adverse eventsImmune checkpoint inhibitorsEarly breast cancerIncidence of AIAdrenal insufficiencyI-SPY2Advanced diseaseBreast cancerRisk of immune-related adverse eventsHigh-risk early breast cancerImmune checkpoint inhibitor doseTriple-negative breast cancerAnti-LAG-3Approval of pembrolizumabEvaluate novel agentsICI-based therapyWeekly x 4Rate of adrenal insufficiencyPhase 2 trialI-SPY2 trialTime to onsetAge of ptsCheckpoint inhibitorsNeoadjuvant settingWeekly paclitaxelNeoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery.
Albain K, Yau C, Petricoin E, Wolf D, Lang J, Chien A, Haddad T, Forero-Torres A, Wallace A, Kaplan H, Pusztai L, Euhus D, Nanda R, Elias A, Clark A, Godellas C, Boughey J, Isaacs C, Tripathy D, Lu J, Yung R, Gallagher R, Wulfkuhle J, Brown-Swigart L, Krings G, Chen Y, Potter D, Stringer-Reasor E, Blair S, Asare S, Wilson A, Hirst G, Singhrao R, Buxton M, Clennell J, Sanil A, Berry S, Asare A, Matthews J, DeMichele A, Hylton N, Melisko M, Perlmutter J, Rugo H, Symmans W, Van't Veer L, Yee D, Berry D, Esserman L. Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery. Clinical Cancer Research 2024, 30: 729-740. PMID: 38109213, PMCID: PMC10956403, DOI: 10.1158/1078-0432.ccr-22-2256.Peer-Reviewed Original ResearchPathological complete responseI-SPY2Breast cancerStage II/III breast cancerPhase II neoadjuvant trialTie2 receptorEarly-stage breast cancerT-cell gene signatureHormone receptorsDoxorubicin/cyclophosphamideHER2-negative diseaseHER2-positive diseaseStandard neoadjuvant therapyEvent-free survivalPhase III trialsPaclitaxel-based chemotherapyBreast cancer trialsPathway-specific biomarkersCell gene signatureNeoadjuvant trialsWeekly paclitaxelNeoadjuvant therapyPrimary endpointIII trialsPCR rate
2023
Impact of Anti-HER2 Therapy Alone and With Weekly Paclitaxel on the Ovarian Reserve of Young Women With HER2-Positive Breast Cancer.
Lambertini M, Ceppi M, Anderson R, Cameron D, Bruzzone M, Franzoi M, Massarotti C, El-Abed S, Wang Y, Lecocq C, Nuciforo P, Rolyance R, Pusztai L, Sohn J, Latocca M, Arecco L, Pistilli B, Ruddy K, Ballestrero A, Del Mastro L, Peccatori F, Partridge A, Saura C, Untch M, Piccart M, Di Cosimo S, de Azambuja E, Demeestere I. Impact of Anti-HER2 Therapy Alone and With Weekly Paclitaxel on the Ovarian Reserve of Young Women With HER2-Positive Breast Cancer. Journal Of The National Comprehensive Cancer Network 2023, 21: 33-41.e16. PMID: 36634607, DOI: 10.6004/jnccn.2022.7065.Peer-Reviewed Original ResearchConceptsAnti-HER2 therapyAMH levelsOvarian reserveWeekly paclitaxelAntimüllerian hormoneBreast cancerWeek 2HER2-positive early breast cancerHER2-positive breast cancerSubsequent ovarian functionAnti-HER2 agentsAnti-HER2 treatmentMedian AMH levelsEarly breast cancerTime of surgeryFrozen serum samplesBiomarker analysisNeoALTTO trialPotential gonadotoxicityPremenopausal womenMedian ageAMH valuesOvarian functionAMH declineGonadotoxicity
2022
Impact of anti-HER2 therapy alone and in association with weekly paclitaxel on the ovarian reserve of young women with HER2-positive early breast cancer: Biomarker analysis of the NeoALTTO trial.
Lambertini M, Ceppi M, Anderson R, Cameron D, El-Abed S, Wang Y, Lecocq C, Nuciforo P, Rolyance R, Pusztai L, Sohn J, Arecco L, Del Mastro L, Partridge A, Saura C, Untch M, Piccart-Gebhart M, Di Cosimo S, de Azambuja E, Demeestere I. Impact of anti-HER2 therapy alone and in association with weekly paclitaxel on the ovarian reserve of young women with HER2-positive early breast cancer: Biomarker analysis of the NeoALTTO trial. Journal Of Clinical Oncology 2022, 40: 12084-12084. DOI: 10.1200/jco.2022.40.16_suppl.12084.Peer-Reviewed Original ResearchAnti-HER2 therapyAnti-Mullerian hormoneAMH levelsAnti-HER2 agentsOvarian reserveWeekly paclitaxelPrimary ovarian insufficiencyWeek 2NeoALTTO trialPremenopausal womenHER2-positive early breast cancerBaseline AMH levelsSubsequent ovarian functionLower AMH levelsBiomarker analysisEarly breast cancerMedian AMH levelsTime of surgeryHER2-positive BCSystemic anticancer treatmentBreast cancer patientsFrozen serum samplesNeoadjuvant trialsOncofertility counsellingPotential gonadotoxicity
2018
Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer
Foldi J, Mougalian S, Silber A, Lannin D, Killelea B, Chagpar A, Horowitz N, Frederick C, Rispoli L, Burrello T, Abu-Khalaf M, Sabbath K, Sanft T, Brandt DS, Hofstatter EW, Hatzis C, DiGiovanna MP, Pusztai L. Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer. Breast Cancer Research And Treatment 2018, 169: 333-340. PMID: 29396664, DOI: 10.1007/s10549-017-4653-2.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerPhase II trialII trialNeoadjuvant chemotherapyPCR rateHormone receptorsBreast cancerGrade 3/4 adverse eventsPathologic complete response rateCyclophosphamide neoadjuvant chemotherapyComplete response rateSymptomatic heart failureAsymptomatic decreaseNeoadjuvant settingWeekly paclitaxelAdverse eventsHeart failureTherapeutic plateauCardiac functionInterim analysisStage IResponse ratePurposeThe purposePatientsNegative cases
2017
Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06)
Ponde N, Bradbury I, Lambertini M, Ewer M, Campbell C, Ameels H, Zardavas D, Di Cosimo S, Baselga J, Huober J, Izquierdo M, Fumagalli D, Bozovic-Spasojevic I, Maetens M, Harbeck N, Pusztai L, Berghorn M, Im YH, Borrego MR, Chen DR, Rodeheffer R, Piccart M, Suter T, de Azambuja E. Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06). Breast Cancer Research And Treatment 2017, 168: 631-638. PMID: 29280043, PMCID: PMC5843537, DOI: 10.1007/s10549-017-4628-3.Peer-Reviewed Original ResearchConceptsAnti-HER2 therapyNT-proBNPBiomarker elevationCardiac toxicityEarly predictorHER2-positive early-stage breast cancerEarly-stage breast cancerAnthracycline-naïve patientsEarly cardiac toxicityLevels of TnTNT-proBNP elevationBrain natriuretic peptideBreast cancer patientsNeoALTTO trialWeekly paclitaxelCardiac dysfunctionTreatment armsCardiac damageNatriuretic peptideCancer patientsCardiac biomarkersBreast cancerPatientsTroponin TAmino-terminal fragmentPathologic complete response (pCR) rates after neoadjuvant pertuzumab (P) and trastuzumab (H) administered concomitantly with weekly paclitaxel (T) and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) chemotherapy for clinical stage I-III HER2-positive breast cancer.
Foldi J, Mougalian S, Silber A, Lannin D, Killelea B, Chagpar A, Horowitz N, Frederick C, Rispoli L, Abu-Khalaf M, Sabbath K, Sanft T, Fischbach N, Brandt D, Hofstatter E, DiGiovanna M, Pusztai L. Pathologic complete response (pCR) rates after neoadjuvant pertuzumab (P) and trastuzumab (H) administered concomitantly with weekly paclitaxel (T) and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) chemotherapy for clinical stage I-III HER2-positive breast cancer. Journal Of Clinical Oncology 2017, 35: 577-577. DOI: 10.1200/jco.2017.35.15_suppl.577.Peer-Reviewed Original ResearchPathologic complete response rateHER2-positive breast cancerDual HER2 blockadeComplete response ratePCR rateEstrogen receptorHER2 blockadeBreast cancerStage IResponse rateGrade 3/4 adverse eventsSymptomatic congestive heart failureClinical stage ICompletion of chemotherapyPhase II studyTaxane-based chemotherapyCongestive heart failureEfficacy of anthracyclinesPositive breast cancerNormal cardiac functionEntire treatment durationER- cancersER cohortNeoadjuvant pertuzumabWeekly paclitaxel
2013
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII‐Tubulin Expression as a Predictive Marker
Saura C, Tseng L, Chan S, Chacko RT, Campone M, Manikhas A, Nag SM, Leichman CG, Dasappa L, Fasching PA, de Mendoza F, Symmans WF, Liu D, Mukhopadhyay P, Horak C, Xing G, Pusztai L. Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII‐Tubulin Expression as a Predictive Marker. The Oncologist 2013, 18: 787-794. PMID: 23853246, PMCID: PMC3720631, DOI: 10.1634/theoncologist.2013-0075.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerStage breast cancerPathologic complete responseΒIII-tubulin expressionBreast cancerTreatment armsWeekly paclitaxelPositive patientsPredictive markerNeoadjuvant doxorubicin/cyclophosphamideRandomized phase II trialΒIII-tubulinCommon nonhematologic toxicitiesDoxorubicin/cyclophosphamideInvasive breast adenocarcinomaPhase II trialCore needle biopsyCycles of ACHigh response rateSignificant differencesNeoadjuvant cyclophosphamideNonhematologic toxicityNeoadjuvant treatmentII trialNegative patients
2010
Evaluation of a 30-Gene Paclitaxel, Fluorouracil, Doxorubicin, and Cyclophosphamide Chemotherapy Response Predictor in a Multicenter Randomized Trial in Breast Cancer
Tabchy A, Valero V, Vidaurre T, Lluch A, Gomez H, Martin M, Qi Y, Barajas-Figueroa LJ, Souchon E, Coutant C, Doimi FD, Ibrahim NK, Gong Y, Hortobagyi GN, Hess KR, Symmans WF, Pusztai L. Evaluation of a 30-Gene Paclitaxel, Fluorouracil, Doxorubicin, and Cyclophosphamide Chemotherapy Response Predictor in a Multicenter Randomized Trial in Breast Cancer. Clinical Cancer Research 2010, 16: 5351-5361. PMID: 20829329, PMCID: PMC4181852, DOI: 10.1158/1078-0432.ccr-10-1265.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBiomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCyclophosphamideDoxorubicinFemaleFluorouracilGene Expression Regulation, NeoplasticHumansMiddle AgedPaclitaxelPredictive Value of TestsPrognosisTreatment OutcomeConceptsPositive predictive valuePathologic complete responseFAC armPCR rateBreast cancerPredictive valueGene expression profilingDifferent molecular subsetsFine-needle aspiration biopsyMulticenter Randomized TrialInternational clinical trialsGenomic predictorsNegative predictive valueTreatment response predictionWeekly paclitaxelNeoadjuvant chemotherapyCyclophosphamide chemotherapyFAC chemotherapyPreoperative chemotherapyComplete responseRandomized trialsTreatment armsPredictive markerClinical trialsMolecular subsets
2009
Evaluation of the Predictive Performance and Regimen Specificity of a 30-Gene Predictor of Pathologic Complete Response in a Prospective Randomized Neoadjuvant Clinical Trial for Stage I-III Breast Cancer.
Tabchy A, Symmans W, Valero V, Vidaurre T, Lluch A, Qi Y, Souchon E, Barajas-Figueroa L, Gomez H, Martin M, Coutant C, Hess K, Hortobagyi G, Pusztai L. Evaluation of the Predictive Performance and Regimen Specificity of a 30-Gene Predictor of Pathologic Complete Response in a Prospective Randomized Neoadjuvant Clinical Trial for Stage I-III Breast Cancer. Cancer Research 2009, 69: 101-101. DOI: 10.1158/0008-5472.sabcs-09-101.Peer-Reviewed Original ResearchPathologic complete responsePositive predictive valueCourses of FACFAC armWeekly paclitaxelFAC chemotherapyPCR rateComplete responseMultigene predictorsTreatment armsBreast cancerStage IPathologic complete response rateGenomic predictorsComplete response rateNeoadjuvant clinical trialsEstrogen receptor statusNegative predictive value 88Treatment response predictionFAC regimenNPV 92Neoadjuvant chemotherapyOnly chemotherapyCyclophosphamide chemotherapyNodal status
2008
Paclitaxel-induced sickle cell crisis
Wilson NM, Espirito JL, Valero V, Pusztai L. Paclitaxel-induced sickle cell crisis. American Journal Of Health-System Pharmacy 2008, 65: 1333-1336. PMID: 18593679, DOI: 10.2146/ajhp070432.Peer-Reviewed Original ResearchConceptsSickle cell diseaseHemoglobin sickle cell diseaseSickle cell crisisMetastatic diseasePainful crisesCell crisisBreast cancerAxillary lymph node dissectionPostmenopausal African-American womenLiver function test valuesLow-dose oxycodoneLymph node dissectionAxillary lymph nodesShortness of breathHistory of cancerSickle cell traitAfrican American womenRib painWeekly paclitaxelChemotherapy regimenNode dissectionSegmental mastectomyBone scanLeft breastLymph nodes
2006
A new measurement of residual cancer burden to predict survival after neoadjuvant chemotherapy
Symmans W, Peintinger F, Hatzis C, Kuerer H, Valero V, Hennessy B, Green M, Singletary E, Hortobagyi G, Pusztai L. A new measurement of residual cancer burden to predict survival after neoadjuvant chemotherapy. Journal Of Clinical Oncology 2006, 24: 536-536. DOI: 10.1200/jco.2006.24.18_suppl.536.Peer-Reviewed Original ResearchDistant relapse-free survivalResidual cancer burdenPathologic complete responseResidual diseaseComplete responsePathologic responseAJCC stageCancer burdenMultivariate Cox regression analysisRCB-3AJCC stage IIIHigh-risk patientsCox regression analysisNeoadjuvant chemotherapy trialsRelapse-free survivalDifferent prognostic groupsMedian followNeoadjuvant trialsPaclitaxel scheduleWeekly paclitaxelChemotherapy trialsNeoadjuvant chemotherapyPCR rateStrength of associationSurvival benefit
2005
Weekly Paclitaxel Improves Pathologic Complete Remission in Operable Breast Cancer When Compared With Paclitaxel Once Every 3 Weeks
Green MC, Buzdar AU, Smith T, Ibrahim NK, Valero V, Rosales MF, Cristofanilli M, Booser DJ, Pusztai L, Rivera E, Theriault RL, Carter C, Frye D, Hunt KK, Symmans WF, Strom EA, Sahin AA, Sikov W, Hortobagyi GN. Weekly Paclitaxel Improves Pathologic Complete Remission in Operable Breast Cancer When Compared With Paclitaxel Once Every 3 Weeks. Journal Of Clinical Oncology 2005, 23: 5983-5992. PMID: 16087943, DOI: 10.1200/jco.2005.06.232.Peer-Reviewed Original ResearchConceptsPrimary systemic chemotherapyWeekly paclitaxelLymph nodesBreast cancerClinical responseFrequent administrationPathologic complete response rateClinical N0 diseaseDoxorubicin/cyclophosphamidePathologic complete remissionSchedule of paclitaxelClinical stage IComplete response rateIIIA breast cancerOperable breast cancerBreast conservation ratesLymph node involvementInvasive breast cancerLymph node statusDoses of paclitaxelFine-needle aspirationN0 diseaseComplete remissionNode involvementSystemic chemotherapy
2004
Gene Expression Profiles Predict Complete Pathologic Response to Neoadjuvant Paclitaxel and Fluorouracil, Doxorubicin, and Cyclophosphamide Chemotherapy in Breast Cancer
Ayers M, Symmans W, Stec J, Damokosh A, Clark E, Hess K, Lecocke M, Metivier J, Booser D, Ibrahim N, Valero V, Royce M, Arun B, Whitman G, Ross J, Sneige N, Hortobagyi G, Pusztai L. Gene Expression Profiles Predict Complete Pathologic Response to Neoadjuvant Paclitaxel and Fluorouracil, Doxorubicin, and Cyclophosphamide Chemotherapy in Breast Cancer. Journal Of Clinical Oncology 2004, 22: 2284-2293. PMID: 15136595, DOI: 10.1200/jco.2004.05.166.Peer-Reviewed Original ResearchConceptsPathologic complete responseBreast cancerNeoadjuvant therapyClinical resultsPredictive valueCompletion of chemotherapySequential weekly paclitaxelComplete pathologic responseNeoadjuvant chemotherapy regimenPercent of patientsPatients' clinical resultsExpected response rateFine-needle aspirationNegative predictive valuePositive predictive valueNeoadjuvant paclitaxelChemotherapy regimenWeekly paclitaxelCyclophosphamide chemotherapyUnselected patientsComplete responsePathologic responseInvasive cancerResponse ratePatientsChanges in plasma levels of inflammatory cytokines in response to paclitaxel chemotherapy
Pusztai L, Mendoza TR, Reuben JM, Martinez MM, Willey JS, Lara J, Syed A, Fritsche HA, Bruera E, Booser D, Valero V, Arun B, Ibrahim N, Rivera E, Royce M, Cleeland CS, Hortobagyi GN. Changes in plasma levels of inflammatory cytokines in response to paclitaxel chemotherapy. Cytokine 2004, 25: 94-102. PMID: 14698135, DOI: 10.1016/j.cyto.2003.10.004.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsAnxietyBloodBreast NeoplasmsCyclophosphamideCytokinesData Interpretation, StatisticalDoxorubicinFatigueFemaleFluorouracilHumansInterleukin-1Interleukin-10Interleukin-12Interleukin-6Interleukin-8Middle AgedNauseaPaclitaxelPainPatient SelectionQuality of LifeTumor Necrosis Factor-alphaConceptsFlu-like symptomsIL-10 levelsIL-6IL-8IL-10Paclitaxel groupHealthy volunteersPaclitaxel chemotherapyJoint painIL-12Inflammatory cytokinesPlasma levelsTNF-alphaDay 3Single-agent paclitaxelBaseline cytokine levelsIL-8 levelsTransient side effectsHigh-dose treatmentWeekly paclitaxelCytokine levelsFAC chemotherapyMusculoskeletal symptomsCancer patientsIL-1beta