2024
Completion Rate and Positive Results Reporting Among Immunotherapy Trials in Breast Cancer, 2004-2023
Mariani M, Viale G, Galbardi B, Licata L, Bosi C, Dugo M, Notini G, Naldini M, Callari M, Criscitiello C, Pusztai L, Bianchini G. Completion Rate and Positive Results Reporting Among Immunotherapy Trials in Breast Cancer, 2004-2023. JAMA Network Open 2024, 7: e2423390. PMID: 39028669, PMCID: PMC11259908, DOI: 10.1001/jamanetworkopen.2024.23390.Peer-Reviewed Original ResearchConceptsCross-sectional studyPhase III trialsIII trialsBreast cancerImmunotherapy trialsLandscape of breast cancerPhase II studyPhase II trialPhase I trialSingle-center studySingle-center trialCancer immunotherapy trialsBreast cancer trialsPatient confidenceMain OutcomesFisher's exact testImmuno-oncology trialsTrial featuresProportion of trialsCompletion ratesAdjuvant settingPhase IIReport outcomesII trialPositive resultsNeoadjuvant 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
Treatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials?
Chehayeb R, Kahn A, Pusztai L. Treatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials? Future Oncology 2023, 19: 1945-1951. PMID: 37767612, DOI: 10.2217/fon-2022-1203.Peer-Reviewed Original ResearchExcellent long-term survivalNeoadjuvant breast cancer trialsResidual cancer burden scorePathologic complete responseBreast cancer trialsLong-term survivalNeoadjuvant chemotherapyPathologic responseComplete responseSurvival improvementBurden scoreResidual diseaseTrial armsSurvival differencesCancer trialsBreast cancerTreatment efficacyStage IIGood surrogateEfficacy scoresTrialsSurvivalScoresRate differencesChemotherapy
2022
Treatment Efficacy Score—continuous residual cancer burden-based metric to compare neoadjuvant chemotherapy efficacy between randomized trial arms in breast cancer trials
Marczyk M, Mrukwa A, Yau C, Wolf D, Chen Y, Balassanian R, Nanda R, Parker B, Krings G, Sattar H, Zeck J, Albain K, Boughey J, Liu M, Elias A, Clark A, Venters S, Shad S, Basu A, Asare S, Buxton M, Asare A, Rugo H, Perlmutter J, DeMichele A, Yee D, Berry D, Veer L, Symmans W, Esserman L, Pusztai L, Consortium I. Treatment Efficacy Score—continuous residual cancer burden-based metric to compare neoadjuvant chemotherapy efficacy between randomized trial arms in breast cancer trials. Annals Of Oncology 2022, 33: 814-823. PMID: 35513244, DOI: 10.1016/j.annonc.2022.04.072.Peer-Reviewed Original ResearchConceptsTrial armsExperimental armSurvival differencesExact testPathologic complete response rateClinical trial armsI-SPY2 trialNeoadjuvant chemotherapy efficacyComplete response rateBreast cancer trialsCytotoxic efficacyFisher's exact testImpact of treatmentNeoadjuvant chemotherapyPCR ratePathologic responseResidual cancerControl cohortCancer trialsAssessed associationsChemotherapy efficacyEarly surrogateOlaparib armResponse rateHigher cytotoxic efficacy
2021
Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer
Symmans WF, Yau C, Chen YY, Balassanian R, Klein ME, Pusztai L, Nanda R, Parker BA, Datnow B, Krings G, Wei S, Feldman MD, Duan X, Chen B, Sattar H, Khazai L, Zeck JC, Sams S, Mhawech-Fauceglia P, Rendi M, Sahoo S, Ocal IT, Fan F, LeBeau LG, Vinh T, Troxell ML, Chien AJ, Wallace AM, Forero-Torres A, Ellis E, Albain KS, Murthy RK, Boughey JC, Liu MC, Haley BB, Elias AD, Clark AS, Kemmer K, Isaacs C, Lang JE, Han HS, Edmiston K, Viscusi RK, Northfelt DW, Khan QJ, Leyland-Jones B, Venters SJ, Shad S, Matthews JB, Asare SM, Buxton M, Asare AL, Rugo HS, Schwab RB, Helsten T, Hylton NM, van ’t Veer L, Perlmutter J, DeMichele AM, Yee D, Berry DA, Esserman LJ. Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer. JAMA Oncology 2021, 7: 1654-1663. PMID: 34529000, PMCID: PMC8446908, DOI: 10.1001/jamaoncol.2021.3690.Peer-Reviewed Original ResearchConceptsEvent-free survivalPathologic complete responseResidual cancer burdenInvestigational agentsInvestigational treatmentBreast cancerInterpretation of efficacyNeoadjuvant treatmentCancer burdenClinical trialsImproved event-free survivalNeoadjuvant breast cancer trialsStage 2/3 breast cancerHigh-risk breast cancerHormone receptorsI-SPY2 trialSecondary end pointsBreast cancer trialsEffective neoadjuvant treatmentI-SPY2Neoadjuvant paclitaxelNeoadjuvant trialsComplete responseEarly recurrencePrognostic significance
2011
Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types
Loi S, Symmans WF, Bartlett J, Fumagalli D, Veer L, Forbes JF, Bedard P, Denkert C, Zujewski J, Viale G, Pusztai L, Esserman LJ, Leyland-Jones BR. Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types. The Lancet Oncology 2011, 12: 1162-1168. PMID: 21684810, DOI: 10.1016/s1470-2045(11)70117-6.Peer-Reviewed Original ResearchConceptsNorth American Breast Cancer GroupBreast International GroupClinical trialsBiopsy procedureNeoadjuvant breast cancer trialsNeoadjuvant clinical trialsBreast cancer clinical trialsBreast cancer groupBreast cancer trialsStart of treatmentCancer clinical trialsNational Cancer InstituteNeoadjuvant trialsDefinitive surgeryNeoadjuvant treatmentCancer groupStudy protocolCancer trialsBreast cancerCancer InstituteUniform collectionTumor tissueBlood collectionTrialsSpecimen types