2022
Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effects
2009
Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy
Ryan P, Tung N, Isakoff S, Golshan M, Richardson A, Corben A, Smith B, Gelman R, Winer E, Garber J. Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy. Journal Of Clinical Oncology 2009, 27: 551-551. DOI: 10.1200/jco.2009.27.15_suppl.551.Peer-Reviewed Original ResearchTriple-negative breast cancerClinical partial responseClinical complete responseNeoadjuvant cisplatinNeoadjuvant therapyPulmonary embolismBreast cancerStable diseaseProgressive diseasePathological responseHearing lossWeeks x 4 cyclesTreatment of TNBCSingle-arm phase II trialArm phase II trialCycles of bevacizumabEfficacy of bevacizumabGrade 4 toxicityComplete pathological responseAddition of bevacizumabPhase II trialMetastatic breast cancerEfficacy of chemotherapyNegative breast cancerTissue-based assays