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
2008
Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease
Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. Preoperative Therapy in Invasive Breast Cancer: Pathologic Assessment and Systemic Therapy Issues in Operable Disease. Journal Of Clinical Oncology 2008, 26: 814-819. PMID: 18258991, DOI: 10.1200/jco.2007.15.3510.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsCongresses as TopicFemaleHumansMastectomy, SegmentalNational Cancer Institute (U.S.)Neoadjuvant TherapyNeoplasm, ResidualPatient Care TeamPatient SelectionPreoperative CareReceptor, ErbB-2Remission InductionUnited StatesConceptsOperable breast cancerPreoperative systemic therapyBreast conservation ratesSystemic therapyInvasive breast cancerBreast cancerTumor responsePreoperative therapyPathologic assessmentNational Cancer Institute StatePostoperative adjuvant systemic therapyInitial tumor responseAdjuvant systemic therapyPathologic complete responseSurrogate end pointsStandard of careMultimodality treatment programBreast cancer biologyAdjuvant settingOperable diseaseOverall survivalPreoperative chemotherapySystemic treatmentComplete responseLymph nodes