2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trials
2017
De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017
Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, Colleoni M, Regan MM, Piccart-Gebhart M, Senn H, Thürlimann B, André F, Baselga J, Bergh J, Bonnefoi H, Brucker S, Cardoso F, Carey L, Ciruelos E, Cuzick J, Denkert C, Di Leo A, Ejlertsen B, Francis P, Galimberti V, Garber J, Gulluoglu B, Goodwin P, Harbeck N, Hayes D, Huang C, Huober J, Khaled H, Jassem J, Jiang Z, Karlsson P, Morrow M, Orecchia R, Osborne K, Pagani O, Partridge A, Pritchard K, Ro J, Rutgers E, Sedlmayer F, Semiglazov V, Shao Z, Smith I, Toi M, Tutt A, Viale G, Watanabe T, Whelan T, Xu B. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Annals Of Oncology 2017, 28: 1700-1712. PMID: 28838210, PMCID: PMC6246241, DOI: 10.1093/annonc/mdx308.Peer-Reviewed Original ResearchConceptsLow-risk patientsBreast cancerNeoadjuvant therapyPostmenopausal womenEarly-stage breast cancerER-positive breast cancerAvoidance of chemotherapyDe-escalate therapyAdjuvant endocrine treatmentRegional nodal irradiationHigh-risk patientsEarly breast cancerSentinel node biopsyHigh-risk tumorsPositive breast cancerBreast cancer recurrenceExpert consensus conferenceSubstantial new evidenceNodal irradiationBisphosphonate useEndocrine treatmentNeoadjuvant treatmentOvarian suppressionPremenopausal womenPrimary therapy