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
2006
The impact of tumor progesterone receptor status on optimal adjuvant endocrine therapy for postmenopausal patients with early‐stage breast cancer
Punglia RS, Kuntz KM, Winer EP, Weeks JC, Burstein HJ. The impact of tumor progesterone receptor status on optimal adjuvant endocrine therapy for postmenopausal patients with early‐stage breast cancer. Cancer 2006, 106: 2576-2582. PMID: 16703595, DOI: 10.1002/cncr.21919.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantCross-Over StudiesDecision Support TechniquesDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMarkov ChainsMiddle AgedModels, StatisticalModels, TheoreticalNeoplasm StagingOdds RatioPostmenopauseRandomized Controlled Trials as TopicReceptors, ProgesteroneTamoxifenTime FactorsTreatment OutcomeConceptsDisease-free survivalAromatase inhibitorsProgesterone receptorEstrogen receptorOptimal adjuvant endocrine therapyEarly-stage breast cancerAdjuvant endocrine therapyNode-positive groupProgesterone receptor statusRandomized clinical trialsSequential treatmentBreast cancer tumorsAI monotherapyAI therapyBiologic subsetsDFS ratesAdjuvant therapyEndocrine therapyPostmenopausal patientsPostmenopausal womenSequential therapyUpfront treatmentLymph nodesReceptor statusPR expression