DESTINY-Breast04 Subgroup Analyses: Efficacy Results (January 11, 2022 DCO Date)1,2
PFS Subgroup Analysis by BICR (HR Positive Cohort)
PFS Subgroup Analyses in All Patients (HR Positive and HR Negative)
PFS by Prior CDK4/6i Use
PFS is Patients With 1 and ≥2 Prior Lines of Chemotherapy
PFS in Patients With HER2 Statuses of IHC 1+ and IHC 2+/ISH−
ORR in the HR Positive Cohort and in All Patients
PFS Subgroup Analysis by BICR (HR Positive Cohort)1
PFS Subgroup Analysis by BICR (HR Positive Cohort).1,a
PFS Subgroup Analysis by BICR (HR Positive Cohort).1,a
aBased on derived data which includes protocol deviations.
PFS Subgroup Analyses in All Patients (HR Positive and HR Negative)2
PFS Subgroup Analyses in All Patients (HR Positive and HR Negative).2
PFS Subgroup Analyses in All Patients (HR Positive and HR Negative).2
Note: Dashed line at 0.50 represents median PFS for all patients.
aMedian PFS is from Kaplan-Meier analysis. CI for median was computed using the Brookmeyer-Crowley method; bHazard ratio is from unstratified Cox proportional hazards model with treatment as the only covariate; cDisease burden was defined by the number of metastatic disease sites at baseline (low = 0-2; high = 3+). At baseline, 69.8% of patients had liver metastases; dRapid progressor status was defined as disease progression within 6 months of concluding a prior course of chemotherapy in early BC; eDefined as prior anticancer therapy of ‘anthracyclines,’ ‘doxorubicin,’ ‘epirubicin,’ ‘daunorubicin,’ or ‘idarubicin’ in CMDECOD and CMTRT in ADCM.
PFS by Prior CDK4/6i Use2
PFS is Patients With 1 and ≥2 Prior Lines of Chemotherapy2
PFS in Patients With HER2 Statuses of IHC 1+ and IHC 2+/ISH−2
ORR in the HR Positive Cohort and in All Patients2
ORR in the HR Positive Cohort and in All Patients.2
ORR in the HR Positive Cohort and in All Patients.2
aSubgroup analyses presented only if at least 10 observations in each group; bDisease burden was defined by the number of metastatic disease sites at baseline (low = 0-2; high = 3+). At baseline, 69.8% of patients had liver metastases; cRapid progressor status was defined as disease progression within 6 months of concluding a prior course of chemotherapy in early BC; dAmong patients with rapid progression, 18 were HR+ and 4 were HR-; eDefined as prior anticancer therapy of 'anthracyclines,' 'doxorubicin,' 'epirubicin,' 'daunorubicin,' or 'idarubicin' in CMDECOD and CMTRT in ADCM.
Abbreviations
ADCM = antibody-drug conjugated micelle
;BC = breast cancer
;BICR = blinded independent central review
;CDK4/6i = cyclin-dependent kinase 4/6 inhibitor
;CMDECOD = generic medication name in WHODrug (World Health Organization’s global dictionary)
;CMTRT = verbatim medication name that is either pre-printed or collected on a case report form
;CNS = central nervous system
;CR = complete response
;DCO = data cut-off
;ECOG = Eastern Cooperative Oncology Group
;HER2 = human epidermal growth factor receptor 2
;HR = hormone receptor
;IHC = immunohistochemistry
;ISH = in situ hybridization
;mPFS = median progression-free survival
;mo = months
;ORR = objective response rate
;PFS = progression-free survival
;PR = partial response
;T-DXd = trastuzumab deruxtecan
;TPC = treatment of physician's choice
References
Document ID: 0ecc6373-81f6-4b23-8e10-3edcd30e370b
Last updated: 06-March-2023
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