2017
DOI: 10.1016/s1470-2045(17)30312-1
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Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial

Abstract: Summary Background The antibody–drug conjugate trastuzumab emtansine is indicated for the treatment of patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Approval of this drug was based on progression-free survival and interim overall survival data from the phase 3 EMILIA study. In this report, we present a descriptive analysis of the final overall survival data from that trial. Methods EMILIA was a randomised, international, open-label, phase 3 study of m… Show more

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Cited by 529 publications
(488 citation statements)
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“…With a median follow-up of 19 months, treatment with T-DM1 improved PFS from 6.4 months to 9.6 months in the control arm with an absolute gain of 3.2 months (hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.55-0.77; p < 0.001). Most importantly, patients in the T-DM1 arm experienced prolonged OS of 4.0 months (29.9 vs. 25.9 months; HR 0.75; p < 0.001) [25]. Moreover, the ORR was also improved with T-DM1 (44 vs. 31%; p < 0.001), mainly due to the greater number of partial responses.…”
Section: Phase III Trialsmentioning
confidence: 97%
See 1 more Smart Citation
“…With a median follow-up of 19 months, treatment with T-DM1 improved PFS from 6.4 months to 9.6 months in the control arm with an absolute gain of 3.2 months (hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.55-0.77; p < 0.001). Most importantly, patients in the T-DM1 arm experienced prolonged OS of 4.0 months (29.9 vs. 25.9 months; HR 0.75; p < 0.001) [25]. Moreover, the ORR was also improved with T-DM1 (44 vs. 31%; p < 0.001), mainly due to the greater number of partial responses.…”
Section: Phase III Trialsmentioning
confidence: 97%
“…Originally, the primary endpoint of the study was PFS assessed by an independent review panel, but later with data still masked, overall survival (OS) was included as a co-primary efficacy endpoint [25]. With a median follow-up of 19 months, treatment with T-DM1 improved PFS from 6.4 months to 9.6 months in the control arm with an absolute gain of 3.2 months (hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.55-0.77; p < 0.001).…”
Section: Phase III Trialsmentioning
confidence: 99%
“…One such example is in breast cancer, where the antibody-drug conjugate T-DM1, a combination of the HER2-targeting antibody trastuzumab with the microtubule-inhibiting chemotherapeutic agent DM1 (emtansine), has been used to deliver cytotoxic therapy directly to breast cancer cells while avoiding the severe adverse event profile often associated with chemotherapy (Verma et al, 2012). In patients with metastatic breast cancer who were resistant to trastuzumab, T-DM1 significantly prolonged time to progression and resulted in an improvement in OS of 4 months compared to lapatinib and capecitabine (29.9 months vs 25.9 months; HR 0.75) (Diéras et al, 2017). T-DM1 is now approved as a treatment for metastatic breast cancer that has progressed on first-line trastuzumab-based therapy.…”
Section: Biological Insights Into Improved Her2 Targetingmentioning
confidence: 99%
“…Patients with luminal breast cancer often have a better prognosis, whereas those with HER2‐enriched or basal‐like types have a poorer prognosis. For HER2‐positive breast cancers, the monoclonal antibody, trastuzumab and the dual tyrosine dual kinase inhibitor, lapatinib, were approved . Because of the heterogeneity of breast cancer, multiple gene prognostic signatures could provide further prognostic information, and several molecular prognostic profiles have been validated for clinical use .…”
Section: Introductionmentioning
confidence: 99%