Article ; Online: Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE.
Annals of oncology : official journal of the European Society for Medical Oncology
2021 Volume 32, Issue 8, Page(s) 1005–1014
Abstract: Background: In the KATHERINE study (NCT01772472), patients with residual invasive early breast ... Patients and methods: KATHERINE enrolled HER2-positive EBC patients with residual invasive ...
| Abstract | Background: In the KATHERINE study (NCT01772472), patients with residual invasive early breast cancer (EBC) after neoadjuvant chemotherapy (NACT) plus human epidermal growth factor receptor 2 (HER2)-targeted therapy had a 50% reduction in risk of recurrence or death with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab. Here, we present additional exploratory safety and efficacy analyses. Patients and methods: KATHERINE enrolled HER2-positive EBC patients with residual invasive disease in the breast/axilla at surgery after NACT containing a taxane (± anthracycline, ± platinum) and trastuzumab (± pertuzumab). Patients were randomized to adjuvant T-DM1 (n = 743) or trastuzumab (n = 743) for 14 cycles. The primary endpoint was invasive disease-free survival (IDFS). Results: The incidence of peripheral neuropathy (PN) was similar regardless of neoadjuvant taxane type. Irrespective of treatment arm, baseline PN was associated with longer PN duration (median, 105-109 days longer) and lower resolution rate (∼65% versus ∼82%). Prior platinum therapy was associated with more grade 3-4 thrombocytopenia in the T-DM1 arm (13.5% versus 3.8%), but there was no grade ≥3 hemorrhage in these patients. Risk of recurrence or death was decreased with T-DM1 versus trastuzumab in patients who received anthracycline-based NACT [hazard ratio (HR) = 0.51; 95% confidence interval (CI): 0.38-0.67], non-anthracycline-based NACT (HR = 0.43; 95% CI: 0.22-0.82), presented with cT1, cN0 tumors (0 versus 6 IDFS events), or had particularly high-risk tumors (HRs ranged from 0.43 to 0.72). The central nervous system (CNS) was more often the site of first recurrence in the T-DM1 arm (5.9% versus 4.3%), but T-DM1 was not associated with a difference in overall risk of CNS recurrence. Conclusions: T-DM1 provides clinical benefit across patient subgroups, including small tumors and particularly high-risk tumors and does not increase the overall risk of CNS recurrence. NACT type had a minimal impact on safety. |
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| MeSH term(s) | Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Breast Neoplasms/drug therapy ; Female ; Humans ; Neoadjuvant Therapy ; Neoplasm Recurrence, Local/drug therapy ; Receptor, ErbB-2 ; Trastuzumab/adverse effects |
| Chemical Substances | Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) |
| Language | English |
| Publishing date | 2021-04-28 |
| Publishing country | England |
| Document type | Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 1025984-3 |
| ISSN | 1569-8041 ; 0923-7534 |
| ISSN (online) | 1569-8041 |
| ISSN | 0923-7534 |
| DOI | 10.1016/j.annonc.2021.04.011 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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