Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
33932503
DOI
10.1016/j.annonc.2021.04.011
PII: S0923-7534(21)01168-6
Knihovny.cz E-zdroje
- Klíčová slova
- HER2, adjuvant, peripheral neuropathy, residual invasive early breast cancer, thrombocytopenia,
- MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie MeSH
- nádory prsu * farmakoterapie MeSH
- neoadjuvantní terapie * MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky MeSH
- receptor erbB-2 MeSH
- trastuzumab škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- receptor erbB-2 MeSH
- trastuzumab MeSH
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.
AGO B and Department of Gynecologic Oncology HELIOS Klinikum Berlin Buch Berlin Germany
AGO B and Klinikum Esslingen Esslingen Germany
Breast Cancer Department Institut Gustave Roussy Villejuif France
Department of Biostatistics F Hoffmann La Roche Basel Switzerland
Department of Clinical Oncology Centro Hemato Oncologico Panama City Panama
Department of Oncology Charles University and General University Hospital Prague Czech Republic
Department of Radiology and Oncology Instituto do Câncer do Estado de São Paulo São Paulo Brazil
Division of Medical Oncology Azienda Ospedaliero Universitaria Pisana Pisa Italy
GBG Neu Isenburg Germany; Center for Haematology and Oncology Bethanien Frankfurt Germany
GBG Neu Isenburg Germany; Marien Hospital Witten SEG Witten Germany
GBG Neu Isenburg Germany; St Johannes Hospital Dortmund Dortmund Germany
NSABP Foundation and; Department of Surgery Orlando Health UF Health Cancer Center Orlando USA
NSABP Foundation and; NSABP Foundation and Stanford University School of Medicine Stanford USA
Oncology Division Sheba Medical Center Tel Hashomer Ramat Gan Israel
Product Development Oncology Genentech Inc South San Francisco USA
Product Development Safety Genentech Inc South San Francisco USA
Yale University School of Medicine Yale Cancer Center and Smilow Cancer Hospital New Haven USA
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