Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE

. 2021 Aug ; 32 (8) : 1005-1014. [epub] 20210428

Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic

Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid33932503
Odkazy

PubMed 33932503
DOI 10.1016/j.annonc.2021.04.011
PII: S0923-7534(21)01168-6
Knihovny.cz E-zdroje

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

Breast Unit Kliniken Essen Mitte Essen Germany; Klinik für Gynäkologie mit Brustzentrum Charité Universitätsmedizin Berlin Berlin Germany

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

Department of Surgery National Taiwan University Hospital and National Taiwan University College of Medicine Taipei Taiwan

Division of Hematology Oncolog Taichung Veterans General Hospital and School of Medicine China Medical University Taichung City Taiwan

Division of Medical Oncology Azienda Ospedaliero Universitaria Pisana Pisa Italy

GBG Neu Isenburg Germany

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

ICANS Strasbourg France

NSABP Foundation and; Department of Surgery Orlando Health UF Health Cancer Center Orlando USA

NSABP Foundation and; NSABP Foundation and Department of Hematology Oncology Kaiser Permanente San Diego USA

NSABP Foundation and; NSABP Foundation and Department of Internal Medicine Division of Hematology and Medical Oncology Houston Methodist Cancer Center Houston USA

NSABP Foundation and; NSABP Foundation and Department of Medical Oncology Providence Cancer Institute Portland USA

NSABP Foundation and; NSABP Foundation and Department of Surgery The University of Pittsburgh Pittsburgh USA

NSABP Foundation and; NSABP Foundation and Division of Hematology Oncology Department of Medicine University of Pittsburgh Pittsburgh 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 Oncology Genentech Inc South San Francisco USA; Seattle Genetics 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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