Results of an interim analysis from KATHERINE trial


We are delighted to inform you that the results of an interim analysis from KATHERINE, a phase III open-labeled trial, have been published in the New England Journal of Medicine.

The KATHERINE study aimed to investigate whether adjuvant T-DM1 was more effective than trastuzumab in patients with HER2-positive primary breast cancer who have received neoadjuvant chemotherapy including trastuzumab and have residual invasive disease after surgery. A total of 1486 patients (743 in the T-DM1 group and 743 in the trastuzumab group) were included in the interim analysis. An invasive disease or death had occurred in 91 patients in the T-DM1 group and in 165 in the trastuzumab group. 3-years invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab group (88.3% vs 77.0% respectively, hazard ratio 0.50 [95%CI 0.39-0.64]; p<0.001). Thus, the risk of recurrence of invasive disease or death was 50% lower with adjuvant T-DM1 than with trastuzumab alone among patients with HER2-positive early breast cancer who had residual invasive disease after completion of neoadjuvant chemotherapy plus HER2-targeted therapy. In terms of toxicity, a higher percentage of patients had adverse events in the T-DM1 group than in the trastuzumab group.

von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wülfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2018 Dec 5. [Epub ahead of print].

Link in PubMed


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