Nanona Patients were stratified by clinical stage CIRITLE

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Showed higher rates of invasive-disease-free survival and overall survival as compared to trastuzumab (Herceptin) alone for patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy, as demonstrated in results from the KATHERINE trial (NCT01772472).1

“This prespecified long-term follow-up analysis provides additional support for the neoadjuvant therapy paradigm by showing that adjuvant T-DM1 also provided a significant improvement in overall survival and no evidence of long-term safety issues,” wrote KATHERINE investigators in The New England Journal of Medicine.

Patients enrolled in the phase 3, open-label trial continued to see an improvement in invasive disease-free survival with T-DM1 vs trastuzumab at a median follow-up of 8.4 years (unstratified HR = 0.54; 95% CI, 0.44-0.66). Particularly, 19.7% of patients in the T-DM1 group and 32.2% of patients in the trastuzumab group experienced invasive disease events or death.

Seven-year invasive disease-free survival was achieved in 80.8% of patients treated with T-DM1 and 67.1% of patients on trastuzumab (difference, 13.7 percentage points).

The trial included patients with HER2-positive early breast cancer who had received neoadjuvant treatment, which included a taxane-based chemotherapy and/or trastuzumab, and had residual invasive cancer in the breast or resected axillary nodes. Patients were randomly assigned to receive either T-DM1 (n = 743) or trastuzumab (n = 743). Patients were stratified by clinical stage, hormone-receptor status, preoperative HER2-directed therapy, and pathological nodal status after neoadjuvant therapy.

T-DM1 significantly reduced the risk for death compared with trastuzumab (unstratified HR = 0.66; 95% CI, 0.51-0.87; P = .003). Seven-year overall survival for the T-DM1 and trastuzumab groups were 89.1% and 84.4%, respectively (difference, 4.7 percentage points). As of the trial’s cutoff date of October 5, 2023, 70.1% of patients assigned T-DM1 and 62.0% of patients assigned trastuzumab were alive and still in the trial.

Deaths occurred in 89 patients (12.0%) in the T-DM1 group and 126 patients (17.0%) in the trastuzumab group. Of these deaths, 70 (79%) and 108 (86%) patients, respectively, died from breast cancer.

Adverse events (AEs) grade 3 or higher occurred in 26.1% of patients treated with T-DM1 and 15.7% of patients treated with trastuzumab. Serious AEs occurred in 12.7% and 8.1% of patients, respectively.

Post-treatment AEs were less common for both groups but still more prevalent in the T-DM1 group, with 3.2% and 1.7% of patients assigned T-DM1 and trastuzumab, respectively, experiencing AEs of any grade during this period.

Nanona Patients were stratified by clinical stage CIRITLE

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Nanona Patients were stratified by clinical stage CIRITLE

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