From the Guidelines
The KATHERINE trial demonstrated that adjuvant T-DM1 significantly improves invasive disease-free survival (IDFS) compared to trastuzumab in patients with HER2-positive breast cancer who have residual invasive disease after surgery, with a 50% reduction in the risk of recurrence 1.
Key Findings
- The trial showed that T-DM1 improved IDFS versus trastuzumab, with a hazard ratio of 0.50 (95% CI 0.39-0.64; p < 0.001) 1.
- The benefits of T-DM1 were apparent in all subgroups, regardless of the extent of residual disease, including those with node-negative disease and residual tumors <1 cm 1.
- The safety profile of T-DM1 was consistent with its known profile, including liver enzyme elevations and thrombocytopenia, with higher discontinuation rates due to adverse events compared to trastuzumab 1.
Treatment Implications
- Based on the KATHERINE trial, T-DM1 is a recommended treatment option for patients with HER2-positive breast cancer who have residual invasive disease after surgery, as it significantly improves IDFS and reduces the risk of recurrence 1.
- The trial's findings support the use of T-DM1 as a post-neoadjuvant therapy to optimize outcomes in women with residual disease, and its benefits are consistent regardless of HR status and previous anti-HER2 therapy 1.
From the Research
KATHERINE Trial Results
There are no research papers provided to directly answer the question about the KATHERINE trial results for breast cancer.
Alternative Studies
However, several studies are available that discuss the results of neratinib in HER2-positive breast cancer:
- The ExteNET trial showed that neratinib significantly improved 2-year invasive disease-free survival when given after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer 2.
- A 5-year analysis of the ExteNET trial demonstrated that neratinib reduced the proportion of clinically relevant breast cancer relapses without increasing the risk of long-term toxicity 3.
- Final efficacy results of the ExteNET trial indicated that neratinib significantly improved invasive disease-free survival in the HER2-positive/hormone receptor-positive population, particularly in those who initiated treatment ≤1 year post-trastuzumab 4.
- An exploratory analysis of the ExteNET trial in Asian patients showed that neratinib reduced disease recurrences in women with HER2-positive breast cancer 5.
- The final analysis of overall survival in the ExteNET trial found that neratinib and placebo had comparable overall survival rates after a median follow-up of 8.1 years in women with early-stage HER2-positive breast cancer 6.
Key Findings
Some key findings from these studies include:
- Neratinib improved invasive disease-free survival in HER2-positive breast cancer patients 2, 3, 4.
- Neratinib reduced the risk of breast cancer relapses without increasing long-term toxicity 3.
- The benefits of neratinib were more pronounced in certain subpopulations, such as those with hormone receptor-positive disease 4.
- Neratinib was effective in reducing disease recurrences in Asian patients with HER2-positive breast cancer 5.
- Overall survival rates were comparable between neratinib and placebo after a median follow-up of 8.1 years 6.