Trastuzumab Deruxtecan in HER2-Low Advanced Breast Cancer | NEJM
Summary
TLDRThis phase 3 study investigates the efficacy of trastuzumab deruxtecan in patients with HER2 low metastatic breast cancer. Involving 557 participants, the trial demonstrated that trastuzumab deruxtecan significantly improved median progression-free survival to 10.1 months, compared to 5.4 months with standard chemotherapy. Overall survival rates also showed marked improvement. While adverse events, particularly neutropenia, were common, 12% of patients experienced drug-related interstitial lung disease, mostly mild. The findings suggest trastuzumab deruxtecan offers substantial benefits for this patient population, highlighting its potential as a key treatment option.
Takeaways
- 😀 A significant proportion of HER2-negative metastatic breast cancers are categorized as HER2 low, with low levels of HER2 expression.
- 😀 Current HER2-directed therapies are not effective for patients with low HER2 expression.
- 😀 A new study evaluated the efficacy and safety of trastuzumab deruxtecan in patients with previously treated HER2 low metastatic breast cancer.
- 😀 The study was a phase 3 open-label randomized trial involving 557 patients.
- 😀 Patients were classified based on a HER2 score of 1+ or 2+ without gene amplification.
- 😀 Participants were assigned to receive trastuzumab deruxtecan or a physician's choice of chemotherapy in a 2:1 ratio.
- 😀 The primary endpoint, median progression-free survival for hormone receptor-positive cancer, was significantly longer with trastuzumab deruxtecan (10.1 months) compared to chemotherapy (5.4 months).
- 😀 Overall survival rates in hormone receptor-positive patients improved significantly with trastuzumab deruxtecan.
- 😀 Common adverse events included grade 3 or higher neutropenia in both treatment groups.
- 😀 Drug-related interstitial lung disease or pneumonitis occurred in 12% of trastuzumab deruxtecan patients, most presenting as mild or moderate illness.
Q & A
What type of breast cancer is the study focused on?
-The study focuses on HER2 low metastatic breast cancer.
What defines HER2 low expression in this context?
-HER2 low expression is defined as a score of 1+ on immunohistochemical analysis or 2+ with no gene amplification.
What was the primary treatment being evaluated in the study?
-The primary treatment evaluated was trastuzumab deruxtecan.
How many patients participated in the trial?
-A total of 557 patients participated in the trial.
What was the median progression-free survival for patients treated with trastuzumab deruxtecan?
-The median progression-free survival for those treated with trastuzumab deruxtecan was 10.1 months.
How did the progression-free survival compare with the physician's choice of chemotherapy?
-The progression-free survival with chemotherapy was 5.4 months, significantly lower than with trastuzumab deruxtecan.
What were the key secondary endpoints measured in the study?
-Key secondary endpoints included overall survival in hormone receptor positive patients and progression-free survival in all patients.
What adverse events were noted in the study?
-Grade three or higher adverse events, particularly neutropenia, were noted, along with 12% of patients experiencing drug-related interstitial lung disease.
What conclusion did the authors reach regarding trastuzumab deruxtecan?
-The authors concluded that trastuzumab deruxtecan significantly improved progression-free and overall survival in patients with previously treated HER2 low metastatic breast cancer.
Where can full trial results be found?
-Full trial results are available at nejm.org.
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