In patients suffering from metastatic triple-negative breast cancer, the progression-free and overall survival were found to be substantially longer with sacituzumab govitecan in comparison with single-agent chemotherapy, says a phase III study conducted by Aditya Bardia et al.
Investigators carried out a randomized trial to explore sacituzumab govitecan in comparison with single-agent chemotherapy of the clinician’s choice (capecitabine, eribulin, vinorelbine, or gemcitabine) in subjects suffering from relapsed or refractory metastatic triple-negative breast cancer. Progression-free survival among patients without brain metastases was the major outcome.
In total, 468 subjects (median age 54 years) without brain metastases were randomly allocated to either the sacituzumab govitecan group (n=235) or chemotherapy group (n=233). All the subjects had previous usage of taxanes. The median progression-free survival, the median overall survival, and the percentage of patients with an objective response were found to be greater in the sacituzumab govitecan group compared to the chemotherapy group, as depicted below:
Sacituzumab govitecan group | Chemotherapy group | |
Median progression-free survival | 5.6 months | 1.7 months |
Median overall survival | 12.1 months | 6.7 months |
% of patients with an objective response | 35% | 5% |
The occurrence of key therapy-associated side effects of grade 3 or higher were neutropenia, leukopenia, diarrhea, anemia, and febrile neutropenia.
Sacituzumab govitecan group | Chemotherapy group | |
Neutropenia | 51% | 33% |
Leukopenia | 10% | 5% |
Diarrhea | 10% | <1% |
Anemia | 8% | 5% |
Febrile neutropenia | 6% | 2% |
Notably, three deaths occurred owing to adverse effects in each group. However, no deaths were considered to be associated with sacituzumab govitecan therapy. In sacituzumab govitecan recipients, diarrhea and myelosuppression were found to be more frequent.
Thus, compared with single-agent chemotherapy, sacituzumab govitecan appears to yield remarkable benefit in individuals having relapsed or refractory metastatic triple negative breast cancer in terms of overall survival and progression-free survival.
Also read, Alpelisib and Margetuximab receive FDA Approval to treat breast cancer.
Source | The New England Journal of Medicine |
Link: | https://www.nejm.org/doi/full/10.1056/NEJMoa2028485 |
Original title of the article | Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer |
Authors: | Aditya Bardia et al. |
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