A research study showed the effectiveness of trastuzumab deruxtecan (Enhertu) in clients with HER2-positive sophisticated or metastatic breast cancer, consisting of those with brain metastases.
Senior author Nancy Lin, MD, provided these main outcomes of the DESTINY-Breast12 trial at the European Society for Medical Oncology Congress 2024. These findings were released concurrently in the journal Nature Medicine
Brain metastases are a considerable issue in HER2-positive breast cancer, impacting roughly half of clients with metastatic illness, stated Lin, of the Dana-Farber Cancer Institute in Boston. Historically, these clients have actually dealt with minimal treatment alternatives and bad diagnoses, she continued.
“Although tucatinib-based programs can be efficient, the mean progression-free survival in clients with brain metastases in the HER2CLIMB scientific trial was less than 8 months, and extra reliable treatment choices are required,” she stated. That trial compared tucatinib vs placebo in mix with capecitabine and trastuzumab in clients with innovative HER2+ breast cancer.
The DESTINY-Breast12 research study, a stage 3b/4 multicenter, open-label trial, intended to resolve this crucial unmet requirement.
Research Study Design and Patient Population
DESTINY-Breast12 registered 504 clients, with 263 in the brain metastases mate and 241 in the non-brain metastases friend. Clients got trastuzumab deruxtecan (T-DXd) at a dosage of 5.4 mg/kg intravenously every 3 weeks. The main endpoints were progression-free survival (PFS) for the brain metastases friend and unbiased action rate (ORR) for the non-brain metastases associate.
Lin discussed that of the 263 clients with brain metastases, 157 had steady brain metastases, and 106 had active brain metastases. Of the clients with active brain metastases, 39 had formerly unattended illness, and 67 had actually formerly dealt with however progressive illness at research study entry.
The research study consisted of clients who had actually gotten absolutely no to 2 previous lines of treatment in the metastatic setting, with an Eastern Cooperative Oncology Group (ECOG) efficiency status of 0 to 1. Lin highlighted that clients who got prior tucatinib-based treatment were left out. Around 2 thirds of clients had hormonal agent receptor-positive illness, and the bulk had quantifiable illness.
Cristina Saura Manich, MD, PhD, head of the Breast Cancer Unit of the Service of Medical Oncology at Vall d’Hebron University Hospital in Barcelona, highlighted the significance of this research study. “This not just supplied access to the drug in nations where it was not yet repaid, however likewise made it possible for specialists to get experience in handling the drug in the scientific trial setting.” She likewise kept in mind that the research study offers essential proof for a populatio