ADCs in Endocrine-Refractory Breast Cancer Treatment
Here’s a breakdown of the key details from the text, organized by the questions asked:
1. Updates in NCCN Guidelines for Endocrine-Refractory Breast Cancer:
Trastuzumab deruxtecan (T-DXd) is now a Category 1 preferred agent in the first-line setting for patients with HER2-low disease, according too the NCCN guidelines.
This applies to patients considered endocrine refractory, not just those in immediate crisis.
2. Trial Data Supporting Sacituzumab Use:
TROPiCS-02 (NCT03901339) was a Phase 3 study evaluating sacituzumab vs. physician’s choice chemotherapy (eribulin, capecitabine, vinorelbine, gemcitabine) in metastatic hormone receptor-positive, HER2-negative patients. Patient Population: Patients had progressed after at least one endocrine therapy, a taxane, and a CDK4/6 inhibitor, and had received 2-4 prior lines of chemotherapy.
Primary Endpoint: Progression-Free Survival (PFS)
Results:
Sacituzumab showed a statistically important improvement in median PFS: 5.5 months vs. 4.0 months with chemotherapy.
Overall Survival (OS) was also significantly improved with sacituzumab: 14.4 months vs.11.2 months (HR 0.79, 95% CI 0.65-0.96,P = .020).
3. Sacituzumab Tolerability in the Trial:
Treatment-emergent adverse events (AEs) were generally well-balanced, but there were slightly more Grade 3 AEs, as well as more dose delays and reductions with sacituzumab.
No new safety signals were identified with extended follow-up.
* Key AEs to be mindful of: Neutropenia.