Patient-reported outcomes from the TBCRC 022 study of neratinib and ado-trastuzumab emtansine for HER2-positive breast cancer brain metastases.
BreastJul 20, 2026 (epub)
Thomas Grinda, Hillary M Heiling, Nabihah Tayob et al.
✦ AI-curated · Sources linked
In 30 seconds
The TBCRC 022 study, a Phase II multicenter clinical trial, evaluated the gastrointestinal toxicities of neratinib and ado-trastuzumab emtansine in patients with HER2-positive breast cancer brain metastases. Patient-reported outcomes indicated a significant increase in GI symptoms, with a peak mean increase of 6.62 in PROMIS scores by Cycle 3 (p = 0.002).
Key findings
- GI symptom burden increased significantly over Cycles 1-3.
- PROMIS scores worsened by a mean of 6.62 by Cycle 3 (95% CI: 2.67-10.59; p = 0.002).
- Moderate-to-severe diarrhea was reported by 20.5% of patients.
- Agreement between PRO-CTCAE and clinician-reported CTCAE was low (kappa <0.2).
Why it matters
Understanding patient-reported outcomes is crucial for accurately assessing treatment-related toxicities, which can significantly affect quality of life. This study emphasizes the need for incorporating patient perspectives in clinical evaluations.