BOSTON, March 11, 2024 – A new combination therapy is offering significant hope for patients battling an aggressive form of breast cancer. Adding the drug palbociclib to standard treatment extended the time before disease progression by more than 15 months in individuals with “double-positive” metastatic breast cancer,according to research published today in the New England Journal of Medicine. It’s a substantial leap forward, and frankly, a welcome one in a field where resistance to existing treatments is a constant challenge.
Extending Progress: New Hope for double-Positive Breast Cancer
A phase 3 trial shows a significant advancement in progression-free survival with the addition of palbociclib to standard care.
- Approximately 10% of breast cancers are hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+).
- The PATINA study demonstrated a median progression-free survival of 44.3 months with palbociclib, compared to 29.1 months without.
- Common side effects were manageable, primarily involving blood cell counts, fatigue, and mild digestive issues.
- Overall survival data is still being collected and analyzed.
The results were striking. The median progression-free survival reached 44.3 months for patients treated with palbociclib alongside anti-HER2 therapy (either trastuzumab or trastuzumab plus pertuzumab) and endocrine therapy. in contrast, patients receiving anti-HER2 therapy and endocrine therapy alone experienced a median progression-free survival of 29.1 months – an extension of over 15 months with the addition of palbociclib.
“This publication in the New England Journal of medicine underscores the importance of these findings for the global breast cancer community,” saeid Otto Metzger, MD, Principal Investigator of PATINA and Associate Medical Director of International strategic Initiatives at Dana-Farber Cancer Institute. “The ability to meaningfully extend progression-free survival with a well-tolerated regimen offers new hope for individuals living with this challenging subtype of metastatic breast cancer.”
The safety profile of palbociclib in the PATINA study aligned with what’s already known from its use in HR+, HER2-negative metastatic breast cancer, and no previously unseen safety concerns emerged.The most frequently observed side effects were related to blood cell counts, including neutropenia and leukopenia. Other side effects, such as fatigue, stomatitis, and diarrhea, were generally mild to moderate in severity.
the PATINA study was sponsored by Alliance Foundation Trials, LLC (AFT) in collaboration with cancer research groups in the U.S., France, Germany, Italy, Spain, Australia, and New Zealand. Funding was provided by Pfizer.
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