Researchers from the Dana-Farber Most cancers Institute and worldwide analysis teams have revealed information in The New England Journal of Drugs exhibiting that including the treatment Ibrance (palbociclib) to upkeep remedy considerably extends the time sufferers with double-positive metastatic breast most cancers stay with out their illness progressing.
The section 3 PATINA trial discovered that including Ibrance to the present standard-of-care first-line upkeep remedy resulted in a 15.2-month enchancment in progression-free survival, or the time sufferers lived with out their illness spreading or worsening, in sufferers with hormone receptor-positive (HR+), human epidermal progress issue receptor 2-positive (HER2+) metastatic breast most cancers. The findings, initially introduced throughout a late-breaking oral session on the forty seventh San Antonio Breast Most cancers Symposium in December 2024, deal with a selected subtype that accounts for roughly 10% of all breast cancers.
Major information that help the findings
The ultimate outcomes of the PATINA research display that the addition of Ibrance to upkeep anti-HER2 and endocrine therapies led to a major enchancment in progression-free survival in comparison with customary remedy. Sufferers handled with the Ibrance mixture skilled a median progression-free survival of 44.3 months. In distinction, sufferers handled with anti-HER2 remedy and endocrine remedy alone skilled a median progression-free survival of 29.1 months.
This extension in median progression-free survival represents an enchancment of over 15 months.
On the time of this evaluation, which occurred at a median follow-up of 53.5 months, the information for general survival weren’t but mature. Principal investigator Dr. Otto Metzger famous in a information launch issued by Dana-Farber Most cancers Institute that the power to meaningfully prolong the time earlier than illness development with a well-tolerated routine affords new hope for people dwelling with this difficult subtype of metastatic breast most cancers, the place the event of resistance to anti-HER2 and endocrine remedy stays a problem.
Trial particulars
PATINA was a section 3, open-label, randomized trial that enrolled sufferers with HR-positive, HER2-positive metastatic breast most cancers. To take part, sufferers should not have had illness development after receiving 4 to eight cycles of preliminary chemotherapy plus HER2-targeted remedy.
A complete of 518 sufferers underwent randomization, with 261 sufferers assigned to the Ibrance group to obtain upkeep HER2-targeted and endocrine therapies plus Ibrance and 257 sufferers assigned to the standard-therapy group to obtain upkeep HER2-targeted and endocrine therapies alone.
The upkeep anti-HER2 remedy used within the trial included Herceptin or a mixture of Herceptin and Perjeta. Ibrance is a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4/6). Preclinical and scientific information steered that including this inhibitor may overcome resistance to each endocrine and HER2-directed therapies.
Security
The protection and tolerability of Ibrance within the PATINA research was per its identified profile in HR-positive, HER2-negative metastatic breast most cancers, and researchers recognized no new security alerts. Nonetheless, the research did discover that the Ibrance group had elevated poisonous results in comparison with the standard-therapy group.
Grade 3 (extreme) and 4 (life-threatening) unwanted side effects occurred in 79.7% and 10% of sufferers within the Ibrance group, respectively. As compared, 30.6% and three.6% of sufferers within the standard-therapy group skilled grade 3 and 4 occasions. The most typical adversarial occasions had been hematologic toxicities, primarily neutropenia and leukopenia, or low white blood cell counts.
Non-hematologic adversarial occasions included fatigue, stomatitis and diarrhea. These unwanted side effects had been typically reported as gentle to reasonable in severity. Whereas the addition of Ibrance led to a better fee of poisonous results, particularly neutropenia, the routine was characterised by researchers as well-tolerated for sufferers with this particular subtype of metastatic breast most cancers.
References
- “Palbociclib for Hormone-Receptor–Constructive, HER2-Constructive Superior Breast Most cancers” by Dr. Otto Metzger et al., The New England Journal of Drugs.
- “Addition of CDK 4/6 inhibitor advantages sufferers with HR+, HER2+ metastatic breast most cancers, new research reveals,” information launch; https://www.dana-farber.org/newsroom/news-releases/2026/addition-of-cdk-46-inhibitor-benefits-patients-with-hr-her2-metastatic-breast-cancer-new-study-shows
Editor’s be aware: This text is for informational functions solely and isn’t an alternative to skilled medical recommendation, as your individual expertise might be distinctive. Use this text to information discussions together with your oncologist. Content material was generated with AI and reviewed by a human editor.
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