Dalpiciclib Plus Endocrine Therapy in HR+/HER2- Advanced Breast Cancer: DAWNA-2 Trial
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On May 11, 2023, Dr. Pin Zhang and colleagues from the Chinese Academy of Medical Sciences published the results of the DAWNA-2 Phase 3 clinical trial in The Lancet Oncology. This study investigated the efficacy and safety of Dalpiciclib, a CDK4/6 inhibitor, in combination with an aromatase inhibitor (Letrozole or Anastrozole) as a first-line treatment for patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer.
Study Design: DAWNA-2 Trial
DAWNA-2 was a multicenter, randomized, double-blind Phase 3 trial. Treatment-naive patients were randomized in a 2:1 ratio to receive:
- Dalpiciclib Group: Dalpiciclib (150 mg once daily for 3 weeks followed by 1 week off) + Letrozole (2.5 mg) or Anastrozole (1 mg) daily.
- Placebo Group: Placebo + Letrozole or Anastrozole.
The primary endpoint was progression-free survival (PFS).
Key Efficacy Results (Median Follow-up 21.6 Months)
- Median Progression-Free Survival (PFS):
- Dalpiciclib Group: 30.6 months
- Placebo Group: 18.2 months
- The addition of Dalpiciclib resulted in a significant extension of PFS, nearly doubling the time without disease progression compared to endocrine therapy alone.
Safety Profile
The incidence of Grade 3 or 4 adverse events was 90% in the Dalpiciclib group compared to 12% in the placebo group. The most common hematological side effects were:
- Neutropenia: 86% in the Dalpiciclib group vs. 0% in the placebo group.
- Leukopenia: 67% in the Dalpiciclib group vs. 0% in the placebo group.
- Serious Adverse Events: Occurred in 12% of the Dalpiciclib group vs. 7% of the placebo group.
Conclusion
The DAWNA-2 trial demonstrated that the combination of Dalpiciclib and an aromatase inhibitor significantly improves PFS in treatment-naive patients with HR+/HER2- advanced breast cancer. These findings establish Dalpiciclib as a effective new first-line treatment option for this patient population.
Source: The Lancet Oncology - DAWNA-2 Trial Results
#BreastCancer #HRPositive #Dalpiciclib #CDK46Inhibitor #DAWNA2 #CancerResearch #EndocrineTherapy
Considering medical care in Japan? Need information and support?
We help you organize the information needed for medical travel to Japan, liaise with Japanese medical institutions, and arrange a second-opinion consultation.The first consultation is free; an advisor will help you clarify the next steps.
Figure 1