The FINANCIAL — Results from a Phase 3 study show that patients with metastatic breast cancer who were treated previously with an anthracycline in the adjuvant setting experienced a significant improvement in time to disease progression (TTP) and overall response rates after receiving a combination of DOXIL (doxorubicin HCl liposome injection) and docetaxel as compared to docetaxel alone.
Results from this randomized, parallel-group, open-label, multi-center study were presented today at the 31st Annual San Antonio Breast Cancer Symposium (SABCS). The study included only patients previously treated with anthracyclines who had a disease-free interval of at least one year.
The study found that patients treated with the DOXIL and docetaxel combination had a 35% risk reduction for developing disease progression compared with docetaxel alone (hazard ratio = 0.65; 95% confidence interval [0.55, 0.77]; p=0.000001). There is an almost three-month improvement in median TTP for patients treated with the combination compared with docetaxel monotherapy (9.8 versus 7.0 months, respectively).
The safety profile was consistent with known toxicities of the two agents. Additionally, the incidence of symptomatic cardiac events was 5% in the combination group versus 4% in the monotherapy group (³ Grade 2 cardiac adverse events). Symptomatic congestive heart failure was reported in 1% of subjects in both groups. Arrhythmia was reported in 4% of the combination group and 3% of the monotherapy group. Protocol‑defined LVEF decreases occurred in 5% of subjects in both groups.
“Anthracyclines are active drugs for metastatic breast cancer, but concerns about cardiac toxicity have prevented oncologists from using them in those who received anthracyclines as part of their adjuvant therapy," said Dr. Joseph Sparano, Director of the Breast Evaluation Center at the Montefiore-Einstein Cancer Center and Professor of Medicine & Women's Health at the Albert Einstein College of Medicine in New York, and lead investigator on the study. “The study suggests that the combination of DOXIL and docetaxel may be an effective treatment for patients with metastatic breast cancer who have relapsed after prior adjuvant anthracycline therapy.”