Phase II evaluation of liposomal doxorubicin with docetaxel in patients with metastatic breast cancer

Background: Taxanes are effective in treating metastatic breast cancer. Liposomal doxorubicin (LD) is as effective as doxorubicin but less toxic. Patients and Methods: This phase II trial assessed the combination of LD and docetaxel (D). Between 12/2002 and 9/2005, 12 women received monthly LD (30 mg/m²) and weekly D (30 mg/m²). Cycles were continued until progression or toxicity. Primary outcome was time to progression. Secondary endpoints included response rate, time to treatment failure, duration of response, survival, and toxicity. Results: Median age was 49 (31-60) years. 9 (75%) patients had estrogen receptor-positive or progesterone receptor-positive tumors. 5 (41.7%) women had her-2/neu-positive tumors. 4 women stopped participation due to toxicity, and 7 due to progression. 8 (67%) participants (95% confidence interval (CI) 51.6-94.5%) had a partial response, and 2 (16.7%) had stable disease. Median time to progression was 9.6 months (95% CI 4.7-12.2). Median time to treatment failure was 6.5 months (95% CI 4.4-10.5). Median survival was 22.1 months (95% CI 9.6-40.8). Median duration of partial response was 2.7 months (95% CI 2.4-10.5). 10 (83%) women experienced grade 3/4 toxicities: neutropenia 3 (25%), infection 3 (25%), stomatitis 5 (41.7%), nausea 2 (16.7%), vomiting 1 (8.3%), dyspnea 2 (16.7%), pericardial effusion 1 (8.3), and palmarplantar erythrodysesthesia 1 (8.3%). Conclusions: LD and D resulted in an encouraging response and unacceptable toxicities.