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

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907 Background: The combination of anthracyclines and taxanes are effective in the treatment of metastatic breast cancer. Liposomal doxorubicin has been shown to be as effective as doxorubicin with less toxicity, however its efficacy in combination with docetaxel has yet to be determined. Methods: Monthly liposomal doxorubicin (Doxil 30 mg/m2) in combination with weekly docetaxel (30 mg/m2) was evaluated in women with metastatic breast cancer. Cycles were continued until disease progression or unacceptable toxicity. Radiologic assessment was performed every 2 months. The primary outcome was time to progression. Secondary endpoints included overall response rate, median survival and toxicity. Results: Between 12/2002 and 6/2004, 8 women were enrolled. Seven were available for evaluation, 4 with recurrent disease and 3 with a new diagnosis. The mean age was 48 (33–60) years. Three (43%) tumors were ER/PR negative, and 5 (71%) over-expressed her-2/neu. ECOG performance status 0:1:2 was 1:5:1. The median number of cycles was 4 (2–10). Four women stopped due to intolerable toxicity and 3 due to progressive disease. After 2 cycles, 5 (71%) had a partial response, and 2 (29%) had stable disease. The median time to progression was 12 (4.5- 19) months. Once off-study, all women received additional therapy. With a median 14.5 (4–23) month follow-up, there have been no deaths. All patients had Grade 3/4 toxicities, including: stomatitis 4 (57%), neutropenia 3 (43%), infections 3 (43%), and nausea/vomiting 3 (43%). Conclusions: Monthly liposomal doxorubicin plus weekly docetaxel in woman with metastatic breast cancer resulted in an encouraging response, but was poorly tolerated. Further evaluation of this combination with improved supportive care may be warranted. No significant financial relationships to disclose.

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