Miltefosine as a topical treatment for cutaneous metastases in breast carcinoma

Background: Recurrent cutaneous breast cancer is difficult to manage, with surgery, radiotherapy and systemic therapy all having their limitations. Miltefosine is a topical cytostatic agent which may provide an alternative approach in its treatment. Patients and methods: Patients with previously treated progressive cutaneous lesions from breast cancer were treated with miltefosine on a named-patient compassionate supply basis. Miltefosine was applied topically to the skin at a dose of 2 drops/10 cm(2) skin area. Results: Twenty-five patients were treated, most of whom had been heavily pre-treated. Treatment was continued for a median of 14 weeks (range 2-164). In 7 patients grade I skin toxicities were observed, and in 4 patients grade 3 local toxicities necessitated dose adjustments. A response was seen in 9 patients (1 complete response, 2 partial responses, 6 minor responses) giving a total response rate of 36%, with stable disease in 11 patients (44%) and progressive disease in 5 (20%). Those lesions which were superficial or <2 cm in diameter were most likely to respond. Conclusions: Miltefosine, either used alone or in conjunction with other therapies for distant metastases, is an effective and tolerable local treatment for cutaneous breast cancer.