DAILY ORAL MILTEFOSINE (HEXADECYLPHOSPHOCHOLINE) IN PATIENTS WITH ADVANCED BREAST-CANCER - A PHASE-II STUDY

Background: A clinical phase II study with an oral formulation of Milt efosine (INN of hexadecylphosphocholine) was performed in patients wit h locally advanced or metastatic breast cancer. Material and Methods: Eligibility criteria included histological proof of breast cancer, mea surable disease without previous radiotherapy of the indicator lesions , pretreatment with chemotherapy, WHO performance status of grade less -than-or-equal-to 2, and informed consent. The drug was given twice da ily at a single dose of 50 mg for the first week with the option of in creasing the daily dose to 150 mg in the second week if tolerability w as good. The minimum treatment duration was 9 weeks. Results: 23 patie nts have been entered into the study and 17 were evaluable for toxicit y. 11 patients were evaluable for response. There was no objective tum or response. 4 out of 11 patients had reached a no-change status. Prog ressive disease was seen in 7 patients with 2 early deaths. Gastrointe stinal side effects like nausea and vomiting (15/17) and loss of appet ite (15/17) reached a maximum of WHO grade 4, diarrhea (4/17) was at t he most of WHO grade 3. Conclusion: Miltefosine given daily by oral ro ute showed no therapeutic activity in patients with advanced metastati c breast cancer.