RANDOMIZED PHASE-II STUDY OF EPIRUBICIN-VINDESINE VERSUS MITOXANTRONE-VINDESINE IN METASTATIC BREAST-CANCER

The purpose of this study was to compare the activity and toxicity of epirubicin-vindesine (EV) with mitoxantrone-vindesine (MV) in patients with metastatic breast cancer. A total of 295 patients was randomly a llocated to treatment with vindesine 3 mg/m(2) combined with either ep irubicin 40 mg/m(2) or mitoxantrone 10 mg/m(2). All drugs were given b y intravenous push, treatment cycles were repeated at 3-4 week interva ls. 255 patients were available for response, and 283 for toxicity. EV and MV yielded similar objective response rates (34 and 26%, respecti vely), response durations, times to progression and survival. Median t ime to remission was 1.8 and 3.1 months (P = 0.006) with EV and MV, re spectively. In patients with visceral metastases, response tate was hi gher with EV than IMV (40 versus 23%; P = 0.03). Patients receiving MV had less nausea/vomiting (P = 0.007) and alopecia (P = < 0.001) of WH O grade greater than or equal to 2. Bone marrow, cardiac and other tox icities were mild with both treatments. The observed differences in ac tivity and toxicity between the two regimens appear to have clinical r elevance. EV proved to be more active in visceral disease and to be ab le to induce remissions more rapidly. Accordingly, patients with visce ral metastases or severe tumour-related symptoms may benefit from epir ubicin-based treatment. Subjective toxicities, i.e. nausea/vomiting an d alopecia, were less frequent and severe with MV. Thus, MV may prove useful in patients with more indolent disease and appears to warrant p hase III evaluation in such patients.