CISPLATIN PLUS VP16 AS SALVAGE TREATMENT FOR ADVANCED BREAST-CARCINOMA RESISTANT OR RECURRENT AFTER 1ST LINE CHEMOTHERAPY FOR METASTATIC DISEASE

Forty patients with chemotherapy refractory metastatic breast carcinom a were enrolled in a phase II study of cisplatin 80 mg/m2 on day 1 plu s VP16 100 mg/m2 on days 1-3 every 28 days. The overall response rate was 32% (95% CL 17-47%), with 2 patients (5%) showing a CR with a mean duration of 11.3 months, and 11 patients (27%) a PR with a mean durat ion of 7.8+ months. Seven patients (17%) had stable disease, and 20 pa tients (50%) progressed despite chemotherapy. One complete response an d 4 partial responses were obtained in patients previously untreated w ith antracyclines. The overall survival was 10.2+ months. The mean sur vival of responding patients (CR+PR) was 15.5+ months, while that of n on responders (NC+PD) was 8.6+ months. A total of 188 cycles were admi nistered (4.7 cycles/patient) and the most frequent toxicities were ga strointestinal and hematological side-effects. The most severe toxicit ies were intense vomiting and anemia. Grade 3 vomiting was seen in 11 patients (27%), and grade 1-2 anemia in 30% of cases. Severe grade 3 l eukopenia was seen in only 12% of cases. Mild renal toxicity was recor ded only in 2 cases, while alopecia was observed in almost all patient s. In conclusion, although CDDP plus VP16 regimen, may be safely given on an outpatient basis, its routine use as salvage treatment for chem otherapy refractory metastatic breast carcinoma is not recommended. Th is regimen may, however, be employed as second line chemotherapy in se lected cases.