A RANDOMIZED STUDY OF EPIRUBICIN MONOTHERAPY EVERY 4 OR EVERY 2 WEEKSIN ADVANCED BREAST-CANCER - A HELLENIC COOPERATIVE ONCOLOGY GROUP-STUDY

Purpose: To evaluate the impact on the response rate in patients with advanced breast cancer (ABC) of the doubling of the dose intensity (DI ) of epirubicin monotherapy. Patients and methods. From January 1991 u ntil April 1996, 167 patients with ABC were randomized to receive epir ubicin (110 mg/m(2)) either every four (81 patients, group A) or every two weeks (86 patients, group B). Filgrastim (5 mu g/kg/daily) was ad ministered prophylactically on days 2-12 of each cycle. Results. The t wo groups were equally balanced in terms of major patient and tumor ch aracteristics. Even though the median cumulative dose of epirubicin wa s identical in the two groups (651 mg/m(2)), the median DI of epirubic in was doubled in group B (27.2 vs. 52.9 mg/m(2)/wk, respectively). Th e complete response (CR) rate was significantly increased in group B ( 5%, 95% CI: 0.16%-9.84% vs, 17%, 95% CI: 8.9%-25.08%, P = 0.011), alth ough overall response rates were similar (49% vs. 53%, P = 0.5957). Al so, there was no significant difference in the incidence of grade 3-4 toxicity between the two groups. After a median follow-up of 25 months (range, 0.43-43.3+) no significant difference was observed in the dur ation of response (median, 10 months vs, 8.5 months, P = 0.5130), time to progression (median, 7.2 months vs. 7.4 months, P = 0.2970) or sur vival (median, 14.6 months vs, 14.9 months, P = 0.4483). Logistic regr ession analysis showed that performance status was a significant varia ble for response (P = 0.0068) and multivariate analysis using the Cox proportional hazards model revealed that performance status was signif icant for survival (P = 0.0049), while the presence of multiple metast ases (P = 0.0020) was significant for time to progression. Conclusion. Doubling the planned DI of epirubicin monotherapy significantly incre ases the CR rate but has no influence on time to progression or surviv al in patients with ABC.