Springer Online Journal Archives 1860-2000
Abstract Purpose: To evaluate the impact on the response rate in patients withadvanced breast cancer (ABC) of the doubling of the dose intensity (DI) ofepirubicin monotherapy. Patients and methods: From January 1991 until April 1996, 167 patientswith ABC were randomized to receive epirubicin (110 mg/m2)either every four (81 patients, group A) or every two weeks (86 patients,group B). Filgrastim (5 µg/kg/daily) was administered prophylacticallyon days 2–12 of each cycle. Results: The two groups were equally balanced in terms of major patientand tumor characteristics. Even though the median cumulative dose ofepirubicin was identical in the two groups (651 mg/m2), themedian DI of epirubicin was doubled in group B (27.2 vs. 52.9mg/m2/wk, respectively). The complete response (CR) rate wassignificantly increased in Group B (5%, 95% CI:0.16%–9.84% vs. 17%, 95% CI:8.9%–25.08%, P = 0.011), although overall response rateswere similar (49% vs. 53%, P = 0.5957). Also, there was nosignificant difference in the incidence of grade 3–4 toxicity betweenthe two groups. After a median follow-up of 25 months (range,0.43–43.3+) no significant difference was observed in the duration ofresponse (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 survival (median, 14.6months vs. 14.9 months, P = 0.4483). Logistic regression analysis showedthat performance status was a significant variable for response (P = 0.0068)and multivariate analysis using the Cox proportional hazards model revealedthat performance status was significant for survival (P = 0.0049), while thepresence of multiple metastases (P = 0.0020) was significant for time toprogression. Conclusion: Doubling the planned DI of epirubicin monotherapy significantlyincreases the CR rate but has no influence on time to progression or survivalin patients with ABC.
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