A randomized study of epirubicin monotherapy every four or every two weeks in 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 until April 1996, 167 patients with ABC were randomized to receive epirubicin (110 mg/r2 eith...

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Bibliographic Details
Published in:	Annals of oncology Vol. 8; no. 12; pp. 1213 - 1220
Main Authors:	Fountzilas, G., Athanassiades, A., Giannakakis, T., Briasoulis, E., Bafaloukos, D., Kalogera-Fountzila, A., Onienaoum, A., Kalofonos, H., Pectasides, D., Andreopoulou, E., Bamia, C., Kosmidis, P., Pavlidis, N., Skarlos, D.
Format:	Journal Article
Language:	English
Published:	Oxford Oxford University Press 01-12-1997
Subjects:	Adult Aged Antibiotics, Antineoplastic - administration & dosage Antibiotics, Antineoplastic - adverse effects Antineoplastic agents Biological and medical sciences breast neoplasms Breast Neoplasms - drug therapy Chemotherapy Disease-Free Survival Drug Administration Schedule epirubicin Epirubicin - administration & dosage Epirubicin - adverse effects Female Humans Medical sciences Middle Aged Pharmacology. Drug treatments Survival Analysis Treatment Outcome Antineoplastic agent Human Drug combination Malignant tumor Filgrastim Mammary gland diseases Chemotherapy Granulocyte colony stimulating factor Randomization Treatment Phase II trial Female Advanced stage Anthracyclins Epirubicin Mammary gland High dose
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Summary:	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 until April 1996, 167 patients with ABC were randomized to receive epirubicin (110 mg/r2 either every four (81 patients, group A) or every two weeks (86 patients, group B). Filgrastim (5 μg/kg/daily) was administered prophylactically on days 2–12 of each cycle. Results The two groups were equally balanced in terms of major patient and tumor characteristics. Even though the median cumulative dose of epirubicin was identical in the two groups (651 mg/m2), the median DI of epirubicin was doubled in group B (27.2 vs. 52.9 mg/m2/wk respectively). The 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), although overall response rates were similar (49% vs. 53%, P = 0.5957). Also, 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 duration 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 survival (median, 14.6 months vs. 14.9 months, P = 0.4483). Logistic regression analysis showed that performance status was a significant variable for response (P = 0.0068) and multivariate analysis using the Cox proportional hazards model revealed that performance status was significant for survival (P = 0.0049), while the presence of multiple metastases (P = 0.0020) was significant for time to progression. Conclusions Doubling the planned DI of epirubicin mono-therapy significantly increases the CR rate but has no influence on time to progression or survival in patients with ABC.
Bibliography:	istex:71542A0A84BB552F2CDA7D9B6D16E0EF3D24F2C3 ark:/67375/HXZ-MX7ZL2QK-0 Correspondence to: George Fountzilas, MD First Department of Internal Medicine Oncology Section ‘AHEPA’ Hospital Aristotle University of Thessaloniki Thessaloniki Macedonia Greece Part of this work was presented at the 33rd ASCO meeting, Denver, CO, USA, May 1997. ArticleID:8.12.1213
ISSN:	0923-7534 1569-8041
DOI:	10.1023/A:1008270307264