Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 1050
© 2008 American Society of Clinical Oncology

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Abstract

A comparative study of gemcitabine/doxorubicin and cyclophosphamide/doxorubicin combinations in first-line metastatic breast cancer

University Hospital of Oran, Oran, Algeria

1050

Background: Doxorubicin is a major drug for the treatment of breast cancer. D combination with cyclophosphamide (C) is commonly used in the treatment of breast cancer. Previous studies reported promising activity of the combination of gemcitabine (G) and D. This study was conducted to assess the efficacy and safety of GD and CD combination regimens in previously untreated patients with metastatic breast cancer (MBC). Methods: Previously untreated patients (pts) with MBC received either GD (G 1,200 mg/m² and D 25 mg/m² both on days 1 and 8) or CD (C 600 mg/m² and D 60 mg/m² on day 1). Cycles were repeated every 21 days. Treatments were continued until disease progression or unacceptable toxicity. Primary endpoint was overall response rate (ORR). Secondary endpoints were time to progression (TTP), overall survival (OS) and toxicity assessment. Results: 109 pts were enrolled in this trial, 55 in GD arm and 54 in CD arm. Median age was 41 years (GD) and 45 years (CD). Most patients were anthracyclines naives (65.5% vs. 67%). Visceral metastases were present in 94.5 % and 93% of pts, respectively. A median number of 6.6 and 5.6 cycles were delivered in GD and CD arms respectively. GD resulted in a significatively higher ORR (55% vs. 34%) and TTP (13.3 vs. 8.13 months). Detailed efficacy results are reported in the table. G3/4 hematologic toxicities were neutropenia (7.5% vs. 10%), thrombopenia (2% vs. 5%) and anemia (5.5% vs. 6%). The following G3/4 adverse events were significantly lower in GD arm: nausea (10% vs. 20%), vomiting (8% vs. 25%) and alopecia (60% vs. 80%). Conclusions: GD is superior to CD as first line treatment for metastatic breast cancer in terms of ORR and TTP with a better safety profile.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly

Abstract presentation from the 2008 ASCO Annual Meeting