Abstract
Purpose
The purpose was to evaluate the activity and toxicity of split-dose paclitaxel or
docetaxel in combination with gemcitabine in patients with metastatic breast cancer
(MBC) who had previously received anthracyclines.
Patients and methods
A total of 210 patients were randomly assigned to one of three treatment arms: gemcitabine
1250 mg/m2 Days 1 and 8 and paclitaxel 175 mg/m2 as a 3-h infusion on Day 1 (GP1); gemcitabine 1000 mg/m2 Days 1 and 8 and paclitaxel 100 mg/m2 as a 1-h infusion on Days 1 and 8 (GP2); gemcitabine 1000 mg/m2 Days 1 and 8 and docetaxel 40 mg/m2 as a 1-h infusion on Days 1 and 8 (GD). Cycles were repeated every 3 weeks.
Results
For the 204 patients evaluable for response assessment, the response rates were 48.6%
for GP1, 52.2% for GP2, and 52.3% for GD. Median response duration, time to treatment
failure, and time to progression (TTP) were similar in each arm. Median TTP for GP1,
GP2 and GD was 7.5, 7.0 and 7.4 months, respectively. For the 208 patients evaluable
for safety, the most common grade 3/4 toxicity for each regimen was neutropaenia,
with 64%, 57%, and 68% for GP1, GP2, and GD, respectively. Grade 4 neutropaenia, grade
3/4 anaemia, febrile neutropaenia, and diarrhoea were more common in the docetaxel
arm, as was the use of intravenous antibiotics and blood transfusions.
Conclusion
The study confirmed the high activity of gemcitabine–taxane combinations in MBC. Split-dose
paclitaxel had similar activity and toxicity to the 3-weekly administration. The split-dose
docetaxel regimen had similar activity to the paclitaxel combinations though associated
with higher toxicity.
Keywords
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Article info
Publication history
Accepted:
May 5,
2006
Received in revised form:
May 3,
2006
Received:
February 14,
2006
Footnotes
☆Preliminary data from this study were published in the Proceedings of the American Society of Clinical Oncology, 2004. This study was sponsored by Eli Lilly and Company, Indianapolis, IN.
Identification
Copyright
© 2006 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
