Journal
CANCER INVESTIGATION
Volume 30, Issue 4, Pages 309-316Publisher
TAYLOR & FRANCIS INC
DOI: 10.3109/07357907.2012.658938
Keywords
Multitargeted antifolate; Failed standard adjuvant therapy; Pharmacokinetics; Breast cancer; Randomized phase II trial
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Funding
- Eli Lilly and Company, Indianapolis, Indiana, USA
- Eli Lilly Austria
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Pemetrexed/cyclophosphamide was evaluated as first-line treatment for patients with locally advanced/metastatic breast cancer. In this randomized phase II study (NCT00190671), therapy consisted of either 600 mg/m(2) (P600) or 1,800 mg/m(2) (P1800) pemetrexed, followed by 600 mg/m(2) cyclophosphamide, every 21 days; 103 females (42 P600; 61 P1800) were enrolled. P600 was discontinued, as response rate (19.1%) was lower than targeted. In the P1800 arm, 20 patients had partial response (32.8%; 95% CI: 21.0-44.6) and 26 (42.6%) had stable disease. Median progression-free survival was 6.3 months (range: 0.3-31.1). P1800 plus cyclophosphamide 600 represents a regimen of reasonable efficacy and acceptable tolerability.
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