A phase II study of pemetrexed as second-line chemotherapy for the treatment of metastatic castrate-resistant prostate cancer (CRPC); Hoosier Oncology Group GU03-67
Date
2009
Authors
Hahn, N.
Zon, R.
Yu, M.
Ademuyiwa, F.
Jones, T.
Dugan, W.
Whalan, C.
Shanmugam, R.
Skaar, T.
Sweeney, C.
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Journal article
Citation
Annals of Oncology, 2009; 20(12):1971-1976
Statement of Responsibility
N. M. Hahn, R. T. Zon, M. Yu, F. O. Ademuyiwa, T. Jones, W. Dugan, C. Whalen, R. Shanmugam, T. Skaar & C. J. Sweeney
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Abstract
Background: No standard therapy exists for post-docetaxel castrate-resistant prostate cancer (CRPC) patients. This trial aimed to determine the safety and efficacy of pemetrexed in post-docetaxel CRPC patients. Materials and methods: CRPC patients with progression after docetaxel (Taxotere) therapy received pemetrexed (500 mg/m2) i.v. every 3 weeks. The primary end point was prostate-specific antigen (PSA) response. A pharmacogenetic analysis of the reduced folate carrier-1 gene (RFC1) G80A polymorphism was also carried out. Results: Forty-nine patients were enrolled: median age 68 years, median baseline PSA 72 ng/ml, and median Karnofsky performance status of 90. Grade 3 or 4 toxicity occurred in 20 (43%) and four patients (8%), respectively. Confirmed >50% PSA decline occurred in four patients (8%), stable PSA lasting at least 12 weeks in 10 patients (20%). A significant relationship was observed between time from prior docetaxel therapy and overall survival. Pharmacogenetic analyses of RFC1 G80A genotype frequencies showed no relationship between genotypes and clinical efficacy. Conclusions: Pemetrexed treatment of CRPC patients after docetaxel therapy was associated with only modest clinical activity. Further investigation of pemetrexed as a single agent in a nonenriched CRPC population is unlikely to add significant clinical benefit over that seen with traditional second-line chemotherapy agents such as mitoxantrone.
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.