UroToday.com- Traditionally a number of hormonal, immunotherapeutic, and chemotherapy agents have been the basis of treatment in metastatic renal cell carcinoma (mRCC) however, they are typically associated with low response rates and considerable toxicity in patients that receive them. There is preclinical data that suggests the M2-affecting ribonucleotide reductase (RR) inhibitor Triapine® might be associated with anti-tumoral activity while demonstrating acceptable toxicity. Here, the authors report on the results of a single-arm, phase II clinical trial that examines the efficacy and toxicity of Triapine®.
In this trial 19 eligible patients with mRCC and without prior treatment received Triapine® in dosages of 96 mg/m2 x 4 days every two weeks with a four-week period constituting one cycle of treatment. The primary endpoint of the trial was response rate (RR) with secondary endpoints of progression free survival (PFS), overall survival (OS), and toxicity. |
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Only 15 of the 19 patients were evaluable for response after the first treatment cycle. There was one PR, seven SD, and seven PD responses to regimen. The median PFS for this 15 patient group was 3.6 months and the median OS was 14.6 months. Toxicity was evaluated in all 19 patients. Of note, grade 3 toxicity was observed in fifteen patients (79%) which required the need for dose reductions.
The authors conclude that this treatment offers little efficacy and significant toxicity for mRCC. In fact, the study was stopped after stage 1 because the minimum efficacy criteria had not been met. Triapine® has some demonstrated activity in mRCC, but one might question the relevance of this finding in the setting of the more active targeted therapies currently used in mRCC.
Segota E, Mekhail T, Olencki T, Hutson TE, Dreicer R, Wacker B, Osterwalder B, Elson P, Zhou M, Bukowski RM
Urologic Oncology: Seminars and Original Investigations. 25(1):46-52, May 2007 doi:10.1016/j.urolonc.2006.02.016
Reported by UroToday.com Contributing Editor Christopher G. Wood, MD
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