Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial.
Journal Article (Clinical Trial, Phase III;Multicenter Study;Journal Article)
Purpose
This multinational, double-blind, randomized, placebo-controlled, phase III trial assessed the efficacy and tolerability of the oral platinum analog satraplatin in patients with metastatic castrate-refractory prostate cancer (CRPC) experiencing progression after one prior chemotherapy regimen.Patients and methods
Nine hundred fifty patients were randomly assigned (2:1) to receive oral satraplatin (n = 635) 80 mg/m(2) on days 1 to 5 of a 35-day cycle and prednisone 5 mg twice daily or placebo (n = 315) and prednisone 5 mg twice daily. Primary end points were progression-free survival and overall survival (OS). The secondary end point was time to pain progression (TPP).Results
A 33% reduction (hazard ratio [HR] = 0.67; 95% CI, 0.57 to 0.77; P < .001) was observed in the risk of progression or death with satraplatin versus placebo. This effect was maintained irrespective of prior docetaxel treatment. No difference in OS was seen between the satraplatin and placebo arms (HR = 0.98; 95% CI, 0.84 to 1.15; P = .80). Compared with placebo, satraplatin significantly reduced TPP (HR = 0.64; 95% CI, 0.51 to 0.79; P < .001). Satraplatin was generally well tolerated, although myelosuppression and GI disorders occurred more frequently with satraplatin.Conclusion
Oral satraplatin delayed progression of disease and pain in patients with metastatic CRPC experiencing progression after initial chemotherapy but did not provide a significant OS benefit. Satraplatin was generally well tolerated. These results suggest activity for satraplatin in patients with CRPC who experience progression after initial chemotherapy.Full Text
Duke Authors
Cited Authors
- Sternberg, CN; Petrylak, DP; Sartor, O; Witjes, JA; Demkow, T; Ferrero, J-M; Eymard, J-C; Falcon, S; Calabrò, F; James, N; Bodrogi, I; Harper, P; Wirth, M; Berry, W; Petrone, ME; McKearn, TJ; Noursalehi, M; George, M; Rozencweig, M
Published Date
- November 2009
Published In
Volume / Issue
- 27 / 32
Start / End Page
- 5431 - 5438
PubMed ID
- 19805692
Electronic International Standard Serial Number (EISSN)
- 1527-7755
International Standard Serial Number (ISSN)
- 0732-183X
Digital Object Identifier (DOI)
- 10.1200/jco.2008.20.1228
Language
- eng