Table I.
Results of phase II studies including patients with castrate-resistant prostate cancer treated with sorafenib
| Author | Patient population | End points | Results of treatment |
|---|---|---|---|
| Steinbild et al. 2007 [13] | • 57 patients | Primary objective: | at 12 weeks |
| • ECOG < 2 | rate of progression-free survival ≥ 12 weeks | • 4 – stable disease (RECIST) | |
| • HGB > 9 g/dl | Secondary end points: | • 11 – stable disease (PSA-response) | |
| • Creatinine ≤ 1.5×ULN | • Overall response | • 2 – PSA-responders | |
| • Overall survival | – The 1 year PFS rate was 13% (95% CI: 6-28%) | ||
| • Toxicity | – The 1-year OS rate: 68% (95% CI: 56-82%) | ||
|
| |||
| Chi et al. 2008 [14] | • 28 patients | Primary end point: | • The PSA response rate was 3.6% |
| • ECOG: 0 or 1 | PSA response defined as a ≥ 50% decrease for ≥ 4 weeks | • 5 patients had stable disease (among 12 with measurable disease) | |
| • HGB ≥ 10 g/dl | Secondary end point: | • Time to PSA progression was 2.1 months (95% CI 1.8-6.4) | |
| • Creatinine within normal limits | • Measurable disease responses | • OS was 12.25 months (95% CI 6.7-16.46) | |
| • Creatinine clearance ≥ 60 ml/min | • PFS and OS | ||
|
| |||
| Dahut et al. 2008 [15] | • 22 patients | Primary end point: | • No complete or partial response was noted |
| • ECOG: 0 to 2 | disease progression (RECIST) or increase in PSA | • No patient had a PSA decline of > 50% | |
| • HGB – 13.05 g/dl (10.2-15.1) | Secondary end point: | • The median progression-free survival duration was 1.8 months: | |
| • Creatinine < 1.5×ULN | • Overall response rate | – 7 patients were progression-free by PSA criteria at 4 months | |
| • GFR > 60 ml/min/1.73 m2 | • Overall survival | – 9 of 14 patients who progressed at or before 4 months progressed only by PSA consensus criteria | |
| • Life expectancy of ≥ 12 weeks | |||
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| |||
| Aragon-Ching et al. 2009 [16] | • 24 patients | Primary end point: | • 1 patient had a partial response |
| • ECOG: 0 or 1 | progression by RECIST criteria | • 10 patients had stable disease | |
| • HGB: 12.4 g/dl (10.4-14.2) | Secondary end point: | • Median duration 18 weeks (15-48 weeks) | |
| • Pharmacokinetics | • Median PFS was 3.7 months | ||
| • Toxicity | • Median OS was 18.0 months | ||
| • Overall survival | |||
|
| |||
| Safarinejad et al. 2010 [17] | • 64 patients | Primary end point: | Median OS: 14.6 months (CI: 8.2-22.2) |
| • ECOG 0-3 | PSA response (50% reduction) | Partial response: | |
| • HGB ≥ 10 g/dl, | Secondary end point: | • 7/35 patients (20%) with measurable extraosseous disease | |
| • Creatinine ≤ 2 mg/dl, | • Objective measurable disease responses | • 13/64 patients (20.3%) achieved ≥ 50% reduction in PSA level after two cycles: | |
| • Life expectancy >6 months | • Overall survival (OS) | – Median response duration: 2.5 months (95% CI: 1.4-4.8), | |
| • Time to progression (TTP) | |||
| • Toxicity | – Median time to progression: 5.9 months (95% CI: 3.6-7.6) | ||
| • Pain response | |||