Entry Detail
| General information | |
| Database: | DB00212 |
| Objective: | Vascular endothelial growth factor receptor (VEGFR) and plateletderived growth factor receptor (PDGFR) correlate with poor prognosis in castrationresistant prostate cancer (CRPC). Sunitinib has shown activity in CRPC and at the time of this analysis there was no standard therapy for docetaxelrefractory CRPC. |
| Authors: | Castellano D |
| Title: | Experience in the use of sunitinib given as a single agent in metastatic chemoresistant and castrationresistant prostate cancer patients. |
| Journal: | Expert Opin Pharmacother |
| Year: | 2011 |
| PMID: | 21671835 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a case series data collection |
| Key Patients Feature: | patients with a median age of 73 years, CRPC and rising prostatespecific antigen (PSA).Median Eastern Cooperative Oncology Group (ECOG) performance status score was 2. Patients received a median of two previous treatment lines for the hormonerefractory setting. Baseline median PSA was 280 ng/ml. Patients received a median of 16 weeks of therapy (4 48+). |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received sunitinib 37.5 mg continuous daily dose. One cycle comprised a 4week period. Patients were evaluated by CT scan every 8 weeks and PSA was monitored every 4 weeks. |
| Primary End Point: | NA |
| Secondary End Point: | NA |
| Patients Number: | 19 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | One patient achieved a partial response (5%) and 12 (66.7%) achieved stable disease for at least 3 months according to RECIST criteria. |
| Disease Control Rate: | PSA declined > 50% in 5/19 (26.3%) and stabilized in 7/19 (37%) patients. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4 months |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Frequent adverse events were grade 3 asthenia (21%), grade 3 diarrhea (10%) and grade 3 handfoot syndrome (15.7%). |
| Conclusions: | Activity with sunitinib was observed in highly pretreated docetaxelrefractory CRPC with acceptable tolerability. Additional studies should confirm the role of antiangiogenic agents in this setting. |