Entry Detail
| General information | |
| Database: | DB00208 |
| Objective: | They evaluated angiogenesistargeted sunitinib therapy in a randomized, doubleblind trial of metastatic castrationresistant prostate cancer (mCRPC). |
| Authors: | Michaelson MD |
| Title: | Randomized, placebocontrolled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castrationresistant prostate cancer. |
| Journal: | J Clin Oncol |
| Year: | 2014 |
| PMID: | 24323035 |
| Trial Design | |
| Clinical Trial Id: | NCT00676650 |
| 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: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | sunitinib+prednisone |
| Study Type: | a randomized, placebocontrolled, phase III trial |
| Key Patients Feature: | Men with progressive mCRPC after docetaxelbased chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | prednisone alone |
| Treatment Info: | patients were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo. Patients also received oral prednisone 5 mg twice daily. |
| Primary End Point: | overall survival (OS); |
| Secondary End Point: | progression free survival (PFS). |
| Patients Number: | 873 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS was significantly improved in the sunitinib arm (median 5.6 v 4.1 months; HR, 0.725; 95% CI, 0.591 to 0.890; stratified logrank test, P < .001). |
| Median OS A vs. C: | 13.1 vs 11.8([HR], 0.914; 95% CI, 0.762 to 1.097; stratified logrank test, P =0.168). |
| Adverse Event(agent arm): | Toxicity and rates of discontinuations because of adverse events (AEs; 27% v 7%) were greater with sunitinib than placebo. The most common treatmentrelated grade 3/4 AEs were fatigue (9% v 1%), asthenia (8% v 2%), and handfoot syndrome (7% v 0%). Frequent treatmentemergent grade 3/4 hematologic abnormalities were lymphopenia (20% v 11%), anemia (9% v 8%), and neutropenia (6% v < 1%). |
| Conclusions: | The addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxelrefractory mCRPC. The role of antiangiogenic therapy in mCRPC remains investigational. |