Entry Detail
| General information | |
| Database: | DB00953 |
| Objective: | Patients with metastatic renal cell carcinoma (mRCC) received sunitinib in a global expandedaccess program (EAP). Here, they report the efficacy and safety results for the EAP subpopulation in Italy. |
| Authors: | Sternberg CN, et al |
| Title: | Safety and efficacy of sunitinib in patients from Italy with metastatic renal cell carcinoma: final results from an expandedaccess trial. |
| Journal: | Oncology. |
| Year: | 2015 |
| PMID: | 25592399 |
| Trial Design | |
| Clinical Trial Id: | NCT00130897 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | final results from an expandedaccess trial |
| Key Patients Feature: | Patients more than and equal to 18 years old with previously treated or treatmentna ve mRCC |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received oral sunitinib 50 mg/day on a 4weekson/2weeksoff schedule. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 521 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 12% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.1 months |
| Median OS A vs. C: | 27.2 months |
| Adverse Event(agent arm): | The most common anygrade treatmentrelated AEs were asthenia (44%, plus 15% reporting fatigue), thrombocytopenia and stomatitis (both 37%), diarrhea (36%), mucosal inflammation (29%), hypertension (26%), and dysgeusia (25%). The most common grade 3/4 treatmentrelated AEs were thrombocytopenia (10%), asthenia (9%, plus 3% reporting fatigue), neutropenia, stomatitis (both 6%), and hypertension (5%). |
| Conclusions: | In a large population of Italian mRCC patients, sunitinib had a manageable safety profile and encouraging efficacy |