Entry Detail
| General information | |
| Database: | DB00493 |
| Objective: | To evaluate the efficacy and safety of targeted agents (sorafenib and sunitinib) as postoperative adjuvant therapy in Chinese patients with clear cell renal cell carcinoma (CCRCC) who are at high risk for disease recurrence. |
| Authors: | Zhao J, et al |
| Title: | Sorafenib or sunitinib as postoperative adjuvant therapy for Chinese patients with locally advanced clear cell renal cell carcinoma at high risk for disease recurrence. |
| Journal: | Urol Oncol. |
| Year: | 2013 |
| PMID: | 22658883 |
| 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: | renal cell carcinoma |
| Cancer Subtype: | advanced clear cell renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a single center, open label, historicallycontrolled study |
| Key Patients Feature: | Patients histologically and clinically confirmed with locally advanced CCRCC and without any metastatic lesiondetected within 4 weeks of the initiation of study therapywere eligible for inclusion into the current study. Patientswere aged 18 years, had an Eastern Cooperative OncologyGroup performance status (ECOG PS) of 1. Adequatebone marrow, liver, and renal function were required (platelet count 100, 000/ l, hemoglobin 9.0 g/dl, an absoluteneutrophil count 1, 500/ l, total bilirubin 1.5 times theupper limit of normal [ULN], alanine aminotransferase [serum glutamic pyruvic transaminase] 2.5 times the ULN, aspartate aminotransferase [serum glutamic oxaloacetictransaminase] 2.5 times the ULN, and serum creatinine 1.5 times the ULN or measured or calculated [using the CockcroftGault equation] creatinine clearance 40 mL/min). Resolution of any preexisting complication fromprior nephrectomy operation was required. Each patient wasevaluated according to the Leibovich risk model (MayoClinic SSIGN Score) of 6 (high risk of developing metastases) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib (group A, n = 20) or sunitinib (group B, n = 23) |
| Treatment Info: | After radical nephrectomy, patients received either sorafenib (group A, n = 20) or sunitinib (group B, n = 23) and were follotheyd up for at least 1 year to determine the efficacy and safety of the test products. |
| Primary End Point: | overall rate of recurrence;Diseasefree survival (DFS);The adverse effects |
| Secondary End Point: | NA |
| Patients Number: | 43 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The common adverse effects of targeted therapy included handfoot syndrome, fatigue, diarrhea, taste disturbance, rash, hypertension, alopecia, stomatitis, neutropenia, nausea, pruritus, hypothyroidism in groups A and B. The adverse effects were mild in both groups and the incidence was not significantly different between groups A and B. |
| Conclusions: | Targeted adjuvant therapy postoperatively with sorafenib or sunitinib in patients with CCRCC who are at a high risk for disease recurrence was well tolerated and effective in reducing the rate of CCRCC recurrence in these patients. This study is an attempt to assess the utility of adjuvant tyrosine kinase inhibitors (TKIs) after surgery for renal carcinoma. The apparently improved outcomes, compared with a historical control population, are of sufficient interest to support the continuation of an ongoing randomized clinical trial to validate the hypothesis. |