Entry Detail
| General information | |
| Database: | DB00954 |
| Objective: | Preclinical investigations support combining sorafenib with IL2 in the treatment of metastatic renal cell carcinoma (mRCC). |
| Authors: | Procopio G, et al |
| Title: | Sorafenib with interleukin2 vs sorafenib alone in metastatic renal cell carcinoma: the ROSORC trial. |
| Journal: | Br J Cancer. |
| Year: | 2011 |
| PMID: | 21448165 |
| Trial Design | |
| Clinical Trial Id: | NCT00609401 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 15 |
| Therapeutic Combination Content: | Sorafenib with interleukin2 |
| Study Type: | openlabel, phase II study |
| Key Patients Feature: | Eligible patients were aged 18 years or older, with a life expectancy of at least 3 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of two or less. They were required to have a histologically confirmed diagnosis of advanced or metastatic RCC |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients with mRCC were randomised to receive oral sorafenib, 400 mg twice daily, plus subcutaneous IL2, 4.5 million international units (MIU) five times per week for 6 in every 8 weeks, or sorafenib alone. After enrolment of the first 40 patients, IL2 dose was reduced to improve the tolerability. |
| Primary End Point: | PFS |
| Secondary End Point: | objective response rate (ORR), OS, and the safety profile of the two therapeutic regimens. |
| Patients Number: | 123 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | With combination therapy: 27.3% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 33 weeks with sorafenib plus IL2, and 30 weeks with sorafenib alone (P=0.109). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The incidence of AEs in the sorafenib plus IL2 combination therapy group was 80% for any grade and 38% for grade 3 AEs. In the sorafenib monotherapy group, 92% of patients reported AEs of any grade and 25% reported grade 3 AEs. The most common (incidence >5%) grade 3 AEs (combination vs monotherapy) were: skin (14 vs 9%), gastrointestinal (8 vs 5%), and general disorders (8 vs 3%). |
| Conclusions: | The combination of sorafenib and IL2 did not demonstrate improved efficacy vs sorafenib alone. Improvements in PFS appeared greater in patients receiving higherdose IL2. |