SORCE
Adjuvant sorafenib for renal cell carcinoma at intermediate or high risk of relapse (SORCE): international randomised phase 3 intergroup trial
Phase 3N = 1,711NCT00492258
- Population
- Renal cell carcinoma at intermediate or high risk of recurrence after surgical excision of the primary tumour; 84% had clear cell histology, 53% intermediate risk and 47% high risk.
- Design
- International, randomised (2:3:3), double-blind, three-arm trial, July 2007 to April 2013: 3 years of placebo, 1 year of sorafenib followed by 2 years of placebo, or 3 years of sorafenib. The sorafenib dose started at 400 mg twice per day and was amended to 400 mg daily. The primary analysis was revised in response to external results to investigator-reported DFS comparing 3 years of sorafenib with placebo. The ClinicalTrials.gov record lists estimated enrolment of 1656; the abstract reports 1,711 participants.
- Primary endpoint
- DFS
- Arms
- Placebo (arm A) (control, n = 430): Placebo for 3 years
- Sorafenib 1 year (arm B) (experimental, n = 642): Sorafenib for 1 year followed by placebo for 2 years
- Sorafenib 3 years (arm C) (experimental, n = 639): Sorafenib for 3 years
- People
- Eisen T
DFSHR 1.01 (95% CI 0.83–1.23)
Show the numbers
| Endpoint | Analysis | Sorafenib 1 year (arm B) / Sorafenib 3 years (arm C) | Placebo (arm A) | Effect |
|---|---|---|---|---|
| DFSRandomly assigned participants (primary comparison 3 years of sorafenib vs placebo; analysis population not labelled in the abstract) | primaryEisen 2020 | — | — | HR 1.01 (95% CI 0.83–1.23)P=0.95Three years of sorafenib versus placebo. Median DFS was not reached in either group. Hazards were not proportional: restricted mean survival time 6.81 years with sorafenib and 6.82 years with placebo (difference 0.01 year; 95% CI -0.49 to 0.48; P=0.99). No differences in DFS or overall survival were seen in all randomly assigned patients, in the high-risk subgroup or in clear cell patients. More than half of participants stopped treatment by 12 months; grade 3 hand-foot skin reaction occurred in 24% on sorafenib. |
| Endpoint | Analysis | Sorafenib 1 year (arm B) / Sorafenib 3 years (arm C) | Placebo (arm A) | Effect |
|---|---|---|---|---|
| DFSRandomly assigned participants (primary comparison 3 years of sorafenib vs placebo; analysis population not labelled in the abstract) | primaryEisen 2020 | — | — | HR 1.01 (95% CI 0.83–1.23)P=0.95Three years of sorafenib versus placebo. Median DFS was not reached in either group. Hazards were not proportional: restricted mean survival time 6.81 years with sorafenib and 6.82 years with placebo (difference 0.01 year; 95% CI -0.49 to 0.48; P=0.99). No differences in DFS or overall survival were seen in all randomly assigned patients, in the high-risk subgroup or in clear cell patients. More than half of participants stopped treatment by 12 months; grade 3 hand-foot skin reaction occurred in 24% on sorafenib. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 1.01 | 0.83–1.23 |