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CARMENA showed that removing the kidney before starting sunitinib did not help people with kidney cancer that had already spread live longer, which ended the routine practice of upfront nephrectomy for intermediate- and poor-risk patients.
Removing the primary kidney tumour before systemic therapy had been standard since trials in the interferon era showed a survival benefit. CARMENA, a French non-inferiority phase 3 trial, randomised 450 patients with metastatic clear cell renal cell carcinoma of MSKCC intermediate or poor risk to nephrectomy followed by sunitinib or to sunitinib alone. The primary endpoint was overall survival.
Sunitinib alone was non-inferior to nephrectomy plus sunitinib for overall survival, and the poor-risk group did numerically better without surgery. Together with the SURTIME trial it moved practice towards starting systemic therapy first and reserving nephrectomy for selected patients with a good response or few metastases; the question is being revisited in the immunotherapy era.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
452 enrolled.
Non-inferiority boundary 1.20 for the upper 95% CI; median follow-up 50.9 months; 450 enrolled
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (planned interim analysis, non-inferiority)primary | Sunitinib alone | - | 18.4 months | 0.89 (0.71 to 1.1) | - | link |
| Nephrectomy then sunitinib | - | 13.9 months |
Shares Sunitinib, Anti-angiogenic therapy, Renal cell carcinoma, Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Clear cell renal cell carcinoma, Renal cell carcinoma and the tag subtype-trials.
Shares Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Anti-angiogenic therapy, Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Anti-angiogenic therapy and the tag subtype-trials.
Shares Anti-angiogenic therapy and the tag subtype-trials.