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Three phase III clinical trials (Keynote 426, Checkmate 9ER and Checkmate 214) assessing first-line treatment with immunotherapy in metastatic renal cell carcinoma (RCC) compared to sunitinib were analysed for patients who had prior nephrectomy compared to those who did not.
Patients who had prior nephrectomy had a longer time before the immunotherapy stopped working and the cancer started growing again (progression-free survival) in two of the trials that were looked at: CheckMate 9ER and CheckMate 214, but not in Keynote-426. For comparison, in the pivotal trial comparing sunitinib with interferon as first-line treatment for metastatic RCC, the patients who had prior nephrectomy also had longer progression-free survival. However, only those patients in CheckMate 9ER who had a nephrectomy had better overall survival.
In conclusion, progression-free survival was improved in metastatic RCC patients who had a prior nephrectomy in two of three immunotherapy trials. The Keynote-426 trial had a high proportion of intermediate- or poor-risk patients, and a small number of patients who had a prior nephrectomy, which may explain the lack of survival benefit seen in this study.