This presentation is still coming after the presentation that I’ve made last year in the plenary session. Last year we presented the CARMENA trial and the results of this trial were that cytoreductive nephrectomy should no longer be considered standard of care for patients with metastatic kidney cancer. After this presentation there were a lot of comments and we decided to make a post-hoc analysis of the study to focus and to try to find a population for which it is necessary to make a cytoreductive nephrectomy.
So the results of the study were that, first, cytoreductive nephrectomy remains not superior to sunitinib alone in patients with metastatic kidney cancer with a longer follow-up of 61.5 months, that’s the first point. The second point is that the results are consistent with MSKCC classification and IMDC classification because we made a reclassification of patients according to these classifications. That’s the second point. The third point is that patients who have just one risk factor according to the IMDC classification and one metastatic site could be beneficial to have a nephrectomy, a cytoreductive nephrectomy. The fourth point is that for patients who had a systemic therapy for their treatment without nephrectomy and for those patients who have a very good response after the systemic therapy it is a very good approach to make a nephrectomy which would be a delayed nephrectomy for these patients with a very long overall survival for these patients.
Besides the number of metastatic sites, what else can be used or might be useful to help identify good candidates for surgery?
The post-hoc analysis says that the number of metastases is not really helpful to define which are the best candidates to have a nephrectomy or not. But it could be possible to think according to these results that the patients with just lung mets have a better overall survival when they have an operation versus those without an operation. It’s not statistically significant but there is a trend. So we think that patients with one risk factor, one metastatic site, and actually lung mets, could be a good candidate to have surgery before being treated by sunitinib.
Should this strategy be applied to only patients with secondary nephrectomy?
We tried to see what about the patients having a secondary nephrectomy. 40 patients had a secondary nephrectomy, patients were included in the arm sunitinib alone but for 40 patients we decided to make a nephrectomy, in 7 cases for symptoms linked to the primary tumour, in cases of emergency, things like that, but for more than 80% of these we decided to make a nephrectomy after a complete or near complete response in metastatic sites. It was an ethical reason for us because metastasis decreases making a nephrectomy for these patients. When we are doing this nephrectomy the overall survival is very good, 48 months versus 15.7 for the patients who have not delayed secondary nephrectomy. It’s definitely statistically significant. So for these patients we decided to make systemic therapy; if they had a good response it is absolutely necessary to make a secondary nephrectomy with a very long overall survival.