Phase-III-trial finds many people do not need surgery

<p class="article-intro">A randomized phase-III-trial showed that many people with advanced kidney cancer can avoid nephrectomy without compromising survival. The median overall survival for people who received only sunitinib was 18,4 months, compared to 13,9 months for those who received surgery followed by sunitinib, the current standard of care.</p> <hr /> <p class="article-content"><p>The CARMENA-trial enrolled 450 patients with synchronous metastatic renal cell carcinoma (mRCC). The patients were randomly assigned to receive surgery followed by sunitinib or sunitinib alone. In the surgery group, patients started sunitinib 4 6 weeks after surgery to allow time for recovery from surgery.</p> <p>Patients were followed for a median time of 50,9 months. Survival was not worse with sunitinib alone than with surgery and sunitinib. This was true for the study population as a whole (median survival was 18,4 months without surgery vs. 13,9 months with surgery), as well as for subgroups with an intermediate (median survival was 23,4 vs. 19 months) and poor prognosis (median survival was 13,3 vs. 10,2 months) groups. The difference in median survival seems to suggest a greater benefit with sunitinib alone. However, this cannot be concluded, as this trial was not designed to prove that one treatment is superior to the other, noted Dr. Mejean. <br />The rate of tumor response to therapy (tumor shrinkage) was the same in the two treatment groups (27,4 % and 29,1 % ) and the median time until the cancer worsened was slightly longer for patients who received sunitinib alone compared with those who also had surgery (8,3 months vs. 7,2 months). Clinical benefit was experienced by 47,9 % of patients treated with sunitinib only, compared with 36,6 % of patients treated by surgery and sunitinib.</p> <p>The authors remarked that kidney surgery is still the gold standard for people who do not need systemic therapy, such as those with only one metastasis. Those patients were not included in this clinical trial. <br />Some patients in the study had a very good response to sunitinib alone and received surgery after completing systemic treatment. The researchers plan to continue following outcomes in these patients, as well as in other subgroups of study participants. Genomic research on tumor tissue collected on the study is underway.</p> <p><strong>Reference:</strong> <br />Mejean A et al.: CARMENA: Cytoreductive nephrectomy followed by sunitinib versus sunitinib alone in metastatic renal cell carcinoma Results of a phase III noninferiority trial. ASCO Annual Meeting 2018, abstract #LBA3</p></p>