For many patients diagnosed with metastatic renal cell carcinoma, sunitinib alone is not inferior to surgery followed by sunitinib.
For many patients with newly diagnosed metastatic renal cell carcinoma (mRCC), it is possible to forego surgery without reducing survival time, according to results from the randomized phase III noninferiority CARMENA study (abstract LBA3), presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 1–5 in Chicago.
Median overall survival among patients receiving only sunitinib was 18.4 months compared with 13.9 months for surgery and sunitinib therapy, the current standard of care, reported study coauthor Arnaud Mejean, MD, PhD, of the HoÌpital EuropeÌen Georges-Pompidou, Paris Descartes University in France.
This finding should allow some patients to avoid the risk of surgical complications like infection and pulmonary embolism, noted Sumanta K. Pal, MD, of City of Hope Comprehensive Cancer Center in Duarte, California.
Kidney removal and recovery from surgery also delay tumor-directed therapy for a period of several weeks, sometimes allowing tumors the opportunity to progress.
“Until now, nephrectomy has been considered the standard of care for patients with kidney cancer who have metastatic disease when the cancer is first diagnosed,” Mejean said. “Our study is the first to question the need for surgery in the era of targeted therapies, and clearly shows that surgery for certain people with kidney cancer should no longer be the standard of care.”
The study enrolled 450 patients diagnosed with mRCC and randomly assigned them to receive either surgery followed 4 to 6 weeks later by sunitinib targeted therapy or sunitinib without surgery. Importantly, patients with only one metastasis, or who for other reasons did not require systemic therapy, were not enrolled. For these patients, nephrectomy remains the “gold standard,” Mejean noted.
At a follow-up of 50.9 months, survival was comparable between the two study groups overall (18.4 months without surgery compared with 13.9 months with surgery), as well as in subgroup analyses for poor- and intermediate-risk patients.
Tumor response rates were also similar between the two groups (27% vs 29%), and median time to progression was 8.3 months compared with 7.2 months for patients undergoing surgery.
Because the study was designed to determine noninferiority rather than superiority, it cannot be concluded that sunitinib alone outperforms surgery followed by sunitinib.