|The following article features coverage from the American Society of Clinical Oncology (ASCO) 2018 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
CHICAGO—Sunitinib monotherapy was not inferior to cytoreductive nephrectomy (CN) followed by sunitinib among patients with intermediate- and poor-risk metastatic renal cell carcinoma (mRCC), according to data presented during the Plenary Session at the American Society of Clinical Oncology 2018 Annual Meeting on Sunday, June 3.1
Many studies have supported CN as the standard of care among patients with mRCC and has led to its utilization in this capacity for more than 2 decades. The emergence and efficacy of targeted therapies, however, has called into question the conventional standard of using CN prior to sunitinib.
In the phase 3 CARMENA study (ClinicalTrials.gov Identifier: NCT00930033) researchers randomly assigned 450 patients with synchronous mRCC amenable to CN, to receive sunitinib 50 mg after CN or sunitinib alone. Enrolled participants had clear cell histology, no evidence of brain metastases, acceptable organ function, and were eligible for sunitinib therapy.
Among patients in the CN arm, 55.6% and 44.4% were categorized by the Memorial Sloan Kettering Cancer Center (MSKCC) risk groups as intermediate and poor risk, respectively, and 58.5% and 41.5% in the sunitinib alone arm were MSKCC intermediate and poor risk, respectively.
After a median follow-up of 50.9 months there was a total of 326 deaths.
Overall survival was not found to be inferior among patients who received sunitinib alone with 18.4 months compared with 13.9 months among patients who underwent CN before sunitinib (hazard ratio [HR], 0.89; 95% CI, 0.71-1.10). The median progression-free survival was 8.3 months among patients in the sunitinib alone arm versus 7.2 months among patients who received standard of care.
The overall response rate was identical with 35.9% in both study arms.
The authors concluded that “Sunitinib alone is not inferior to CN followed by sunitinib in synchronous mRCC both in intermediate and poor MSKCC risk groups. CN should not be anymore the standard of care when medical treatment is required.”
- Mejean A, Escudier B, Thezenas S, et al. CARMENA: Cytoreductive nephrectomy followed by sunitinib versus sunitinib alone in metastatic renal cell carcinoma—Results of a phase III noninferiority trial. Late breaking abstract at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.