Results of the CARMENA trial suggest caution with upfront cytoreductive nephrectomy (CN) in patients with metastatic renal carcinoma (mRCC). However, 17% of patients in the sunitinib alone arm underwent deferred CN (dCN). Identification of patients suitable for CN may be accomplished using upfront systemic therapy as a litmus test for suitability, but data on outcomes are limited.
Bimal Bhindi, MD, and colleagues conducted a study designed to characterize outcomes of dCN after upfront sunitinib relative to sunitinib alone. Results of the study were reported during a poster session at the ASCO 2019 Annual Meeting.
The researchers utilized the International mRCC Database Consortium (IMDC) to identify patients with newly diagnosed mRCC receiving upfront sunitinib from 2006 to 2018. With the exception of CNs that were performed after sunitinib failure, all CNs done after initial sunitinib were included. The outcomes of interest were overall survival and time to treatment failure. The researchers conducted Kaplan Meier and multivariable Cox regression analyses; to account for immortal time bias, dCN was analyzed as a time-varying covariate.
Of the 708 patients in the cohort, 7.5% (n=53) underwent dCN at a median of 6.5 months from diagnosis. Patients in the dCN group were more likely to have better Karnofsky performance status (KPS), intermediate IMDC risk, fewer metastatic sites, and response to upfront sunitinib.
During a median follow-up of 63 months, there were 604 deaths. Median overall survival and time to treatment failure were 43.5 months and 19.8 months with dCN versus 9.4 months and 4.3 months without dCN.
In multivariable analysis, the association between dCN and overall survival remained significant (hazard ratio [HR], 0.45; 95% confidence interval, [CI] 0.31-0.56; P<.001). The association between dCN and time to treatment failure did not remain significant (HR, 0.73; 95% CI, 0.52-1.01; P=.056).
In conclusion, the researchers said, “Patients who received dCN were carefully selected and achieved long overall survival. With these benchmark outcomes, optimal selection criteria need to be identified and confirmation of the role of dCN in a clinical trial is warranted.
Source: Bhindi B, Graham J, Wells C, et al. Deferred cytoreductive nephrectomy among patients with newly diagnosed metastatic renal cell carcinoma treated initially with sunitinib. Abstract (4578) of a poster presented at the American Society of Clinical Oncology Annual Meeting 2019, May 31-June 4, 2019, Chicago, Illinois.