Radical nephrectomy (RN) has been central to the treatment of renal cancer for decades, but nephron-sparing surgery (NSS) has been applied to patients in certain circumstances to preserve renal function. These two treatments had not, however, been compared in a randomized prospective study. In the EORTC non-inferiority phase III trial 30904, 541 patients with small (< 5 cm), solitary, T1–T2 N0 M0 tumors suspicious for renal cell carcinoma and a normal contra lateral kidney were randomized to receive NSS, 268 patients, or RN, 273 patients 1.
At a median follow-up of 9.3 years, the intention-to-treat analysis shows 10-year overall survival rates of 81.1% for patients receiving RN and 75.7% for patients receiving NSS. The test for non-inferiority is not significant (p = 0.77), and the test for superiority is significant (p = 0.03) with HR = 1.50 (95% CI, 1.03–2.16). However, in renal cell carcinoma patients and clinically and pathologically eligible patients, the difference is less pronounced (HR = 1.43 and 1.34, respectively), and the superiority test is no longer significant (p = 0.07 and 0.17, respectively).
Regarding the secondary end point, progression was detected in twelve patients in the NSS group and in nine patients in the RN group.
This study confirms the oncologic efficacy of RN and provides the first level 1 evidence comparing RN and NSS.
In an editorial prefacing the published results of this study, Carlo Terrone and Alessandro Volpe congratulate the authors for conducting this important study, and argue that further studies will be required to clarify remaining clinical issues concerning these treatments 2.
EORTC, Medical Science Writer
1 H. Van Poppel, L. Da Pozzo, W. Albrecht, V. Matveev, A. Bono, A. Borkowski, M. Colombel, L. Klotz, E. Skinner, T. Keane, S. Marreaud, S. Collette, R. Sylvester. A Prospective, Randomised EORTC Intergroup Phase 3 Study Comparing the Oncologic Outcome of Elective Nephron-Sparing Surgery and Radical Nephrectomy for Low-Stage Renal Cell Carcinoma. Eur Urol 2011;59:543-552.
2 C. Terrone and A. Volpe. Can Emerging Level 1 Evidence ‘‘Discourage’’ Elective Nephron-Sparing Surgery for Small Renal Tumors? Eur Urol 2011;59:553-555.