A new approach in the treatment of metastatic renal cell cancer

Stakhovsky E.O. 1, Vitruk Y.V.1, Voylenko O.A. 1, Stakhovsky O.E. 1, Kononenko O.A.1, Pikul M.V. 1, Semko S.L.1, Vucalovych P.S.1, Grechko B.O. 1, Koshel D.O. 1, Tymoshenko A.V.1, Buivol O.V. 1, Vitruk V.Y.2, Harbar R.F.2, Petrishcheva O.Kh.2, Pasichnyk S.M.3

Summary. Materials and methods. The paper presents the results of an interim analysis of a prospective non-randomized clinical trial evaluating efficacy of cytoreductive partial nephrectomy in the treatment of metastatic kidney cancer, which ongoing since 2008 at the National Cancer Institute of the Ministry of Health of Ukraine. Inclusion criteria are: age (18–75 years); pathologically confirmed metastatic clear-cell renal-cell carcinoma (T1-4/N0-1/M1); presence of thrombosis of vena cava inferior; remaining functioning parenchyma of the affected kidney over 50%. Exclusion criteria — bilateral kidney tumors, chronic kidney disease (total glomerular filtration rate <30 ml/min), concomitant oncologic disease. 109 patients were recruited to the study before data base cut-off: the first group included 55 (50.5%) patients that underwent cytoreductive partial nephrectomy, the second group included 54 (49.5%) patients, that underwent cytoreductive nephrectomy. The aim of the investigation was to state indications for partial nephrectomy in metastatic kidney cancer patients. Results. Groups were comparable by age, sex, body mass index, general status, concomitant pathology, kidney function, number of metastatic sites and Fuhrman grade. Groups differed in the maximum lesion diameter, R.E.N.A.L. score, remaining functioning parenchyma volume, T-stage and risk groups according to International Metastatic Renal Cancer Database Consortium. Groups didn’t differ statistically in terms of survival (p=0.093 by log-rank test), although indicator of 7-year overall survival rate in the nephrectomy group was 7.3±3.9% vs 23.9±6.3% in the partial nephrectomy group. Partial nephrectomy significantly reduces the risk of death compared to nephrectomy (p=0.037), hazard ratio=0.62 (95% confidence interval 0.39–0.97). Groups were comparable by main surgical safety parameters. There were no lethal episodes in both groups. Medium remaining functioning parenchyma volume was 56% in partial nephrectomy cohort (85.4% of cases with polar or lateral location; 14.6% — centrally located tumors). Conclusion. Cytoreductive partial nephrectomy is a safe surgical method that provides effective debulking, preserves functioning parenchyma, decreases the risk of kidney insufficiency and avoids possible side effects of the systemic therapy. Although there were found no statistically significant difference in terms of overall survival in both groups, survival function was better in partial nephrectomy group.

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