To summarize the evidence on the effectiveness and comparative effectiveness of strategies for evaluating and treating patients with a renal mass suspicious for renal cell carcinoma, including use of composite models for predicting malignancy at initial diagnosis, use of percutaneous renal sampling (by fine needle aspiration or core biopsy) to establish a diagnosis, and comparative efficacy of radical nephrectomy, partial nephrectomy, thermal ablation, and active surveillance.
We searched MEDLINE®, Embase®, and the Cochrane Central Register of Controlled Trials (CENTRAL) from January 1, 1997, through May 1, 2015, and we looked for studies on Clinicaltrials.gov.
Paired investigators independently screened search results to assess eligibility. Investigators abstracted data sequentially and assessed risk of bias independently. Investigators graded the strength of evidence as a group.
The search identified 147 studies, published in 150 articles. In preoperative composite models of patient and tumor characteristics, male sex and increased tumor size were consistently predictive of malignant pathology. The diagnostic accuracy of core biopsy was evaluated in 18 studies, and had a sensitivity of 97.5 percent, specificity of 96.2 percent, positive predictive value of 99.8 percent, negative predictive value of 68.5 percent, non-diagnostic rate of 14 percent, and complication rate of 5 percent or less. Only one study examined the diagnostic accuracy of fine needle aspiration (sensitivity 63 percent). Cancer-specific survival was excellent among all management strategies with a median 5-year cancer-specific survival of 95 percent. Overall survival rates were 75-99 percent for partial nephrectomy, 71-81 percent for radical nephrectomy, and 83-95 percent for thermal ablation (at 5 years), and 69-94 percent for active surveillance (at 12-35 months). The strength of evidence was low to moderate that local recurrence-free survival was worse for thermal ablation than for radical or partial nephrectomy, but equivalent with partial nephrectomy when multiple ablative treatments were considered. The strength of evidence was moderate that radical nephrectomy had the largest decline in estimated glomerular filtration rate and highest incidence of chronic kidney disease, but the rate of end-stage renal disease was low among all management strategies (0.4-2.8 percent). The strength of evidence was moderate that thermal ablation offered more favorable perioperative outcomes (estimated blood loss, length of hospital stay, and conversion to open surgery), but all interventional strategies were approximately equivalent when evaluating postoperative harms. However, the strength of evidence was low that partial nephrectomy was associated with greater urologic complications, bleeding, and blood transfusion rate, and radical nephrectomy had more respiratory harms and acute kidney injury when compared to partial nephrectomy and thermal ablation.
No composite model reliably predicts malignancy, although tumor size and male sex are highly associated with malignancy. Percutaneous renal mass sampling with core biopsy is a low risk and sensitive procedure, but is associated with a notable non-diagnostic rate (14 percent). Most patients with non-diagnostic biopsies who proceed to surgery are found to have malignancy. Cancer-specific survival was comparable across all management strategies, with differences in overall survival that are explained by competing risks of death. Thermal ablation has the highest local recurrence rate and may require multiple treatments to achieve similar oncologic efficacy as radical or partial nephrectomy. However, thermal ablation has the most favorable perioperative outcomes and harms. Thermal ablation and partial nephrectomy offer improved renal functional outcomes over radical nephrectomy in the long run. Comparative data are lacking on active surveillance. Therefore, selection of a management strategy warrants a conversation between patient and physician to discuss the outcome profile for each strategy based on similar cancer-specific survival but different overall survival (competing health risks), renal functional outcomes, perioperative outcomes, and postoperative harms.
Patel HD, Johnson MH, Pierorazio PM, et al. Diagnostic accuracy and risks of biopsy in the diagnosis of a renal mass suspicious for localized renal cell carcinoma: systematic review of the literature. J Urol. 2016 Feb 18. Epub ahead of print. DOI: 10.1016/j.juro.2015.11.029. PMID: 26901507.