📃 Paper Title: 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
🧍 Author: Van Poppel
🕒 Year: 2011
📚 Journal: European Urology
🌎 Country: Belgium
ㅤContext to the study:
Do you know any evidence to support the oncological safety of partial (versus radical) nephrectomy for an early stage renal tumour?
ㅤ✅ Take-home message of study:
In this non-inferiority randomised controlled trial of nephron-sparing surgery (NSS) and radical nephrectomy (RN), both surgical approaches offered excellent oncological control of isolated, early stage (≤ 5cm), renal cancer
ㅤ Randomised Controlled Trial (Non-Inferiority Phase 3)
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Study participants:
541 patients with solitary renal mass ≤ 5cm, T1-T2 N0 M0 and a normal contralateral kidney
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Key study outcomes:
• Primary: Overall survival and time to progression
• Median follow up 9.3 years
• Progression: 9 after RN and 12 after NSS
• Deaths from RCC: 4 after RN and 8 after NSS
• Intention to treat (ITT) analysis favoured RN for OS; however on target population of RCC patients, this was no longer significant. Note 55 patients switched treatment from ITT
• Ultimately, NSS a/w 4.5% risk of progression and 3% risk of mortality
• Relatively low complication rate in both groups (NSS slightly higher); both deemed safe
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Study Limitations:
• Poor accrual (target 1300 not achieved)
• Quality of life (QoL) and renal function outcomes have not been addressed
• 5cm cut off doesn't correspond to current T staging
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