EORTC 30904
Elective nephron-sparing surgery versus radical nephrectomy for low-stage renal cell carcinoma (EORTC genito-urinary group, intergroup phase 3)
Phase 3N = 541NCT00002473
- Population
- Small (5 cm or less), solitary, T1-T2 N0 M0 (UICC 1978) tumours suspicious for renal cell carcinoma, with a normal contralateral kidney.
- Design
- Randomised, noninferiority, intergroup phase 3 trial. Patients were randomised to nephron-sparing surgery or radical nephrectomy, each with limited lymph node dissection. Recruitment ran from March 1992 to January 2003, when the trial closed early because of poor accrual. The ClinicalTrials.gov record gives no enrolment count.
- Arms
- Nephron-sparing surgery (experimental, n = 268): Elective nephron-sparing surgery with limited lymph node dissection
- Radical nephrectomy (control, n = 273): Radical nephrectomy with limited lymph node dissection
- People
- Van Poppel H, EORTC Genito-Urinary Group
OSHR 1.50 (95% CI 1.03–2.16)Δ 120-month OS−5.4 pointsΔ eGFR below 60−21 pointsΔ eGFR below 30−3.7 pointsΔ eGFR below 15+0.1 points
Show the numbers
| Endpoint | Analysis | Nephron-sparing surgery | Radical nephrectomy | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 9.3 yearsVan 2011 | 75.7% at 10 y | 81.1% at 10 y | HR 1.50 (95% CI 1.03–2.16)P=0.03Hazard ratio for nephron-sparing surgery versus radical nephrectomy (direction as stated in the follow-up paper). The p-value is the test for superiority; the test for noninferiority was not significant (p=0.77). In patients with renal cell carcinoma the HR was 1.43 (superiority p=0.07) and in clinically and pathologically eligible patients 1.34 (p=0.17). The abstract reports 117 deaths in total, 12 of them from renal cancer (4 after radical nephrectomy, 8 after nephron-sparing surgery), and 21 patients with progression (9 and 12). |
| eGFR below 60Patients with follow-up eGFR recorded (259 radical nephrectomy, 255 nephron-sparing surgery), intention-to-treat | exploratorymedian follow-up 6.7 yearsScosyrev 2014 | 64.7% | 85.7% | Based on the lowest recorded follow-up eGFR. Difference 21.0% (95% CI 13.8 to 28.3). Companion analysis; the abstract does not say whether it was prespecified, so it is labelled exploratory. |
| eGFR below 30Patients with follow-up eGFR recorded (259 radical nephrectomy, 255 nephron-sparing surgery), intention-to-treat | exploratorymedian follow-up 6.7 yearsScosyrev 2014 | 6.3% | 10% | Difference 3.7% (95% CI -1.0 to 8.5). Companion analysis; the abstract does not say whether it was prespecified, so it is labelled exploratory. |
| eGFR below 15Patients with follow-up eGFR recorded (259 radical nephrectomy, 255 nephron-sparing surgery), intention-to-treat | exploratorymedian follow-up 6.7 yearsScosyrev 2014 | 1.6% | 1.5% | Difference -0.1% (95% CI -2.2 to 2.1). Companion analysis; the abstract does not say whether it was prespecified, so it is labelled exploratory. |
| Endpoint | Analysis | Nephron-sparing surgery | Radical nephrectomy | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 9.3 yearsVan 2011 | 75.7% at 10 y | 81.1% at 10 y | HR 1.50 (95% CI 1.03–2.16)P=0.03Hazard ratio for nephron-sparing surgery versus radical nephrectomy (direction as stated in the follow-up paper). The p-value is the test for superiority; the test for noninferiority was not significant (p=0.77). In patients with renal cell carcinoma the HR was 1.43 (superiority p=0.07) and in clinically and pathologically eligible patients 1.34 (p=0.17). The abstract reports 117 deaths in total, 12 of them from renal cancer (4 after radical nephrectomy, 8 after nephron-sparing surgery), and 21 patients with progression (9 and 12). |
| eGFR below 60Patients with follow-up eGFR recorded (259 radical nephrectomy, 255 nephron-sparing surgery), intention-to-treat | exploratorymedian follow-up 6.7 yearsScosyrev 2014 | 64.7% | 85.7% | Based on the lowest recorded follow-up eGFR. Difference 21.0% (95% CI 13.8 to 28.3). Companion analysis; the abstract does not say whether it was prespecified, so it is labelled exploratory. |
| eGFR below 30Patients with follow-up eGFR recorded (259 radical nephrectomy, 255 nephron-sparing surgery), intention-to-treat | exploratorymedian follow-up 6.7 yearsScosyrev 2014 | 6.3% | 10% | Difference 3.7% (95% CI -1.0 to 8.5). Companion analysis; the abstract does not say whether it was prespecified, so it is labelled exploratory. |
| eGFR below 15Patients with follow-up eGFR recorded (259 radical nephrectomy, 255 nephron-sparing surgery), intention-to-treat | exploratorymedian follow-up 6.7 yearsScosyrev 2014 | 1.6% | 1.5% | Difference -0.1% (95% CI -2.2 to 2.1). Companion analysis; the abstract does not say whether it was prespecified, so it is labelled exploratory. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 1.5 | 1.03–2.16 |
Appears in
Sources
Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, et al. 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(4):543-52.
Scosyrev E, Messing EM, Sylvester R, Campbell S, Van Poppel H. Renal function after nephron-sparing surgery versus radical nephrectomy: results from EORTC randomized trial 30904. Eur Urol. 2014;65(2):372-7.