Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial: trial

Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial

N = 85

Population

Histologically confirmed metastatic renal-cell carcinoma, progressive at entry

Design

Randomised trial by the EORTC Genitourinary Group of radical nephrectomy followed by interferon-alfa-based immunotherapy versus interferon alfa alone (5x10(6) IU/m2 subcutaneously three times per week) in patients with histologically confirmed, progressive metastatic renal-cell carcinoma, June 1995 to July 1998. Surgery within 4 weeks of randomisation, immunotherapy 2-4 weeks later. Primary endpoints time to progression and overall survival; all analyses by intention to treat.

Primary endpoint

TTP, OS

Arms

Radical nephrectomy plus interferon alfa-based immunotherapy (experimental): Radical nephrectomy, then interferon alfa 5x10(6) IU/m2 subcutaneously three times per week
Interferon alfa alone (control): Interferon alfa 5x10(6) IU/m2 subcutaneously three times per week

People

Mickisch GH, EORTC Genitourinary Group

TTPHR 0.60 (95% CI 0.36–0.97)Δ median TTP+2 monthsOSHR 0.54 (95% CI 0.31–0.94)Δ median OS+10 months

Show the numbers

Results reported for Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial
Endpoint	Analysis	Radical nephrectomy plus interferon alfa-based immunotherapy	Interferon alfa alone	Effect
TTP	primaryMickisch 2001	median 5 months	median 3 months	HR 0.60 (95% CI 0.36–0.97)
OS	primaryMickisch 2001	median 17 months	median 7 months	HR 0.54 (95% CI 0.31–0.94)

Results reported for Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial
Endpoint	Analysis	Radical nephrectomy plus interferon alfa-based immunotherapy	Interferon alfa alone	Effect
TTP	primaryMickisch 2001	median 5 months	median 3 months	HR 0.60 (95% CI 0.36–0.97)
OS	primaryMickisch 2001	median 17 months	median 7 months	HR 0.54 (95% CI 0.31–0.94)

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
TTP	0.6	0.36–0.97
OS	0.54	0.31–0.94

Illustrative — modelled from reported values, not trial data. TTP, primary.

Show curves

Radical nephrectomy plus interferon alfa-based immunotherapy (experimental)
Interferon alfa alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Radical nephrectomy plus interferon alfa-based immunotherapy	Interferon alfa alone
0	100.0%	100.0%
3	66.0%	50.0%
6	43.5%	25.0%
9	28.7%	12.5%
13	16.5%	5.0%

Illustrative — modelled from reported values, not trial data. OS, primary.

Show curves

Radical nephrectomy plus interferon alfa-based immunotherapy (experimental)
Interferon alfa alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Radical nephrectomy plus interferon alfa-based immunotherapy	Interferon alfa alone
0	100.0%	100.0%
11	63.9%	33.6%
21	42.5%	12.5%
32	27.1%	4.2%
43	17.3%	1.4%

Appears in

2001 Nephrectomy before interferon alfa: two randomised trials (2001)

Sources

Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001;358(9286):966-70.
PubMed DOI