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Bending the Curve Trial by Trial
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Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer

Population
Metastatic renal-cell cancer, acceptable candidates for nephrectomy; 120 and 121 eligible patients in the two arms
Design
Randomised trial in patients with metastatic renal-cell cancer who were acceptable candidates for nephrectomy: radical nephrectomy followed by interferon alfa-2b versus interferon alfa-2b alone. Primary end point survival; secondary end point tumour response.
Primary endpoint
OS
Arms
  • Nephrectomy then interferon alfa-2b (experimental, n = 120): Radical nephrectomy followed by interferon alfa-2b
  • Interferon alfa-2b alone (control, n = 121): Interferon alfa-2b
People
Flanigan RC, senior author Crawford ED
Δ median OS+3 months
Show the numbers
Results reported for Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer
EndpointAnalysisNephrectomy then interferon alfa-2bInterferon alfa-2b aloneEffect
OSEligible patients (120 assigned to surgery plus interferon, 121 to interferon alone)primaryFlanigan 2001median 11.1 monthsmedian 8.1 monthsP=0.05The abstract states that the difference in median survival was independent of performance status, metastatic site and the presence of a measurable metastatic lesion.
Results reported for Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer
EndpointAnalysisNephrectomy then interferon alfa-2bInterferon alfa-2b aloneEffect
OSEligible patients (120 assigned to surgery plus interferon, 121 to interferon alone)primaryFlanigan 2001median 11.1 monthsmedian 8.1 monthsP=0.05The abstract states that the difference in median survival was independent of performance status, metastatic site and the presence of a measurable metastatic lesion.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Nephrectomy then interferon alfa-2b (experimental)
  • Interferon alfa-2b alone (control)

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

Data table (modelled values)
MonthsNephrectomy then interferon alfa-2bInterferon alfa-2b alone
0100.0%100.0%
764.6%54.9%
1441.7%30.2%
2126.9%16.6%
2817.4%9.1%
Primary publication: Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, et al. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001;345(23):1655-9. PubMedDOI

Appears in

Sources

  1. Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, et al. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001;345(23):1655-9.

    PubMedDOI