SWOG 8949
Trial question
Is radical nephrectomy followed by therapy with interferon alfa-2b superior to interferon alfa-2b therapy alone in patients with metastatic renal cell cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 241
241 patients (74 female, 167 male).
Inclusion criteria: patients with metastatic renal cell cancer who were acceptable candidates for nephrectomy.
Key exclusion criteria: thrombosis of the IVC below the hepatic veins, uncontrolled cardiac arrhythmias, prior treatment with chemotherapy, hormonal therapy, interferon, or other biologic response modifiers, prior or concomitant radiation therapy to the primary tumor or to metastatic sites.
Interventions
N=120 surgery plus interferon (immediate radical nephrectomy followed by therapy with interferon alfa-2b).
N=121 interferon treatment alone (immediate interferon alfa-2b therapy without surgery).
Primary outcome
Survival
11.1 months
8.1 months
11.1 months
8.3 months
5.5 months
2.8 months
0.0 months
Surgery plus
interferon
Interferon treatment
alone
Significant
increase ▲
Significant increase in survival (11.1 months vs. 8.1 months; AD 3 months, 95% CI 0.13 to 5.87).
Secondary outcomes
No significant difference in survival with performance status 1 (6.9 months vs. 4.8 months; AD 2.1 months, 95% CI -0.25 to 4.45).
Significant increase in survival with lung metastases (14.3 months vs. 10.3 months; AD 4 months, 95% CI 1.04 to 6.96).
Conclusion
In patients with metastatic renal cell cancer who were acceptable candidates for nephrectomy, surgery plus interferon was superior to interferon treatment alone with respect to survival.
Reference
Flanigan RC, Salmon SE, Blumenstein BA et al. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9.
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