EORTC 30947

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Mickisch GH, et al. "Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial". The Lancet. 2001. 358(9286):966-970.
PubMedFull text

Clinical Question

In patients with metastatic renal cell carcinoma, does cytoreductive nephrectomy followed by interferon therapy result in longer progression free and overall survival than interferon alone?

Bottom Line

Radical nephrectomy before interferon-based immunotherapy substantially delays time to progression and improves survival of patients with metastatic renal cell carcinoma who present with good performance status.

Major Points

This study along with SWOG 8949, were the first to demonstrate survival benefit from cytoreductive nephrectomy in the setting of metastatic RCC.

This study found that cytoreductive nephrectomy plus interferon alfa resulted in improved median overall survival when compared to interferon alfa alone (17 vs. 7 months).

Guidelines

Design

  • Multicenter, randomized, controlled trial
  • N=1850,251
    • Cytoreductive Nephrectomy + Interferon alfa (N=42)
    • Interferon alfa alone (N=43)
  • Setting: Centers in Europe, members of EORTC GU Group 
  • Enrollment: June 1995, to July 1998
  • Mean follow-up:
  • Analysis: Intention-to-treat
  • Primary outcome:

Population

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

Interventions

Outcomes

Comparisons are intensive therapy vs. standard therapy.

Primary Outcomes

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading