"Nephrectomy Plus Interferon Alfa-2b versus Interferon Alfa-2b Alone in Metastatic Renal-Cell Cancer"
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Does nephrectomy followed by interferon therapy result in longer survival than interferon therapy alone in patients with metastatic renal-cell cancer?
Nephrectomy followed by interferon therapy results in longer survival among patients with metastatic renal-cell cancer than does interferon therapy alone.
The Southwest Oncology Group conducted a randomized trial to determine whether nephrectomy affects survival in metastatic renal-cell cancer. The trial compared nephrectomy followed by interferon alfa-2b therapy with interferon alfa-2b therapy alone and found that the median survival was 11.1 months in the nephrectomy group, compared to 8.1 months in the interferon-only group.
As a result of this and related studies, nephrectomy followed by interferon therapy is considered a possible standard of care in metastatic renal-cell cancer, and should potentially be used in the control group of future phase 3 trials exploring treatments of this disease.
- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial - N=241 eligible patients with metastatic renal-cell cancer and acceptable candidates for nephrectomy - Randomization to radical nephrectomy plus interferon alfa-2b therapy or interferon alfa-2b therapy alone - Mean follow-up: 368 days - Primary endpoint: Overall survival - Secondary endpoint: Response of tumor to treatment
Inclusion Criteria: - Confirmed diagnosis of metastatic renal-cell carcinoma - Primary tumor considered resectable - Performance status of 0 or 1 according to the Southwest Oncology Group (SWOG) criteria - No prior treatment with chemotherapy, hormonal therapy, or biologic-response modifiers.
Exclusion Criteria: - Uncontrolled cardiac arrhythmias - History of other cancers within the last five years, with exceptions for certain treated skin cancers or in situ cervical cancer.
- Radical nephrectomy through transabdominal, flank, or thoracoabdominal approach, followed by interferon alfa-2b therapy. - Interferon alfa-2b therapy alone, without nephrectomy.
Primary Outcomes: - Median survival: 11.1 months for nephrectomy group vs. 8.1 months for interferon-only group (P=0.05)
Secondary Outcome: - Response rates to interferon therapy were low and similar in both groups (3.3% partial responses in the nephrectomy group vs. 3.6% complete/partial/unconfirmed responses in the interferon-only group).
- The reasons nephrectomy prior to systemic treatment may be beneficial are not well understood. - Some argue the operative morbidity and mortality associated with nephrectomy may offset potential benefits, although this study showed low rates of complications. - The study was not designed to evaluate which patients might most benefit from surgery.
Supported in part by Public Health Service Cooperative Agreements from the National Cancer Institute.
- SWOG-8949, Operations Office, 14980 Omicron Dr., San Antonio, TX 78245-3217