Interleukin-2, interferon-α, 5-fluorouracil, and vinblastine in the treatment of metastatic renal cell carcinoma: A prospective phase II study: The experience of Rambam and Lin Medical Centers 1996-2000

BACKGROUND. The current study evaluated the efficacy and toxicity of interleukin-2 (IL-2), interferon-α (IFN-α), 5-fluorouracil (5-FU), and vinblastine (VBL) in the treatment of metastatic renal cell carcinoma (MRCC). METHODS. Sixty-two MRCC patients, median age 63 years, received immunochemotherapy. Eastern Cooperative Oncology Group performance status was 1 for 45 patients and 2 for 17 patients. Fifty-four patients underwent nephrectomy prior to treatment. Sites of disease were lungs, lymph nodes, bone, kidney, and liver. Treatment consisted of IL-2 10 MIU/m² subcutaneous (SC), three times per week, Weeks 1-4; IFN-α 6 MIU/m² SC, once per week, Weeks 1-4 and 9 MIU/m², three times per week, Weeks 5-7; 5-FU 600 mg/m² and VBL 6 mg/m², intravenous bolus, Day 1 of Weeks 5 and 7. RESULTS. In a median followup of 34 months, 62 patients were evaluated for tumor response. Four patients achieved complete response for 26+, 34+, 51+, and 56+ months, respectively; 14 patients achieved partial response for a median of 14 months; and 20 patients achieved stable disease for a median of 9 months. Seven patients (5 partial response, 2 stable disease) underwent complete resection of residual tumor. Five patients remained alive with no evidence of disease for 27, 32, 36, 42, and 48 months, respectively. Nine patients achieved long-term complete response for a median of 36 months. Three-year survival rate for the entire group and for 11 complete responders was 88%. Common side effects were flu-like symptoms, nausea, headache, and depression. Four patients were excluded because of treatment intolerance, and one patient died after nephrectomy. CONCLUSIONS. Immunochemotherapy is effective and well-tolerated by patients with MRCC. Surgical intervention for resection of residual disease is justified.