BACKGROUNDThe 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).METHODSSixty‐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.RESULTSIn 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.CONCLUSIONSImmunochemotherapy is effective and well‐tolerated by patients with MRCC. Surgical intervention for resection of residual disease is justified. Cancer 2002;95:1644–9. © 2002 American Cancer Society.DOI 10.1002/cncr.10842
