Interleukin-2, interferon-alpha, 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-alpha (IFN-alpha), 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/m(2) subcutaneous (SC), three times per week, Weeks 1-4; IFN-alpha 6 MIU/m(2) SC, once per week, Weeks 1-4 and 9 MIU/m(2), three times per week, Weeks 5-7; 5-FU 600 mg/m(2) and VBL 6 mg/m(2), 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.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009392:Nephrectomy; D011446:Prospective Studies; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage
D016898:Interferon-alpha; D007376:Interleukin-2; D014747:Vinblastine; D005472:Fluorouracil