Outpatient 5-fluorouracil +alpha-interferon + interleukin-2 chemoimmunotherapy in metastatic renal cell cancer patients

Background: Renal cell carcinoma is the most common malignancy of the kidney in adults. The treatment of metastatic disease remains a particularly difficult problem given the resistance of this disease to most treatment options and usually requires hospitalization. This prospective study aimed to determine the efficacy and systemic toxicity of outpatient Chemoimmunotherapy (CIT) in metastatic renal cell cancer (MRCC) patients. Methods: The patients with MRCC received a combination of 5-fluorouracil 400 mg/m2 intravenously on day 1 once a week, interferon-α 10 MU on days 1,3,5 during weeks 1 and 3, interleukin-2 18 MU on days 1,3,5 during weeks 2 and 4 subcutaneously. Results: Twenty-three MRCC patients were enrolled into the study. The performance status was ECOG 0–2. The median age was 60 years. Twenty patients were evaluable. Chemoimmunotherapy was administered for a median of 10 weeks (range 2–32). Partial remission was obtained in two patients, stable disease in five and no complete response was detected. Median overall survival (OAS) was 10.0 months (95% CI 5.5–14.5 months), progression-free survival (PFS) 7.0 months (95% CI 5.1–8.9 months). The 1-year OAS and PFS rate was 27% and 7%, respectively. Median OAS for patients with and without nephrectomy was 10.0 months (95%CI 7.2–12.8 months) and 6.0 months (95%CI 1.4–10.5 months), median PFS 7.0 months (95% CI 4.1–9.9 months) and 5.0 months (95% CI 3.7–6.2 months), respectively, and there was no statistical significant difference (P = 0.27 and P = 0.20). Most common complaints were fatigue, fever and nausea. Grade 3–4 side-effects were not observed. Conclusion: This CIT scheme showed a low objective response rate, but when combined with stable disease, clinical benefit is favorable. Outpatient administration with mild toxicity is advantageous.