Citation

Miyake M, Fujimoto K, Tanaka M, Hirao Y, Uemura H, Otani T, Yoshii M. Journal of Nara Medical Association 2009; 60(1-2): 37-47.

Copyright

(Copyright © 2009)

DOI

unavailable

PMID

unavailable

Abstract

Introduction. We prospectively evaluated the efficacy and safety of immunochemotherapy using INF-α, IL-2, 5-fluorouracil (5-FU), and cimetidine in patients with metastatic renal cell carcinoma (RCC). Patients and Methods. Twenty-two patients with metastatic RCC were given 4 weeks of initial therapy consisting of IFN-α- (3-6x10 6 IU/day 3 times/week), IL-2 (0.7-1.4x10 6 JRU/day for 5 consecutive days/week), 5-FU (150 mg/m2/day for 5 consecutive days/week), and Cimetidine (800 mg/day), followed by maintenance therapy with IFN-α, IL-2, and Cimetidine. The response rate, overall and progression-free survivals, and adverse events were analyzed.

RESULTS. The median periods of therapy and follow-up were 4.4 months (range: 0.4-33) and 28.8 months (range: 1-65), respectively. The early anti-tumor effect was a complete response in one (4.5%), a partial response in 3 (13.6%), no change in 9 (40.9%), and progressive disease in 9 (40.9%). The 2-year progression-free and overall survival rates were 31% and 76%, respectively. The overall survival of cytokine-naïve group was higher than that of cytokine-resistant group (p<0.032). Adverse events of grade ≤3 occurred in 5 patients, and 9 discontinued this therapy due to adverse events.

CONCLUSION. The present regimen had a low response rate despite the high incidence of adverse events and should be limited to patients with cytokine-naïve metastatic RCC.

Language: en

Keywords

adult; human; suicide; female; male; aged; survival rate; depression; clinical trial; fatigue; article; anorexia; controlled study; clinical article; human tissue; unclassified drug; disease course; drug safety; cancer patient; follow up; drug efficacy; diarrhea; leukopenia; alpha interferon; drug withdrawal; immunotherapy; fever; rash; prospective study; side effect; cimetidine; maintenance therapy; alopecia; heart muscle ischemia; stomach ulcer; creatinine blood level; interleukin 2; Interleukin-2; metastasis; malaise; Interferon-α; cytokine; kidney function; respiratory distress; kidney carcinoma; Renal cell carcinoma; hemoglobin blood level; alanine aminotransferase blood level; aspartate aminotransferase blood level; progression free survival; duodenum ulcer; overall survival; advanced cancer; antineoplastic activity; liver function; cancer chemotherapy; fluorouracil; 5-Fluorouracil; Cimetidine; imunase