Biochemotherapy of advanced metastatic renal-cell carcinoma: results of the combination of interleukin-2, alpha-interferon, 5-fluorouracil, vinblastine, and 13-cis-retinoic acid

• Published in: World journal of urology Vol. 13; no. 3; p. 174
• Main Authors: Atzpodien, J, Kirchner, H, Duensing, S, Lopez Hänninen, E, Franzke, A, Buer, J, Probst, M, Anton, P, Poliwoda, H
• Format: Journal Article
• Language: English
• Published: Germany 1995
• Subjects: Adjuvants, Immunologic - adverse effects; Adjuvants, Immunologic - therapeutic use; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Renal Cell - pathology; Carcinoma, Renal Cell - therapy; Combined Modality Therapy; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Humans; Interferon Type I - administration & dosage; Interferon Type I - adverse effects; Interleukin-2 - administration & dosage; Interleukin-2 - adverse effects; Isotretinoin - administration & dosage; Isotretinoin - adverse effects; Kidney Neoplasms - pathology; Kidney Neoplasms - therapy; Male; Middle Aged; Neoplasm Metastasis; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Remission Induction; Treatment Outcome; Vinblastine - administration & dosage; Vinblastine - adverse effects
• ISSN: 0724-4983; 1433-8726
• DOI: 10.1007/BF00184875

We conducted a phase I/II clinical trial evaluating the sequential outpatient combination of S.C. recombinant human interleukin-2 (rIL-2; given at 10 MIU/m2 b.i.d. on days 3-5 weeks 1 and 4 and at 5 MIU/m2 on days 1, 3, and 5 of weeks 2 and 3), s.c. recombinant human alpha-interferon (rIFN-alpha; given at 6 MIU/m2 on day 1 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3 and at 9 MIU/m2 on days 1, 3, and 5 of weeks 5-8), i.v. bolus 5-fluorouracil (5-FU; given at 1,000 mg/m2 once weekly during weeks 5-8), and i.v. bolus vinblastine (given at 6 mg/m2 once weekly during weeks 5 and 8) in conjunction with p.o. 13-cis-retinoic acid (13-C-RA; given at 35 mg/m2 daily during weeks 1-8). Therapy was always given in the outpatient setting. Grade 3 constitutional symptoms (malaise, chills, fevers, anorexia) were observed in 4%-8% of treatment cycles and required a 50% reduction in the doses of rIL-2 and rIFN-alpha. None of the patients experienced major 5-FU-related toxicities such as severe diarrhea and/or stomatitis; up to 20% of patients developed vinblastine-associated peripheral polyneuropathy, which was reversible after the cessation of therapy. 13-cis-Retinoic acid produced no significant side effect; no toxic death occurred. Among 24 patients with progressive metastatic disease, there were 4 complete remissions (lung, lymph nodes) and 6 partial remissions (lung, pleura, liver, lymph nodes, and peritoneal carcinosis), for an overall objective response rate of 42% (95% confidence interval, 22%-63%).