Perioperative immunomodulation with interleukin-2 in patients with renal cell carcinoma: results of a controlled phase II trial
| Autor: | Tobias Klatte, M. Ecke, A. Ittenson, Friedrich-Wilhelm Röhl, M. Böhm, Ernst P. Allhoff |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2006 |
| Předmět: |
Adult
Diarrhea Male Cancer Research medicine.medical_specialty medicine.medical_treatment Injections Subcutaneous renal cancer Kaplan-Meier Estimate Gastroenterology survival Drug Administration Schedule surgery Leukocyte Count Renal cell carcinoma Antigens CD Internal medicine Clinical Studies Carcinoma Leukocytes Medicine Humans Immunologic Factors Progenitor cell Carcinoma Renal Cell Aged Aged 80 and over business.industry Maintenance dose Perioperative Middle Aged medicine.disease Combined Modality Therapy Nephrectomy Kidney Neoplasms Surgery Treatment Outcome Oncology Toxicity Cytokines Interleukin-2 Female immunotherapy business Kidney cancer Constipation Follow-Up Studies |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | We conducted a non-randomised controlled phase II trial to investigate the role of preoperative administration of interleukin-2 (IL-2) in patients with renal cell carcinoma undergoing tumour nephrectomy. A total of 120 consecutive patients were allocated alternately to the two study groups: perioperative immunomodulation with IL-2 (IL-2 group; n=60) and perioperative immunomonitoring without immunomodulation (control group; n=60). Patients from the IL-2 group received four doses of 10 x 10(6) IU m(-2) twice daily subcutaneously a week before operation followed by a daily maintenance dose of 3 x 10(6) IU m(-2) subcutaneously until a day before the operation. Parameters of cellular and humoral immunity (leucocytes, T-cell markers CD3, CD4, and CD8, B-cell marker CD19, monocyte marker CD14, natural killer (NK) cell markers CD16, CD56, and CD57, activation markers CD6, CD25, CD28, and CD69, progenitor cell marker CD34, as well as IL-2, IL-6, IL-10, soluble IL-2 receptor, IL-1 receptor antagonist, transforming growth factor-beta1, and vascular endothelial growth factor) were measured in peripheral venous blood at various intervals. Interleukin-2-related toxicity was WHO grade 1 (24%), 2 (67%), and 3 (9%). In the postoperative period, T-cell markers, activation markers, and NK cell markers decreased, and IL-6 and IL-10 increased. However, all these alterations were significantly less accentuated in patients who had been pretreated with IL-2. Median follow-up was 40 months. Tumour-specific survival in the IL-2 group and the control group was 98 vs 81% after 1 year and 86 vs 73% after 5 years (P=0.04). A similar effect was found for progression-free survival. We conclude that IL-2 can be safely administered in the perioperative period and modulates immunological parameters. However, to validate the survival data, a larger randomised phase III trial is needed. |
| Databáze: | OpenAIRE |
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