Phase II trial of systemic recombinant interleukin-2 in the treatment of refractory nasopharyngeal carcinoma

Citation
Kh. Chi et al., Phase II trial of systemic recombinant interleukin-2 in the treatment of refractory nasopharyngeal carcinoma, ONCOL-BASEL, 60(2), 2001, pp. 110-115
Citations number
25
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
ONCOLOGY
ISSN journal
0030-2414 → ACNP
Volume
60
Issue
2
Year of publication
2001
Pages
110 - 115
Database
ISI
SICI code
0030-2414(2001)60:2<110:PITOSR>2.0.ZU;2-N
Abstract
Background: Interleukin-2 (IL-2) is a cytokine produced by activated T cell s, which has shown powerful immunostimulatory and antineoplastic properties . Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus-associated cancer with abundant lymphocyte infiltration histologically. The activity of IL-2 in the treatment of NPC patients is currently unknown. A phase II study wa s, therefore, initiated to evaluate the efficacy, toxicity and immunologica l consequences of intravenous bolus IL-2 in patients with recurrent/metasta tic NPC. Methods: Between November 1996 and April 1997, 14 patients with re current/metastatic NPC were entered into the study. Recombinant IL-2 (Prole ukin, Chiron) was injected by intravenous bolus every 8 h at 72,000 IU/kg f or a maximum of 15 doses. After 7 days, patients were retreated with a seco nd identical cycle of therapy. Those patients who were stable or responding to treatment 5-6 weeks later went on to receive another course (two cycles ) of therapy. All patients received prophylactic antibiotics and antipyreti c medicine. Response and toxicities were evaluated. Serial plasma level of TNF-alpha, IL-6, soluble IL-2 receptor, IL-10 and soluble CD8 were determin ed. Results: Fourteen patients received a total of 34 cycles of therapy. No response was observed. Fifty percent had stable disease, 50% had progressi ve disease after a median of two cycles of therapy. There was one treatment -related death from acute myocardial infarction. Body weight increase (>5%) occurred in 80% of cycles, and hypotension (BP <80 mm Hg systolic) occurre d in 53%. Serum creatinine increase (>2 mg%) occurred in 24% of cycles, and SGOT/SGPT increase (>3 x) in 10% of cycles. Symptoms of somnolence, genera l malaise, nausea and vomiting, pruritus, xerostomia, desquamation were gen erally mild to moderate but rapidly reversible. Conclusion: The single moda lity of intravenous bolus IL-2 at the dose level of 72,000 IU/kg is clinica lly ineffective in NPC patients. Potential mechanisms of the ineffectivenes s of IL-2 therapy on NPC patients a re discussed. Copyright (C) 2001 S. Kar ger AG, Basel.