INTRAPLEURAL IMMUNOTHERAPY WITH ESCALATING DOSES OF INTERLEUKIN-2 IN METASTATIC PLEURAL EFFUSIONS

Background. The authors assessed the tolerance and efficacy of intrapl eural interleukin-2 (IL-2) in patients with malignant effusion. Method s. Twenty-three patients had a total of 25 metastatic pleural effusion s; the patients were treated with recombinant IL-2 by means of a conti nuous intrapleural infusion for 5 days. The daily dosage used in this Phase I/II trial initially was 3 X 10(6) IU/m2/day; the dosage was inc reased with every third patient, culminating in a dosage of 24 X 10(6) IU/m2/day. Results. One patient who had received the highest dosage d ied of renal failure on day 8. Ninety-six percent of patients had Grad e 2-3 fever, which was easily controlled with paracetamol administrati on. Two (8%) patients had pleural empyema. All other side effects were mild and resolved spontaneously by the end of treatment. The objectiv e response rate was 21.7%. The five patients who responded to IL-2 the rapy were alive 7-24 months after treatment, and the survival rate of the whole group was 59% after 13 months. Conclusion. A daily dose of 1 0-24 X 10(6) IU/m2/day of IL-2 administered intrapleurally gave respon se rates similar to those reported in the literature using the intrave nous route, but a much lower morbidity rate was recorded.