Klin Onkol 1999; 12(5): 169-173.
Summary: The feasibility of IL-2 application in the early phase after autologous stem cell transplantation (ASCT) in dose escalation fashion was studied. 13 patients were recruited, 1 was however excluded due to protocol violation (IL-2 overdose) and refusal. There were 7 pts with Hodgkin´s disease (HD) and 5 with Non-Hodgkin´s lymphoma. The majority of pts (9/12) were treated with BEAM chemotherapy. IL-2 was administered subcutaneously in the following doses: 1 MIU/m2/d, 2 MlU/m2/d and 2.5 MIU/m2/d for 28 days. Therapy was started immediately after hematopoietic reconstitution in the median day 16.5 (12-28) after ASCT. Dose 2 (MIU/m2/d) was found as the maximal tolerated dose. Therapy was stopped in two of three pts treated with 2.5 MlU/m2/d due to signs of capillary leak syndrome. The most frequent adverse event was local cutaneous reaction (11/12, 91.7%), this progressive reaction led to pt withdrawal in one case. A significant increase of CD3+/HLA-DR+ lymphocytes was found during IL-2 therapy (p 0.04). There was an increase of CD16+/CD56+ lymphocytes, but it was not significant. The therapeutic results were compared with a historical case-controlled group (status at ASCT, pretreatment, diagnosis and age). The probability of progression free survival PFS at 2 years was 66.7% (40.1-93.4, CI 95%) in the IL-2 group and 54,0% (23.9-84.1, CI 95%) in the control with median follow-up 2.3 year and 2.8 years respectively. The overall survival probability was 81.8% (40.1-93.4, CI 95%) and 68.2% (38.4-98.0, CI 95%) respectively. We could conclude that the MTD of IL-2 is 2.0 MIU/m2/d in this administration scheme. We were not identity able to any significant therapeutic difference between the treated and case controlled group.
