Phase II trial of subcutaneous injections of human recombinant interleukin-2 for the treatment of mycosis fungoides and Sézary syndrome.
We conducted a phase II trial to evaluate the efficacy and toxicity of subcutaneous injections of recombinant interleukin (IL)-2 in 22 heavily pretreated patients with advanced cutaneous T-cell lymphoma. We observed modest response rates (18%) with a reasonable toxicity profile. The role of IL-2 in vivo for expansion of cytotoxic CD8(+) T cells, CD4(+) T cells, regulatory CD25(+) T cells, or a combination of these has not been elucidated. There was no evidence of expansion of CD8(+) T cells in peripheral blood of patients during treatment. Immunophenotypic analysis revealed an increase of CD25(+) cells in CD3(+) and CD4(+) populations after treatment in a subset of patients possibly reflecting activation of reactive helper T cells, proliferation of neoplastic T cells, or proliferation of T-regulatory cells. In summary, at this dose and schedule recombinant IL-2 is largely ineffective as therapy in patients with advanced cutaneous T-cell lymphoma. Whether IL-2 has the potential to suppress antitumor activity by stimulation of regulatory T cells needs to be clarified.
Querfeld
Christiane
C
Department of Dermatology, Northwestern University, Chicago, IL 60611, USA.
Rosen
Steven T
ST
Guitart
Joan
J
Rademaker
Alfred
A
Foss
Francine
F
Gupta
Rohit
R
Kuzel
Timothy M
TM
D000328:Adult; D000368:Aged; D001707:Biopsy, Needle; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D007279:Injections, Subcutaneous; D053645:Interleukin-2 Receptor alpha Subunit / Q000627:therapeutic use*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D011379:Prognosis; D018570:Risk Assessment; D012751:Sezary Syndrome / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
D053645:Interleukin-2 Receptor alpha Subunit