A clinical randomized study was performed on advanced breast cancer patient
s which were treated by interferons (IFN) beta and gamma in combination wit
h hormonotherapy (Megace or Tamoxifen), Cytokine levels (IL-1 beta, IL-2, I
L-6, TNF-alpha, IFN-gamma) and sIL-2R of individual patients before, during
(3 months) and after (6 months) therapy were evaluated and correlated to c
linical response according to UICC criteria (responder patients-Partial or
Complete Response versus non-responder patients-Stable/Progression). Decrea
ses in IL-1 beta, IL-6 and sIL-2R were associated with clinical response to
therapy versus increases in their levels which corresponded to progression
of disease. A significant and dramatic increase in IFN-gamma levels was as
sociated with a favourable response to therapy in the IFNs-treated patients
, mainly in the group of Tamoxifen, Baseline levels of sIL-2R and of IFN-ga
mma were prognostic of clinical response and were found to be the most sens
itive cytokine parameters for defining the clinical utility of the combinat
ion of IFNs and hormonotherapy in breast cancer patients. (C) 1998 Academic
Press.