Immunogenic features of some malignancies have aroused interest in immunoth
erapy of cancer. Immunotherapy seems most effective in patients with a smal
l tumour burden, and the focus of immunotherapy trials has, thus, lately be
en on adjuvant treatment. To enable further development of immunotherapy we
need to know more about the mechanisms involved in host defence, especiall
y when the system is influenced by extrinsic factors, that is, immunomodula
tive agents. T lymphocytes pray an important role in the host defence again
st tumour cells trying to escape from immune surveillance. The mechanisms t
hat regulate the host defence systems are complex, and the influence of ext
rinsic factors such as immunotherapeutic agents is poorly understood. Most
data on lymphocyte subsets in malignant disease originate from melanoma or
renal cell carcinoma (RCC) studies, although there are scattered data on ly
mphocyte subsets also in other malignancies. There are several studies impl
ying that the relative amount of CD4+, CD8+, and natural kilter (NK) cells
may be important and that, by reducing the tumour burden or by using differ
ent therapeutic agents, we can stimulate the host defence. However, only so
me of these studies imply that these changes can have an impact on clinical
outcome and prognosis. The findings of the studies reviewed in this paper
are mostly encouraging, but whether the lymphocyte subsets have any value a
s prognostic markers in patients with malignancies receiving immunotherapy
is still unclear. Large randomized immunotherapy trials including an observ
ation arm give an ideal opportunity to recognize those immunological change
s that are due to therapy, related to the natural host defence, or whether
they have any prognostic value.