Breast cancer with metastatic disease is presently incurable. Signific
antly shorter survival rates are seen in premenopausal women despite u
sual therapies when compared to survival rates in older women. Median
survival rates of 24-30 months are documented in large-scale prospecti
ve clinical trials of previously untreated women with metastatic breas
t cancer regardless of the protocol employed (chemotherapy, hormone th
erapy). High dose chemotherapy followed by autologous stem cell rescue
(bone marrow or peripheral brood) is associated with significant resp
onse and possibly improved survival in chemosensitive patients with me
tastatic disease without visceral metastases though with significant t
oxicities and cost (median survival rate of 20 months). Patients with
refractory disease have dismal results regardless of therapy (median s
urvival rates of 8-9 months in a number of prospective trials with or
without stem cell rescue). The use of alpha-interferon in such patient
s has not improved response. Whole body hyperthermia is of benefit in
the presence of liver metastases although median survival rate is in t
he range of 12 months. New treatment approaches with curative intent a
re clearly required. We report fifty-nine patients with metastatic bre
ast cancer refractory to common therapies who were treated with whole
body hyperthermia (40 degrees C) with low dose chemotherapy and immuno
modulation: live presented with brain metastases; 13 with multiple bon
e metastases; 8 with liver metastases; 10 with lung metastases; and 23
with multiple soft tissue metastases. Fifteen were premenopausal; 44
postmenopausal. Twenty-three achieved complete remission. Fourteen hav
e been sustained with patients remaining alive from 17-80 months (medi
an, 40 months). Nine failed after 20-40 months of being disease-free (
mean, 32 months). Outcomes did not differ significantly by age or meta
static site. Myelotoxicity, stomatitis, and alopecia were not seen. Re
lief of bone pain was striking.