The aim of this study was to evaluate the efficacy of (186)-Re-1,1 -hydroxy
ethylidene diphosphonate (etidronate) in breast cancer patients with painfu
l bone metastases. Methods: Thirty patients with advanced breast cancer who
had metastatic bone pain were treated with Re-186-etidronate using differe
nt dosages in a noncomparative, open-label study. Twenty-four patients were
evaluated for efficacy (6 patients had incomplete datasets), Dosages varie
d from 1295 to 2960 MBq (35 to 80 mCi). Efficacy was evaluated according to
the multidimensional pain model using a paper-and-pencil diary. The diary
was kept twice daily for 8-10 wk (2 wk before through 6-8 wk after Re-186-e
tidronate treatment). Response was determined with a strict criteria, in wh
ich pain intensity (PI), medication index (MI) and daily activities (DA) we
re core determinants. Response was defined as: (a) Reduced PI greater than
or equal to 5% while MI and DA were at least constant; or (b) Reduced PI <2
5% in combination with improvement of MI or DA greater than or equal to 25%
, without worsening of either factor. Duration of response should always ex
ceed a minimum of 2 wk. Results: Fifty-eight percent (n = 14) of all patien
ts reported a response. The maximum follow-up period was 8 wk. Duration of
response ranged from 2 to 8 wk (mean 4 wk). Patients (14/24) not only exper
ienced considerable pain reduction, but in 12 patients this was also accomp
anied by noteworthy reduction in Mi (greater than or equal to 25%). No clea
r dose-response relationship was found. Conclusion: With strict pain assess
ment criteria, 186Re-etidronate showed a response of 58% in the palliative
treatment of metastatic bone pain originating from breast cancer.