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Oral clodronate will reduce the loss
of bone mineral density in women with
primary breast cancer. 1TJ Powles, 2E McCloskey,
3AHG Paterson, 1S Ashley, 1A
Tidy, 2J Kanis. 1The Royal Marsden Hospital
(RMH), London, EIK; 2The University
of Sheffield, UK; 3Calgary Cancer Centre (CCC),
Canada.
Loss of bone mineral density (BMD) in women
with primary breast cancer may be
increased by cancer treatment and may be reduced
by use of a bisphosphonate. We
have therefore undertaken a double blind randomised
two centre trial (RMH and CCC)
to evaluate BMD in patients with primary breast
cancer given clodronate 1600 mg/day
po (clod) or placebo (plac) for 2 years. By
March 1996, over 300 eligible patients had
been accrued, randomised and received appropriate
primary surgical, and medical
treatment (chemotherapy and tamoxifen) and
had completed follow up for at least 2
years without metastatic relapse. (RMH 103
clod, 93 plat, CCC 53 clod, 62 plac). The
median age, height, weight, menopausal status
and type of primary surgical, adjuvant or
neoadjuvant medical treatment were well matched
for both treatment groups. BMD in
the lumbar spine and hip were measured using
dual energy xray absorptiometry (Hologic
densitometer) at the start of clod/plac and
after one and two years of treatment and
calculated as % change of the initial treatment
reading. The plac group had a mean loss
in spinal BMD of 2.2% whereas the clod group
had a small mean gain of 0.18%
(Treatment effect +2.38%, CI 1.36, 3.41 p<0.001).
Similarly the plac group had loss in
hip BMD of 0.34% compared to a mean gain of
0.40% in the clod group (Treatment
effect +0.74%, CI -0.13, 1.6 p=NS). After
2 years the treatment effect for clod in
spinal BMD was +1.73% (CI 0.12, 3.34 p<0.05)
and hip BMD +1.85% (CI 0.51,
3.20 p<0.01). All subgroups of menopausal
status and type of adjuvant/neoadjuvant
medical treatment appeared to gain benefit.
These results indicate that use of oral
clodronate will significantly reduce the loss
of BMD which occurs in patients who
receive cancer treatment for primary breast
cancer.
Oral clodronate will reduce the loss of bone
mineral density in women with
primary breast cancer. 1TJ Powles, 2E McCloskey,
3AHG Paterson, 1S Ashley, 1A
Tidy, 2J Kanis. 1The Royal Marsden Hospital
(RMH), London, EIK; 2The University
of Sheffield, UK; 3Calgary Cancer Centre (CCC),
Canada.
Loss of bone mineral density (BMD) in women
with primary breast cancer may be
increased by cancer treatment and may be reduced
by use of a bisphosphonate. We
have therefore undertaken a double blind randomised
two centre trial (RMH and CCC)
to evaluate BMD in patients with primary breast
cancer given clodronate 1600 mg/day
po (clod) or placebo (plac) for 2 years. By
March 1996, over 300 eligible patients had
been accrued, randomised and received appropriate
primary surgical, and medical
treatment (chemotherapy and tamoxifen) and
had completed follow up for at least 2
years without metastatic relapse. (RMH 103
clod, 93 plat, CCC 53 clod, 62 plac). The
median age, height, weight, menopausal status
and type of primary surgical, adjuvant or
neoadjuvant medical treatment were well matched
for both treatment groups. BMD in
the lumbar spine and hip were measured using
dual energy xray absorptiometry (Hologic
densitometer) at the start of clod/plac and
after one and two years of treatment and
calculated as % change of the initial treatment
reading. The plac group had a mean loss
in spinal BMD of 2.2% whereas the clod group
had a small mean gain of 0.18%
(Treatment effect +2.38%, CI 1.36, 3.41 p<0.001).
Similarly the plac group had loss in
hip BMD of 0.34% compared to a mean gain of
0.40% in the clod group (Treatment
effect +0.74%, CI -0.13, 1.6 p=NS). After
2 years the treatment effect for clod in
spinal BMD was +1.73% (CI 0.12, 3.34 p<0.05)
and hip BMD +1.85% (CI 0.51,
3.20 p<0.01). All subgroups of menopausal
status and type of adjuvant/neoadjuvant
medical treatment appeared to gain benefit.
These results indicate that use of oral
clodronate will significantly reduce the loss
of BMD which occurs in patients who
receive cancer treatment for primary breast
cancer.
Publication Year: 1997
*461
Adjuvant treatment of breast cancer patients
with the bisphosphonate
clodronate reduces incidence and number of
bone and non-bone
metastases. I.J. Diel, E.-F. Solomayer, R.
Goerner, Ch. Gollan, D.
Wallwiener, G. Bastea. University of Heidelberg,
Dept. of Obstetrics and
Gynecology, Heidelberg, Germany.
Obviously Bisposphonates (BPS) inhibit osteoclastic
activity. This is the reason
why they are widely used in the treatment
of tumor-associated-osteolysis. In the
palliative setting of metastasized breast
cancer BPS decrease skeletal-related
events. Animal experiments already prove that
osteoprotection with BPS leads to
a reduction of number and incidence of bone
metastases. From 1991-1995 we
performed a prospective randomized study at
the University Hospital Heidelberg
including 142 primary breast cancer patients
with positive tumor cell detection in
bone marrow (at the time of primary surgery).
They were treated with the
Bisphosponate Clodronate (1600 mg/d, orally)
over 2 years. The identical
number of patients was used as controls. Prognostic
factors and adjuvant
systemic treatment of both groups showed no
significant differences as well.
Follow-up data were evaluated after a median
of 36 months. 21 patients treated
with Clodronate developed distant metastasis
compared with 36 women without
BSP-treatment (p=0.007); 10 of the BSP-group
showed bone metastases,
whereas 19 of the controls displayed osseous
metastases (p=0.025). The average
number of bone metastases in every individual
differed between 3.1
(clodronate-group) and 6.8 (control-group).
Also the bone relapse-free interval
was longer (23 months) in the BSP-group compared
with the controls (16
months). For the first time our study showed,
that a reduction of number and
incidence of bone metastases is possible by
adjuvant treatment with the BPS
Clodronate (orally administered over 2 years).
It is surprising that even non-bone
metastases were reduced. However, it must
be mentioned, that the number of
patients was limited (n=284) and the time
of follow up was moderate.
Prospective placebo-randomized studies should
be performed to confirm our
results.
Molly114@aol.com wrote:
can you pls tell me about what is goingon now with this drug.the news and
newsday are sayingnow it is being used for metastisis in breast cancer.but
is only available in germany.is it possible to go to germany and purchase
it ? i have failed chemo and a stem cell transplant and i am now back on
chemo,femara,and i am taking essiac tea if you have any info at all on this
new study at the university hospital heidelberg please e-mail me and let
me know. i need 10 more years to raise my grandson . thank you
molly114
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