Re: [MOL] Colorectal/PAM?FROM LILLIAN [00514] Medicine On Line


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Re: [MOL] Colorectal/PAM?FROM LILLIAN



Subject: 
            Re: [MOL] clodronate
       Date: 
            Fri, 07 Aug 1998 01:24:10 -0400
      From: 
            lillian jennings <firefly@islc.net>
        To: 
            mol-cancer@lists.meds.com
 References: 
            1




Molly:  I have found the information that you are seeking and wish you
much success.  With a goal
you have of raising a 10 year old, I am confident your focus will be
strong and you will make it. 
Your friend, Lillian 

     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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