lets ask our Doctors...Clodronate?

Nancy,

Thanks so much for continuing this discussion. It is the forum at its best - giving us information to think about and inquire about. The article I reproduced here is very recent. Like you, I am wondering about the FDA and the doctors' non-use. Would it cut down on 'cancer business' - Oh, nasty, nasty thought - shame on me!

>>>>Drug helps prevent breast cancer spread to bone
Last Updated: 2002-09-23 17:00:39 -0400 (Reuters Health)

By Pam Harrison

SAN ANTONIO (Reuters Health) - Women with early-stage breast cancer were half as likely to see their cancer spread, or metastasize, to their bones when treated with an oral drug called clodronate, researchers report.

Clodronate is a member of a class of drugs called bisphosphonates, which are used to treat the bone-thinning disease osteoporosis.

Since tumor-induced breakdown of bone can promote the development of metastases, Dr. Eugene McCloskey, Sr., clinical research fellow at the University of Sheffield, England, and colleagues decided to investigate whether giving breast cancer patients the drug might prevent their cancer from spreading to the bone.

The researchers assigned patients to take 1,600 milligrams of clodronate or an inactive placebo daily for 2 years. All of the women had operable, early-stage cancers. Treatment was initiated within 6 months of women undergoing primary therapy, which included surgery, radiotherapy, chemotherapy and tamoxifen as required.

During the total follow-up period, which lasted about 5 years, 63 patients in the clodronate group and 80 patients in the placebo group developed bone metastases, a difference that was not significant between the two treatment groups.

In contrast, during the 2-year treatment interval, only 12 women developed bone metastases in the clodronate group compared with 28 women in the placebo group. The difference between the two groups was significant, McCloskey reported.

He presented his results here Sunday during the 24th annual meeting of the American Society for Bone and Mineral Research.

Over the post-medication period, there was again no difference in the number of women developing bone metastases at 51 in the clodronate group and 52 placebo patients. The incidence of metastases that developed outside of bone was also similar between the two treatment groups, at 112 patients in the clodronate arm, and 128 women in the placebo arm.

Most importantly, McCloskey noted, only 98 women in the clodronate group died over the follow-up period compared with 129 in the placebo group, a 23% reduction in mortality risk in favor of active therapy.

"We know there is a conversation between tumor cells and bone marrow, and this conversation is basically a vicious circle whereby tumor cells stimulate bone cells to resorb bone and the resorption of bone feeds backs and stimulates tumor cells," McCloskey told Reuters Health in an interview during the meeting.

The metastases that attack bone "depend on this vicious cycle and by interfering with this cycle, you decrease the number of women who get clinically significant bone metastases, and if they don't get bone metastases, they don't get metastases at other sites and you improve survival," McCloskey commented.

jeancmici said:

I emailed my doctor and here is his reply:

"Clodronate remains unapproved in the US, so for US women, the issue is moot. Why? A follow-up study by a different group did not reproduce the original salutary results. The jury is still out. A tie-breaking study (NSABP B-34) is underway across the country."

Hi everyone. Just to let you know there is a study on clondronate in the United States. I am enrolled on the clondrate vs placebo study through the University of Mass. Its a study designed for early stage breast ca no mets. Information on this study can be found on the website from the National Institute of Cancer or www.cancer.gov Hope this can help someone. Everyone out there think postive and have a great day. Dg51 in Massachusetts