Bone-Strengthening Drug Guards Against Spread of Breast Cancer

barbe, the study shows it not only reduces bone loss, but it reduces the incidence of cancer cells in the bone marrow.  Other studies have shown it reduces distant metastasis in soft tissue as well.  If this is correct, it has multiple benefits, reduces loss in bone density, reduces bone metastasis, reduces distant soft tissue metastasis.  The other studies have also shown it reduces bone density loss due to aromatase inhibitors and related incidents.

I asked my Onc (again) last Thursday about Zometa infusions and her reply was the same as months ago..."not approved for early stage,only metastatic disease".

Sheesh,seems like she is missing the point!

M

When this study came out I brought it to my oncologists attention.  I was already done with chemo but she said "it couldn't hurt to do it now".  The plan was to get the zometa infusion every 6 months for 3 years with the understanding that not only did it strengthen bones and protect them from mets, but that it would even help with a distance recurrence.  I had 4 infusions under my belt before being diagnosed with liver mets.  Not saying it won't work for anyone else though!!

Carol, I don't know if it's approved in Canada to be paid for us, or if it's still at the experimental stage we'd have to pay our own....

On a related note about bisphosphonates:  I was talking to my dentist about this (I'm taking actonel once a week) because of the concern about jaw necrosis (even though it's fairly rare).  The recent studies he has read seem to lay the blame on the twice yearly infusions, rather than the one-pill-a-week dosage.

toby -- Sorry I don't have the studies in front of me, but he said that the incidences of jaw necrosis were found in patients who had twice-yearly infusions.  Again, this is a very rare s/e, but it can happen.

The sad thing is then, you have to have a recurrence (stage IV) to get a drug that may prevent an reccurence?

my onc is doing Zometa for early stage folks as standard, here in San Francisco- I don't know a ton about what he's doing yet but he told me I'd be doing it for sure later. (after I get the surgery and get started on arimidex I think)

From my understanding, the benefits of Zomerta are much better, both for the bones and as insurance against bone nd distant mets,

After six months on Arimidex, my bone density went to osteopenia (sp?) and my insurance company approved Zometa every six months indefintely.

After two infusions, I had my bone density tested and it was even better than it was before menapause at age 47;  But I was smart enough to pay cash for the bone density test and doctor who did it, so insurance will still cover the Zometa infusions for the remainder of the three years--money well spent!

Onc and I had a good laught about stick it to the insurance companies!  He said thanks for telling me, but my records still show you as osteoprenia, and I don[t have a pen handy to make any notes!!

I think it's premature to say Zometa is "standard of care" in the U.S. for reducing the risk of mets in early stage BC.  It might become "standard of care," once it has been reviewed and recommended as such by the NCCN or ASCO or ACS or some other nationally recognized oncology organization.  Oh, and approved by the FDA for that purpose.

At this point, we have the results of just a handful of studies (three?) showing a positive effect.  That might seem like a lot; but some oncologists don't think it's enough evidence to be "practice-changing."  There isn't yet a consensus among oncologists that Zometa and possibly other bisphosphonates should be used to prevent recurrence.  I know some of them are waiting for the results of the SWOG 0307 clinical trial (SWOG S0307:  Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer).

Even so, some oncologists in the U.S. have already started using it in early-stage BC.  It really hasn't been "approved" for that use, though -- it's still considered investigational except in women with bone mets. I know it's aggravating that the acceptance and approval process takes so long.  But, wouldn't we complain just as loudly if drugs were put on the market before they had been thoroughly tested?

otter

My onc (Ont, Canada) just told me that it is only considered a benefit in reducing mets if it is giving around the time of chemo.  She said that I was too far out from tx for it to be helpful.

Do you have a link for this study?  I would like to go back in with the info if possible.  She is a 'by the book' doctor but not unreasonable so it might help to change her mind.  

Lindasa -

Your onc is incorrect regarding ONJ being associated with twice yearly zometa infusions.  In the large Austrian study, there were zero cases of ONJ out of 900 patients that got active drug. 

Zometa IS associated with ONJ when given more frequently - every 3 to 4 weeks to treat bone mets.  Even when given frequently, ONJ is still rare.

My. onc. is using Zometa for breast cancer patients - stage 1 - IV.  She discussed twice a year infusions for me - BUT my insurance denied it as I am stage 1.  My onc. has appealed the denial - still waiting for the final word.  I have also called the manufacturer to see if they have a program to help me pay for it if I chose to do it without insurance, but they do not assist for stage 1.  I am hoping it will be standard of care here soon.

I will look into the SWOG trial - last month all the trials I saw with biphosphonates were closed. 

PIP, I wonder if your doctor was using the eligibility criteria for the SWOG-0307 trial as a reason for saying you had waited too long to benefit.  The trial criteria required that women be no more than 8 weeks out from adjuvant chemotherapy or 12 weeks past their definitive surgery, when they enrolled in the study.  Here are some of the relevant criteria for SWOG-0307:

++++++++++++Quote begins+++++++++++++++++

1. Patients must be women with histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) with no evidence of metastatic disease.  Primary disease within the breast must be resected, either with mastectomy or breast sparing surgery.  An axillary node evaluation should be performed per the standard of care specified at each institution.

2. Patients must receive standard (systemic) adjuvant therapy for their breast cancer.  Chemotherapy, hormone therapy, or combined chemo/hormone therapy is permitted.  Additional therapies are allowed including radiation therapy and biologic agents (e.g. Herceptin®, Avastin®, hematopoietic growth factors).  Patients who receive biologic agents only or local radiation therapy only (without chemotherapy and/or hormone therapy) are not eligible.  Patients who are at such a low risk of recurrence that adjuvant therapy will not be prescribed are ineligible.  Neoadjuvant therapy is permitted, but enrollment must occur after completion of surgery.

3. Patients may be enrolled prior to, simultaneously with, or after beginning adjuvant systemic therapy.  Patients receiving hormonal therapy alone (no chemotherapy) or pre-operative chemotherapy should be enrolled within 84 days (12 weeks) after the date of final surgical procedure.  Patients receiving adjuvant post-operative chemotherapy may be enrolled up to 8 weeks after completion of chemotherapy.  Additional biological therapy or radiation therapy is allowed at any time before or after registration.

++++++++++++Quote ends++++++++++++++

That's from a "Fast Facts" version I found on line somewhere.  Here's a link to an official version of the SWOG-0307 trial protocol: 

http://www.swog.org/Visitors/ViewProtocolDetails.asp?ProtocolID=2007

Just because the trial required women to enroll within a certain length of time after having surgery or completing chemo does not mean the drugs will not work if used after a longer delay.  The reason to start as soon as possible (if the hypothesis is correct) is because they are trying to prevent a recurrence. Obviously, it would be possible to wait too long...  but I don't think anyone knows how long "too long" would be, since this is a fairly new strategy.

My onco told me about the SWOG-0307 trial just as I was starting chemo.  I declined it for several reasons -- transportation issues, concern about ONJ, and because I didn't want the risks associated with the higher bisphosphonate doses and more frequent dosing schedule.  My onco is really anxious to see the results.

otter