Zometa

everyminute

I am on the SWOG (Southwest Oncology Group) Study and I will tell you all I know about it. It is a study for stage 1-3 cancers and those others in remission. It is enrolling 4,500 people. I think the study closes 3/23/09. You must start the study by 12 weeks post surgery or 8 weeks post chemo. Everyminute I bet you could start it during radiation no problem.

It is a 'stage three/three legged' study which means they know it works and are finding which of the 3 brands/types of bisphosphonates is most effective. (As I understand it 'stage one' studies test to see if the drug works. Stage Two Studies test out all kinds of doses to find the effective range. Stage 3 is the final fine tuning before market.) This current SWOG study is a comparison of 3 bisphosphonate drugs. zolodronic acid which is your Zometa given in 4mg infusions every four weeks for 6 months and then once every 3 months for 30 months. The second drug is Clodronate in pill form 1600mg a day for 3 years. The last is Ibandronate in pill form 50mg once a day for 3 years. This is the current SWOG study.

Clodranate is on  fast-track approval with the FDA in the US. It is used in Canada, Europe and Asia. Ibandronate is used in Europe, Central America and Asia. And Zoldronic Acid has been used in the US for a long time (for osteoporosis). 

Now what I have been told and what I read.

I read that the bisphosphonates have been used in Europe for ten years and have something around a %34 reduction in reoccurance rate. I read this in a Reuters article that came out in the beginning of this year. It also said that they use herceptin/hormone and bisphosphonates in Europe routinely without chemotherapy (often times to avoid the toxicity of chemo in people who can not take it I suppose) and end up getting matching or bettering the chances of reoccurance than with the chemptherapy/herceptin/hormone therapy.

I am at a top research hospital in New York City and was advised to get on the study by one of the oncologist doctors who has every one of her patients on it that qualify. It is exciting the results she said that they are seeing and is going to be the new standard in treatment. Another oncologist at the hospital explained that they originally were giving this bone strengthening drug to metastatic patients with bone cancer to help prevent the cancer from breaking the bones. They surprisingly found out it was also stopping the cancer tumors themselves from growing further. Meaning that it was an anti-carcinogen. They started to wonder if it could also prevent cancer from taking hold in the bones. They now have studies to prove it does and as I said it is a standard treatment now in europe. Yet another head oncologist here told me that this is because they think that bisphosphonates make the bones too acidic for the cancer to grow. 

I was randomized to Clodronate and started today. It was also of the three drugs the one that had the least amount of side-effects and the preferred drug by what I understand . It is not yet approved in the US. This may be due to the fact that it is a European not American manufacturer and the American competition (Zometa) has been effective in keeping it out of our large revenue market. In the end Clodronate seems to have proven to be impressively effective enough now that it is fast tracked for approval with the FDA.

At any rate this 3 armed study over the course of 10 years between the three drugs will tell which of the three bisphosphonates is the most effective in treating cancer.   

I took the clodronate on an empty stomic in the morning and do not eat for an hour so it has the best chance to be absorbed. I  had no bad reaction.  For the study I have a schedule of fallow up appointments for tests every two weeks and then every three months during the three years, then I come in I think once a year for ten years if possible to help complete the study.

They will take you off the study if in anyway they feel it is having any bad effects on you, and you can go off the study at anytime you like. 

anyway hope that helps

best,

Faith 

Well I just found this old article from 1998 San Antonio Breast Cancer Symposium regarding the bone benefits for Clodronate in prevention of bone mets.  Frankly I'm a bit angry that it is 2008 and only now the FDA has decided to bump it to the fast track for apporval?!  What the bleep took them so long?  Sounds like a lot of political BS to me.

http://www.medscape.com/viewarticle/424760

Erika,

If I had to bet,I would say that your symptoms of fever, chills and aches were due to side effects from Zometa. My infusion was on Thursday morning and that night at around 11 pm, I started getting really sick. By 2 am Friday morning, my symptoms had gotten so bad that I thought I was dying. As you said, chemo didn't get me this sick. It has been  one week since I had zometa and I am still not feeling well, but compare to last week, I am feeling wonderful! 

EWB - like some of the other gals - I had my ooph done laprascopically - day surgery.  Fatigue was the biggest issue - not too much pain. 

It is covered by my insurance.  It may depend on WHY its being given.  I get monthly infusion because of bone mets.

I had my first infusion of Zometa for mets prevention last month. Didn't expect the insurance to pay since it was off label but the payed the whole amount. That made my day

I did have some nasty se's though, bone, muscle, and abdominal pain. Ibuprophin didn't touch it but vicodin helped. They lasted about 10 days. Reminded me of taxol. I was surprised about the intensity of the pain .Next time I'll be prepared and take  the vicodin earlier. Has anyone else experienced this?

Henny 

Hi ,

Faith thank  you for posting this. I was Dxed with stage IIIC BC May 05., er/pr neg her pos, 12 nodes  pos. . Not pretty.

Anyway, I am also a clinical researcher and did my homework after my brain sorted out my dx , etc. ( It took   a while  , but I did eventually see my way through)

I  then pushed hard for zometa, and  currently receive infusions every 6 mos ( it's been around 2.5 yrs now.) 

Basically bisphosphonates keep the CTCs from latching on , by keep the bone mass dense. ( same principle with ViT D and calcium ).Anyway, I started my Zometa after all my txs and have no S/Es at all

(Sometimes, the S/Es, can be minimalized if the Z infusion runs atleast a full 30 min and given  with a steriod.)

For all you ladies going through chemo now , you will get through this. It's hard, but the emotional and physical pain  evenatully be a memory and you will get back to your life.

 God Bless,

Zometa is approved by the FDA for osteopenia, and I belivee it  be approved for prophyylactive use when studies are completed and yes it takes  YEARS before studies are completed.

My point is we need to protect our bones, and unfortunately we havee to be our own advocates  

Hi all; well it's been 3 weeks since my Z shot and i still feel achy especially in my legs, calves mostly. Is this a taxol SE as well? I haven't had chemo for almost 2 months now and i'm getting really tired of feeling tired! UUUUUGGGGGGHHHHHHHHH

Your right EWB.

I think the reason i don't ask or speak up as much as i should is because sometimes i feel i have just heard enough. Digesting all of this information is mind boggling and out right painful mentally. With that said, i'm going to call my therapist now....lol

Hi there, I was stage3 for breast cancer and I'm recovered and 2 years plus out of surgery, chemo, radiation, the whole nine yards! I was pushed into early menopause at the early age of 36, now 38 due to the estrogen involvement and having my ovaries removed. My doctor wants to put me on Zometa because I'm so young and I had lymph node involvement and says I'm at risk of reoccurance. I'm leaning on doing it, but I'm scared and uncertain. I don't want to put something in my body, if I really don't need to. I exersize 5x a week and do steady weightlifting, I eat well and feel great! Do I still need to be precautionary? I want to do whatever it takes to keep myself strong and well, but I'm just so unclear right now.

HeatherBlocklear - your post was PRICELESS!!!  Thank you for sharing your point of view!!!  Hugs Joann

deb4life



these drugs have been used for 25 years as anti-osteoporosis drugs in USA as I understand it. They have been widely widely prescribed for that. so the safety of use seems well established, side effects aside. there are drugs coming down the pipes here finally in the USA with less side effects as well.



It seems if it keeps 34 out of 100 women from reoccurance/going into stage IV, well I personally would like to see all 34 of those women walking around disease free for the rest of their lives.



I am 41 with grade 3 stage 3. Younger women with breast cancer have a higher mortality rate if you look into the figures. No one wants breast cancer. Its not like before when you just eat healthy and manage a disease-free body. You unfortunately now have to manage a disease legacy too. I can understand never wanting to take a single drug again after treatment for breast cancer. But there is more too it than than unfortunately.



For myself, I feel that putting a widely used osteoporosis drug (given to old ladies to keep their bones strong) into my body to keep out a deadly much more 'invasive pollutant'- stage IV breast cancer, well to me that is such a lucky gift to be given. I'd do it just in the name of one of those 34 women before me who never had that chance.



Faith

Hi girls,

I just got my first infusion of Zometa for prevention of bone mets and will be getting it every 6 months.  Becausse I have no signs of osteopenia (good News) I will have to pay for the Zometa (bad news) but a 35% reduction rate - whoo hoo. I had no appreciable side effects.   The treatment was $1028.00.  Money well spent.  Wonder what the cost of the drug is to the ins. co? Carol

I am new to this idea of multiple infusions of Zometa as a preventative against mets. I have osteopenia- recently dx- and did discuss with the oncology APRN the possiblity of one Zometa infusion.

I wonder if I am a poor candidate because I have had dental problems. I have 4 cleanings a year- 2 with the periodontist. I have no acute dental problems right now but there's always the potentional with me, despite regular care and my efforts at home.

Reading this thread I wonder if I should be more proactive in pursuing the Zometa option, maybe discuss it with my dentist(s) too.