Zometa

Faith1

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 

everyminute

Faith - thanks so much.  I checked my onc group website and dont see the study listed - I am going to call in the am to see if my onc is even able to offer - if not, I may be switching oncs - unless of course I can get the zometa as a preventative.  I am desperate, I know, but I feel like I have to do something more to improve my odds!

 Thank you for all your info!

cp418

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

ekenny315

I was recently put on this study as well:

http://www.lbbc.org/content/clinical-trial/research-study-looks-at-bisphosphonates-for-early-stage-breast-cancer.asp?section_tag=G

I am 3c, grade 3 with 16/22 pos. nodes

I have read about the SE's and decided to go ahead with it because the good out weighed the bad.

My first infusion was Nov 3rd, it lasted about 15 minutes and went well, however; i did  wake up at 2 in the morning on the 4th with chills , fever and severe aching. I was nursing a cold and was wondering if i may have caught something from my kids??? Well i went to the ER and after a chest xray, catscan, blood tests etc...they agreed it was some sort of a viral infection. I have to admit it was the worst. I didn't feel anywhere close to that when i was on chemo. Now my body is very sore and i'm not sure if it's from the residual effects from chemo, the zometa infusion or the vita D i was taking for 6 weeks, Can i feel this achey almost a month after my chemo completion? I'm tired of taking narcotics for this pain. am i alone?

swmmom

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

You can ask for the infusion to be given over a longer period of time. That seems to help a lot of women

karen1956

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

lexislove

Thanks Faith for that post! ekenney315 I also got muscle pains after the infusion. My infusion took about 1/2 an hour and about 2- 4 hours later the aches came. I took an extra strength tylenol and it seemed to help. The next day I was fine. I did not get any fever or chills though. My next infusion is in Jan 2009 so we will see then.

I feel so lucky to have the Zometa available it seems so promising. I did not even know about it untill my onc came back from Chicago and told me . He asked if I wanted to do it and I said of course! I do pay a little out of pocket. I am not covered ( no extended health plan) The 4 mg is  $600 and then I fax my receipt to Novartis ( the drug company). They reinburse me half so $300. So $600 a year is not bad. By the way I'm in Canada and I'm not sure if insurance companies cover Zometa for adjuvant therapy or not yet.

EWB

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

lexislove

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henny

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 

EWB

You can ask for the infusion to be givien over a longer period of time, be sure to mention the SEs to onc and nurses.

Good luck 

lkc

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  

HeatherBLocklear

Hi all,

I was amazed by the SEs as well. According to both the leaflet info and the chemo nurse, effects would be minimal to none. Imagine my panic when I got so sick with high fever and all sorts of flu symptoms during the night that I though I was DYING!

What is it with these idiots that they can't be honest with patients? Even if it's rare for people to get really sick, they need to tell them that it can happen.

Also, what's with the cup with an effing plastic BONE inside it? Are they making fun of us or what? This has really upset me. It's like handing out Mickey Mouse ears for people with brain mets. I can't believe the sophomoric vapidity of the US medical and pharmaceutical industries. What's next? A plastic liver with spots on it included with patient information for a drug dealing with liver mets? Please, a little more of the sublime and a bit less of the ludicrous. Heaven help us all.

Love Annie Camel Bones

ekenny315

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

EWB

I have said this on some of the other threads but I think it is worth repeating.  It is very imortant for us all to talk with docs/nurses/social workers and anyone else we come in contact with about side effects. If no one speaks up then no one will think its much of a problem, and no one will work of fixing or coming up with ways to improve management of the side effects.  Speak up and be heard, not complaining, not whining, but speak the true about whats going on.  Doctors and nurses work for us; we spend a lot of money (directly out of pocket or thru insur payments) at pharm companies---we are the consumer---we have a voice.

Pray today is a good day for all. 

ekenny315

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

EWB

Erika-   it is all so over whelming, I certainly agree!  When were you diagnosed?  I think some times it takes time to absorb all the information about the disease itself as well as treatment options, side effects, impact on day to day living etc.  Once everything settles down for you--come join the ranks of the Vocal Patients...as we all know- its all about US. Some how I have to turn Vocal Patients into VIP---any thoughts?

Hope today is a good day, Happy Thanksgiving

Gentle hugs and kick ass prayers...Elaine 

everyminute

Just got off the phone with my oncologist - she has okd me to get zometa once every six months for prevention of osteoporosis (for insurance purposes)  She said she is looking forward to other studies before she gets to excited but saw no harm in getting me started!  Yay.

So I am getting all my dental work out of the way and she said she would probably do the first infusion in January.  God, I hope this is the miracle drug of the future!

lexislove

everyminute,

I just answered your dental question. But I'm very happy about your onc agreeing to Zometa! What a great Holiday gift. I personally beleive that in a few years it will change treatment.

We are very fortunate to have this available to us.

Deb4life

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.

everyminute

My feeling about Zometa is that it is showing promise in clinical studies - I am going to start it right after radiation.  It is an infusion once every six months.  After everything else I have had to do to my body this is no worse (in my opinion).  There are more Zometa studies coming out over the next few months - If they dont show as much promise as early studies do, I can always stop BUT if they do (35% reduction of recurrence) then I am in on the ground floor, so to speak.

Do a google search on zometa.

Best of luck to you!

cp418

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

Celtic_Spirit

I had my first Zometa infusion (as a cancer preventative) on Dec. 6. I had so many issues going on at the same time that I'm not sure which side effect to blame on what medication/condition (infected chemo port removal, staph infection, Tamoxifen, fatigue from radiation). I had some mild flu-like symptoms for a 36-hour period (aches, fever of 99.5, tiredness). I was feeling crappy beforehand, so I'm not sure it made me feel much worse. Anyway, I can put up with a little malaise for a 35% reduction of recurrence!

Really, the worst part was the student nurse jabbing away at my hand, trying to insert the IV needle for the Zometa. I'm a two-year-old about needles as it is. My boyfriend finally hailed a staff nurse and had her finish the job.

Faith1

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

formygirls

Hi,

I am on the SWOG study and I was randomized for chlodronate. I have been taking it for 3 months now with no SE. That I tell--I am so messed up from all my txs that it is difficult to tell what problem is because of what tx. Anyway I feel no worse than when I started. My question is if anyone had heard good things about chlodronate. Most of the information is about Zometa and my onc will not give me Zometa. I was hoping to get on the Zometa arm but did not get on that arm.

Thanks.

Carol1220

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

everyminute

Carol - My onc got it approved for me by my insurance company for the prevention of osteoporosis because I had a hyst/ooph.  I am hopeful it prevents more than osteoporosis..mets to bone and maybe even soft tissue as well!

paige-allyson

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.

lexislove

allysonw,

Definatly talk to your onc about Zometa. And if you already have Oseopenia, it will have greater benefits! If you are concerned about your dental history talk it over with your dentist and if you decide to have Zometa, have all dental work completed before hand Ex, extractions especially. cleanings are ok while on the Zometa it's the "major" work thats a bit tricky.

* Good Luck *