Hey everyone,
This just in!
Another praise!
As we mentioned in our blog Aug 16th, Laurie had to get a nodule on her thyroid checked out (seen on PET scan in Dec). She was able to get an appt with Dr Rogacz within 5 weeks which is a miracle in itself (it is very hard to get quick appts with endocrinologists!). That appt was last week, which led to further appts for blood work (last Friday) and a needle biopsy (this past Tuesday). Both tests came back normal, so all is well. They are recommending a follow-up sonogram in 6 months (just like the GYN) but no further action at this time. This is really wonderful news!
God is so cool!
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Friday, September 25, 2009
Clinical Trial for Biophosphonates 9-25-09
Hey everyone,
The 3 year Clinical Trial that Laurie is participating in is designed to determine if adding a biophosphonate to hormonal therapy and/or chemotherapy will help prevent breast cancer from spreading to the bones or other parts of the body. About 4,500 women are taking part in this study. There are 3 different groups within the study, each being given a different type of biophosphonate for 3 years as note below. (there is no placebo in this study)
1. 4 mg infusion of zoledronic acid through a needle in the vein every 4 weeks for the first 6 months and then once every 3 months for the other 30 months
2. 1600 mg of clodronate by mouth (2 tablets) every day for 36 months
3. 50 mg of ibandronate by mouth once every day for 36 months (marketed as Boniva here in US, similar to Actonel)
Biophosphonates are a class of drugs that prevent the bone from breaking down. Low doses are used for osteoporosis here in the US and higher dosages are used for bone cancers (currently zoledronic). This clinical trial is using higher dosages. For example, someone taking Boniva for osteoporosis (you probably have seen Sally Fields in a TV ad on this) would take 2.5 mg daily or 150 monthly. As you see under #3 above, participants in this study take 50 mg daily. The purpose of the study is to see if biophosphonates should be added to the treatment regiment for breast cancer patients, and if so, which one of these works the best (best stats with least amount of side effects). Side effects from the 3 options vary but overall, side effects include nausea, vomiting, reflux and diarrhea. Uncommon, but serious side effects include the possibility of a specific type of damage to the jawbone (osteonecrosis of the jaw) and damage to an unborn child or a baby who is breastfeeding (not a concern for Laurie!). They will run routine blood tests every month for the first 6 months and then every 3 months thereafter. The blood tests will check normal levels as well as serum creatinine to ensure the kidneys are working properly.
For those medical folks out there, you know that bisphosphonates prevent the breakdown of bone by bone cells called osteoclasts. For the rest of us, Laurie’s dentist explained it a little easier to understand: “The bones are like roads. Before they are repaved, a layer is removed, and then a new layer of asphalt is added. Bones are similar. There are cells that are breaking down the bone, and then new cells are created. The biophosphonates decrease the activity of the cells that are “breaking down or removing” bone density and since the new cells are still being created, the bones become more dense and stronger.”
The medication she is taking is being used in Canada, the United Kingdom and Italy, where it is marketed as Bonefos, Loron and Clodron. Oral Bonefos is approved in 67 countries outside the United States largely for the treatment of tumor-induced osteolysis and hypercalcemia. So far, nearly 20 years of use and 300,000 patient-years of experience with Bonefos have been accumulated worldwide.
So, now you know a bit more about what and why Laurie is participating in this clinical trial. The bottom line is that she hopes to provide data that will one day lead to a cure for others that may experience what she has already gone through.
May God continue to bless you as He has so richly blessed our family!
.
The 3 year Clinical Trial that Laurie is participating in is designed to determine if adding a biophosphonate to hormonal therapy and/or chemotherapy will help prevent breast cancer from spreading to the bones or other parts of the body. About 4,500 women are taking part in this study. There are 3 different groups within the study, each being given a different type of biophosphonate for 3 years as note below. (there is no placebo in this study)
1. 4 mg infusion of zoledronic acid through a needle in the vein every 4 weeks for the first 6 months and then once every 3 months for the other 30 months
2. 1600 mg of clodronate by mouth (2 tablets) every day for 36 months
3. 50 mg of ibandronate by mouth once every day for 36 months (marketed as Boniva here in US, similar to Actonel)
Biophosphonates are a class of drugs that prevent the bone from breaking down. Low doses are used for osteoporosis here in the US and higher dosages are used for bone cancers (currently zoledronic). This clinical trial is using higher dosages. For example, someone taking Boniva for osteoporosis (you probably have seen Sally Fields in a TV ad on this) would take 2.5 mg daily or 150 monthly. As you see under #3 above, participants in this study take 50 mg daily. The purpose of the study is to see if biophosphonates should be added to the treatment regiment for breast cancer patients, and if so, which one of these works the best (best stats with least amount of side effects). Side effects from the 3 options vary but overall, side effects include nausea, vomiting, reflux and diarrhea. Uncommon, but serious side effects include the possibility of a specific type of damage to the jawbone (osteonecrosis of the jaw) and damage to an unborn child or a baby who is breastfeeding (not a concern for Laurie!). They will run routine blood tests every month for the first 6 months and then every 3 months thereafter. The blood tests will check normal levels as well as serum creatinine to ensure the kidneys are working properly.
For those medical folks out there, you know that bisphosphonates prevent the breakdown of bone by bone cells called osteoclasts. For the rest of us, Laurie’s dentist explained it a little easier to understand: “The bones are like roads. Before they are repaved, a layer is removed, and then a new layer of asphalt is added. Bones are similar. There are cells that are breaking down the bone, and then new cells are created. The biophosphonates decrease the activity of the cells that are “breaking down or removing” bone density and since the new cells are still being created, the bones become more dense and stronger.”
The medication she is taking is being used in Canada, the United Kingdom and Italy, where it is marketed as Bonefos, Loron and Clodron. Oral Bonefos is approved in 67 countries outside the United States largely for the treatment of tumor-induced osteolysis and hypercalcemia. So far, nearly 20 years of use and 300,000 patient-years of experience with Bonefos have been accumulated worldwide.
So, now you know a bit more about what and why Laurie is participating in this clinical trial. The bottom line is that she hopes to provide data that will one day lead to a cure for others that may experience what she has already gone through.
May God continue to bless you as He has so richly blessed our family!
.
Monday, September 7, 2009
Merry Labor Day!
Hey everyone,
Several people have said it’s time for an update since we left you hanging the last time, so here is the latest, and we apologize for the delay.
After much prayer, we decided that Laurie should participate in the clinical trial as it can help other patients down the road. She feels that her medical treatment has been outstanding, and that is in part due to other women being willing to participate in trials that helped them create the current treatment plans. So, Laurie started the clinical trial on 14 Aug 09 and it will continue for 3 years. She was put into the 2nd group, which is taking 1600 mg of Clodronate once each day (currently in use in Canada, UK and Italy under names of Bonefos, Loron and Clodron). The most likely side effect is nausea, but she has been very fortunate that she has not experienced any side effects. Luckily, she learned to swallow large pills when she was a teenager, so she is able to take the two “horse” pills each morning 1 hour before eating anything. However, her stomach is also starting to let her know when it’s hungry so her stomach has started growling (which is nice to her as her body wasn’t telling her when it was hungry before).
She also was able to go to the Gyn specialist (Dr Scott Forrest, so easy for her to remember his name) relating to the spot on her ovary, and he feels very confident that it is related to her infertility struggles, and while we will check it again in 6 months, does not believe it is something to be concerned about. As he said, it could have been there for years, and we only know about it because of the PET scan. The endocrinologist appt is in mid September, where we will have the spot on the thyroid checked out. Laurie’s friend Sheila, who is a nurse, set our expectations that we may have to have a needle biopsy before we have final answers, but we will let you know as we find out.
Laurie will also be starting her hormone treatment this week. Although she was put into menopause by the chemotherapy, the doctor cannot start her on Aromatase inhibitors (AI) until they are sure her menstrual cycles don’t return. If they did put her on AI’s and then her ovary began to produce estrogen again, then it would actually overproduce, thinking her body needed it, and that would actually create a perfect environment for her estrogen positive breast cancer to return. So she will be starting Tamoxifen, one 20 mg tablet a day. The side effects of Tamoxifen are similar to some of the symptoms of menopause, with two of the most common side effects being hot flashes and vaginal discharge. Other side effects in women may include headache, nausea and/or vomiting, skin rash, fatigue and fluid retention and/or weight gain.
One thing that Laurie asked for her birthday (although it was hard to admit she needed it) was the “daily pill box.” Although it did make her feel old to have to use one, her kind nurse at the oncologist’s office said it was just another way to be “organized”. So that is the story she is sticking with now. ;-) This box helps her remember the pills she needs to take, which include:
- Clinical trial – 2 800 mg tablets of Clodronate, first thing in am, 1 hr before food
- Vitamins – 1 One-A-Day Essential vitamin and 1 Vitron C (extra Iron) at lunch
- Calcium with Vitamin D – 1 chewable Caltrate tablet at lunch, and 1 chewable at night (have to take these at 2 different times since your body can only absorb so much calcium at one time)
- Hormone therapy – 1 20 mg pill at night
We’re not sure how many “pills” you need to be taking before you get this type of “organizer” but 7 is way beyond what Laurie’s simple mind can handle without this helper!!
Tomorrow, the kids begin school. Brooke & Ridge are in 3rd grade and Forrest starts 6th grade. Once we settle back into a routine with school and extracurricular activities, football, baseball and volleyball, Laurie will give us more detail on the clinical trial and what Radiation therapy was like. Stay tuned.
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