Avastin - new data
WASHINGTON — U.S. government health advisers say unanimously that a follow-up study of the Roche drug Avastin failed to show meaningful benefits for breast cancer patients.
A Food and Drug Administration panel of experts voted 13-0 that the risks and side effects of Avastin outweighed its benefits when used alongside a chemotherapy drug.
The FDA in 2008 approved Avastin for breast cancer based on a trial showing it significantly lengthened the time until the disease worsened. But two follow-up studies recently completed by Roche failed to show the same ability to delay disease progression.
The FDA panel is reviewing the results of the studies. Later the panel will vote on whether Avastin's approval in breast cancer should be withdrawn.
Comments
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Just heard this news
Just heard this news today.
I was actually part of a six-month study of which one of the drugs were avastin.
For me; I only received a six-month remission after the study.
I personally never experienced any negative side-effects while on it. But I was told at the time that the possibility of "perforation of the intestines" and a potential for "heart problems" were a strong cause for concern.
Thank God none of these occured. But who knows what the long-term effect of any of these drugs will cause?
Sharon0 -
Avastin - new data
I am new to the board, just posted new discussion "newly diagnosed". Treatment with Avastin (both IV and IP, depending on what group I would get put in) is part of the clinical trial I am considering going with. Lots of concerns about it's side effects.0 -
avastin
My mom and I spoke about this news this morning. She is scheduled to start Avastin, methotrexate and cytoxan(I think that is the 3rd drug) on Friday. She has been on taxotere/carbo and doxil in the past year or so.
From what I have read, Avastin can still be prescribed for other cancer treatments without concern that it won't be covered under insurance. My mom has been told that blood pressure problems are what they watch for with Avastin and that they will work with her on it before abandoning the treatment. Mom is already on blood pressure meds.
Nancy, I thought of you this morning, because I thought that you were on Avastin. Are you still on it or are you on Gemzar? Something else?
So many unknowns. So many Doctors have differing opinions, as well.
Sending positive energy your way,
Eileen0 -
Avastin concerns
Hi Nancy,
A friend of my sister had Avastin at Yale. She had some tough side effects, including blood pressure and heart arythmias. She was hospitalized twice while on it. At this time, she is in full remission from stage 4. Her doctor was Dr. Tom Rutherford at Yale, of you wanted to call there.0 -
Was your sister's remission due to Avastin?Lisa13Q said:Avastin concerns
Hi Nancy,
A friend of my sister had Avastin at Yale. She had some tough side effects, including blood pressure and heart arythmias. She was hospitalized twice while on it. At this time, she is in full remission from stage 4. Her doctor was Dr. Tom Rutherford at Yale, of you wanted to call there.0 -
Sister's friendeward said:Was your sister's remission due to Avastin?
My sister's friend went through a regimen that included avastin so I don't know if it is due to the avastin, but...she was stage 4 when diagnosed and is still cancer free....My mother was stage III c, and has her first recurrance....she did not have avastin...who knows what drugs works for who and why...God's will...0 -
Sister's friendeward said:Was your sister's remission due to Avastin?
My sister's friend went through a regimen that included avastin so I don't know if it is due to the avastin, but...she was stage 4 when diagnosed and is still cancer free....My mother was stage III c, and has her first recurrance....she did not have avastin...who knows what drugs works for who and why...God's will...0 -
Here's an editorial comment from OncologySTAT on this news:Lisa13Q said:Sister's friend
My sister's friend went through a regimen that included avastin so I don't know if it is due to the avastin, but...she was stage 4 when diagnosed and is still cancer free....My mother was stage III c, and has her first recurrance....she did not have avastin...who knows what drugs works for who and why...God's will...
Supplementary editorial provided by OncologySTAT
EXPERT COMMENTARY
Lee Schwartzberg, MD, Editor-in-Chief
The stunning reversal of ODAC's previous recommendation against the use of bevacizumab in breast cancer may well signal a sea of change in the way FDA approaches approval for oncology products. Rejecting progression-free survival as a meaningful outcome will have a dramatic impact on many pipeline products. This stand is controversial at best and in breast cancer, ill-advised. The natural history of this disease is one of chronicity with benefit achieved by multiple lines of therapy, diluting the survival effect of any specific line of treatment. When asked, patients vote for therapy that extends time with stable to improved symptoms; which is something that bevacizumab achieves. Overshadowing this decision is the high cost of bevacizumab. One wonders if we are entering an era of approval based on de facto cost-effectiveness without transparency about how economic factors are considered in the equation.
(My take: I've never been into the 'conspiracy therories' involving cancer treatment, but a commentary from such a respected source like this has to make you wonder. I know I'll take Avastin when it comes up as the next thing to try! Linda)0 -
I thought I had read, and my oncologist told me, the best results with Avastin are from long term maintenance. Maybe they knock it out with a high dose then go to a lower dose to maintain.msfanciful said:Just heard this news
Just heard this news today.
I was actually part of a six-month study of which one of the drugs were avastin.
For me; I only received a six-month remission after the study.
I personally never experienced any negative side-effects while on it. But I was told at the time that the possibility of "perforation of the intestines" and a potential for "heart problems" were a strong cause for concern.
Thank God none of these occured. But who knows what the long-term effect of any of these drugs will cause?
Sharon
A friend of my sisters was treated with Avastin for recurrent breast. She ended up with a bowel perforation after several infusions.0 -
Gemzareward said:avastin
My mom and I spoke about this news this morning. She is scheduled to start Avastin, methotrexate and cytoxan(I think that is the 3rd drug) on Friday. She has been on taxotere/carbo and doxil in the past year or so.
From what I have read, Avastin can still be prescribed for other cancer treatments without concern that it won't be covered under insurance. My mom has been told that blood pressure problems are what they watch for with Avastin and that they will work with her on it before abandoning the treatment. Mom is already on blood pressure meds.
Nancy, I thought of you this morning, because I thought that you were on Avastin. Are you still on it or are you on Gemzar? Something else?
So many unknowns. So many Doctors have differing opinions, as well.
Sending positive energy your way,
Eileen
Eileen,
I am still on Gemzar as a single agent. My scan is next month. If there is any progression the plan is to switch my chemo and add Avastin. My oncologist were hesistant to add Avastin to my regimen earlier due to my history of bowel obstruction and temporary illeostomy. I don't know if this new information will change their thinking. My blood pressure has always been low, still is. I don't think my blood pressure will be a problem but I am worried about the bowel issues!
Thanks for all the positive thoughts!!!0 -
gemzarnancy591 said:Gemzar
Eileen,
I am still on Gemzar as a single agent. My scan is next month. If there is any progression the plan is to switch my chemo and add Avastin. My oncologist were hesistant to add Avastin to my regimen earlier due to my history of bowel obstruction and temporary illeostomy. I don't know if this new information will change their thinking. My blood pressure has always been low, still is. I don't think my blood pressure will be a problem but I am worried about the bowel issues!
Thanks for all the positive thoughts!!!
How is gemzar for you?0 -
not badnancy591 said:Gemzar
Eileen,
I am still on Gemzar as a single agent. My scan is next month. If there is any progression the plan is to switch my chemo and add Avastin. My oncologist were hesistant to add Avastin to my regimen earlier due to my history of bowel obstruction and temporary illeostomy. I don't know if this new information will change their thinking. My blood pressure has always been low, still is. I don't think my blood pressure will be a problem but I am worried about the bowel issues!
Thanks for all the positive thoughts!!!
tough on my blood counts but otherwise I can't complain. I've developed this pimply rash on my arms and legs. One more cycle to go.0 -
Some statslindaprocopio said:Here's an editorial comment from OncologySTAT on this news:
Supplementary editorial provided by OncologySTAT
EXPERT COMMENTARY
Lee Schwartzberg, MD, Editor-in-Chief
The stunning reversal of ODAC's previous recommendation against the use of bevacizumab in breast cancer may well signal a sea of change in the way FDA approaches approval for oncology products. Rejecting progression-free survival as a meaningful outcome will have a dramatic impact on many pipeline products. This stand is controversial at best and in breast cancer, ill-advised. The natural history of this disease is one of chronicity with benefit achieved by multiple lines of therapy, diluting the survival effect of any specific line of treatment. When asked, patients vote for therapy that extends time with stable to improved symptoms; which is something that bevacizumab achieves. Overshadowing this decision is the high cost of bevacizumab. One wonders if we are entering an era of approval based on de facto cost-effectiveness without transparency about how economic factors are considered in the equation.
(My take: I've never been into the 'conspiracy therories' involving cancer treatment, but a commentary from such a respected source like this has to make you wonder. I know I'll take Avastin when it comes up as the next thing to try! Linda)
According to the Cancer Statistics for 1995, published by the ACS in their small journal (2), the 5-year survival rate has improved from 50%-56% for whites and 39%-40% for blacks from 1974/1976 - 1983/1990. However, the data is taken from FIVE of the states with the lowest death rates AND the smallest populations! NONE of the 10 states with the highest death rates AND comprising 34% of the Total U.S. Cancer Deaths, were included in the data! Also, in prior years, the Composite (Ave.) 5-year survival rate for ALL Cancers Combined was computed and published. This Ave. 5-year survival crept upward to 50%, in the early nineties. It now stands around 51-52%, due primarily to the improvement of 11% survival for Colon and 13% increased survival for Prostate. It gets worse. The ACS boasts of "statistically significant" results when Uterine Ca survival drops from 89%/60%-85%/55% (W/B)?? Also, Pancreas Ca is 3-3 (W) and Laryngeal Ca survival drops from 59%-53% (B) while Cervical Ca drops from 63%-56% (B). Liver Ca improves from 4%-7%. I wonder how many Pancreatic and Hepatic Ca patients cheered these dramatic results? Ovarian Ca = 36%/40% - 42%/38% (W/B) and Breast Ca = 75%/63% - 82%/66% (W/B). In 16 years the Breast Ca rate improved 3-7%, while Uterine Ca decreased 4-5%. Aren't these marvelous results that the Cancer Establishment should boast about??----RD Hodgell, M.D.0 -
thanksnancy591 said:not bad
tough on my blood counts but otherwise I can't complain. I've developed this pimply rash on my arms and legs. One more cycle to go.
Thanks for getting back to me so quickly! I am glad gemzar is not so difficult to deal with. I hope it is working for you and that you get a chemo break once you finish it.
xo
Eileen0 -
Actual results in patientslindaprocopio said:Here's an editorial comment from OncologySTAT on this news:
Supplementary editorial provided by OncologySTAT
EXPERT COMMENTARY
Lee Schwartzberg, MD, Editor-in-Chief
The stunning reversal of ODAC's previous recommendation against the use of bevacizumab in breast cancer may well signal a sea of change in the way FDA approaches approval for oncology products. Rejecting progression-free survival as a meaningful outcome will have a dramatic impact on many pipeline products. This stand is controversial at best and in breast cancer, ill-advised. The natural history of this disease is one of chronicity with benefit achieved by multiple lines of therapy, diluting the survival effect of any specific line of treatment. When asked, patients vote for therapy that extends time with stable to improved symptoms; which is something that bevacizumab achieves. Overshadowing this decision is the high cost of bevacizumab. One wonders if we are entering an era of approval based on de facto cost-effectiveness without transparency about how economic factors are considered in the equation.
(My take: I've never been into the 'conspiracy therories' involving cancer treatment, but a commentary from such a respected source like this has to make you wonder. I know I'll take Avastin when it comes up as the next thing to try! Linda)
Actual results in patients count and theory doesn’t matter as much as the evidence that it does what we want it to do. It would be more advantegeous to sort out what’s the best profile in terms of which patients benefit from this drug.
Some scientists are not sure whether Avastin or any other anti-angiogenic agents are working primarily by pruning new blood vessels, increasing the delivery of another anti-cancer therapy, or potentially another mechanism.
Clinical oncologists involved with functional tumor cell profiling analysis, can actually examine this. They have a method for testing anti-angiogenic/anti-microvascular agents, such as Avastin and testing for synergy between different anti-microvascular agents on an individual patient, individual tumor basis. Avastin appears to better deliver the effects of other classes of drugs.
Avastin facilitates vascular access of cytotoxics to tumors. It will take combination antivascular therapy to make a big difference, but this is definitely coming and it’s the most promising thing on the near term therapeutic horizon.
As for Avastin’s side effects. Evidence in the Journal of Clinical Oncology shows that many of the highly expensive targeted drugs like Avastin may be just as effective and produce fewer side effects if taken over shorter periods and in lower doses. Avastin is one example. The dose being used is 15 milligrams per kilogram of body weight, despite research showing it may work with 3 milligrams per kilogram.
The rationale underlying the use of anti-angiogenesis drugs, like Avastin, against ovarian cancer is that (1) VEGF pathways are strongly associated with the development of malignant ascites, malignant pleural effusions and carcinomatosis, and (2) both VEGF receptors and VEGF ligands can be over-expressed in ovarian cancer.
Angiogenesis is dependent on VEGF (Vascular Endothelial Growth Factor), a chemical signal produced by cells that stimulates the growth of new blood vessels. Avastin is known to be driving by the VEGF pathway. Avatin directly binds to VEGF to directly inhibit angiogenesis.
How long does it take for Avastin to work? In cell function analysis (with Functional Tumor Cell Profiling), within 24 hours of VEGF inhibition, endothelial cells have been shown to shrivel, retract, fragment and die by apoptosis. Tumors which secrete relatively low levels of VEGF might be more susceptible to an agent like Avastin which works by blocking VEGF (Avastin "sensitive" tumors). It potently inhibits the formation of new blood vessels.
Many doctors have been using Avastin "off-label" against a variety of cancer types. An estimated 60 percent of anti-cancer drugs are used off-label. It has been very routine and well-accepted practice to prescribe drugs in cancer types and disease stages outside of those in which the drugs originally received FDA approval. Generally, insurance companies have paid for drugs used outside of FDA-approved settings because the treating physician finds their use in those instances to be medically necessary.0
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