Herceptin & HER2

gdpawel
gdpawel Member Posts: 523 Member
edited March 2014 in Breast Cancer #1
The needed change in the "war on cancer" will not be on the types of drugs being developed, but on the understanding of the drugs we have. There are already over 100 different therapeutic drug regimens out there, and 400 are in the pipeline. Any one or combination of them can help cancer patients. The system is overloaded with drugs and under loaded with wisdom and expertise for using them.

There are many cancer drug regimens, all of which have approximately the same probability of working. The tumors of different patients have different responses to chemotherapy. Tumors grow and spread in different ways and their response to treatment depends on these unique characteristics. The amount of chemotherapy that each patient can tolerate varies considerably from patient to patient. It requires individualized treatment based on testing the individual properties of each patient's cancer.

Under this approach, scientists study how an individual's cancerous cells respond to drugs. Doctors have learned that even when the disease is the same type, different patients' tumors respond differently to chemotherapeutic drugs. More and more physicians and patients are turning to "individualized therapies" to treat cancers, not just "targeted therapies." Without individualized testing, it's difficult to determine which drugs are best for patients who don't respond to standard therapies.

Herceptin is only for the estimated 20% of breast cancer women at risk for recurrence. However, Gene Expression Assays are panels of markers that can predict the likelihood of cancer recurrence in various populations. By testing the gene expression markers of a patient, oncologists can identify those patients unlikely to benefit from chemotherapy from those that would, saving the other 80% of cancer patients the added expense, suffering and even death from having to take chemotherapy.

What a cancer patient would like ideally, is to know whether they would benefit from adjuvant chemotherapy. If so, which active drugs have the highest probability of working, which Chemotherapy Sensitivity and Resistance Assays can test for drug activity against a tumor, and what drugs are relatively non-toxic in a given patient , which Pharmacogenomic Testing can identify.

Whether a patient would benefit from adjuvant therapy depends on two things: (1) whether the tumor is "destined" to come back in the first place and (2) whether the tumor is sensitive to drugs which might be used to keep it from coming back.

The gene expression markers (assays) actually can be calibrated to provide information both about the possibility of recurrence and also chemosensitivity. The problem is dissecting one from the other. Studies to date have just looked at whether people had a recurrence.

You can identify gene expression patterns (via assays) which correlate with this. But it can be hard and even impossible to tell what exactly you are measuring: is it intrinsic aggressiveness of the tumor? sensitivity to adriamycin? sensitivity to cyclophosphamide? sensitivity to taxol? sensitivity to tamoxifen? You find a gene expression panel which correlates with something, but picking apart the pieces is hard.

You can begin to do this if you combine gene expression studies with cell culture studies. Use the cell culture as the gold standard to define the difference between sensitivity and resistance. Then see which pattern correlates with which for individual tumors and individual drugs. It can theoretically be done (and certainly will be done, over time), but it's not easy.

And then you come to the 1,000 pound gorilla of a question: What effect will the different individual drugs have in combination in different, individual tumors? This is where cell culture assays will always be able to provide uniquely valuable information. But it's not one versus the other. The best thing is to combine these different tests in ways which make the most sense. One month's worth of herceptin + avastin costs $8000. That's without any docetaxel and blood cell growth factors and anti-emetics. If nothing else, we can't afford too much trial and error treatment.

Human Genome Project Information: http://www.ornl.gov/sci/techresources/Human_Genome/medicine/pharma.shtml

Human Tumor Assay Journal: http://www.weisenthal.org/

ACGT, Inc.: http://www.acgtinc.com/gene_expression.htm

Comments

  • inkblot
    inkblot Member Posts: 698 Member
    Hi there gdpawel: It's been a while since I've noted one of your posts here.

    The info you've posted is encouraging to everyone...those of us who've had cancer as well as to those who may get it in the future. It's at least a step beyond what most of us have at our disposal currently to help us in our decision making about treatments.

    However, there remains certain questions which science cannot begin to answer at this point (and not in the forseeable future):

    Her2neu/herceptin: Herceptin doesn't work for everyone who is presumed to potentially benefit from it. Some Her2/neu positive women have taken the prescribed course of Herceptin and still suffered recurrence and/or mets. Why?

    Still other women have been Her2/neu positive (3*)
    have not taken Herceptin and have experienced no recurrence/mets, after many years? Why? The reports of successes/failures have been the same across the board, for many chemotherapeutic agents, alone and in various coctail combinations.
    What accounts for this?

    I tend to believe, at this point in the scientific timeline, that as much as we're all considered to be the same on the inside, we're actually not.

    Our immune systems are different, our hormone levels are different, our diets and exercise habits are different, our supplement use is different, our spiritual belief systems are different and our local environments are different, the very air we breathe can vary greatly from one region of the country to another.
    W eeach have different genetic propensities. We each have different levels of stress in our lives and we each have different methods of managing that stress.

    Of particular importance, I believe, are the levels of contamination (carcinogenic pathogens)
    in our food sources and drinking water. This can also vary widely from region to region. I believe all this combines to render each of us quite different on a biological level. Some perhaps living in a more contaminated environment, but somehow having a strong immune system which may gobble up threats before they can become a problem, while others in the same community may get cancer.

    Logically, any two of us with the same path report and same test results can and do respond differently to the same treatment(s). Why? Could the answer for the differences be found in our environment?

    Another point we often overlook is that many times, surgery alone can be curative, so to speak.
    We may actually not benefit from either radiation or chemotherapy of any kind. The million dollar question, which again, science cannot answer, is who are the ones who will not benefit from further treatment(s)? Until that question can be answered we have terms such as the "gold standard" of treatment for particular cancers. Treatment recommended across the board for certain cancers. This leaves patients in the quandry of "what should I choose", based upon statistics and a particular physicians recommendations.

    This leads us to logically seek 2nd opinions, for doctors can differ widely in recommendations, based upon all the same factors, including path report findings. This also leads us to read and research, talk to others with the same/similar dx's and then decide how we want to proceed. The bottom line is that we all want to feel that we've done everything we can to rid ourselves of any and all cancer cells lurking within our bodies, while also preserving a reasonable standard of life thereafter. (Side effects can be anything from dreadful to mild even among people on the same regimen of chemo) We all want to live and we hope
    our futures will not be shortened 5, 15 or 20 years down the road, by virute of chemo/radiation exposures.

    We're throwing tons of money at trying to close the barn door AFTER the horses are out. (While it's the best thing we have, we can do so much better)

    Until our government is willing to acknowledge, as unacceptable, many of the elements they allow in our environment, which are compromising our lives every day and ultimately killing many of us, the research for a magic bullet to stop cancer (once it has already been diagnosed) will continue for many, many generations to come. If we refuse to address the known causes of so much disease, then our only logical option is to continue trying to find a cure. Cancer treatment and research is a multi billion dollar business.

    I believe we should focus strongly on addressing the known causes of cancer. We know what many of them are. The problem is one of economy/politics vs. health/human life. An age old problem. Without strong, committed leadership and support from our elected officials, we cannot hope to make progress in this direction. Big business lobbying is a tough competitor for any group to successfully challenge.

    We live in a world wherein beached whales are often treated as "toxic waste". Who cares or wonders why? We often look the other way. Asthma rates are climbing at an astounding rate in the general population and particularly in our children. We pour funds into newer, stronger, more effective treatment as opposed to the cause. Childhood cancers are on the rise. Levels of toxins within our bodies are testing higher and no one even knows what some of these toxins can do to us in combination. A recent report by EWG stated that toxic chemicals by the hundreds were found in the cord blood of just 10 newborns around the country. This report points out huge gaps in our federal safety net which should concern all of us as inhabitants of this planet. (Environmental Working Group is a research and advocacy organization) Go to: www.ewg.org/reports/bodyburden2/ for the full report. Also, check out www.ewg.org for more general enviromental info. Joining and/or supporting other solid environmental organizations is another way to get information and participate in effecting change. www.greenpeace.org Environmental News Service is another good source of info. Just a few sites among many others, composed of well educated, talented scientists and educators with a focus upon the health dangers/hazards which exist in our everyday environment and efforts to effect positive changes.

    We must work to educate ourselves. Sadly, we cannot depend upon our government agencies to be above board and truthful with us about what's going on or not going on in our environment which is making us sick. Profits and big business often
    shape/color their decisions and reports. Through aligning ourselves with like minded, concerned people, working for improvement and change, we can make a difference. We can exert pressure upon the powers that be, in large enough numbers, from the EPA right down to our local health departments, to help bring about positive change. Demanding a healthier environment, cleaner food, air and water. Mandated changes in farming practices, manufacturing, chemical processing,
    demanding "positively" safe disposal of all nuclear fuel/weapons products and by products, demanding that our military clean up all areas which they contaminate/destroy during "training" processes. The list is literally a mile long.
    This is method through which we could virtually guarantee a decrease in number of diseases and debilitating conditions which plauge us today. In our effort to help stop cancer, we need only look at the known causes and eliminate them. If this requires giving up a some conveniences and paying
    more for certain necessary items, then we have some choices to make. Sadly too many of us cannot bear the thought of giving up anything, particularly our ability to "keep up with the Joneses". We all pay a health related price for conspicious consumerism/materialistic thinking. A thinking often spoon fed to us from the time we can talk and walk. We are taught little else actually, from elementary school throughout college. We must intent upon making the most money, driving the most expensive vehicles, buying the biggest houses and staying on that track until we die. It's the yardstick by which society mostly judges us...our level of consumerism. We are mostly taught to value that judgment.

    In the meantime, those of us so unfortunate to have already gotten a dread disease, which possibly arose directly from environmental pollutants, must do the best we can with our treatment options and our decision making processes to prolong and/or improve our lives.

    My greatest hope is that we can find a way to offer our children and/or grandchildren a cleaner environment in which to live, work, play and bring up their own children. A world they will learn to value and protect as the lifeblood that it is to each of us. Ideally, future generations would not need to worry about their safety when doing something so simple as eating or having a drink of water or just taking in a deep breath of clean air. The very idea of such a state of living sounds eutopian but it's certainly food for thought, and certainly an attainable goal within our lifetimes, if (and that's a huge IF) enough of us find it important.

    Love, light and laughter,
    Ink
  • gdpawel
    gdpawel Member Posts: 523 Member
    inkblot said:

    Hi there gdpawel: It's been a while since I've noted one of your posts here.

    The info you've posted is encouraging to everyone...those of us who've had cancer as well as to those who may get it in the future. It's at least a step beyond what most of us have at our disposal currently to help us in our decision making about treatments.

    However, there remains certain questions which science cannot begin to answer at this point (and not in the forseeable future):

    Her2neu/herceptin: Herceptin doesn't work for everyone who is presumed to potentially benefit from it. Some Her2/neu positive women have taken the prescribed course of Herceptin and still suffered recurrence and/or mets. Why?

    Still other women have been Her2/neu positive (3*)
    have not taken Herceptin and have experienced no recurrence/mets, after many years? Why? The reports of successes/failures have been the same across the board, for many chemotherapeutic agents, alone and in various coctail combinations.
    What accounts for this?

    I tend to believe, at this point in the scientific timeline, that as much as we're all considered to be the same on the inside, we're actually not.

    Our immune systems are different, our hormone levels are different, our diets and exercise habits are different, our supplement use is different, our spiritual belief systems are different and our local environments are different, the very air we breathe can vary greatly from one region of the country to another.
    W eeach have different genetic propensities. We each have different levels of stress in our lives and we each have different methods of managing that stress.

    Of particular importance, I believe, are the levels of contamination (carcinogenic pathogens)
    in our food sources and drinking water. This can also vary widely from region to region. I believe all this combines to render each of us quite different on a biological level. Some perhaps living in a more contaminated environment, but somehow having a strong immune system which may gobble up threats before they can become a problem, while others in the same community may get cancer.

    Logically, any two of us with the same path report and same test results can and do respond differently to the same treatment(s). Why? Could the answer for the differences be found in our environment?

    Another point we often overlook is that many times, surgery alone can be curative, so to speak.
    We may actually not benefit from either radiation or chemotherapy of any kind. The million dollar question, which again, science cannot answer, is who are the ones who will not benefit from further treatment(s)? Until that question can be answered we have terms such as the "gold standard" of treatment for particular cancers. Treatment recommended across the board for certain cancers. This leaves patients in the quandry of "what should I choose", based upon statistics and a particular physicians recommendations.

    This leads us to logically seek 2nd opinions, for doctors can differ widely in recommendations, based upon all the same factors, including path report findings. This also leads us to read and research, talk to others with the same/similar dx's and then decide how we want to proceed. The bottom line is that we all want to feel that we've done everything we can to rid ourselves of any and all cancer cells lurking within our bodies, while also preserving a reasonable standard of life thereafter. (Side effects can be anything from dreadful to mild even among people on the same regimen of chemo) We all want to live and we hope
    our futures will not be shortened 5, 15 or 20 years down the road, by virute of chemo/radiation exposures.

    We're throwing tons of money at trying to close the barn door AFTER the horses are out. (While it's the best thing we have, we can do so much better)

    Until our government is willing to acknowledge, as unacceptable, many of the elements they allow in our environment, which are compromising our lives every day and ultimately killing many of us, the research for a magic bullet to stop cancer (once it has already been diagnosed) will continue for many, many generations to come. If we refuse to address the known causes of so much disease, then our only logical option is to continue trying to find a cure. Cancer treatment and research is a multi billion dollar business.

    I believe we should focus strongly on addressing the known causes of cancer. We know what many of them are. The problem is one of economy/politics vs. health/human life. An age old problem. Without strong, committed leadership and support from our elected officials, we cannot hope to make progress in this direction. Big business lobbying is a tough competitor for any group to successfully challenge.

    We live in a world wherein beached whales are often treated as "toxic waste". Who cares or wonders why? We often look the other way. Asthma rates are climbing at an astounding rate in the general population and particularly in our children. We pour funds into newer, stronger, more effective treatment as opposed to the cause. Childhood cancers are on the rise. Levels of toxins within our bodies are testing higher and no one even knows what some of these toxins can do to us in combination. A recent report by EWG stated that toxic chemicals by the hundreds were found in the cord blood of just 10 newborns around the country. This report points out huge gaps in our federal safety net which should concern all of us as inhabitants of this planet. (Environmental Working Group is a research and advocacy organization) Go to: www.ewg.org/reports/bodyburden2/ for the full report. Also, check out www.ewg.org for more general enviromental info. Joining and/or supporting other solid environmental organizations is another way to get information and participate in effecting change. www.greenpeace.org Environmental News Service is another good source of info. Just a few sites among many others, composed of well educated, talented scientists and educators with a focus upon the health dangers/hazards which exist in our everyday environment and efforts to effect positive changes.

    We must work to educate ourselves. Sadly, we cannot depend upon our government agencies to be above board and truthful with us about what's going on or not going on in our environment which is making us sick. Profits and big business often
    shape/color their decisions and reports. Through aligning ourselves with like minded, concerned people, working for improvement and change, we can make a difference. We can exert pressure upon the powers that be, in large enough numbers, from the EPA right down to our local health departments, to help bring about positive change. Demanding a healthier environment, cleaner food, air and water. Mandated changes in farming practices, manufacturing, chemical processing,
    demanding "positively" safe disposal of all nuclear fuel/weapons products and by products, demanding that our military clean up all areas which they contaminate/destroy during "training" processes. The list is literally a mile long.
    This is method through which we could virtually guarantee a decrease in number of diseases and debilitating conditions which plauge us today. In our effort to help stop cancer, we need only look at the known causes and eliminate them. If this requires giving up a some conveniences and paying
    more for certain necessary items, then we have some choices to make. Sadly too many of us cannot bear the thought of giving up anything, particularly our ability to "keep up with the Joneses". We all pay a health related price for conspicious consumerism/materialistic thinking. A thinking often spoon fed to us from the time we can talk and walk. We are taught little else actually, from elementary school throughout college. We must intent upon making the most money, driving the most expensive vehicles, buying the biggest houses and staying on that track until we die. It's the yardstick by which society mostly judges us...our level of consumerism. We are mostly taught to value that judgment.

    In the meantime, those of us so unfortunate to have already gotten a dread disease, which possibly arose directly from environmental pollutants, must do the best we can with our treatment options and our decision making processes to prolong and/or improve our lives.

    My greatest hope is that we can find a way to offer our children and/or grandchildren a cleaner environment in which to live, work, play and bring up their own children. A world they will learn to value and protect as the lifeblood that it is to each of us. Ideally, future generations would not need to worry about their safety when doing something so simple as eating or having a drink of water or just taking in a deep breath of clean air. The very idea of such a state of living sounds eutopian but it's certainly food for thought, and certainly an attainable goal within our lifetimes, if (and that's a huge IF) enough of us find it important.

    Love, light and laughter,
    Ink

    Very interesting points Ink. I don't think the following information will be very encouraging, but the knowledge of it will help the understanding.

    As reported at the 27th Annual San Antonio Breast Cancer Symposium, using a technique that quantifies circulating tumor cells, German investigators from Friedrich-Schiller University in Jena, have shown that chemotherapy with paclitaxel (taxol) causes a massive release of cells into the circulation, while at the same time reducing the size of the tumor. The finding could help explain the fact that complete pathologic responses do not correlate well with improvements in survival.

    Circulating tumor cells (CTCs) are cancer cells that have detached from solid tumors and entered the blood stream. This can begin the process of metastasis, the most life-threatening aspect of cancer. To metastasize, or spread cancer to other sites in the body, CTCs travel through the blood and can take root in another tissue or organ.

    In the study, according to Katharina Pachmann, M.D., professor of experimental oncology and hematology, breast cancer patients undergoing neoadjuvant chemotherapy gave blood samples in which epithelial antigen-positive cells were isolated. Such cells are detected in most breast cancer patients but are rarely found in normal subjects. The investigators measured the levels of cirulating tumor cells before and during primary chemotherapy with several different cytotoxic agents.

    Paclitaxel (taxol) produces the greatest degree of tumor shrinkage but also the greatest release of circulating tumor cells. In three different paclitaxel-containing regimens, circulating cell numbers massively increased, whereas tumor size decreased. These cells remained in the circulation for at least five months after surgery.

    The tumor shrinks, but more cells are found in the circulation. This corresponds with a high pathologic complete response during paclitaxel treatment, but in the end, this is not reflected in improved survival. These cells are alive in the circulation. The results indicate that monitoring of circulating tumor cells can contribute to understanding of tumor-blood interactions and may provide a valuable tool for therapy monitoring in solid tumors.

    (Oncol News Int'l, Vol 14, #5, May '05)

    What this recent study has shown, so far, that in three different paclitaxel (taxol) containing regimens, as the tumor collapses (a clinical response, not cure), it produces the greatest release of circulating tumor cells. The study has not looked at any other combination regimens.

    With these cells being alive in the circulation, it may mean that a patient with invasive breast cancer without lymph node involvement (where systemic treatment "may" benefit), or a patient with invasive breast cancer that involves lymph nodes (where systemic treatment is "usually" recommended), would need additional (anti-estrogen) treatment, such as Tamoxifen (it may be given alone or in addition to chemotherapy, if given).

    It has been shown that Tamoxifen treatment will reduce circulating tumor cells in some patients, but not all. It has been shown that Herceptin treatment will reduce circulating tumor cells in patients with HER2-negative tumors, but less pronounced in HER2-positive tumors.

    A study from the Dana Farber Cancer Institute identified central nervous system (CNS) metastases in women who receive trastuzumab-based (Herceptin) therapy for metastatic breast carcinoma. Central nervous system disease is defined as one or more brain metastases or leptomeningeal carcinomatosis (carcinomatous meningitis).

    Central nervous system metastases was identified in 34% of patients at a median of 16 months after diagnosis of metastatic breast cancer and 6 months from the beginning of Herceptin treatment. Patients receiving Herceptin as first-line therapy for metastatic disease frequently developd brain metastases while responding to or stable on Herceptin.

    The authors of the study say that efforts to characterize other risk factors for development of CNS disease, optimal screening algorithms, and new treatment strategies may be warranted.

    (Cancer 2003 Jun 15;97(12):2972-7)

    The potential benefits and risks of Herceptin have renewed concerns about the reliability of HER2 testing. Some studies have shown that the test produces false positives as often as 26% of the time, and may also carry some risk of false negatives. Herceptin also doesn't offer any benefit to women with HER2-negative cancer.
  • tlmac
    tlmac Member Posts: 272 Member
    inkblot said:

    Hi there gdpawel: It's been a while since I've noted one of your posts here.

    The info you've posted is encouraging to everyone...those of us who've had cancer as well as to those who may get it in the future. It's at least a step beyond what most of us have at our disposal currently to help us in our decision making about treatments.

    However, there remains certain questions which science cannot begin to answer at this point (and not in the forseeable future):

    Her2neu/herceptin: Herceptin doesn't work for everyone who is presumed to potentially benefit from it. Some Her2/neu positive women have taken the prescribed course of Herceptin and still suffered recurrence and/or mets. Why?

    Still other women have been Her2/neu positive (3*)
    have not taken Herceptin and have experienced no recurrence/mets, after many years? Why? The reports of successes/failures have been the same across the board, for many chemotherapeutic agents, alone and in various coctail combinations.
    What accounts for this?

    I tend to believe, at this point in the scientific timeline, that as much as we're all considered to be the same on the inside, we're actually not.

    Our immune systems are different, our hormone levels are different, our diets and exercise habits are different, our supplement use is different, our spiritual belief systems are different and our local environments are different, the very air we breathe can vary greatly from one region of the country to another.
    W eeach have different genetic propensities. We each have different levels of stress in our lives and we each have different methods of managing that stress.

    Of particular importance, I believe, are the levels of contamination (carcinogenic pathogens)
    in our food sources and drinking water. This can also vary widely from region to region. I believe all this combines to render each of us quite different on a biological level. Some perhaps living in a more contaminated environment, but somehow having a strong immune system which may gobble up threats before they can become a problem, while others in the same community may get cancer.

    Logically, any two of us with the same path report and same test results can and do respond differently to the same treatment(s). Why? Could the answer for the differences be found in our environment?

    Another point we often overlook is that many times, surgery alone can be curative, so to speak.
    We may actually not benefit from either radiation or chemotherapy of any kind. The million dollar question, which again, science cannot answer, is who are the ones who will not benefit from further treatment(s)? Until that question can be answered we have terms such as the "gold standard" of treatment for particular cancers. Treatment recommended across the board for certain cancers. This leaves patients in the quandry of "what should I choose", based upon statistics and a particular physicians recommendations.

    This leads us to logically seek 2nd opinions, for doctors can differ widely in recommendations, based upon all the same factors, including path report findings. This also leads us to read and research, talk to others with the same/similar dx's and then decide how we want to proceed. The bottom line is that we all want to feel that we've done everything we can to rid ourselves of any and all cancer cells lurking within our bodies, while also preserving a reasonable standard of life thereafter. (Side effects can be anything from dreadful to mild even among people on the same regimen of chemo) We all want to live and we hope
    our futures will not be shortened 5, 15 or 20 years down the road, by virute of chemo/radiation exposures.

    We're throwing tons of money at trying to close the barn door AFTER the horses are out. (While it's the best thing we have, we can do so much better)

    Until our government is willing to acknowledge, as unacceptable, many of the elements they allow in our environment, which are compromising our lives every day and ultimately killing many of us, the research for a magic bullet to stop cancer (once it has already been diagnosed) will continue for many, many generations to come. If we refuse to address the known causes of so much disease, then our only logical option is to continue trying to find a cure. Cancer treatment and research is a multi billion dollar business.

    I believe we should focus strongly on addressing the known causes of cancer. We know what many of them are. The problem is one of economy/politics vs. health/human life. An age old problem. Without strong, committed leadership and support from our elected officials, we cannot hope to make progress in this direction. Big business lobbying is a tough competitor for any group to successfully challenge.

    We live in a world wherein beached whales are often treated as "toxic waste". Who cares or wonders why? We often look the other way. Asthma rates are climbing at an astounding rate in the general population and particularly in our children. We pour funds into newer, stronger, more effective treatment as opposed to the cause. Childhood cancers are on the rise. Levels of toxins within our bodies are testing higher and no one even knows what some of these toxins can do to us in combination. A recent report by EWG stated that toxic chemicals by the hundreds were found in the cord blood of just 10 newborns around the country. This report points out huge gaps in our federal safety net which should concern all of us as inhabitants of this planet. (Environmental Working Group is a research and advocacy organization) Go to: www.ewg.org/reports/bodyburden2/ for the full report. Also, check out www.ewg.org for more general enviromental info. Joining and/or supporting other solid environmental organizations is another way to get information and participate in effecting change. www.greenpeace.org Environmental News Service is another good source of info. Just a few sites among many others, composed of well educated, talented scientists and educators with a focus upon the health dangers/hazards which exist in our everyday environment and efforts to effect positive changes.

    We must work to educate ourselves. Sadly, we cannot depend upon our government agencies to be above board and truthful with us about what's going on or not going on in our environment which is making us sick. Profits and big business often
    shape/color their decisions and reports. Through aligning ourselves with like minded, concerned people, working for improvement and change, we can make a difference. We can exert pressure upon the powers that be, in large enough numbers, from the EPA right down to our local health departments, to help bring about positive change. Demanding a healthier environment, cleaner food, air and water. Mandated changes in farming practices, manufacturing, chemical processing,
    demanding "positively" safe disposal of all nuclear fuel/weapons products and by products, demanding that our military clean up all areas which they contaminate/destroy during "training" processes. The list is literally a mile long.
    This is method through which we could virtually guarantee a decrease in number of diseases and debilitating conditions which plauge us today. In our effort to help stop cancer, we need only look at the known causes and eliminate them. If this requires giving up a some conveniences and paying
    more for certain necessary items, then we have some choices to make. Sadly too many of us cannot bear the thought of giving up anything, particularly our ability to "keep up with the Joneses". We all pay a health related price for conspicious consumerism/materialistic thinking. A thinking often spoon fed to us from the time we can talk and walk. We are taught little else actually, from elementary school throughout college. We must intent upon making the most money, driving the most expensive vehicles, buying the biggest houses and staying on that track until we die. It's the yardstick by which society mostly judges us...our level of consumerism. We are mostly taught to value that judgment.

    In the meantime, those of us so unfortunate to have already gotten a dread disease, which possibly arose directly from environmental pollutants, must do the best we can with our treatment options and our decision making processes to prolong and/or improve our lives.

    My greatest hope is that we can find a way to offer our children and/or grandchildren a cleaner environment in which to live, work, play and bring up their own children. A world they will learn to value and protect as the lifeblood that it is to each of us. Ideally, future generations would not need to worry about their safety when doing something so simple as eating or having a drink of water or just taking in a deep breath of clean air. The very idea of such a state of living sounds eutopian but it's certainly food for thought, and certainly an attainable goal within our lifetimes, if (and that's a huge IF) enough of us find it important.

    Love, light and laughter,
    Ink

    The reality is there isn't a single treatment that works for everyone, even under seemingly identical circumstances. Perhaps there will never be ONE best treatment. A team from the University of Texas Southwestern at Dallas, publishing in the journal Clinical Cancer Research, studied women who were 15-20 years past breast cancer treatment and who had zero recurrances. One third of 36 former breast cancer patients were found to have tumor cells in their blood. How did these 9 women manage to avoid stage IV? The researchers believe women who stay cancer-free may have a system for keeping a tumor under control. It's possible that the optimal treatment will forever need to be individualized by tumor characteristics and other health considerations, such as those Ink identified.
    terri
  • gdpawel
    gdpawel Member Posts: 523 Member
    The traditional criteria ever used to evaluate laboratory tests has been the predictive 'accuracy' of the test. The American Society of Clinical Oncology (ASCO) reviews of cell culture assay tests specifically excluded all studies reporting the predictive 'accuracy' of the tests. In other words, they excluded reports that only reported correlations between assay results and clinical outcomes.

    Instead, ASCO reviews included old, previously-reviewed studies comparing outcomes of patients who had treatment based on assay results versus patients with empirically chosen therapy. The criteria of laboratory assay 'efficacy', as opposed to laboratory assay 'accuracy' sound reasonable, but it is unprecendented with regard to any other laboratory test ever evaluated.

    None of the available laboratory tests used in the selection of treatments for cancer patients have ever been tested for 'efficacy'. This includes estrogen receptor, progesterone receptor, Her2/neu, immunohistochemical staining for tumor classification, bacterial culture and sensitivity testing, CT, MRI and Pet Scans to measure tumor response to treatment. The only data supporting any of them relate to test 'accuracy', and there is a total lack of information regarding test 'efficacy'. (randomized trials with outcome measurements for diagnostic tests)

    Also, no one is seriously proposing that any of the molecular tests now available (Oncotype DX, EGFR amplification/mutation) should have to be proven 'efficacious', as opposed to merely 'accurate', before they are used in clinical decisions regarding treatment selection.

    ASCO says that there is no literature establishing clinical 'efficacy' of assay tests, because the costs of such clinical trials are prohibitive, granting agency support is non-existent, and no other analogous tests have been or will likely ever be subjected to such an unreasonably high bar criterion for clinical use.

    Cell culture assay tests have been well proven to have predictive 'accuracy' with that of estrogen receptor, progesterone receptor, Her2/neu and the newer molecular tests. In light of the precious little in the way of guidance from clinical trials with respect to best empiric therapy (where the only thing that has been proven to correlate with treatment decisions is reimbursement to the prescribing oncologist) and the importance of basing cancer treatment at least in part on patient preferences, it is entirely reasonable to support judicious application of laboratory tests which have been well characterized with respect to test 'accuracy'. This is a diagnostic test and should be held to that criteria, and not to that of therapy.

    This laboratory test is a tool for the oncologist. The oncologist should take advantage of all the tools available to him/her to treat a patient. And since studies show that only 25-30% of patients do respond to chemotherapy that is available to them, there should be due consideration to looking at the advantage of human tissue assay tests to the resistance that has been found to chemotherapy drugs.

    Cell culture drug resistance testing is for preventing use of known anti-cancer drugs that are not likely effective in the specific tumor. Cell culture drug sensitivity testing tries to determine specific drug and dose effectiveness. The distinction between sensitivity and resistance is more semantic than substantive.

    In virtually all forms of cancer, clinical trials have failed to identify best drug regimens for use in all individuals with a given form of cancer.

    Oncologists have been documented to use reimbursement (payment to the oncologist) as the most important criterion for selecting between the large array of otherwise equally acceptable regimens.

    The established criterion on which to judge all laboratory tests used to help in the selection of cancer treatment is test 'accuracy' and not test 'efficacy'.

    Cell culture assay tests with cell-death endpoints have been exceedingly and reproducibly well established to be usefully 'accurate' in correlation with and predicting for clinical outcomes, including tumor response and patient survival.

    Molecular assays have established absolutely no data relating to assay 'efficacy', and with much less data relating to assay 'accuracy' than exist to support the application of cell culture assays.

    ASCO is an organization which has been zealous in its support of an inherently corrupt system which won't allow drugs to be chosen on the basis of tumor biology but instead protects the ability of oncologists to choose drugs largely on the basis of profit margin or least inconvenience to research clinics.

    There should an expansion of reimbursement to promote even greater utilization and development of laboratory-based mechanisms for improving the match between tumors and an ever-increasing number of partially effective and very expensive drug therapies.