Article worth reading--"Colon Cancer Research:Time to Learn From Mistakes"

coloCan
coloCan Member Posts: 1,944 Member
edited August 2012 in Colorectal Cancer #1
www.clinicaloncology.com

Comments

  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    you are the man, thanks steve
    i put this article as the ending of my blog for my clinical trial.

    as if the deaths are not enough, here we have in a nutshell what seems to me to be the pit falls of evidence based medicine, don't read this if you are squeamish.

    hugs,
    pete

    ps i printed this off as i am walking out the door to see my 4th oncologist, its supposed to be a 30 minute consult. how long before i get booted out the door. if he does not offer hope, no pay. no hope then no pay. my rules, if he accepts then i am in.
  • tanstaafl
    tanstaafl Member Posts: 1,313 Member
    nice title
    ...but then the guy proceeds into imposing his own questionable judgements.

    I ask myself whether I could get my wife on first base following his recommendations. Not a chance.

    “No tissue, no marker, no trial,” ... a drug should not move beyond early clinical development unless researchers can demonstrate that it hits its target
    Demonstrate good results any way you can, more delays are not welcome. Markers are nice, and they are under utilized. They are not a drop dead requirement nor is finding them or proving them an excuse for delay.

    The trials showed a benefit for patients while they were on bevacizumab, but this benefit disappeared once patients stopped treatment.
    Gee, well duh. Took me all of day #1 to figure this out about cimetidine for permanent uses, another VEGF inhibitor, a lot less noxious and expensive, with some impressive papers.
  • steved
    steved Member Posts: 834 Member
    Interesting
    I like the article though it is very pessimistic and doesn't reflect some of the positive progress made with things like aflibercept and regorefenib as well as some hinge in vaccines that are close to approval. It will be interesting to watch these progress as the first two are only evidence based in advanced cancers and time will tell if they follow previous treatments in not showing efficacy in earlier stages. One reservation I have about this though is that they then are compared to the current regimes such as as folfox to see if they are superior and bevucizamab and cetuximab have been found not to be- I do wonder though that whether they could still have a role earlier in treatment in combination with drugs like xeloda and be a more acceptable treatment that folfox which many of us find difficult to tolerate. These studies are so expensive to run however that such studies are unlikely.

    I wouldn't want this article though to be interpreted as providing evidence against our current drugs. We do lack recent progress but we should be reassured by the rigorous ness off the studies that are occurring before the drugs are approved in less advanced cancer. We do still sit and wait that significant step forward.

    Steve
  • coloCan
    coloCan Member Posts: 1,944 Member
    steved said:

    Interesting
    I like the article though it is very pessimistic and doesn't reflect some of the positive progress made with things like aflibercept and regorefenib as well as some hinge in vaccines that are close to approval. It will be interesting to watch these progress as the first two are only evidence based in advanced cancers and time will tell if they follow previous treatments in not showing efficacy in earlier stages. One reservation I have about this though is that they then are compared to the current regimes such as as folfox to see if they are superior and bevucizamab and cetuximab have been found not to be- I do wonder though that whether they could still have a role earlier in treatment in combination with drugs like xeloda and be a more acceptable treatment that folfox which many of us find difficult to tolerate. These studies are so expensive to run however that such studies are unlikely.

    I wouldn't want this article though to be interpreted as providing evidence against our current drugs. We do lack recent progress but we should be reassured by the rigorous ness off the studies that are occurring before the drugs are approved in less advanced cancer. We do still sit and wait that significant step forward.

    Steve

    Whether this holds true for other cancers,
    not only do our CRC cancers differ from each other but the results of a biopsy from this part of a tumor may be quite different biologically/genomically than a sample from another part and the makeup of the primary will be different than that of the mets. What works for you need not work for me; what helps her a little may help him even more.....While there seem to be no new pathways being uncovered,periodically researchers somewhere come up with a previously unknown gene or protein or whatever that msy or may not indicate something if you have it.....The article following the one cited, on chromosomaL instability and microsatellite instability(what?)should also be read to take from it what you will as some interesting points are made .

    PS:There;s Reolysin (with FOLFIRI);and TAS-102**, which is getting positive press at phase 2;Aflibercept(Zaltrap) ,also with FOLFIRI.......But never fast enough nor powerful /effecteive enough thus far

    Also:curetoday.com
    current issue has interesting article on oxi,Xelox.Folfox and neuropathy, among others....

    **for kras mutation
  • steved
    steved Member Posts: 834 Member
    coloCan said:

    Whether this holds true for other cancers,
    not only do our CRC cancers differ from each other but the results of a biopsy from this part of a tumor may be quite different biologically/genomically than a sample from another part and the makeup of the primary will be different than that of the mets. What works for you need not work for me; what helps her a little may help him even more.....While there seem to be no new pathways being uncovered,periodically researchers somewhere come up with a previously unknown gene or protein or whatever that msy or may not indicate something if you have it.....The article following the one cited, on chromosomaL instability and microsatellite instability(what?)should also be read to take from it what you will as some interesting points are made .

    PS:There;s Reolysin (with FOLFIRI);and TAS-102**, which is getting positive press at phase 2;Aflibercept(Zaltrap) ,also with FOLFIRI.......But never fast enough nor powerful /effecteive enough thus far

    Also:curetoday.com
    current issue has interesting article on oxi,Xelox.Folfox and neuropathy, among others....

    **for kras mutation

    The balance
    I guess the critical issue in drug development is to balance the speed with which new treatments are developed (which is our priority as patients) against confidence and knowledge of their effectiveness. These are multibillion dollar companies and getting a drug to FDA approval costs millions. Estimates of the average phase one trial is $18 million, phase two $28million and phase three $110 million so adding more preclinical trials around evidencing the biochemical actions wil put mo arrives up to these companies developing drugs.

    In psychiatry where I work there is an acceptance that whilst we have some basic knowledge of how the drugs work the is an acceptance that the illness processes of most psychiatric illnesses are too complex to currently fully understand with our level of sophistication of understanding of the brain. If we required full understanding of how a drug works before using it we would be holding effective treatments back from patients. Cancer isn't dissimilar as our level of understanding of many cancers is also very primitive.

    It is a difficult balance to get right.

    Steve
  • janie1
    janie1 Member Posts: 753 Member
    steved said:

    The balance
    I guess the critical issue in drug development is to balance the speed with which new treatments are developed (which is our priority as patients) against confidence and knowledge of their effectiveness. These are multibillion dollar companies and getting a drug to FDA approval costs millions. Estimates of the average phase one trial is $18 million, phase two $28million and phase three $110 million so adding more preclinical trials around evidencing the biochemical actions wil put mo arrives up to these companies developing drugs.

    In psychiatry where I work there is an acceptance that whilst we have some basic knowledge of how the drugs work the is an acceptance that the illness processes of most psychiatric illnesses are too complex to currently fully understand with our level of sophistication of understanding of the brain. If we required full understanding of how a drug works before using it we would be holding effective treatments back from patients. Cancer isn't dissimilar as our level of understanding of many cancers is also very primitive.

    It is a difficult balance to get right.

    Steve

    Good one, Tans (gee, duh).
    Good one, Tans (gee, duh). Had the same thoughts.
    ...grrrrrrrr.
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    coloCan said:

    Whether this holds true for other cancers,
    not only do our CRC cancers differ from each other but the results of a biopsy from this part of a tumor may be quite different biologically/genomically than a sample from another part and the makeup of the primary will be different than that of the mets. What works for you need not work for me; what helps her a little may help him even more.....While there seem to be no new pathways being uncovered,periodically researchers somewhere come up with a previously unknown gene or protein or whatever that msy or may not indicate something if you have it.....The article following the one cited, on chromosomaL instability and microsatellite instability(what?)should also be read to take from it what you will as some interesting points are made .

    PS:There;s Reolysin (with FOLFIRI);and TAS-102**, which is getting positive press at phase 2;Aflibercept(Zaltrap) ,also with FOLFIRI.......But never fast enough nor powerful /effecteive enough thus far

    Also:curetoday.com
    current issue has interesting article on oxi,Xelox.Folfox and neuropathy, among others....

    **for kras mutation

    multiple samples !!!!i was reading this today as well
    in the 23 page tallberg theory article, which i will put on my blog if i am permitted.
    well the autolohous vaccine strategy i have up my sleave, well guess what ?

    you guessed it, take plenty of samples of the mets, get the samples prepared while being operated on to remove suspect lymph nodes , etc etc.

    hugs,
    pete

    ps we are the smartest colorectal community on the planet by a long way. one mission to educate onc's without them realising it.