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<p>[Harold</a> Pinter’s poem: Cancer Cells | By genre | Guardian Unlimited Books](<a href=“http://books.guardian.co.uk/departments/poetry/story/0,,666973,00.html]Harold”>Cancer Cells | Poetry | The Guardian)</p>
<p>(Pinter, who was awarded the Nobel Prize in Literature in 2005, was diagnosed with cancer of the esophagus in 2001. [Harold</a> Pinter - Wikipedia, the free encyclopedia](<a href=“http://en.wikipedia.org/wiki/Harold_Pinter]Harold”>Harold Pinter - Wikipedia))</p>
<p>I just had to share - this actually makes me laugh - today I added a cardiologist to the team. As I examine various trials, and look at the potential impact of repeated chemotherapy due to relapse etc., or even just more and more drugs, the potential long term impact to other vital systems etc., and, I don’t think very many studies have been done on this because I don’t think anyone who has this lives long enough for anyone to study anything - and they haven’t met ME yet - so I decided it makes sense to get a cardio person on board now rather than later - anyway, my cardiologist has a VETERINARY DEGREE in addition to a medical degree. </p>
<p>For some reason this makes me irrationally happy. I wonder if perhaps there could be some solution in veterinary science that might cure human cancer? After all, mice were totally cured of cancer long ago, weren’t they? </p>
<p>I probably need to stop thinking about this for a while…E, that last poem is sort of scary…but awesome for Pinter…if I’m not mistaken he survived his cancer…I think of cancer cells as hopelessly stupid; small cell in particular is ridiculously easy to kill if one can just somehow stay on top of it…</p>
<p>latetoschool–you are the overachiever of cancer patients! With the veterinary degree, I think you have ALL the bases covered. :)</p>
<p>latetoschool – you made me laugh too. I really liked Norman Cousins book on the healing power of laughter, and I believe it!</p>
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<p>Yes, Pinter is still very much alive. In fact, he may now be even livelier - even more provocative - than ever:</p>
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<p>[Books</a> and Writing - 15/9/2002: Harold Pinter](<a href=“ABC Radio National”>ABC Radio National)</p>
<p>Yay for Pinter! I’m glad he won. I love it when people win; it makes it seem even more likely that I can, as well. :)</p>
<p>Mommusic, I don’t think I’ve overlooked any “-ologist”. But the cardiac stuff is downright scary, when you think about the impact of chemo on top of chemo. I really don’t think anyone has studied this stuff on lung cancer patients because virtually no one lives. But I’m wondering if the part of the reason the prognosis is so poor is because of intercurrent diseases, like heart disease. I don’t think the SEER people know because they collect their data off of death certificates and there isn’t anywhere else to get the data. It stone cold won’t do to beat the cancer only to have a cardiac event…</p>
<p>Even PCI, which is supposed to be such a great, wonderful thing, I’m not so sure about at all. I don’t think anyone really knows about the long term impact…</p>
<p>I think the marmots on this list will be very pleased to hear about the new addition to your team, LTS! :)</p>
<p>LOL, on the cardiologist with the veterinary degree. Latetoschool, I think that is a very wise decision because if you turn into a bear … you are still covered – and it does seem that you are going in that direction. ;)</p>
<p>Oh!. The Alley denizens forgot to send the marmots. What were we thinking? Do they need to wear scrubs?</p>
<p>LTS, just Internet silliness but whatever resources we have as a community ought to be yours.</p>
<p>on the problems with clinical trials…</p>
<p>[How</a> poorly designed trials for cancer drugs are hurting patients. - By Jessica Wapner - Slate Magazine](<a href=“http://www.slate.com/id/2181789]How”>How poorly designed trials for cancer drugs are hurting patients.)</p>
<p>I am amazed epistrophy did not beat me to it!!!</p>
<p>SBmon, It is pure nonsense. The title alone would have told you that this is nothing but sensational journalism with little factual basis. Single arm Phase II trials are perfectly valid for cancer drugs. Most of these trials are done with relapse patients for which no other treatments are forthcoming. Thus, it is impossible to design a comparator arm. Secondly, endpoints on survival, time to disease progression and remission duration are parameters that can be meaningfully compared to historical records. For example, any oncologist would agree that a median survival of 15 months of any PII results on relapse NSCL is unlikely to be a dud. Importantly, many of the new cancer drugs are in fact approval by the FDA based soley on PII results. These include Gleevec, Velcade and Revlimid, three relatively recent new additions to blood cancers that come readily in my mind. The first was approved based on single agent studies as well. It took the FDA a bit over two months to approve Gleevec, and a bit over three months to approve Velcade. The entire development time from Phase I to approval took 3.5 years for Velcade. </p>
<p>Cancer is just hard to treat. Unless we understand cancer better, we don’t have better approaches than those currently used, and we will continue to have many more failures than success. </p>
<p>Sorry for the rant.</p>
<p>Hey, no offense here… I have no knowledge of this stuff…</p>
<p>[Confronting</a> Cancer Through Art](<a href=“Arthur Ross Gallery”>Arthur Ross Gallery)</p>
<p>Padad, I think I’m confused. Do you mean the FDA can approve a drug that has NOT been through a phase III or IV trial? I thought everything HAD to go through phase III…</p>
<p>FWIW, I do have single-arm phase II trial options on my desk right now. </p>
<p>SBmom imagine what the typical cancer patient goes through, trying to sort fact from fiction…</p>
<p>LTS, Yes, many cancers drugs have been approved with single arm PII data. This is especially true for “first-in-class” drugs, where they work on new targets. In fact “activity” of such new drugs can usually be seen in Phase I. Becasue these drugs wrok by a new mechanism, it is usually done, at least in Phase I, as a single agent. FDA will grant priority review for these new drugs, meaning that the total review process will be done within six months. Such priority reviews are granted under the criterion that there is an unmet medical need, which essentially applies to all cancers. Where the activity of a drug is truly good, the FDA people usually work through weekends and nights (no overtime pay) to get the review done. For example, Velcade review was done within 3.5 months, 2.5 months short of the deadline. the record is held by Gleevec, which took 2.5 months. There are some truly dedicated people at the FDA! (I don’t work there). Note that the review has to ensure the quality of the drug production, the validity of each patient result, the side effect profile of each patient, and in depth examination of each treatment related mortality.</p>
<p>Somethings to keep in mind regarding choice of single arm trials is to make sure that the trial doctor has been involved in the PI trial. Better yet will be the person who was the lead investigator. Here, personal experience with the particular agent do count. The other thing is drug resistance. Because cancer cells do develop resistance to previously used agents, try to eliminate trials that use agents that have similar resistance mechanisms. </p>
<p>Glad to hear that you are tolerating your treatment so well. Tolerability is critical as it enables you to go through the regimens without interruption, which provides the maximal efficacy benefit. Best wishes. </p>
<p>SBmom, I apologize for the rant. It wasn’t meant to be directed at you. Such articles pop up frequently. I am not quite sure what they intend to achieve. One of the trial involved a very promising new agent that work against blood vessel formation around tumors. the trial was on metastatic breast cancer and adding the new agent into the standard drug. We all recognize it failed but it was a noble (for the patients who enrolled in the trial) and sincere effort (on the part of the trial doctors). There was nothing wrong with that trial design. Folkman, who conceived the novel idea of starving tumor of blood supply, just passed away. I received his death notice just minutes before I scanned through the article. It just hit me poorly.</p>
<p>I saw an excellent tv show about Folkman, I believe. Was he the one who was working on vascularization for years, snubbed by the top people, not funded well, presenting his work in ‘alternative’ venues? Worked with Thalidomide? Not sure if it is the same guy.</p>
<p>It was a fascinating program because what it brought home to me was first that it requires incredible intellectual courage (bordering on craziness) to push knowledge forward… You have to be willing to be thought of a kooky, wrong, un-fundable, etc… You have to be willing to go through years of disappointments-- and yet PRESS ON. You know that if you give up, you may be giving up just shy of a breakthrough. However, if you press on, you may spend your whole career chasing a dead end. What a dramatic paradox to spend 30 years inside.</p>
<p>I think THAT explains why more innovations/breakthroughs don’t happen. The people driving them need to be that extraordinary.</p>
<p>Yes, the very person. Judah Folkman actually became extremely well respected in academia in the last fifteen years. He was well ahead of his time, proposing something that we know virtually nothing at the time. We now know at least some of the protein and physiology in blood vessel formation, and at least one new cancer drug (Avastin) works on this pathway. His idea on thalidomide was wrong but was the reason why it is now used widely as a firstline therapy for multiple myeloma (a white blood cell cancer). its successor is Revlimid, which I mentioned in a previous post. </p>
<p>“I think THAT explains why more innovations/breakthroughs don’t happen. The people driving them need to be that extraordinary.” That is true for all science. If it is so logical then it won’t be a breakthrough. But that is venturing into another topic.</p>
<p>[Silicon</a> Valley venture capitalist backs offbeat cancer cure ideas](<a href=“http://66.35.240.8/cgi-bin/article.cgi?f=/c/a/2008/01/15/BU56UE0QR.DTL]Silicon”>http://66.35.240.8/cgi-bin/article.cgi?f=/c/a/2008/01/15/BU56UE0QR.DTL)</p>
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<p>[CommuniCancer</a> - You Are Not Alone](<a href=“http://www.communicancer.com/AboutTheSite.html]CommuniCancer”>http://www.communicancer.com/AboutTheSite.html)</p>