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  • bioinvestor2000 bioinvestor2000 Feb 10, 2002 12:07 AM Flag

    Gem Vs Rubi Part-I

    OK, I went to the library and obtained the actual articles.

    The character radiationmd has made it a big thing of how the phase-II response rate for the gemcitabine trial is 11% and, because the Stehlin study had an overall response rate of 8.4%, this means Rubitecan is a weak drug.

    First let�s look at the phase-II gemcitabine results. This was a study published in 1994 by Ephrain S and co-workers published in Investigational New Drugs, 12: 29-34. In this study they had 44 patients. NO PATIENT HAD PREVIOUS CHEMOTHERAPY (my emphasis), or prior radiotherapy to the sites of measurable disease.

    Here they define response rate by the traditional criteria that a partial response is at least a 50% reduction in tumor size for at least one month. But they add, and I quote, �for situations in which a previously measurable pancreatic mass became smaller, but less well defined, A PARTIAL RESPONSE WAS DECLARED IF IN THE OPINION OF THE REFERENCE RADIOLOGIST (my emphasis), there was substantial reduction in the mass effect, and the radiographic findings were associated with clinical improvement�. Why is this important? Because of the five patients that experienced partial responses, one patient had a tumor that changed in such a way that the tumor became unmeasurable. However, they classified this patient as a partial responder because the patient had �dramatic clinical and unequivocal radiographic response�! What this means is that they could not validate that the reduction in tumor size was the required 50%, but the patient looked so good by other criteria, that they declared it a partial responder! Heck in the Stehlin study there were patients that did not have quite a 50% tumor shrinkage but nevertheless had major improvements in other parameters! Furthermore, in the Stehlin study when the margins of the tumor mass could not be distinguished from surrounding pancreatic tissue �the entire enlarged portion of the pancreas was measured�. This could have led to underestimation of tumor reduction! But the point of the above is, as you may by now realize, that if the true number of responders is 4 out of 44 (instead of 5), the response rate falls to 9.1 %! This is not so far from the Stehlin study result!

    If by now you are rolling your eyes, I agree with you. The above just points to the folly of saying that a drug is weak if it has a response rate of 8.4 %, but strong if it has one of 11%. Such is the effect that a misclassification of a patient could have in a study with 44 patients. But there is more!

    A response rate, by itself, is useless; you have to give an idea of what the error term associated with this response rate is. Why? Because you are trying to extrapolate this response rate to what the response rate would be if the entire population of patients from where you recruited were to take the drug. When you say that your study had a response rate of 11%, is that really different from 9%, or 12%, or 8%, or 13%? The authors of this study give a 95% confidence interval for the 11% response rate of the study; this confidence interval is 2-20%. This means they are 95% certain that gemcitabine�s response rate is SOMEWHERE between these two numbers. With such a confidence interval it is impossible to say that the response rate is 11% and not 9%, or 12%, or 8%, or 13%! Therefore it is impossible to say that gemcitabine�s 11% is greater than Rubi�s 8.4%.

    In this study they do not report the staging of the patients (this is important, more on that later). They report a median survival of 5.6 months but they do not calculate a confidence interval for this figure (yes median survival also has confidence intervals; this is also important, more on that later).


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    • Heading that way soon, if I find any of that wild ass, (I'll look for the xray doc too) I'll be sure to let you know. You, I and golfguy may be the only people that know how to get there from here.

    • You forgot "Fat Ass". That seems to be a real irritant.

    • Dig your own pool. Please, by all means take these message board posts to your lawyer and pay him/her the $250/hr, or whatever they get these days -- I wouldn't know -- to review them for libel. I'd love to be paid $250/hr for a good laugh. Talk about a cheap thrill! As for me, I plead insanity and if my stocks don't recover soon, I'll need a court appointed attorney. They're free, right?

    • Ead, that is a terrible thing to say to a man and I am calling my attorney.
      It is about time you realized that I have feelings, besides I will look good in your pool.

    • That's true. And I have not sued you for libel or slander despite my strong assertion (including posting a picture of my ass in my ID) to the contrary.

      Carry on, shrivel dick.

    • "terrible manners" ???


    • I agree Terry, I have called Ead "Fat Ass" numerous times yet she failed to mention that.
      If the shoe fits......

    • joeclam_pissedoffcitizen joeclam_pissedoffcitizen Feb 15, 2002 11:54 AM Flag

      >>But degrading a person publicly in his or her
      profession is legally a libel, both civil and criminal.<<

      Degrading a person is, yes. Degrading a message board alias is not. "We The People" do generate the words here, but what appears once we do are only our disembodied opinions, not ourselves. "We" become only words, spoken by nameless actors on an invisible stage. Radio Doc's medical credentials are noteworthy, but they are also putative, however persuasively his knowledgable writing might indicate otherwise. The only thing he, or any of us, writes that is NOT putative are the opinions themselves: they stand for what they are. A non-identity with a putative profession cannot suffer libel, no matter how virulent the attack. He would need to reveal that identity and demonstrate damage to the profession to even claim it. Ead, in my personal, disembodied opinion, does not have legal worries over expressing HER opinion of Radio Doc to Radio Doc and to the board, whether it's a degrading one or not. Radio Doc can just deal with it, on the board, if he wants, and however he's able. Unless, of course, he wants to "publicly" become "Such-and such, MD, from Somewhere, USA" and drag his lawyer along with him. Wouldn't be my choice, if I were him...

      And even though I, for the same reasons as Socster, enjoy his presence here and the debate he sparks, as far as Ead's somewhat negative view of the guy goes I fully support her feelings and defend her right to express them. I already touched on the issue in an earlier message to Radio Doc --
      -- and here as there will not elaborate on Ead's personal details, other than to assure you she is highly principled and a person of her word. When she says she dumped the last of her SUPG stock because of the company's deplorable behavior concerning compassionate use, she means exactly that. She does not "make money" caring about fighting cancer, or about helping any and all she can who fight it. She just cares, period. As far as I'm concerned she has earned every right to demand a higher level of consciousness on the issue from those who "professionally" (putatively) also fight cancer. Especially from them.

    • Viking, you even surpass Dig for being worthless. He is an UNNAMED person who suffers no damage from what is being said. Show me harm and there is a case, but you can't. Continually you voice your opinion with a naive perspective. Ead can call him anything she wants.


    • It's my opinion he's evil. She shorts oncology stock and he claims to be an oncologist.

      I have been called, on this board, "The World's Highest Paid Secretary" (untrue); "Bitch" (sometimes true); "Short" (untrue); "Insane" (only a little - which is my plea by the way); and a host of other things I'd rather not rehash.

      As to "degrading" someone. I can assure you I have no power to do that to ANYONE. I am neither his supervisor or his mother. Now if he "feels" degraded, that's another thing. I doubt he does, but if so, that's his problem.

      It's like "equality." Women fight so hard for it. Why? We're equal. We always have been. In order to feel a need to be "equalized" one must first feel "inferior." I never have felt inferior to anyone in my life. Nor have I ever felt superior to anyone. I have my talents and gifts, and I'm sure radiationmd has his. I have my foibles and evilities... and so does he. He's welcome to spew what he thinks mine are all over this board. I'll slap back, but never with a lawsuit.


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