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Old 12-09-2005, 09:07 PM   #1
Lolly
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Unhappy CLT Ann - MEA CULPA!

Ann, I must apologise for my "soap box" rant yesterday about clinical trials and placebos, as I have discovered that there ARE some Phase II trials that use placebos on a control group. One such trial for an AID's vaccine is currently being planned. Here's the link, and it just goes to show I should check my facts BEFORE I go spouting off...

http://www3.niaid.nih.gov/news/newsr.../globalvax.htm


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Old 12-10-2005, 04:04 PM   #2
CLTann
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Hi,

No problem. Things are never clearly black and white. The protocols could indeed be different, but most of them consist of a new treatment regimen against a placebo. We are together to fight the common enemy, all info are welcome.

Ann
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Old 12-10-2005, 05:29 PM   #3
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I have not read your post but there are often questions to be asked, and some do. This site is a great motivator. 10/10 for having the courage to publicly correct. Here is an example which I saved. You have to log in but do get access to some Lancet material which can be useful.

RB

http://www.thelancet.com/journals/la...3868X/fulltext

Breast cancer survival advantage with radiotherapy
Jens Overgaard a and Harry Bartelink a
Sir
Unfortunately, the analysis presented by EBCTCG1 fails to fulfil its potential to answer major questions of clinical interest and need, because the authors do not address the most pertinent issues. What are the possibilities of modern treatment techniques to avoid vascular damage? Which patient groups will benefit from radiotherapy by improving their locoregional control? Which patients will also improve their survival chances?.....
The investigators say that old-fashioned radiotherapy may cause more late morbidity. The EBCTCG accumulation of clinical trials includes trials which, by today's standards, are clearly unacceptable. The paper represents a history rather than guidance for how patients should be treated. It is also questionable if the role of radiotherapy can be described in as simple terms as in the overview, namely in the form of dose, a crude target, and then a few prognostic parameters. The issue is much more complex, especially when it comes to cardiac involvement. It is obvious from several studies2–4 that if the dose to the heart is reduced substantially, the excess non-cancer morbidity and death rate is reduced or avoided. Therefore, the radiation technique and target is of importance, but these areas were not assessed sufficiently. The investigators are not correct in their argument that the observation time is too short in the modern trials. The observation time in the Danish studies,2–4 where a modern radiotherapy technique avoiding cardiac irradiation was applied, is now 10–18 years without excess non-cancer deaths. The experience from the Stockholm trials clearly shows that the enhanced cardiac morbidity occurs within a much shorter time.
The pre-treatment assessment in the EBCTCG series is also incomplete. Some of the older trials are based on clinical assessment only in the axilla, which is no longer acceptable. The relevance of such trials in this context is therefore questionable. Information on tumour size, number of positive nodes, and nodes removed, together with menopausal and hormone receptor status, age, and the histopathology and grade of tumour are all needed to be able to describe the appropriate prognostic characteristics. Only then can clinical guidance be given for the treatment of patients today.
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Old 12-10-2005, 05:36 PM   #4
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Heres another one.


RB

http://www.thelancet.com/journals/la...38708/fulltext


The Lancet 2000; 356:1270-1271
DOI:10.1016/S0140-6736(05)73870-8
Breast cancer survival advantage with radiotherapy
Sean Bydder a, Nigel Spry a, David J Joseph a and Hany Elsaleh a
Sir
The method used by the EBCTCG1 to define cause of death: “all deaths after recurrence were classified as breast cancer deaths”, is potentially flawed. This assumes that no recurrences are salvageable, which may be untrue, especially for the breast conservation trials. Patients who develop a local recurrence within a conserved breast, have a quite different outlook to women who develop metastatic disease as their first relapse. Because radiotherapy reduces the recurrence rate by a third, the proportion of patients in the control groups whose cause of death is misclassified by this assumption is much larger than in the radiotherapy groups. Because the percentage difference in breast cancer deaths was relatively small (18•6% vs 21•3%), this classification procedure alone could account for the difference.
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Old 12-10-2005, 08:12 PM   #5
Lolly
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Thanks Ann, for being so understanding. It's so true that things are not so black and white, especially in the new territory we're all navigating together

And RB, those are intriguing studies, thank you once again for your vigilance.

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