http://her2support.org/vbulletin/sho...145#post297145
ATAC trial: reporting interim results is not helpful
Heather Goodare, chairBreast UK (Breast-cancer Research Ethics and Advocacy Strategy), Horsham, West Sussex RH13 6DF ; Email:
hm.goodare@virgin.net
Clare Dimmer, secretaryBreast UK Waterlooville, Hants PO7 6LA ; Email:
clare@solvatec.demon.uk
Kathy Page, treasurer
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Editor—We should like to raise some concerns about the ATAC (arimidex, tamoxifen alone or in combination) trial, which was reported on in the
Lancet after only half the time stipulated in the protocol (2.5 years instead of 5).
1 Ravdin has raised important points: “Early reporting rules can powerfully affect what information can be gleaned from a trial, particularly if they cause a trial to be reported when many of the patients have not completed therapy.”
2 In spite of this, the “results” of the trial were reported in the United Kingdom's national lay press.
3
However, is arimidex really the best bet? Of course we still don't know as some of the more serious adverse events may not emerge until the five year mark is reached. The problems in patients with endometrial cancer who were taking tamoxifen took many years to become obvious. Why publish results at the halfway mark only? Does this not indicate a lack of respect for the participants?
4
Early reporting of the trial was certainly good for AstraZeneca, after losing patent protection for tamoxifen. But was it good for patients? Was it good for science? Publication of interim results can seriously mislead, as in the case of the infamous study of women attending the Bristol Cancer Help Centre.
5 As Ravdin says: “It remains to be seen how many of the patients on the two remaining blinded arms will continue to take the therapy that they were randomised to.”
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References
1. ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 2002;359: 2131-9. [
PubMed]
2. Ravdin P. Aromatase inhibitors for the endocrine adjuvant treatment of breast cancer [commentary]. Lancet 2002;359: 2126. [
PubMed]
3. Derbyshire D. New drug prevents breast cancer. Telegraph 2002. June 21.
4. MP. Case study: I was an ATAC guinea pig. What Doctors Don't Tell You 2003;13: 8.
5. Bagenal FS, Easton DF, Harris E, Chilvers CED, McElwain TJ. Survival of patients with breast cancer attending Bristol Cancer Help Centre. Lancet 1990;336: 606-10. [
PubMed]