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Reply to S. Kilickap et al, Y. Karakas et al, and I.A. Voutsadakis
Reply to S. Kilickap et al, Y. Karakas et al, and I.A. Voutsadakis
+ Author Affiliations
- Corresponding author: James P. Morden, MSc, Clinical Trials and Statistics Unit, Division of Clinical Studies, The Institute of Cancer Research, 15 Cotswold Rd, Sutton, London, United Kingdom
We thank Kilickap and Tural,1 Karakas et al,2 and Voutsadakis3 for their correspondence regarding the Adjuvant Hormone Therapy (AHT) trial results in our recent article in Journal of Clinical Oncology,4 and we would like to respond to the comments raised.
Although the correspondents are correct in
their assertion that a more marked numerical difference between randomly
assigned
treatment groups was seen with respect to nonovarian
cancer deaths (AHT, three of 75 [4%]; control, 12 of 75 [16%]) than to
ovarian cancer deaths (AHT, 50 of 75 [67%]; control,
56 of 75 [75%]), we do not feel that this invalidates the most important
finding of our study (ie, that if ovarian cancer
treatment results in debilitating menopausal symptoms, then we do not
have
evidence that hormone-replacement therapy [HRT] should
be withheld). We recognize that in any study of this size there is
a risk of anomalous findings, but we have observed no
evidence of an increase in the risk of death with HRT.
The AHT trial was initiated in 1990; as acknowledged in our discussion, there were a number of data items that would now be
collected as standard in a newly initiated trial, which were not collected at the time......REFERENCES
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