Journal of the National Cancer Institute Advance Access originally published online on July 29, 2008
JNCI Journal of the National Cancer Institute 2008 100(15):1117-1118; doi:10.1093/jnci/djn218
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© The Author 2008. Published by Oxford University Press.
CORRESPONDENCE |
Response
Affiliations of author: Medical Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, and Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
Correspondence to: Kathleen I. Pritchard, MD, FRCPC, Medical Oncology, Sunnybrook Odette Cancer Centre, 207 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada. (e-mail: kathy.pritchard{at}sunnybrook.ca).
I am pleased to consider Dr Weiss' comments about my editorial. I was indeed aiming to be somewhat provocative and am pleased that I succeeded.
Certainly my comment that these randomized trials "clearly provide a definite answer" is debatable. One must consider, however, that the Stockholm trial, which ran concurrently with the HABITS trial and which showed no negative effect of hormonal replacement therapy (HRT), was closed to further accrual based on the statistically significant detrimental effects seen in the HABITS trial at interim analysis. It is my view that the negative results seen in HABITS, together with the underlying biology/physiology, which would strongly suggest that HRT could be harmful, have, together, probably closed the door to the possibility of further randomized trials in this area.
Dr Weiss makes an important point in suggesting that the difference between progestin-containing HRT and estrogen alone could be an important one. This is also supported by randomized data from the Women's Health Initiative study. Whether another group of investigators, their research ethics boards, and patients would be willing to mount and carry out an additional randomized study in this area, however, seems dubious.
Although I agree that the outcomes of breast cancer mortality are most definitive, I disagree with Dr Weiss' suggestion that breast cancer recurrence is not a valid endpoint. It is hard to be biased in ascertaining breast cancer recurrence, which is generally quite clear. Furthermore, breast cancer recurrence is clearly a harbinger of ultimate breast cancer mortality but of course occurs sooner and more frequently in the early years of follow-up. In a trial this small and with only an additional 2 years of follow-up, the fact that no additional deaths have occurred following recurrences is not surprising because many women live much longer than 2 years after recurrence of breast cancer.
I am pleased that Dr Weiss agrees with me that interventional studies with robust control design should be implemented when feasible. However, as mentioned above, I think that another randomized trial of HRT in this setting might prove difficult.
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J Natl Cancer Inst 2008 100: 1117.
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