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Select Excerpts from the Interview
Tracks 3-4
DR LOVE: Can you discuss the side effects and complications of tamoxifen
versus the aromatase inhibitors? DR SAINSBURY: Vasomotor symptoms are less troublesome with the aromatase
inhibitors. They’re not absent completely, but they seem to disappear more
quickly than when our patients were on tamoxifen. Lesley Fallowfield has
shown that the patients stop complaining about those symptoms earlier than
when they take tamoxifen (Fallowfield 2004).
Gynecologic problems are seen much less often with the aromatase inhibitors. The data that Sean Duffy produced from the ATAC endometrial subprotocol have clearly shown a reduced number of investigations, a reduced number of hysterectomies and therefore a much better gynecologic side-effect profile (Duffy 2006).
The serious complications for tamoxifen are ones that are difficult to manage, such as thromboembolic events, which cause major morbidity. The major side effects for the aromatase inhibitors appear to be the joint and bone problems, but at least those are manageable. While patients are receiving the aromatase inhibitors, we have also seen an increase in fracture rate of approximately 1.5 to two percent per year (Locker 2003). Once they stop the aromatase inhibitor, the fracture rate drops dramatically and quickly. These are preliminary data, but in the ATAC bone subprotocol, many patients returned to normal a year after finishing therapy.
DR LOVE: The ATAC trial and the other studies of aromatase inhibitors didn’t
include preventive bone density monitoring or the use of bisphosphonates.
When those kinds of strategies are used, do you believe the fracture rate will
still be increased?
DR SAINSBURY: I don’t believe we’ll see that. If we identify the patients who
are already at risk up front and treat them appropriately, I don’t think we will
see an excess risk of fractures.
Track 6
DR LOVE: Can you comment on what’s been seen in terms of cardiovascular
events in the adjuvant trials using the aromatase inhibitors? DR SAINSBURY: When BIG 1-98 was first reported, a slight excess of
nonbreast cancer deaths was observed, and that appeared to be related to
cardiac deaths with letrozole (Thürlimann 2006). That seemed to be different
from the ATAC trial. The ATAC Safety Monitoring Committee observed
that specifically and found no excess deaths with anastrozole (ATAC Trialists’
Group 2006). The other main difference between the anastrozole and
letrozole randomized studies was the excess of Grade I hypercholesterolemia
seen with letrozole. Whether that is clinically significant is uncertain because
this was just a biochemical increase, which was not seen nearly as much with
anastrozole. The adjuvant exemestane study (IES) also showed a slight excess
of cardiac events but not to the same extent as letrozole (Coombes 2004).
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