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Select Excerpts from the Interview
Track 2
DR LOVE: What do we know about the impact of delayed endocrine
therapy in postmenopausal patients with breast cancer who are five to 10
years out from their initial diagnosis?
DR GOSS: The Oxford overview has substantial and reliable data out to 15
years of follow-up, and in the MA17 trial, we have good data with postmenopausal
patients who are five to eight years post-tamoxifen, so 12 to 13 years
postdiagnosis. In the data, we see that this disease has a chronic relapsing
nature that, by and large, doesn’t lose its endocrine sensitivity.
DR LOVE: Should physicians be recommending adjuvant endocrine therapy to
women years after diagnosis if they have not already received it?
DR GOSS: I believe that if you have a patient who never received adjuvant
endocrine therapy or she received an abbreviated version or even if she has completed standard endocrine therapy, you need to discuss delayed therapy
with these patients.
DR LOVE: What is a patient’s risk of relapse in that five- to 10-year window?
DR GOSS: For patients with node-positive breast cancer, it’s four percent
per annum. So between years five and 10, it’s a 20 percent risk. For patients
with node-negative disease, it’s two percent per annum — in other words, 10
percent in those five years (Kennecke 2007).
Within those percents per annum, there are three types of recurrence — metastases, ipsilateral local recurrence and contralateral breast cancer — and the absolute benefit of therapy is reduced if the patient had a single or bilateral mastectomy.
However, in no patient is the level of risk of metastasis less than approximately 0.8 percent per annum, and the FDA approved tamoxifen for prevention of new primary breast cancer in women with a risk much lower than that — 0.3 percent per annum.
Why would we not consider delayed endocrine therapy for these patients? With metastases, not only is the risk higher, but it is a 0.8 percent per annum risk of death. Even in the patient at the lowest risk, the risk of death exceeds the risk of getting a new primary for patients that are FDA approved to receive tamoxifen.
Track 4
DR LOVE: What about adjuvant endocrine therapy for premenopausal
patients?
DR GOSS: The questions of whether to perform an oophorectomy and
whether to administer an aromatase inhibitor combined with ovarian suppression
are still unanswered. In clinical practice, we are using the “old-fashioned”
five years of tamoxifen in these patients. Both the TEXT and SOFT trials are
addressing whether ovarian suppression in a premenopausal woman is advantageous,
and I believe the answer will be yes.
Then the questions are, at what cost and in which patients? We know that bone loss is profound, and a paper recently published in Neurology suggests there may be a risk of dementia and Parkinsonism in the long-term follow-up of patients who have undergone premature oophorectomy (Rocca 2007a, 2007b).
That’s not to say we wouldn’t treat a woman at high risk in light of these risks, because you still have to consider her risk of dying from breast cancer.
Tracks 5-6
DR LOVE: What are the major unresolved issues relative to treating
postmenopausal women with hormone-receptive breast cancer?
DR GOSS: Many issues are outstanding, such as the optimal duration of
aromatase inhibitor therapy: Is the optimal duration 10 years or 15 years, or
is it indefinite? If so, for which patients? What will be the cost? Which is the
optimal agent?
One class study is comparing anastrozole versus exemestane, and a potency trial, the FACE study, is comparing letrozole to anastrozole.
Other issues include intermittent endocrine therapy and the idea of combining endocrine therapies, such as fulvestrant combined with an aromatase inhibitor.
DR LOVE: What about aromatase inhibitors and bone density?
DR GOSS: In 2006, I published two papers on aromatase inhibitors and bone
health, in one of which I included a simple chart informing physicians exactly
how to monitor patients with regard to bone health, how much calcium and
how much vitamin D to recommend and which formulations are available
for administration (Chien 2006; Perez 2006). ASCO also has a set of national
guidelines.
If you follow the guidelines and monitor a patient’s bone health appropriately, you need not alter what you’re doing at all should she begin an aromatase inhibitor.
DR LOVE: Is a patient with a normal bone density at increased risk for fracture
if she takes an aromatase inhibitor?
DR GOSS: In trials in which the patients were not properly monitored and
treated, we noted an increased risk for fracture. However, now that we know
more about the benefits of monitoring and salvage bisphosphonates, the answer
is no.
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