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Some Women do Fine with Only Tamoxifen

Posted 9/14/2013

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  This is more evidence of the growing trend to even better individualize treatment. Tamoxifen is the oldest targeted treatment for breast cancer, having been around since the 1970s. For decades it was the only available hormonal therapy for women with ER positive breast cancers. Since the advent of the AIs, it has been more commonly used for pre-menopausal women or others who, for one or another reason, should not take one of the AIs.

  And a short aside here: Studies have proven that the AIs are a teeny bit more effective for post-menopausal women, but the emphasis should be on "teeny". I often speak with women who are worried about their doctor's recommendation, because of other medical issues, that they take Tam instead of, say, Femara. I always reassure them that  the difference between the two types of drugs is very small, and that Tam is a most effective therapy.

  Generally speaking, women who have positive lymph nodes are advised to take chemotherapy in addition to a hormonal treatment. This study from Sweden, published in The Breast, suggests that some women at intermediate risk of recurrence (defined here as having between one and three positive lymph nodes) do just as well with only Tam.  As we learn more and more about how to identify who will do best with what treatment, there will be fewer generalizations and many more individualized treatment plans.

Here is the abstract :

Identi!cation of intermediate risk breast cancer patients with1e3
positive lymph nodes and excellent survival after tamoxifen as only
systemic adjuvant therapy by use of markers of proliferation and
apoptosis

B.K. Linderholm a,b,*, S. Linder c, L.-G. Arnesson d, O. Stål et,

a b s t r a c t
Background: According to current guidelines, patients with primary breast cancer and 1e3 lymph node
metastases will in general be offered adjuvant chemotherapy.

Aim: Our objective was to investigate the relationship between markers of proliferation and apoptosis
with survival for patients subjected to adjuvant tamoxifen solely.

Material and methods: Tumour cytosol samples from 409 consecutive patients with operable oestrogen
receptor positive BC, stage IeIII and treated with tamoxifen for 2 or 5 years were assessed for levels of
caspase-cleaved cytokeratin-18 (ccCK18), an indicator of apoptosis, by use of an ELISA assay. Data on Sphase raction (SPF) were available for 370 patients. Survival analyses were performed according to levels
of ccCK18 and SPF separately, as well as combined.

Results: A wide range of ccCK18 protein levels was found, median 9.97, range 0.0e87.3 pg/mgDNA.
Increasing SPFs were signi!cantly associated with a lower distant recurrence-free survival (DRFS)
(p ¼ 0.025) and breast cancer survival (BCS) (p ¼ 0.046). In the group with low SPF (below mean), low
amounts of ccCK/18 correlated with a shorter DRFS (p ¼ 0.0028) and BCS (p ¼ 0.0027). A Proliferation
Index (PI); a quotient of ccCK18/SPF was constructed. Low PI (high ccCK18/SPF ratios) were signi!cantly
correlated with an improved survival both when analysed as continuous variables; DRFS (p ¼ 0.021), BCS
(p ¼ 0.038) and when divided into quartiles; DRFS (p < 0.001) and BCS (p ¼ 0.0012). A similar correlation
was found in patients with 1e3 lymph node metastases; DRFS (p ¼ 0.089) and BCS (p ¼ 0.019). A Cox’s
proportional hazard model including age, tumour size, lymph node status, PgR and ccCK18/SPF was used
for multivariate analysis. High ccCK18/SPF ratios correlated with improved survival; DRFS (HR ¼ 0.47
(0.22e0.98), p ¼ 0.043), and BCS (HR ¼ 0.39 (0.16e1.00), p ¼ 0.049), respectively.

Conclusion: By use of a proliferation index based on markers of proliferation and apoptosis, a group of patients with 1e3 lymph node metastases with good outcome following adjuvant tamoxifen was
identi!ed; this group could possibly be spared adjuvant chemotherapy.

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