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Low-dose tamoxifen reduced recurrence and new disease for patients with DCIS
Adaugat pe 08/08/2019 18:21:13 de freemexy

Treatment with a low dose of tamoxifen (5 mg per day) halved the risk
of disease recurrence and new disease for women who had been treated
with surgery following a diagnosis of breast intraepithelial neoplasia
compared with placebo, and it did not cause more serious adverse events,
according to data from the randomized, phase III TAM-01 clinical trial
presented at the 2018 San Antonio Breast Cancer Symposium, held Dec.
4-8.Nolvadex results


“Breast intraepithelial neoplasia is a term for a group of
noninvasive conditions in which abnormal cells are found in the breast,
including ductal carcinoma in situ (DCIS), lobular carcinoma in situ
(LCIS), and atypical ductal hyperplasia (ADH),” said Andrea De Censi,
MD, director of the medical oncology unit at the National Hospital E.O.
Ospedali Galliera – S.C. Oncologia Medica in Genoa, Italy. “These
conditions significantly increase a woman’s risk for invasive breast
cancer. Because they are often driven by the hormone estrogen, treatment
commonly includes five years of tamoxifen, given at 20 mg per day,
after surgery and, if needed, radiotherapy.


“Unfortunately, tamoxifen is associated with an increased risk of
endometrial cancer and of venous thromboembolism, and can cause
menopausal symptoms that lead to treatment discontinuation,” continued
De Censi. “Our data show that in a randomized trial, low-dose tamoxifen
was effective at reducing the risk of breast cancer development and
recurrence for women with DCIS, LCIS, and ADH, and it did not cause
significant serious adverse events or any increase in menopausal
symptoms. Therefore, we strongly believe that these data are
practice-changing.”


De Censi and colleagues randomized 500 women with DCIS, LCIS, and ADH
who had been treated with surgery and, if needed, radiotherapy to
either low-dose tamoxifen or placebo. Treatment continued for three
years and patients were seen by the research team every six months and
had a mammogram annually.

After a median follow-up of 5.1 years, 14 of the 253 (5.5 percent)
patients in the low-dose tamoxifen arm and 28 of the 247 (11.3 percent)
patients in the placebo arm had disease recurrence or new disease. These
data led the researchers to calculate that low-dose tamoxifen reduced
the risk of recurrence or new disease by 52 percent.


Among the patients who had a recurrence or new disease in the
opposite breast, three of the 14 in the low-dose tamoxifen arm had
invasive breast cancer and 11 had breast intraepithelial neoplasia. In
the placebo arm, 10 had invasive breast cancer and 18 had breast
intraepithelial neoplasia.


There were 12 serious adverse events among the patients in the
low-dose tamoxifen arm and 16 among those in the placebo arm. There was
one case of endometrial cancer among the patients in the low-dose
tamoxifen arm and none among those in the placebo arm. There was one
venous thromboembolism in the tamoxifen arm and one pulmonary embolism
in the placebo arm.





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