A prospective study on women with a history of breast cancer and with or without estrogen replacement therapy

Objective: Because a categorical refusal of estrogen replacement therapy (E RT) from postmenopausal patients with a history of breast cancer is not bas ed on any research evidence and may be more harmful than beneficial, we eva luated the safety and efficacy of ERT in these women. Methods: We recruited 131 patients who had been treated for breast cancer for a mean of 4.2 year s (range 1 month to 20 years) before. Eighty-eight decided to use ERT, wher eas 43 refused or had no need for ERT. At recruitment. the patients were ca refully examined for breast and gynaecologic findings. Non-hysterectomized patients wishing to receive ERT (n = 54) then started using estradiol as or al tablets (2 mg/day) (n = 44) or as transdermal gel (1.5 mg/day) (n = 10) in combination with 10-day courses of oral medroxyprogesterone acetate at 4 -week intervals, whereas hysterectomized patients (n = 34) used only estrad iol, orally (2 mg/day) (n = 31) or transdermally (1.5 mg/day) (n = 3). The patients using ERT were carefully examined 6 and 12 months later, and then annually at a specific outpatient department, and the mean follow-up time i s now 2.5 years (range from 1 month to 5.2 years, 216 woman-years). The 43 patients not wishing to receive ERT were followed annually at the oncologic department for a mean of 2.6 years (range from 1 month to 4.7 years), and served as a control group. Results: ERT significantly reduced climacteric s ymptoms, and the Kupperman score fell by 63%, from 26.9 +/- 8.6 to 9.9 +/- 6.7 (mean +/- SID). In non-hysterectomized women, medroxyprogesterone aceta te triggered withdrawal bleeding in all except seven women. Seven patients (13%) experienced spotting during ERT. In 27 women, endometrial thickness e xceeded 10 mm. and two of the total of 54 patients (3.7%) had simple hyperp lasia. This vanished spontaneously in 3-6 months. Ten patients terminated t he use of ERT within the first 12 to 39 months due to the lack of severe va somotor symptoms (n = 4) or due to the recurrence of breast cancer or to ca ncer of the contralateral breast (n = 6). Eighty-one of the 88 patients (92 %) using ERT showed no evidence of recurrence, whereas five patients (5.7%) had recurrence in 12-36 months and two patients (2.3%) developed a cancer of the contralateral breast in 14-24 months; another one of those wanted to continue with ERT. Thus the combined risk of recurrence or a new cancer of the contralateral breast in ERT users was 7/216 woman-years (3% per year). In the control group, 38 of 43 patients (88.4%) showed no evidence of recu rrence or contralateral cancer, whereas four patients had recurrence and on e developed a contralateral breast cancer (5.112 woman-years, 4% per year). Conclusions: Symptomatic climacteric patients with a history of breast can cer benefited from E RT without increasing their risk of recurrence, but th e short follow-up and the small number of patients limit any definitive rec ommendations. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.