Abstract

To evaluate collateral effects of a TAM prolonged treatment, we analyzed, in a retrospective study, 243 pts, whose mean age was 59.2 years (27-85), all BC treated with radical surgery and adjuvant TAM for more than 2 years, 61/243 in premenopausal (25.1%) and 182/243 in postmenopausal age (74.9%). Twenty-nine out of 243 pts (11.9%) had a precedent hysterectomy for other benign gynaecological diseases. Fortythree pts (17.7%) received TAM 20 mg/die and 200 (82.3%) 30 mg/die; median treatment duration was 50.5 months (24-120 m) (front 2 to 3 years: 58 pts, from 3 to 4 years: 39 pts, from 4 to 5 years: 97 pts, > 5 years: 49 pts, in which TAM was readministrated as first line too). The median follow-up was 70.3 m (2-15 years). For intolerance, 22 (9.1%) pts reduced TAM from 30 to 20 mg/die while 12 (4.9%) pts stopped for the same problem. We reported these side effects: thrombophlebitis in 13 pts (5.3%), epigastralgia of mild entity in 18 pts (7.4%), leucopaenia grade I WHO in 5 pts (2.1%), thrombocytopenia grade II in 2 pts (0.8%), mild hyperglycemia in 15 pts (6.2%), mild nausea in 8 pts (3.3%), leukorrea in 5 pts (2.1%), flashing in 12 pts (4.9%), spotting from endometrial hyperplasia in 22/214 pts (10.3%). Only 3 pts had a contralateral BC (1.2%). We reported 4 gynaecological cancers (1.9%): 2 endometrial adenocarcinomas after 22 and 60 months of TAM treatment, 1 ovarian granulosa-cells tumor after 30 months and 1 ovarian tumor-not style typized-after 60 months. Two pts (0.8%) had gallbladder cancer (1 pt after 52 months; 1 pt after 67), 1 pt (0.4%) had a stomach cancer after 6 months interruption of therapy with TAM for 96 months, I pt (0.4%) had a pancreas cancer after 51 months. In conclusion, our results reflect the literature about the risk of a secondary endometrial cancers in long term treated pts (Lancet 1989, i, 117); the correlation between TAM and endometrial cancer is sure; there is no evidence of correlation with other tumors. We suggest periodic gynaecological control in patients treated with TAM for more than two years.

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