Gerber Bernd, Krause Annette, Reimer Toralf, Mylonas Ionas, Makovitzky Josef, Kundt Günther, Janni Wolfgang
Department of Obstetrics and Gynecology, Klinikum Innenstadt, Ludwig-Maximilians University, Munich, Germany.
Clin Cancer Res. 2006 Feb 15;12(4):1245-50. doi: 10.1158/1078-0432.CCR-05-0225.
To investigate the effect of switching from adjuvant tamoxifen to anastrozole (Arimidex) treatment in postmenopausal women with endocrine-responsive breast cancer and histologically proven tamoxifen-induced benign endometrial pathology.
Two hundred twenty-six postmenopausal women who had received adjuvant tamoxifen 20 mg/d (> or =12 months, < or =48 months) and developed abnormal vaginal bleeding and/or an asymptomatic endometrial thickness >10 mm [measured by transvaginal ultrasound (TVUS)] were subjected to hysteroscopy and dilation and curettage (D&C). Thereafter, 171 patients were randomized in a phase III study to continue tamoxifen treatment (n = 88) or switch to anastrozole 1 mg/d (n = 83). Patients were monitored for < or =42 months using TVUS at 6-monthly intervals.
At study entry, there were no significant differences in vaginal bleeding, endometrial thickness, and histologic findings between the two treatment groups. Throughout the treatment period, there was no significant difference in recurrent vaginal bleeding between groups [anastrozole, 4 of 83 (4.8%); tamoxifen, 9 of 88 (10.2%); P = 0.18]. Six months after randomization, the mean endometrial thickness for patients who switched to anastrozole was significantly reduced compared with those who continued tamoxifen treatment (P < 0.0001). Significantly fewer anastrozole patients required a repeat hysteroscopy and D&C compared with those on tamoxifen [4 of 83 (4.8%) and 29 of 88 (33.0%), respectively; P < 0.0001]. Repeat hysteroscopy and D&C revealed endometrial atrophy in all 4 cases in the anastrozole group and 14 polyps, 8 hyperplasias, and 7 atrophies in the tamoxifen group.
Switching from tamoxifen to anastrozole treatment significantly reduced the need for a second hysteroscopy and D&C due to recurrent vaginal bleeding or thickening of the endometrium in postmenopausal breast cancer patients with tamoxifen-induced endometrial abnormalities.
探讨绝经后内分泌反应性乳腺癌且经组织学证实有他莫昔芬诱导的良性子宫内膜病变的女性从辅助性他莫昔芬转换为阿那曲唑（瑞宁得）治疗的效果。
226名绝经后女性接受了20mg/d的辅助性他莫昔芬治疗（≥12个月，≤48个月），并出现异常阴道出血和/或无症状子宫内膜厚度>10mm[经阴道超声（TVUS）测量]，这些女性接受了宫腔镜检查及扩张刮宫术（D&C）。此后，171名患者在一项III期研究中被随机分组，继续接受他莫昔芬治疗（n = 88）或转换为1mg/d的阿那曲唑治疗（n = 83）。使用TVUS每隔6个月对患者进行≤42个月的监测。
在研究开始时，两个治疗组在阴道出血、子宫内膜厚度和组织学检查结果方面没有显著差异。在整个治疗期间，两组之间复发性阴道出血没有显著差异[阿那曲唑组，83例中有4例（4.8%）；他莫昔芬组，88例中有9例（10.2%）；P = 0.18]。随机分组6个月后，转换为阿那曲唑治疗的患者的平均子宫内膜厚度与继续接受他莫昔芬治疗的患者相比显著降低（P < 0.0001）。与接受他莫昔芬治疗的患者相比，阿那曲唑组需要重复进行宫腔镜检查及D&C的患者明显更少[分别为83例中有4例（4.8%）和88例中有29例（33.0%）；P < 0.0001]。重复进行宫腔镜检查及D&C显示，阿那曲唑组的所有4例患者子宫内膜萎缩，他莫昔芬组有14例息肉、8例增生和7例萎缩。
对于有他莫昔芬诱导的子宫内膜异常的绝经后乳腺癌患者，从他莫昔芬转换为阿那曲唑治疗可显著减少因复发性阴道出血或子宫内膜增厚而需要进行第二次宫腔镜检查及D&C的需求。
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