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[他莫昔芬作为辅助治疗的耐受性及55例绝经前乳腺癌女性的长期随访,这些患者在洛林癌症研究所接受他莫昔芬治疗]

[Tolerance of Tamoxifen as an adjuvant therapy and long-term follow up of 55 premenopausal breast cancer women, cared for at the Institut de cancérologie de Lorraine, treated with Tamoxifen].

作者信息

Sebaoun Perle, Frederic Marchal, Weryha Georges, Hamdaoui Sara El, Salleron Julia, Lesur Anne

机构信息

Département du Parcours Sein, Institut de cancérologie de Lorraine, 6, avenue de Bourgogne, 54519 Vandœuvre-lès-Nancy, France.

Département de chirurgie, Institut de cancérologie de Lorraine, 6, avenue de Bourgogne, 54519 Vandœuvre-lès-Nancy, France.

出版信息

Bull Cancer. 2019 Dec;106(12S1):S75-S100. doi: 10.1016/S0007-4551(20)30050-3.

Abstract

INTRODUCTION

Objectives: the purpose of this study is to assess TAM safety in terms of side effects and hormonal status, the persistence of the treatment over a five years time-frame and to report the remote follow-up data.

METHODS

Fifty five patients were included patients between January 2001 and November 2002 at the Institut de cancérologie de Lorraine. The subjects were aged 50 years or less, premenopausal at diagnosis and treated with adjuvant TAM therapy at a daily dose of 20 mg, for an expected duration of 5 years, at a daily. After 2 years, prospective evaluation was completed and monitoring of ovarian function was performed as usual in the institution (1x/year). All data were retrospectively evaluated in 2019.

RESULTS

In these 55 patients, the cumulative incidences of cysts and hot flushes 5 years after treatment were 68.5 % and 77.6 %, respectively. Of the 33 patients with chemoreactive amenorrhea, half had cycles which resumed within a median of 9 months. In the 10 patients without chemotherapy-induced amenorrhea, 4 had a cycle stop. Of these, 3 patients had cycles that, resumed within 1, 4 and 8 months. 34 patients (61.3 %) had taken Tamoxifen for at least 5 years. After 15 years of treatment, overall and progression-free survival was 90.7 % and 67.4 %, respectively.

CONCLUSION

The observation of the tolerance to the treatment for 5 years and beyond, contributes to the quality of information delivered to future patients starting the treatment, allowing a better understanding and in the long term a better observance.

摘要

引言

目的:本研究的目的是从副作用和激素状态方面评估他莫昔芬的安全性、治疗在五年时间范围内的持续性,并报告远期随访数据。

方法

2001年1月至2002年11月期间,洛林癌症研究所纳入了55例患者。这些受试者年龄在50岁及以下,诊断时处于绝经前,接受辅助性他莫昔芬治疗,每日剂量为20毫克,预期持续时间为5年。两年后,完成前瞻性评估,并按机构常规进行卵巢功能监测(每年1次)。2019年对所有数据进行回顾性评估。

结果

在这55例患者中,治疗后5年囊肿和潮热的累积发生率分别为68.5%和77.6%。在33例化疗引起闭经的患者中,半数患者的月经周期在中位时间9个月内恢复。在10例未发生化疗引起闭经的患者中,4例出现月经周期停止。其中,3例患者的月经周期分别在1、4和8个月内恢复。34例患者(61.3%)服用他莫昔芬至少5年。治疗15年后,总生存率和无进展生存率分别为90.7%和67.4%。

结论

对该治疗5年及更长时间耐受性的观察,有助于提高向开始接受该治疗的未来患者提供的信息质量,使其能更好地理解并长期更好地遵守治疗。

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