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他莫昔芬、醋酸甲地孕酮或他莫昔芬联合醋酸甲地孕酮对转移性乳腺癌患者治疗反应和生存影响的随机对照研究

Randomized comparison of the effects of tamoxifen, megestrol acetate, or tamoxifen plus megestrol acetate on treatment response and survival in patients with metastatic breast cancer.

作者信息

Gill P G, Gebski V, Snyder R, Burns I, Levi J, Byrne M, Coates A

机构信息

Department of Surgery, Royal Adelaide Hospital, South Australia.

出版信息

Ann Oncol. 1993 Nov;4(9):741-4. doi: 10.1093/oxfordjournals.annonc.a058658.

DOI:10.1093/oxfordjournals.annonc.a058658
PMID:8280654
Abstract

BACKGROUND

The antioestrogen tamoxifen and progestins act via different receptors and may therefore have complementary effects against human breast cancer. This possibility was tested in a randomized study which compared the effects of tamoxifen, standard-dose megestrol acetate, and these two agents in combination, in patients with metastatic breast cancer.

PATIENTS AND METHODS

184 post-menopausal patients with metastatic breast cancer were randomized to initial treatment with either tamoxifen (TAM) 40 mg daily, megestrol acetate (MA) 160 mgm daily, or the combination of the two administered simultaneously. Patients crossed over to the alternative single agent on relapse or disease progression. Patients were evaluated for response, time to initial and ultimate treatment failure, and survival.

RESULTS

There were no significant differences between the three groups with respect to response rates, nor the other parameters. Patient survival was significantly associated with age > 60 years, ER positive status, and the absence of visceral metastases.

CONCLUSIONS

TAM and MA are both equally effective in response induction as initial treatments and the combination has no advantage. Sequential treatment is still optimal, TAM being the preferred initial agent in view of the reported side effects with MA.

摘要

背景

抗雌激素药物他莫昔芬和孕激素通过不同受体起作用,因此可能对人类乳腺癌具有互补作用。在一项随机研究中对这种可能性进行了测试,该研究比较了他莫昔芬、标准剂量醋酸甲地孕酮以及这两种药物联合使用对转移性乳腺癌患者的疗效。

患者与方法

184例绝经后转移性乳腺癌患者被随机分为初始治疗组,分别接受每日40毫克他莫昔芬(TAM)、每日160毫克醋酸甲地孕酮(MA)或两者同时给药。患者在复发或疾病进展时改用另一种单一药物。对患者的反应、初始和最终治疗失败时间以及生存率进行评估。

结果

三组在反应率及其他参数方面无显著差异。患者生存率与年龄>60岁、雌激素受体阳性状态以及无内脏转移显著相关。

结论

TAM和MA作为初始治疗在诱导反应方面同样有效,联合使用并无优势。序贯治疗仍然是最佳选择,鉴于MA已报道的副作用,TAM是首选的初始药物。

相似文献

1
Randomized comparison of the effects of tamoxifen, megestrol acetate, or tamoxifen plus megestrol acetate on treatment response and survival in patients with metastatic breast cancer.他莫昔芬、醋酸甲地孕酮或他莫昔芬联合醋酸甲地孕酮对转移性乳腺癌患者治疗反应和生存影响的随机对照研究
Ann Oncol. 1993 Nov;4(9):741-4. doi: 10.1093/oxfordjournals.annonc.a058658.
2
Sequential treatment of metastatic breast cancer with tamoxifen after megestrol acetate therapy and vice versa (a retrospective study).
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Megestrol acetate versus tamoxifen in advanced breast cancer: 5-year analysis--a phase III trial of the Piedmont Oncology Association.醋酸甲地孕酮与他莫昔芬治疗晚期乳腺癌的5年分析——皮埃蒙特肿瘤协会的一项III期试验
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Megestrol acetate v tamoxifen in advanced breast cancer: correlation of hormone receptors and response.醋酸甲地孕酮与他莫昔芬治疗晚期乳腺癌:激素受体与疗效的相关性
Semin Oncol. 1986 Dec;13(4 Suppl 4):9-14.
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Comparison of antiestrogen and progestogen therapy for initial treatment and consequences of their combination for second-line treatment of recurrent breast cancer.抗雌激素和孕激素疗法用于复发性乳腺癌一线治疗的比较及其联合用于二线治疗的结果
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Megestrol acetate: first-line therapy for advanced breast cancer.醋酸甲地孕酮:晚期乳腺癌的一线治疗方法。
Semin Oncol. 1986 Dec;13(4 Suppl 4):15-9.
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Megestrol acetate in advanced breast carcinoma after failure to tamoxifen and/or aminoglutethimide.他莫昔芬和/或氨鲁米特治疗失败后,醋酸甲地孕酮用于晚期乳腺癌治疗
Oncology. 1994 May-Jun;51(3):258-61. doi: 10.1159/000227345.
8
Megestrol acetate v tamoxifen in advanced breast cancer: a phase III trial of the Piedmont Oncology Association (POA).醋酸甲地孕酮与他莫昔芬治疗晚期乳腺癌:皮埃蒙特肿瘤协会(POA)的一项III期试验
Semin Oncol. 1985 Mar;12(1 Suppl 1):55-61.
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Megestrol acetate v tamoxifen in advanced breast cancer in postmenopausal patients.醋酸甲地孕酮与他莫昔芬治疗绝经后晚期乳腺癌患者的疗效比较
Semin Oncol. 1985 Mar;12(1 Suppl 1):43-7.
10
Quantitative estrogen and progesterone receptor levels related to progression-free interval in advanced breast cancer patients treated with megestrol acetate or tamoxifen.与接受醋酸甲地孕酮或他莫昔芬治疗的晚期乳腺癌患者无进展生存期相关的雌激素和孕激素受体定量水平。
Semin Oncol. 1988 Apr;15(2 Suppl 1):26-33.

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