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他莫昔芬与孕激素治疗绝经后女性转移性乳腺癌:已发表随机临床试验的定量综述

Treatment with tamoxifen and progestins for metastatic breast cancer in postmenopausal women: a quantitative review of published randomized clinical trials.

作者信息

Parazzini F, Colli E, Scatigna M, Tozzi L

机构信息

Istituto di Richerche Farmacologiche Mario Negri, Milano, Italia.

出版信息

Oncology. 1993 Nov-Dec;50(6):483-9. doi: 10.1159/000227233.

Abstract

The efficacy of tamoxifen (TAM) was compared to that of progestins (medroxyprogesterone acetate, MPA, and megestrol acetate, MA) in the treatment of metastatic breast cancer in postmenopausal women by a quantitative analysis of the results of published randomized clinical trials. Seven studies involving a total of 801 subjects compared TAM with MPA. Overall, the frequency of complete and partial response was 9 and 18%, respectively, in the women treated with TAM, versus 9 and 28% in those given MPA. Considering complete and partial responses together, the frequency of response was 29% in the TAM group and 39% in the MPA group, the corresponding pooled odds ratio (OR) of response being 1.5 (95% confidence interval, CI, 1.1-2.0). The median duration of response was greater in the TAM-treated patients; however, the difference was small (14 vs. 11 months). The probability of response to MPA treatment was about 3-fold higher compared with the response to TAM treatment in the subgroup with bone metastases (OR 3.4), and 2-fold higher in the subgroup with visceral metastases (OR 2.2), but the difference in the OR estimates was not statistically significant. The response to the two drugs was similar in the subgroup with metastases in soft tissues. Four studies compared TAM with MA, taking in 463 subjects. The overall frequency of complete and partial response was 35% in the patients who received TAM compared with 29% in those treated with MA. The corresponding pooled OR was 0.8 (95% CI 0.5-1.1). Analysis of the results according to site of metastases revealed no significant difference in the frequency of complete or partial response in the two treatment groups.

摘要

通过对已发表的随机临床试验结果进行定量分析,比较了他莫昔芬(TAM)与孕激素(醋酸甲羟孕酮,MPA,和醋酸甲地孕酮,MA)在绝经后女性转移性乳腺癌治疗中的疗效。七项研究共纳入801名受试者,比较了TAM与MPA。总体而言,接受TAM治疗的女性中完全缓解和部分缓解的频率分别为9%和18%,而接受MPA治疗的女性中分别为9%和28%。将完全缓解和部分缓解合并考虑,TAM组的缓解频率为29%,MPA组为39%,相应的合并反应比值比(OR)为1.5(95%置信区间,CI,1.1 - 2.0)。TAM治疗患者的中位缓解持续时间更长;然而,差异较小(14个月对11个月)。在骨转移亚组中,MPA治疗的反应概率比TAM治疗高约3倍(OR 3.4),在内脏转移亚组中高2倍(OR 2.2),但OR估计值的差异无统计学意义。在软组织转移亚组中,两种药物的反应相似。四项研究比较了TAM与MA,纳入463名受试者。接受TAM治疗的患者中完全缓解和部分缓解的总体频率为35%,而接受MA治疗的患者中为29%。相应的合并OR为0.8(95% CI 0.5 - 1.1)。根据转移部位分析结果显示,两个治疗组中完全或部分缓解的频率无显著差异。

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