他莫昔芬治疗乳腺导管内癌：国家外科辅助乳腺和肠道项目B-24随机对照试验

Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial.

作者信息

Fisher B, Dignam J, Wolmark N, Wickerham D L, Fisher E R, Mamounas E, Smith R, Begovic M, Dimitrov N V, Margolese R G, Kardinal C G, Kavanah M T, Fehrenbacher L, Oishi R H

机构信息

National Surgical Adjuvant Breast and Bowel Project, Allegheny University of the Health Sciences, Pittsburgh, PA 15212-5234, USA.

出版信息

Lancet. 1999 Jun 12;353(9169):1993-2000. doi: 10.1016/S0140-6736(99)05036-9.

DOI:10.1016/S0140-6736(99)05036-9

PMID:10376613

Abstract

BACKGROUND

We have shown previously that lumpectomy with radiation therapy was more effective than lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether lumpectomy, radiation therapy, and tamoxifen was of more benefit than lumpectomy and radiation therapy alone for DCIS.

METHODS

1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57-93). We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years.

FINDINGS

Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8.2 vs 13.4%, p=0.0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4.1% at 5 years: 2.1% in the ipsilateral breast, 1.8% in the contralateral breast, and 0.2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis.

INTERPRETATION

The combination of lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.

摘要

背景

我们之前已经表明，保乳手术联合放射治疗在治疗导管原位癌（DCIS）方面比单纯保乳手术更有效。我们进行了一项双盲随机对照试验，以确定保乳手术、放射治疗和他莫昔芬联合使用是否比单纯保乳手术和放射治疗对DCIS更有益。

方法

1804例DCIS女性患者，包括切除样本边缘有肿瘤累及的患者，被随机分配接受保乳手术、放射治疗（50 Gy）和安慰剂（n = 902），或保乳手术、放射治疗和他莫昔芬（每日20 mg，共5年，n = 902）。中位随访时间为74个月（范围57 - 93个月）。我们比较了5年内侵袭性或非侵袭性同侧和对侧肿瘤的年事件发生率和累积概率。

结果

他莫昔芬组女性在5年时的乳腺癌事件少于安慰剂组（8.2%对13.4%，p = 0.0009）。他莫昔芬组5年时所有侵袭性乳腺癌事件的累积发生率为4.1%：同侧乳房为2.1%，对侧乳房为1.8%，区域或远处部位为0.2%。即使样本边缘包含肿瘤且DCIS与粉刺样坏死相关时，他莫昔芬组同侧乳腺癌的风险也较低。