研究發(fā)現(xiàn)：阿那曲唑可有效預(yù)防高危女性乳腺癌
英國倫敦瑪麗女王大學(xué)Jack Cuzick研究小組在研究中取得進展。他們分析了使用阿那曲唑預(yù)防乳腺癌的長期效果。這一研究成果發(fā)表在2019年12月12日出版的國際學(xué)術(shù)期刊《柳葉刀》上。
兩項大型臨床試驗表明，在使用芳香化酶抑制劑后的5年隨訪中，高危婦女乳腺癌的發(fā)生率有所降低。
IBIS-II是一項國際性、隨機、雙盲、安慰劑對照試驗。2003年2月2日至2012年1月31日，研究組共招募了3864名絕經(jīng)后乳腺癌風(fēng)險增加的女性，按1：1隨機分組，1920名女性接受阿那曲唑治療，1944名接受安慰劑治療，為期5年。
研究組每年都對這些女性進行隨訪。中位隨訪131個月后，阿那曲唑組的乳腺癌發(fā)病率下降49%，前5年下降幅度較大，但5年后仍有顯著性差異，不過與前5年相比差異不顯著。
浸潤性雌激素受體陽性乳腺癌發(fā)病率降低54%，且在治療結(jié)束后持續(xù)有效。導(dǎo)管原位癌的發(fā)病率降低了59%，尤其是雌激素受體陽性的患者。兩組患者的總死亡率和乳腺癌死亡率均無顯著差異。阿那曲唑亦可顯著降低非乳腺癌的發(fā)病率，主要為非黑色素瘤性皮膚癌。兩組均未發(fā)現(xiàn)骨折或心血管疾病發(fā)生率增加。
總之，阿那曲唑可顯著降低乳腺癌高?；颊叩幕及┞?，且沒有新的毒副作用。
附：英文原文
Title: Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial
Author: Jack Cuzick, Ivana Sestak, John F Forbes, Mitch Dowsett, Simon Cawthorn, Robert E Mansel, Sibylle Loibl, Bernardo Bonanni, D Gareth Evans, Anthony Howell
Issue&Volume: December 12, 2019
Abstract:
Background
Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase inhibitors (MAP.3 and International Breast Cancer Intervention Study II [IBIS-II]). Here, we report blinded long-term follow-up results for the IBIS-II trial, which compared anastrozole with placebo, with the objective of determining the efficacy of anastrozole for preventing breast cancer (both invasive and ductal carcinoma in situ) in the post-treatment period.
Methods
IBIS-II is an international, randomised, double-blind, placebo-controlled trial. Postmenopausal women at increased risk of developing breast cancer were recruited and were randomly assigned (1:1) to either anastrozole (1 mg per day, oral) or matching placebo daily for 5 years. After treatment completion, women were followed on a yearly basis to collect data on breast cancer incidence, death, other cancers, and major adverse events (cardiovascular events and fractures). The primary outcome was all breast cancer.
Findings
3864 women were recruited between Feb 2, 2003, and Jan 31, 2012. 1920 women were randomly assigned to 5 years anastrozole and 1944 to placebo. After a median follow-up of 131 months (IQR 105–156), a 49% reduction in breast cancer was observed for anastrozole (85 vs 165 cases, hazard ratio [HR] 0·51, 95% CI 0·39–0·66, p<0·0001). The reduction was larger in the first 5 years (35 vs 89, 0·39, 0·27–0·58, p<0·0001), but still significant after 5 years (50 vs 76 new cases, 0·64, 0·45–0·91, p=0·014), and not significantly different from the first 5 years (p=0·087). Invasive oestrogen receptor-positive breast cancer was reduced by 54% (HR 0·46, 95% CI 0·33–0·65, p<0·0001), with a continued significant effect in the period after treatment. A 59% reduction in ductal carcinoma in situ was observed (0·41, 0·22–0·79, p=0·0081), especially in participants known to be oestrogen receptor-positive (0·22, 0·78–0·65, p<0·0001). No significant difference in deaths was observed overall (69 vs 70, HR 0·96, 95% CI 0·69–1·34, p=0·82) or for breast cancer (two anastrozole vs three placebo). A significant decrease in non-breast cancers was observed for anastrozole (147 vs 200, odds ratio 0·72, 95% CI 0·57–0·91, p=0·0042), owing primarily to non-melanoma skin cancer. No excess of fractures or cardiovascular disease was observed.
Interpretation
This analysis has identified a significant continuing reduction in breast cancer with anastrozole in the post-treatment follow-up period, with no evidence of new late side-effects. Further follow-up is needed to assess the effect on breast cancer mortality.
DOI: 10.1016/S0140-6736(19)32955-1
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32955-1/fulltext
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