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柳叶刀肿瘤学:抗癌药物依西美坦或有造成骨丢失的风险

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发布日期:2012-07-06 17:44 文章来源:丁香园
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据2012年2月6日《纽约时报》报道,发表在柳叶刀肿瘤学的一篇论文称,抗癌药物依西美坦或有造成骨丢失的风险。这一发现可能使女性更不愿意使用依西美坦,并且可能导致健康成年人采取服药的方式来减少他们患癌症的风险。

美国匹兹堡大学的流行病学家Jane A. Cauley 评论说:“抗癌治疗中,人们可能对依西美坦的使用不太放心。”

依西美坦被广泛用来防止乳腺癌复发,去年六月发表的一项大型研究显示,在高危风险的女性中,与安慰剂相比,依西美坦可以大大减少患浸润性乳腺癌的风险;而其他两个已经批准用以抗乳腺癌的药物他莫昔芬和雷洛昔芬,因为血栓等严重的副作用,很少用于防止乳腺癌复发。依西美坦不会有这些副作用,这使研究人员希望它有可能成为女性防治乳腺癌的可行的选择。

这项新研究的首席研究员Angela M. Cheung博士认为,这一发现不应该影响乳腺癌高风险的女性对药物的选择。

多伦多大学健康网络总监骨质疏松症的方案的Cheung博士说:“有时候我们的选项应该是,对于乳房,选择切除,还是选择药物治疗?“

这项新的研究实际上是一个详细的骨质量评估,研究人员对研究对象进行了新技术高分辨率外周定量CT检查。约两年后,研究人员发现,服用依西美坦女性腕关节骨密度平均下降6.1%,而服用安慰剂的女性仅下降1.8%。

研究人员认为,服用过依西美坦的患者有越来越多的证据证明其削弱骨骼结构,这表明,传统的骨密度测试,可能无法检测所有的药物造成的损害。

雌激素刺激乳腺癌生长,而依西美坦是芳香酶抑制剂类药物,它能降低体内雌激素水平。由于雌激素对骨骼健康很重要,长期以来一直有学者怀疑,依西美坦可能对骨骼不利。

首席研究员Paul E博士则认为,新发现“没有新的可操作的临床数据”,这对女性在选择药物方面会产生影响。

美国马萨诸塞州总医院乳腺癌研究主任Goss博士说,高分辨率外周定量CT检查并没有证明骨结构变化会增加骨折风险。在整体研究中,服用法依西美坦的病人并没有发生更多的骨折。女性可以服用骨质疏松症的药物,来对抗依西美坦的副作用。

目前尚不清楚依西美坦被用于预防究竟达到怎样广泛的程度,而许多医生和病人对女性使用依西美坦预防乳腺癌表示怀疑。他们列举出依西美坦具有其他副作用,譬如关节痛,以及该药没有被FDA批准用来预防乳腺癌。

摘要号:501

题目:Effect of osteoporosis in postmenopausal breast cancer patients randomized to adjuvant exemestane or anastrozole: NCIC CTG MA.27.


绝经后乳腺癌患者辅助依西美坦或阿拉曲唑的骨质疏松效应:NCIC CTG MA.27

摘要:

Background: NCIC CTG MA.27 compared adjuvant steroidal [exemestane (E)] and non-steroidal [anastrozole (A)] aromatase inhibitors (AIs) and showed neither to be superior in breast cancer outcomes. AIs are known to increase the risk of osteoporosis. We examined the effects of baseline or subsequent self reported osteoporosis on disease outcomes.

Methods: MA.27 enrolled 7,576 women. Event free survival (EFS) was the primary endpoint. Distant disease-free-survival (DDFS) was a secondary outcome. MA.27 permitted bisphosphonates to prevent or treat osteopenia or osteoporosis unless prohibited by enrollment to one of two cohorts in a bone substudy. Osteoporosis was considered present for this analysis if reported at baseline or prior to relapse or breast cancer death. Multivariate stratified Cox regression was used to examine the effects of trial therapy, osteoporosis, baseline patient and tumour characteristics on EFS; DDFS; bone only relapse; bone concurrent with other relapse; and non-bone recurrence. Bone marrow recurrence (N=8) was excluded.

Results: Osteoporosis was reported at baseline by 654 of 7576 (8.6%) women, and prior to relapse by an additional 661 women. EFS events occurred in 693/7576 (9.15%). Osteoporosis was significantly associated with better EFS [HR 0.81 (95% CI 0.66-0.99), p=0.04] with no difference in multivariate HR of E vs A: 1.02, 95% CI 0.88-1.19, p=0.77. Women experienced 313 (4.1%) DDFS events. Osteoporosis was associated with better DDFS [HR 0.71 (95% CI 0.51-0.98), p=0.04], adjusted HR of E to A: 0.94 (95% CI of 0.75-1.17), p=0.56. Both EFS and DDFS interactions of osteoporosis with trial therapy were not significant (p>0.05). Osteoporosis was not significantly associated with the site of relapse.

Conclusions: Osteoporosis had a significant prognostic association with improved EFS and DDFS in women treated with AIs. We plan to investigate the use of bisphosphonates, raloxifene treatment prior to randomization, and markers of bone resorption with outcome.

编辑: xy 作者:丁香园通讯员

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