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许多乳腺癌老年患者可以省去放疗

Radiotherapy can be omitted for many older breast cancer patients
来源:爱思唯尔 2013-12-18 09:14点击次数:1025发表评论

圣安东尼奥——低危老年患者术后放疗(PRIME II)试验的结果表明,对于许多早期乳腺癌老年患者而言,避免全乳放疗是一个合理甚至受欢迎的治疗选择。PRIME II基于相对良性自然史发现的适合省去术后放疗的患者人群为:年龄大于或等于65岁,雌激素受体水平高、腋窝淋巴结阴性乳腺癌,边缘清楚,乳房肿瘤切除术后接受辅助激素治疗。
 
在圣安东尼奥乳腺癌研讨会上,来自爱丁堡大学的临床肿瘤学教授Ian H. Kunkler 博士报告称,PRIME II是一项6国试验,共有1,326例年龄大于或等于65岁的激素受体阳性早期乳腺癌患者在保乳手术和内分泌治疗后被随机分配至接受放疗或者不放疗。作为该试验的主要终点,同侧乳腺癌复发的5年精确发生率在放疗组为1.3%,在没有接受放疗的患者组中为4.1%。


Kunkler 博士称,在91%的雌激素受体水平较高(定义为ER评分至少达到7分)的受试者中,放疗的相对效益就更小了。放疗组的局部复发率为3.2%,非放疗组为0.8%。虽然2.4%的绝对差异有统计学意义,但可以认为其临床意义不大。在每100例符合PRIME II明确描述的标准并且接受了放疗的患者中,可以避免3例复发,1例仍然会复发,其余96例的治疗是没有效益的。


Kunkler 博士说:“我认为我们确实存在过度治疗的问题。我建议医生应该和患者讨论放疗很轻微的效益是否值得去冒潜在并发症的风险,是否值得承担继续治疗的负担以及医疗服务的成本。放疗会让老年患者感到很烦恼,其相对效益又非常小,省去放疗环节患者的总生存期也不会受到影响。”


值得重视的是,在9%的雌激素受体水平较低的患者中,非放疗组的局部复发率为11.1%,而放疗组为零。Kunkler 博士指出:“对于这类患者,放疗不可省略。”


在所有早期乳腺癌患者中,一半以上年龄都大于或等于65岁。虽然乳房肿瘤切除术后开展放疗一直以来都是标准治疗方案,无论年龄和其他危险因素,但支持这种方案用于老年患者的高质量证据其实很少。
 
据Kunkler 博士估计,PRIME II试验的结果适用于60%~70%的年龄大于65岁的乳腺癌患者。他预测道,PRIME II试验“很可能”改变英国的临床实践。作为会议的主持人之一,美国贝勒医学院Dan L. Duncan癌症中心和Lester and Sue Smith乳腺中心主任C. Kent Osborne博士也预测道,该试验也可能改变美国的临床实践。


Osborne博士说:“在我读书时,每个人都认为治疗越多越好:多一点药物治疗,多一点放疗,多一点手术,大剂量化疗以及骨髓移植。随着过去三十年的发展,我们慢慢发现事实并非如此。我认为对于部分适合的患者,我们正在逐渐减少治疗,无论是放疗还是手术,以此来控制局部疾病。我认为越来越多的人将开始接受这种做法。”


PRIME II试验由苏格兰首席科学家办公室资助。Kunkler博士声明没有利益冲突。


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By: BRUCE JANCIN, Internal Medicine News Digital Network


SAN ANTONIO – Avoiding whole-breast radiation therapy is a reasonable – and even attractive – option for many older women with early-stage breast cancer, according to the results of the Postoperative Radiotherapy in Minimum-Risk Elderly (PRIME II) trial.


The patient population identified in PRIME II as being suitable for omission of postoperative radiotherapy on the basis of a relatively benign natural history consists of women aged 65 or older who are on adjuvant hormone therapy after undergoing lumpectomy with clear margins for estrogen receptor–rich, axillary node–negative breast cancer.
 
PRIME II was a six-country trial in which 1,326 patients 65 or older with hormone receptor–positive early breast cancer were randomized to radiotherapy or no radiotherapy following breast-conserving surgery and endocrine therapy. The 5-year actuarial rate of ipsilateral breast cancer recurrence – the primary study endpoint – was 1.3% in those who received radiotherapy and 4.1% in those who did not, Dr. Ian H. Kunkler reported at the San Antonio Breast Cancer Symposium.


The 5-year actuarial rate of overall survival was 94.2% in patients randomized to radiotherapy and closely similar at 93.8% in the no-radiotherapy group, added Dr. Kunkler, professor of clinical oncology at the University of Edinburgh.


The relative benefit of radiotherapy was even smaller in the 91% of subjects who had estrogen-rich tumors as defined by an ER score of at least 7. They had a local recurrence rate of 3.2% with radiotherapy and 0.8% without. While that absolute 2.4% difference was statistically significant, it is arguably not clinically meaningful. For every 100 women who fit the description carefully defined in PRIME II and who undergo radiotherapy, three will have a recurrence prevented, one will have a recurrence anyway, and 96 will have had treatment that was not beneficial, he said.
 
"I think we’re really at the cusp of overtreatment here. I think it’s a matter for discussion between the physician and patient as to whether that very modest benefit is worth the potential complications of radiotherapy and the burdens of ongoing treatment, as well as the costs to the health service. Older patients find radiotherapy very burdensome, the relative benefits are very small, and there is no compromise in terms of overall survival with its omission," Dr. Kunkler said.


An important caveat: Among the 9% of patients with low estrogen receptor status, the local recurrence rate was 11.1% with no radiotherapy compared to zero with radiation.


"This is a group for whom radiotherapy should not be omitted," Dr. Kunkler declared.


More than one-half of all early breast cancers present in women aged 65 or older. While postoperative radiotherapy after lumpectomy has been the standard of care regardless of age and other risk factors, there has been only sparse high-quality supporting evidence for this practice in older patients.


Dr. Kunkler estimated that the PRIME II findings are generalizable to 60%-70% of all breast cancer patients over age 65. He predicted that the PRIME II study will "very likely" alter practice in the United Kingdom, and symposium codirector Dr. C. Kent Osborne predicted that the study will be practice changing in the United States as well.


"When I was in training, everybody thought that more was better: more drug treatment, more radiation, more surgery, high-dose chemotherapy, and bone marrow transplant. As we’ve evolved over the last 3 decades, that’s turning out not to be the case. I think we’re gradually doing less and less treatment, either with radiotherapy or with surgery, to control the local disease in appropriate patients. And I think more and more people will begin to accept it," said Dr. Osborne, director of the Dan L. Duncan Cancer Center and the Lester and Sue Smith Breast Center at Baylor College of Medicine, Houston.


PRIME II was funded by the Chief Scientist Office for Scotland. Dr. Kunkler declared having no conflicts of interest.


学科代码:肿瘤学 妇产科学 放射学   关键词:圣安东尼奥乳腺癌研讨会 早期乳腺癌老年患者 避免全乳放疗
来源: 爱思唯尔
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