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乳腺癌临床试验的入组:专科团队的重要性。苏格兰乳腺癌焦点小组和苏格兰癌症治疗网络。

Entry into clinical trials in breast cancer: the importance of specialist teams. Scottish Breast Cancer Focus Group and Scottish Cancer Therapy Network.

作者信息

Twelves C J, Thomson C S, Young J, Gould A

机构信息

Cancer Research Campaign Department of Medical Oncology.

出版信息

Eur J Cancer. 1998 Jun;34(7):1004-7. doi: 10.1016/s0959-8049(97)10126-5.

Abstract

The aim of this study was to identify the factors influencing entry of women with invasive breast cancer into clinical trials in Scotland. Women diagnosed during 1987 and 1993 were identified from cancer registry data records and their case notes reviewed. Entry into clinical trials was recorded, along with clinical and demographic data for 4688 patients. In 1987, the proportion of women entering clinical trials was 12.3% and, allowing for shorter follow-up, this appeared unchanged in 1993. Patients seen by surgeons with a high case load and those referred to an oncologist were approximately seven times and three times, respectively, more likely to enter a clinical trial (P < 0.0001). The area of Scotland (Health Board) where the woman was first treated also influenced study entry (P < 0.0001), whereas social deprivation had no effect (P = 0.93). Older women, especially those over 80 years of age, were less likely to enter studies (P = 0.05). Extending the management of patients by specialist multidisciplinary teams should increase recruitment into clinical trials and help to identify better treatments for women with breast cancer.

摘要

本研究旨在确定影响苏格兰浸润性乳腺癌女性进入临床试验的因素。通过癌症登记数据记录识别出1987年至1993年期间确诊的女性,并对其病历进行审查。记录了4688例患者进入临床试验的情况以及临床和人口统计学数据。1987年,进入临床试验的女性比例为12.3%,考虑到随访时间较短,1993年这一比例似乎没有变化。病例量高的外科医生诊治的患者以及转诊至肿瘤学家的患者进入临床试验的可能性分别约为其他患者的7倍和3倍(P<0.0001)。女性首次接受治疗的苏格兰地区(卫生委员会)也会影响进入研究的情况(P<0.0001),而社会剥夺状况则没有影响(P=0.93)。老年女性,尤其是80岁以上的女性,进入研究的可能性较小(P=0.05)。由专科多学科团队扩大患者管理应能增加临床试验的入组人数,并有助于为乳腺癌女性确定更好的治疗方法。

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