Dept of Health Care Policy, Harvard Medical School, 180A Longwood Ave, Boston, MA 02115, USA.
J Clin Oncol. 2010 Jan 10;28(2):215-21. doi: 10.1200/JCO.2008.21.3652. Epub 2009 Nov 23.
During the last 25 years, National Cancer Institute (NCI) cooperative trial groups have extended trial networks from academic centers to include certain community and Veterans Health Administration (VHA) centers. We compared trial patients' attributes and outcomes by these enrollment settings.
Studying 2,708 patients on one of 10 cooperative group, randomized lung trials at 272 institutions, we compared patient attributes by enrollment setting (ie, academic, community, and VHA affiliates). We used adjusted Cox regression to evaluate for survival differences by setting.
Main member institutions enrolled 44% of patients; community affiliates enrolled 44%; and VHAs enrolled 12%. Patient attributes (ie, case-mix) of age, ethnicity, sex, and performance status varied by enrollment setting. After analysis was adjusted for patient case-mix, no mortality differences by enrollment setting were noted.
Although trial patients with primarily advanced-stage lung cancer from nonacademic centers were older and had worse performance statuses than those from academic centers, survival did not differ by enrollment setting after analysis accounted for patient heterogeneity. An answer for whether long-term outcomes for patients at community and VHA centers affiliated with cooperative trial groups are equivalent to those at academic centers when care is delivered through NCI trials requires additional research among patients with longer survival horizons.
在过去的 25 年中，美国国家癌症研究所（NCI）合作试验组已经将试验网络从学术中心扩展到包括某些社区和退伍军人健康管理局（VHA）中心。我们比较了这些入组设置下的试验患者的特征和结果。
在 272 个机构的 10 个合作组随机肺试验中，对 2708 名患者进行了研究，我们比较了入组设置（即学术、社区和 VHA 附属机构）患者的特征。我们使用调整后的 Cox 回归来评估设置对生存的影响。
主要成员机构入组了 44%的患者；社区附属机构入组了 44%；VHA 入组了 12%。患者的年龄、种族、性别和表现状态等特征因入组设置而异。在对患者病例组合进行分析调整后，未发现入组设置与死亡率之间存在差异。
尽管来自非学术中心的主要为晚期肺癌的试验患者比来自学术中心的患者年龄更大，表现状态更差，但在考虑到患者异质性后，分析结果显示，入组设置与生存之间没有差异。关于社区和 VHA 中心与合作试验组附属机构的患者的长期结局是否与学术中心相当，当通过 NCI 试验提供治疗时，这需要在具有更长生存前景的患者中进行进一步的研究。
