Go Ronald S, Frisby Kathleen A, Lee Jennifer A, Mathiason Michelle A, Meyer Christine M, Ostern Jodi L, Walther Sara M, Schroeder Jonean E, Meyer Lori A, Umberger Kathryn E
Sections of Hematology and Medical Oncology, Gundersen Lutheran Cancer Center, Gundersen Lutheran Health System, La Crosse, Wisconsin 54601, USA.
Cancer. 2006 Jan 15;106(2):426-33. doi: 10.1002/cncr.21597.
To the authors' knowledge, only limited data are available regarding clinical trial accrual patterns and the barriers encountered among newly diagnosed patients seen at community-based cancer centers.
In the current study, the authors prospectively collected clinical and sociodemographic data from all adult patients seen at a community-based cancer center who had new cancers diagnosed between 2003-2004. Clinical trial enrollment decisions were noted and factors that prevented accrual were identified.
There was a total of 1012 new cancer patients. In 587 patients (58%), clinical trials appropriate for the diagnosis and stage of disease were not available. Among those patients for whom trials were available, 19.8% did not meet eligibility criteria, and only 9.9% of patients were enrolled. Although more trials were found to be available for women compared with men (51% vs. 32%; P < 0.01), the accrual rates were equal (11.2% vs. 7.6%; P = 0.24). Elderly patients comprised approximately 59.4% of those patients with available trials, but they were less likely to be enrolled (5.1% vs. 16.8%; P < 0.01). The major barriers to nonparticipation can be grouped into protocol limitations (68.1%), physician triage (16%), and patient decisions (15.9%). The overall accrual rate when all patients were included was 4% (42 of 1012 patients).
At the study institution, participation in clinical trials is reported to be low. The unavailability of appropriate clinical trials represents the most significant barrier. Continuing efforts to encourage physicians and to educate patients remain necessary. If the current study findings are found to be applicable to other community-based cancer centers, making a larger variety of clinical trials available to the community may help to improve the accrual of patients to national cancer clinical trials.
据作者所知，关于社区癌症中心新诊断患者的临床试验入组模式及所遇到的障碍，仅有有限的数据。
在本研究中，作者前瞻性地收集了2003年至2004年间在一家社区癌症中心就诊的所有新诊断癌症成年患者的临床和社会人口统计学数据。记录临床试验入组决策，并确定阻碍入组的因素。
共有1012例新癌症患者。587例患者（58%）没有适合其疾病诊断和分期的临床试验。在有试验可用的患者中，19.8%不符合入选标准，仅有9.9%的患者入组。尽管发现女性比男性有更多可用试验（51%对32%；P<0.01），但入组率相当（11.2%对7.6%；P = 0.24）。老年患者约占可参加试验患者的59.4%，但他们入组的可能性较小（5.1%对16.8%；P<0.01）。不参与的主要障碍可分为方案限制（68.1%）、医生筛选（16%）和患者决策（15.9%）。纳入所有患者后的总体入组率为4%（1012例患者中有42例）。
在研究机构，据报道参与临床试验的比例较低。缺乏合适的临床试验是最主要的障碍。持续努力鼓励医生并对患者进行教育仍然必要。如果当前研究结果适用于其他社区癌症中心，为社区提供更多种类的临床试验可能有助于提高患者参与全国癌症临床试验的比例。
