Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 0431, Houston, TX 77030, USA.
Department of Neurology, University of Mississippi Medical Center, 2500 N. State Street, Jackson, MS 39216, USA.
Eur J Cancer. 2019 May;112:83-93. doi: 10.1016/j.ejca.2019.02.007. Epub 2019 Apr 2.
It is estimated only 8-11% of patients with glioblastoma (GBM) enrol in clinical trials, limiting treatment development. We analysed the clinical and demographic features of patients with GBM enroled in clinical trials at the University of Texas MD Anderson Cancer Center (MDACC).
We reviewed the records of adult patients treated for primary GBM between 2007 and 2012 at the MDACC. A total of 755 patients were identified: 133 were deemed non-eligible, 111 were deemed trial eligible but received standard care and 511 participated in a clinical trial (311 for newly diagnosed glioblastoma [nGBM] and 200 for recurrent glioblastoma [rGBM]). Population characteristics were analysed using descriptive statistics, and survival end-points were evaluated with the Kaplan-Meier method.
The median age of clinical trial participants and trial eligible patients was 53.2 years (standard deviation 12.1). Most patients (49.4%) were enroled in a clinical trial protocol for nGBM. The majority of nGBM trial participants were male patients (65.1%), white (86.3%), married (84.4%) and in state (59.9%). Employment status, education, symptoms, tumour location, performance status, extent of resection and treatment facility differed between nGBM trial participants and non-participants. Patients who were eligible but did not enrol tended to be older, have worse performance status and live farther away from the MDACC.
Numerous disease and demographic barriers exist in trial enrolment in patients with GBM. This study highlights some of these obstacles, which require attention to improve patient enrolment to clinical trials. Patient and physician engagement in novel therapeutic strategies is essential to improving outcomes in this disease.
据估计，胶质母细胞瘤（GBM）患者中仅有 8-11%参加临床试验，这限制了治疗方法的发展。我们分析了在德克萨斯大学 MD 安德森癌症中心（MDACC）参加临床试验的 GBM 患者的临床和人口统计学特征。
我们回顾了 2007 年至 2012 年间在 MDACC 接受原发性 GBM 治疗的成年患者的记录。共确定了 755 例患者：133 例被认为不符合条件，111 例被认为符合试验条件但接受标准治疗，511 例参加了临床试验（311 例为新诊断的胶质母细胞瘤[nGBM]，200 例为复发性胶质母细胞瘤[rGBM]）。使用描述性统计分析人口特征，使用 Kaplan-Meier 方法评估生存终点。
临床试验参与者和符合试验条件的患者的中位年龄为 53.2 岁（标准差 12.1）。大多数患者（49.4%）参加了 nGBM 的临床试验方案。nGBM 临床试验参与者中大多数为男性（65.1%）、白人（86.3%）、已婚（84.4%）和在州内（59.9%）。nGBM 临床试验参与者和非参与者的就业状况、教育程度、症状、肿瘤位置、表现状态、切除程度和治疗机构存在差异。符合条件但未参加试验的患者年龄较大，表现状态较差，且距离 MDACC 较远。
GBM 患者参加临床试验存在许多疾病和人口统计学障碍。本研究强调了其中一些障碍，需要加以关注以提高患者参加临床试验的比例。患者和医生参与新的治疗策略对于改善该疾病的预后至关重要。
