Harvard Radiation Oncology Program, Massachusetts General Hospital and Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts.
Department of Radiation Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Cancer. 2021 Dec 1;127(23):4464-4469. doi: 10.1002/cncr.33853. Epub 2021 Aug 11.
Phase 1 trials are increasingly important in the molecularly driven era of oncology, but few studies have examined phase 1 participation disparities. The authors of this study investigated factors associated with phase 1 versus phase 2/3 trial enrollment.
They authors conducted a cross-sectional study using serial samples of patients age ≥18 years enrolling on cancer trials from October 2011 to November 2014 at an academic cancer center. They used univariable and multivariable logistic regression models to analyze sociodemographic and clinical associations with phase 1 versus phase 2/3 trial enrollment.
Among 3103 patients enrolled in cancer trials, 2657 unique patients participated in phase 1/2/3 trials. For patients enrolled in phase 1 (n = 1401) versus phase 2/3 (n = 1256) trials, we found no significant differences by age, insurance status, marital status, and income. Overall, 1216 (93%) White, 72 (6%) Asian, and 21 (2%) Black patients enrolled on phase 1 trials, whereas 1068 (93%) White, 40 (3%) Asian, and 43 (4%) Black patients enrolled on phase 2/3 trials. Adjusting for age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year, compared with White patients, Black patients had lower phase 1 enrollment (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.25-0.82), as did Hispanic/Latino (OR, 0.25; 95% CI, 0.08-0.79) and male patients (OR, 0.77; 95% CI, 0.62-0.94). Asian patients had higher phase 1 enrollment (OR, 1.38; 95% CI, 0.88-2.16).
Disparities in phase 1 versus phase 2/3 cancer clinical trial enrollment underscore the urgent need for interventions addressing inequities in early-phase trial participation.
Phase 1 trials are of increasing importance in oncology. The authors of the study analyzed all patients enrolling on cancer clinical trials at a large academic cancer center from October 2011 to November 2014. Among the 2657 trial participants, when age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year were taken into account, Black, Hispanic/Latino, and male patients were less likely to enroll on phase 1 trials versus phase 2/3 trials. These findings suggest a need for targeted interventions to improve access to and education about phase 1 trials for Black and Hispanic/Latino patients.
在肿瘤学的分子驱动时代，1 期临床试验越来越重要，但很少有研究探讨 1 期临床试验参与的差异。本研究的作者调查了与 1 期与 2/3 期试验入组相关的因素。
作者使用 2011 年 10 月至 2014 年 11 月在一家学术癌症中心参加癌症试验的≥18 岁患者的连续样本进行了一项横断面研究。他们使用单变量和多变量逻辑回归模型分析了与 1 期与 2/3 期试验入组相关的社会人口学和临床关联。
在纳入癌症试验的 3103 名患者中，有 2657 名患者参加了 1 期/2/3 期试验。对于参加 1 期（n=1401）和 2/3 期（n=1256）试验的患者，我们发现年龄、保险状况、婚姻状况和收入没有显著差异。总体而言，1216 名（93%）白人、72 名（6%）亚裔和 21 名（2%）黑人患者参加了 1 期试验，而 1068 名（93%）白人、40 名（3%）亚裔和 43 名（4%）黑人患者参加了 2/3 期试验。调整年龄、性别、种族、民族、保险状况、婚姻状况、收入、癌症类型、疾病状况、旅行距离和试验年份后，与白人患者相比，黑人患者的 1 期入组率较低（比值比[OR]，0.46；95%置信区间[CI]，0.25-0.82），西班牙裔/拉丁裔（OR，0.25；95%CI，0.08-0.79）和男性患者（OR，0.77；95%CI，0.62-0.94）也是如此。亚裔患者的 1 期入组率较高（OR，1.38；95%CI，0.88-2.16）。
1 期与 2/3 期癌症临床试验入组的差异突显了迫切需要采取干预措施解决早期试验参与的不平等问题。
背景：在肿瘤学的分子驱动时代，1 期临床试验变得越来越重要。该研究的作者分析了 2011 年 10 月至 2014 年 11 月期间在一家大型学术癌症中心参加癌症临床试验的所有患者。在 2657 名试验参与者中，当考虑年龄、性别、种族、民族、保险状况、婚姻状况、收入、癌症类型、疾病状况、旅行距离和试验年份等因素时，黑种人、西班牙裔/拉丁裔和男性患者参加 1 期试验而非 2/3 期试验的可能性较低。这些发现表明，需要针对黑人和西班牙裔/拉丁裔患者开展有针对性的干预措施，以增加他们对 1 期试验的了解并改善他们的参与机会。
