来自种族和族裔少数群体（例如亚洲人、西班牙裔和非西班牙裔黑人患者）的患者在临床试验中的代表性较低，尤其是在癌症的 1 期试验中。这些试验为通过标准治疗经历疾病进展的晚期癌症患者提供了宝贵的选择。 确定参加 1 期癌症试验的好处是否扩展到亚裔、西班牙裔和非西班牙裔黑人患者，与非西班牙裔黑人患者一样多西班牙裔白人患者。对 1999 年 1 月至 2016 年 12 月期间单个机构的患者记录进行了审查。记录治疗相关的反应、毒性作用和死亡。所有 1 期研究均被纳入。数据由多名观察者按照系统评价和荟萃分析的首选报告项目 (PRISMA) 报告指南独立提取。主要结局为总体结果生存期 (OS)，使用单变量和多变量事件时间分析进行评估。总共 738 名患者（中位[范围]，60 [22-93] 岁；467 [63.3] 女性），包括 197 名西班牙裔患者 (26.7%) 、238 名非西班牙裔黑人患者 (32.2%) 和 282 名非西班牙裔白人患者 (38.2%) 参加了 64 项 1 期试验，包括 33 项细胞毒性试验 (51.5%)、21 项生物试验 (32.8%) 和10 项联合治疗试验（15.6%）。主要癌症诊断为结直肠癌（187 例患者 [25.3%]）、卵巢癌（141 例患者 [19.1%]）、肺癌（58 例患者 [7.9%]）、子宫癌（49 例患者 [6.6%]）和乳腺癌（41 例患者） [5.6%]）。患者在试验入组前接受了中位数（范围）为 3 (0-13) 种治疗。在评估缓解的 558 名患者中，临床获益率（即疾病稳定加缓解率）为 49.1%，总体缓解率为 6.5%。 27.8%（95% CI，24.6%-31.3%）的患者观察到 3 级或 4 级非血液学毒性反应，19.7%（95% CI，17.0%-22.8%）的患者观察到 3 级或 4 级血液学毒性反应。患者。治疗相关死亡率为 0.9%（95% CI，0.4%-1.9%）。西班牙裔患者的中位 OS 为 9.6 (95% CI, 8.2-11.0) 个月，非西班牙裔黑人患者为 8.3 (95% CI, 6.7-10.4) 个月，非西班牙裔黑人患者为 9.8 (95% CI, 8.5-11.4) 个月。 -西班牙裔白人患者（P = .13）。在多变量分析中，年龄超过 60 岁，东部肿瘤合作组表现状态评分为 2 或更高，转移部位超过 2 个，乳酸脱氢酶 1 级或 2 级，低白蛋白 2 级或更高，总胆红素 1 级或更高， 2 级或以上贫血与较差的预后相关，而大于 1 级的白细胞增多与较好的 OS 相关。 在这项荟萃分析中，评估了来自少数种族和族裔、西班牙裔和非西班牙裔患者的 1 期癌症试验结果黑人患者的获益与非西班牙裔白人患者相似。

Patients from racial and ethnic minority groups (eg, Asian, Hispanic, and non-Hispanic Black patients) have low representation in clinical trials, especially in phase 1 trials in cancer. These trials represent valuable options for patients with advanced cancer who experience disease progression with standard therapy.To determine whether the benefit of enrollment to phase 1 cancer trials extends to Asian, Hispanic, and non-Hispanic Black patients as much as it does for non-Hispanic White patients.Patient records at a single institution from January 1999 to December 2016 were reviewed. Treatment-related responses, toxic effects, and deaths were recorded.All phase 1 studies were included.Data underwent independent extraction by multiple observers following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.The primary outcome was overall survival (OS), assessed using univariate and multivariable time-to-event analyses.A total of 738 patients (median [range], 60 [22-93] years; 467 [63.3] female) including 197 Hispanic patients (26.7%), 238 non-Hispanic Black patients (32.2%), and 282 non-Hispanic White patients (38.2%), were enrolled in 64 phase 1 trials, including 33 cytotoxic trials (51.5%), 21 biologic trials (32.8%), and 10 combined therapy trials (15.6%). The primary cancer diagnoses were colorectal (187 patients [25.3%]), ovarian (141 patients [19.1%]), lung (58 patients [7.9%]), uterine (49 patients [6.6%]), and breast (41 patients [5.6%]). Patients underwent a median (range) of 3 (0-13) therapies prior to trial enrollment. Among 558 patients evaluated for response, the clinical benefit rate (ie, stable disease plus response rates) was 49.1%, and the overall response rate was 6.5%. Grade 3 or 4 nonhematological toxic effects were observed in 27.8% (95% CI, 24.6%-31.3%) of patients and grade 3 or 4 hematological toxic effects were observed in 19.7% (95% CI, 17.0%-22.8%) of patients. The treatment-related mortality rate was 0.9% (95% CI, 0.4%-1.9%). Median OS was 9.6 (95% CI, 8.2-11.0) months among Hispanic patients, 8.3 (95% CI, 6.7-10.4) months among non-Hispanic Black patients, and 9.8 (95% CI, 8.5-11.4) months among non-Hispanic White patients (P = .13). In a multivariable analysis, age older than 60 years, Eastern Cooperative Oncology Group performance status score of 2 or greater, more than 2 metastatic sites, lactate dehydrogenase grade 1 or 2, grade 2 or greater low albumin, grade 1 or greater total bilirubin, and grade 2 or greater anemia were associated with worse prognosis, whereas leukocytosis greater than grade 1 was associated with better OS.In this meta-analysis assessing outcomes in phase 1 cancer trials among patients from racial and ethnic minority groups, Hispanic and non-Hispanic Black patients had benefits similar to those of non-Hispanic White patients.