Outcomes and toxicity in african-american and caucasian patients in a randomized adjuvant chemotherapy trial for colon cancer.
Outcomes and toxicity in african-american and caucasian patients in a randomized adjuvant chemotherapy trial for colon cancer.
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结肠癌随机辅助化疗试验中非裔美国人和白人患者的结果和毒性。
DOI：
10.1093/jnci/94.15.1160
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发表时间：
2002
期刊：
影响因子：
--
通讯作者：
Fuchs,CharlesS
中科院分区：
文献类型：
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作者：
McCollum,ADavid;Catalano,PaulJ;Haller,DanielG;Mayer,RobertJ;Macdonald,JohnS;Benson3rd,AlB;Fuchs,CharlesS
背景：先前的研究表明，非裔美国人结肠癌患者的总体生存率和分期特异性生存率低于白人。这些差异可能反映了获得医疗保健、肿瘤生物学或治疗效果的差异。关于非裔美国人和高加索人之间化疗相关毒性的潜在差异知之甚少。在这项研究中，我们研究了非洲裔美国人和白人患者的生存率和毒性作用，在一个大型的，随机III期试验的辅助化疗切除结肠cancer.Methods：我们分析了3380例患者（344非洲裔美国人和3036高加索人）参加了一项随机试验的辅助5-氟尿嘧啶为基础的化疗与II期（高风险）和III期结肠癌患者的数据，以评估结果和毒性的差异。我们采用Kaplan-Meier方法比较了非裔美国人和白人的无病生存期（DFS）和总生存期（OS），采用多变量分析计算了考克斯比例风险，采用Fisher精确检验比较了治疗相关毒性发生率。所有的统计检验都是双侧的。结果：我们发现非洲裔美国人和白人患者之间的DFS或OS没有差异。5年DFS为57%（95%置信区间[CI] = 52%至62%），非裔美国人和58%（95% CI = 56%-60%），白人非裔美国人的5年OS为65%（95% CI = 60%-70%），白人为66%（95% CI = 64%-68%）（P= 0.38）。在多变量分析中，未检测到人种/种族组之间疾病复发或死亡的统计学显著差异（非洲裔美国人与白人的风险比：疾病复发= 1.1，95% CI = 0.9至1.3;死亡= 1.1，95% CI = 0.9至1.3）。非裔美国人和白人患者的治疗相关毒性不同，非裔美国人的腹泻发生率在统计学上显著较低（P<.001），恶心（P<.001），呕吐（P= .01），口腔炎（P<0.001），总体毒性（P= .005）.结论：在这项对获得类似医疗保健资源和接受辅助化疗治疗的患者的研究中，我们发现患有II期和III期结肠癌的非裔美国人和高加索人的5年DFS和OS相似。两组从辅助化疗中获得相似的益处。此外，非洲裔美国人似乎经历了较少的治疗相关毒性。
Background:Previous studies have demonstrated that African-Americans with colon cancer have worse overall and stage-specific survival rates than Caucasians. Such differences could reflect variation in access to health care, in tumor biology, or in treatment efficacy. Little is known about potential differences in chemotherapy-related toxicities between African-Americans and Caucasians. In this study, we examined survival and toxic effects among African-American and Caucasian patients enrolled in a large, randomized phase III trial of adjuvant chemotherapy for resected colon cancer.Methods:We analyzed data on 3380 patients (344 African-Americans and 3036 Caucasians) enrolled in a randomized trial of adjuvant 5-fluorouracil-based chemotherapy in patients with stage II (high risk) and stage III colon cancer to evaluate differences in outcomes and toxicity. We compared disease-free survival (DFS) and overall survival (OS) between African-Americans and Caucasians by the Kaplan–Meier method, computed Cox proportional hazards by multivariable analysis, and compared treatment-related toxicity rates by Fisher's exact test. All statistical tests were two-sided.Results:We found no differences in DFS or OS between African-American and Caucasian patients. Five-year DFS was 57% (95% confidence interval [CI] = 52% to 62%) for African-Americans and 58% (95% CI = 56% to 60%) for Caucasians (P= .15), and 5-year OS was 65% (95% CI = 60% to 70%) for African-Americans and 66% (95% CI = 64% to 68%) for Caucasians (P= .38). On multivariable analysis, no statistically significant difference in disease recurrence or death was detected between the racial/ethnic groups (hazard ratios for African-Americans versus Caucasians: disease recurrence = 1.1, 95% CI = 0.9 to 1.3; death = 1.1, 95% CI = 0.9 to 1.3). Treatment-related toxicity differed between the African-American and Caucasian patients, with African-Americans experiencing statistically significantly lower rates of diarrhea (P<.001), nausea (P<.001), vomiting (P= .01), stomatitis (P<.001), and overall toxicity (P= .005).Conclusions:In this study of patients with similar access to health care resources and treatment with adjuvant chemotherapy, we found similar 5-year DFS and OS in African-Americans and Caucasians with stage II and III colon cancer. The two groups derived similar benefits from adjuvant chemotherapy. Moreover, African-Americans appeared to experience less treatment-related toxicity.