Li B D, Brown W A, Ampil F L, Burton G V, Yu H, McDonald J C
Department of Surgery, Division of Radiation Oncology, Louisiana State University Health Science Center in Shreveport, Shreveport, Louisiana 71103, USA.
Ann Surg. 2000 Jun;231(6):883-9. doi: 10.1097/00000658-200006000-00013.
To determine the compliance with a standard breast-conservation therapy (BCT) program in a predominantly indigent, minority population of patients with early breast cancer (stage I and II) served by a rural state institution in the South; to compare the clinical outcomes of this group with those reported in clinical trials; and to examine the socioeconomic factors that may have contributed to the rate of compliance.
Disease-free survival and overall survival in early breast cancer treated by BCT versus modified radical mastectomy are reported to be equivalent in prospective randomized trials. However, patients enrolled in clinical trials may not be representative of patients living in the various diverse communities that make up the United States. The authors' hypothesis is that patients enrolled in clinical trials at the national level may not be representative of indigent patients in the rural South and that clinical trial results may not be directly applicable.
A retrospective review of 55 women with early-stage breast cancer treated from 1990 to 1995 was performed. Clinical data, compliance with treatment and clinical follow-up, and recurrence rates were examined. Statistical analysis performed include the Fisher exact test, Kaplan-Meier survival analysis, and log-rank test.
Full compliance (defined as completion of the entire course of radiation therapy and clinical follow-up) with the BCT program was observed in only 36% of patients. Fifteen of the 35 noncompliant patients did not complete radiation therapy. A significantly higher local failure rate was observed: 8 of these 15 patients (53%) have had local failure. In contrast, patients who were either in full compliance with the BCT program or were deficient only in that they missed part of their clinical follow-up had local failure rates of 5% (1/20) and 10% (2/20), respectively. Age, race, stage of cancer, economic status (measured by availability of medical insurance), distance of patient's residence from the hospital, and education level were evaluated as potential predictors of compliance. None predicted patient compliance, although a trend toward higher compliance was noted in patients with a higher education level, as determined by literacy testing.
Compliance with the BCT protocol at the authors' institution was worse than reported in clinical trials, and noncompliance translated into a significant increase in the local failure rate. Factors examined suggest that literacy may play a role in predicting compliance. Although BCT should be discussed with all breast cancer patients, the judicious application of clinical trial data to an institution's local population is warranted.
确定一所位于美国南部的农村州立机构为主要由贫困少数族裔组成的早期乳腺癌（I期和II期）患者提供的标准保乳治疗（BCT）方案的依从性；将该组患者的临床结果与临床试验报告的结果进行比较；并研究可能导致依从率的社会经济因素。
在前瞻性随机试验中，据报道BCT治疗的早期乳腺癌与改良根治性乳房切除术的无病生存率和总生存率相当。然而，参加临床试验的患者可能不能代表构成美国的各种不同社区中的患者。作者的假设是，在国家层面参加临床试验的患者可能不能代表美国南部农村的贫困患者，并且临床试验结果可能无法直接适用。
对1990年至1995年治疗的55例早期乳腺癌女性患者进行回顾性研究。检查临床数据、治疗依从性和临床随访情况以及复发率。进行的统计分析包括Fisher精确检验、Kaplan-Meier生存分析和对数秩检验。
仅36%的患者完全依从BCT方案（定义为完成整个放疗疗程和临床随访）。35例未依从的患者中有15例未完成放疗。观察到局部失败率显著更高：这15例患者中有8例（53%）出现局部失败。相比之下，完全依从BCT方案或仅错过部分临床随访的患者局部失败率分别为5%（1/20）和10%（2/20）。对年龄、种族、癌症分期、经济状况（通过医疗保险的可获得性衡量）、患者居住地与医院的距离以及教育水平进行评估，作为依从性的潜在预测因素。尽管通过识字测试确定，教育水平较高的患者有依从性较高的趋势，但没有一个因素能预测患者的依从性。
作者所在机构对BCT方案的依从性比临床试验报告的情况更差，不依从导致局部失败率显著增加。所研究的因素表明识字能力可能在预测依从性方面起作用。虽然应该与所有乳腺癌患者讨论BCT，但有必要谨慎地将临床试验数据应用于机构的当地人群。
