Patient compliance is critical for equivalent clinical outcomes for breast cancer treated by breast-conservation...

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.