Patient Compliance Is Critical for Equivalent Clinical Outcomes for Breast Cancer Treated by Breast-Conservation Therapy

Several studies have reported that the percentage of patients with breast carcinoma treated by breast-conservation therapy (BCT) is lowest in the southern region of the United States. 1–4 Socioeconomic factors, such as age, race, income level, access to regional treatment centers, and education level, have also been proposed as determinants of the use of BCT for the treatment of early breast cancer. 5–7 Based on carefully designed prospective randomized trials, the result of BCT for the treatment of early-stage breast cancer, as measured by local recurrence and overall survival, is equivalent to that of modified radical mastectomy. 8–11 The investigators from the National Surgical Adjuvant Breast and Bowel Project (NSABP B-06) concluded after a 12-year follow-up that no significant differences were found in overall survival, disease-free survival, or distant disease-free survival in patients treated by lumpectomy, axillary node dissection, and radiation therapy (XRT) compared with modified radical mastectomy. 10 Based on data from this and other prospective randomized trials evaluating BCT versus modified radical mastectomy, the National Institutes of Health issued recommendations after a consensus development conference that BCT with XRT was preferable for most women with stage I and II breast cancer. 12 Large clinical trials are performed under optimal conditions with excellent compliance and follow-up rates. The success of BCT is highly dependent on compliance with XRT to minimize the risk for local recurrence. In the reanalysis of the NSABP B-06 trial at 12 years of follow-up, patients treated with lumpectomy without XRT had a local failure (LF) rate of 35%. The LF rate was approximately 10% in patients treated with lumpectomy and XRT. These results were comparable to those of other clinical trials addressing the same issue. 9,10 The success of BCT is also highly dependent on clinical follow-up to identify, in a timely fashion, patients in whom local recurrence does develop. In the NSABP B-06 trial, patients with local recurrence underwent mastectomy, and this resulted in overall survival rates equivalent to modified radical mastectomy. 10 However, if local recurrence were not identified in a timely fashion by a clinical follow-up program, the chance for cure is likely to be reduced. Patients enrolled in clinical trials may not be representative of patients living in the various diverse communities that make up the United States. Regional access to healthcare and socioeconomic factors such as education level, cultural background, and personal income may have an impact on compliance. 4–7 Our 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. Thus, in this study, we intend to examine compliance with a BCT program and the resulting clinical outcomes in a population of primarily indigent patients served by a public hospital in the rural South. The objectives are to determine the compliance with a standard BCT program (XRT and clinical follow-up), to compare the clinical outcomes of these patients with those reported in clinical trials, and to examine the socioeconomic factors that may have contributed to the rate of compliance.