Originally published as JCO Early Release 10.1200/JCO.2004.01.042 on September 27 2004

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Patterns of Locoregional Failure in Patients With Operable Breast Cancer Treated by Mastectomy and Adjuvant Chemotherapy With or Without Tamoxifen and Without Radiotherapy: Results From Five National Surgical Adjuvant Breast and Bowel Project Randomized Clinical Trials

From the National Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, National Surgical Adjuvant Breast and Bowel Project; Department of Biostatistics, University of Pittsburgh, Graduate School of Public Health; and Department of Radiation Oncology, University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA; Department of Radiation Oncology, Massachusetts General Hospital/Boston Medical Center, Boston, MA; and Aultman Cancer Center, Canton, OH

Address reprint requests to Alphonse Taghian, MD, PhD, Department of Radiation Oncology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114; e-mail: ataghian{at}partners.org

PURPOSE: To assess patterns of locoregional failure (LRF) in lymph node–positive (LN+) breast cancer patients treated with mastectomy and adjuvant chemotherapy (± tamoxifen) and without postmastectomy radiotherapy (PMRT) in five National Surgical Adjuvant Breast and Bowel Project trials.

PATIENTS AND METHODS: We examined 5,758 patients enrolled onto the B-15, B-16, B-18, B-22, and B-25 trials. Median follow-up time was 11.1 years. Distribution of pathologic tumor size was 2 cm, 2.1 to 5 cm, and more than 5 cm in 30%, 52%, and 11% of patients, respectively. Distribution of the number of LN+ was one to three, four to nine, and 10 in 51%, 32%, and 16% of patients, respectively. Ninety percent of patients received doxorubicin-based chemotherapy.

RESULTS: The overall 10-year cumulative incidences of isolated LRF, LRF with or without distant failure (DF), and DF alone as first event were 12.2%, 19.8%, and 43.3%, respectively. Cumulative incidences for LRF as first event with or without DF for patients with one to three, four to nine, and 10 LN+ were 13.0%, 24.4%, and 31.9%, respectively (P < .0001). For patients with a tumor size of 2 cm, 2.1 to 5.0 cm, and more than 5.0 cm, these incidences were 14.9%, 21.3%, and 24.6%, respectively (P < .0001). Multivariate analysis showed age, tumor size, premenopausal status, number of LN+, and number of dissected LN as significant predictors for LRF as first event.

CONCLUSION: In patients with large tumors and four or more LN+, LRF as first event remains a significant problem. Although PMRT is currently recommended for patients with four or more LN+, it may also have value in selected patients with one to three LN+. However, in the absence of a randomized trial examining the worth of radiotherapy in this group of patients, the value of PMRT remains unknown.

Supported by Public Health Service Grant Nos. U10CA-12027, U10CA-69974, and U10CA-69651-10 from the National Cancer Institute, Department of Health and Human Services, Bethesda, MD.

Presented at the 43rd American Society of Therapeutic Radiology and Oncology Meeting, San Francisco, CA, November 4-8, 2001.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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