Originally published as JCO Early Release 10.1200/JCO.2008.19.8424 on April 6 2009

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Prognosis After Ipsilateral Breast Tumor Recurrence and Locoregional Recurrences in Patients Treated by Breast-Conserving Therapy in Five National Surgical Adjuvant Breast and Bowel Project Protocols of Node-Negative Breast Cancer

From the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh; National Surgical Adjuvant Breast and Bowel Project, Biostatistical Center; Department of Surgery, University of Pittsburgh School of Medicine; National Surgical Adjuvant Breast and Bowel Project Operations Center and Allegheny General Hospital, Pittsburgh, PA; Department of Surgery, Stanford University School of Medicine, Stanford, CA; Department of Health Studies and Cancer Research Center, University of Chicago, Chicago, IL; and Aultman Cancer Center, Northeastern Ohio State University, Canton, OH.

Corresponding author: Stewart J. Anderson, PhD, University of Pittsburgh Graduate School of Public Health, 130 DeSoto St, 302 Parran Hall, Pittsburgh, PA 15261; e-mail: sja{at}pitt.edu.

Purpose Locoregional failure (LRF) after breast-conserving therapy (BCT) is associated with increased risk of distant disease and death. The magnitude of this risk has not been adequately characterized in patients with lymph node-negative disease.

Patients and Methods Our study population included 3,799 women randomly assigned to five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative disease (ie, B-13, B-14, B-19, B-20, and B-23) who underwent lumpectomy and whole breast irradiation with or without adjuvant systemic therapy. Cumulative incidences of ipsilateral breast tumor recurrence (IBTR) and other locoregional recurrence (oLRR) were calculated, along with distant-disease–free interval (DDFI) and overall survival (OS) after these events. Cox models were employed to model mortality by using clinical and pathologic factors jointly with these events.

Results Four hundred nineteen patients (11.0%) experienced LRF: 342 (9.0%) experienced IBTR, and 77 (2.0%) experienced oLRR. The 12-year cumulative incidences of IBTR and oLRR in patients treated with adjuvant systemic therapy were 6.6% and 1.8%, respectively. Overall, 37.1% of IBTRs and 72.7% of oLRRs occurred within 5 years of diagnosis. Older age, black race, higher body mass index (BMI), larger tumors, and occurrence of IBTR or oLRR were significantly associated with increased mortality. The 5-year OS after IBTR and oLRR were 76.6% and 34.9%, respectively. Adjusted hazard ratios for mortality associated with IBTR and oLRR were significantly higher in estrogen receptor (ER)–negative patients than in ER-positive patients (P = .002 and P < .0001, respectively). Patients with early LRF had worse OS and DDFI than those with later-occurring LRF.

Conclusion Although LRF is uncommon in patients with node-negative breast cancer who are treated with lumpectomy, radiation, and adjuvant systemic therapy, those who do develop LRF have substantially worse OS and DDFI.

Supported by Public Health Service Grants No. U10-CA-12027, U10-CA-69651, U10-CA-37377, and U10-CA-69974 from the National Cancer Institute, Department of Health and Human Services.

Presented at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

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

Clinical Trials' registry information for this article available at www.jco.org.

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