Ipsilateral breast tumor recurrence postlumpectomy is predictive of subsequent mortality: results from a randomized trial. Investigators of the Ontario Clinical Oncology Group.

PURPOSE: To determine whether ipsilateral breast tumor recurrence (IBTR) postlumpectomy was independently predictive of distant relapse and mortality in women with node negative breast cancer. METHODS AND MATERIALS: A randomized trial was conducted in Ontario between 1984 and 1989, in which 837 women with node negative disease who had undergone lumpectomy and axillary dissection were randomized to either postoperative radiation (40 Gy in 16 fractions to the whole breast, followed by a boost of 12.5 Gy in five fractions to the primary site), or no further treatment. A Cox proportional hazards regression analysis was performed for the endpoints mortality and distant relapse using the fixed covariates, treatment, age, tumor size, estrogen receptor status, progesterone receptor status, and nuclear grade; and the time dependent variable IBTR.
RESULTS: The analysis was based on 799 patients for which all fixed covariate data was available. Median follow-up was 66 months. The cumulative rate of IBTR at 5 years was significantly greater for the no treatment group compared to the radiation group; 30% vs. 8% respectively (p < 0.0001). No difference was detected in overall survival between the treatment groups (p = 0.45). Significant independent predictors for mortality were nuclear grade, high vs. medium or low (relative risk (RR) = 2.28, p = 0.0001); and tumor size > or = 2 cm. vs. < 2 cm. (RR = 1.64, p = 0.01). In addition, IBTR predicted increased mortality (RR = 2.18, p < 0.0006). Similar results were observed for distant relapse. An IBTR within 1 year of surgery was associated with a higher risk of distant relapse and mortality.
CONCLUSION: Local breast recurrence following lumpectomy is associated with an increased risk of distant relapse and death.

RCT Entities:   Population Interventions Outcomes