Objective: To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer.
Design: Randomized controlled clinical trial.
Setting: Multicenter study involving 26 general hospitals in Italy.
Patients: A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer.
Intervention: Patients were randomly assigned to an intensive surveillance, which included physician visits and performance of bone scan, liver echography, chest roentgenography, and laboratory tests at predefined intervals (n = 655), or to a control regimen (n = 665), in which patients were seen by their physicians at the same frequency but only clinically indicated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer.
Main outcome measures: Primary end points were overall survival and health-related quality of life.
Results: Compliance to the two follow-up protocols was more than 80%. At a median follow-up of 71 months, no difference was apparent in overall survival with 132 deaths (20%) in the intensive group and 122 deaths (18%) in the control group. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (ie, overall health and quality-of-life perception, emotional well-being, body image, social functioning, symptoms, and satisfaction with care) at 6, 12, 24, and 60 months of follow-up did not show differences by type of care received.
Conclusions: Results of this trial support the view that a protocol of frequent laboratory tests and roentgenography after primary treatment for breast cancer does not improve survival or influence health-related quality of life. Routine use of these tests should be discouraged.