Impact of follow-up testing on survival and health-related quality of life in breast cancer patients. A multicenter randomized controlled trial. The GIVIO Investigators

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.

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