The GIVIO trial on the impact of follow-up care on survival and quality of life in breast cancer patients

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Abstract
Background : The aim of the study was to prospectively assess the impact on survival and health-related quality of life of two different follow-up policies in patients with early breast cancer. Patients and methods : A consecutive sample of 1320 women with stage I, II and HI unilateral primary breast cancer, aged up to 70 years, were randomly assigned to an intensive surveillance which included physician visits, and performance of bone scans, liver sonograms, chest X-rays and laboratory tests at predefined intervals (655 patients) or to a control regimen (665 patients) in which patients were seen by their doctors at the same frequency but only clinically motivated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer. The primary end-points were overall survival and health-related quality of life. Results : Compliance to the two follow-up policies was over 80%. After a median follow-up of 71 months, no difference was apparent in overall survival with 132 (20%) and 122 (18%) deaths in the intensive and control group, respectively. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (i. e., 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 differ according to regimen. Conclusions : Results of this trial support the view that a policy of frequent laboratory and X-ray tests and procedures after primary treatment for breast cancer does not improve survival nor influence health-related quality of life. Routine use of these tests should be discouraged.