THE GIVIO TRIAL ON THE IMPACT OF FOLLOW-UP CARE ON SURVIVAL AND QUALITY-OF-LIFE IN BREAST-CANCER PATIENTS

Background: The aim of the study was to prospectively assess the impac t on survival and health-related quality of life of two different foll ow-up policies in patients with early breast cancer. Patients and meth ods: A consecutive sample of 1320 women with stage I, II and III unila teral primary breast cancer, aged up to 70 years, were randomly assign ed to an intensive surveillance which included physician visits, and p erformance 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 sam e frequency but only clinically motivated tests were performed. Both g roups received a yearly mammogram aimed at detecting contralateral bre ast cancer. The primary end-points were overall survival and health-re lated quality of life. Results: Compliance to the two follow-up polici es 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 i n the intensive and control group, respectively. No significant differ ences 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 ima ge, social functioning, symptoms and satisfaction with care) at 6, 12, 24 and 60 months of follow-up did not differ according to regimen. Co nclusions: Results of this trial support the view that a policy of fre quent laboratory and X-ray tests and procedures after primary treatmen t for breast cancer does not improve survival nor influence health-rel ated quality of life. Routine use of these tests should be discouraged .