Rate of over-diagnosis of breast cancer 15 years after end of Malmö mammographic screening trial: follow-up study.

OBJECTIVE To evaluate the rate of over-diagnosis of breast cancer 15 years after the end of the Malmö mammographic screening trial. DESIGN Follow-up study. SETTING Malmö, Sweden. SUBJECTS 42 283 women aged 45-69 years at randomisation. INTERVENTIONS Screening for breast cancer with mammography or not (controls). Screening was offered at the end of the randomisation design to both groups aged 45-54 at randomisation but not to groups aged 55-69 at randomisation. MAIN OUTCOME MEASURES Rate of over-diagnosis of breast cancer (in situ and invasive), calculated as incidence in the invited and control groups, during period of randomised design (period 1), during period after randomised design ended (period 2), and at end of follow-up. RESULTS In women aged 55-69 years at randomisation the relative rates of over-diagnosis of breast cancer (95% confidence intervals) were 1.32 (1.14 to 1.53) for period 1, 0.92 (0.79 to 1.06) for period 2, and 1.10 (0.99 to 1.22) at the end of follow-up. CONCLUSION Conclusions on over-diagnosis of breast cancer in the Malmö mammographic screening trial can be drawn mainly for women aged 55-69 years at randomisation whose control groups were never screened. Fifteen years after the trial ended the rate of over-diagnosis of breast cancer was 10% in this age group.