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To the Editor: Two randomized trials performed in Italy^1-2 failed to show any impact of intensive diagnostic follow-up on 5-year mortality for patients with primary breast cancer. We have now evaluated the mortality at 10 years in 1 of these large trials, designed to compare the effectiveness of 2 alternative follow-up protocols (intensive vs clinical) offered to study participants during the first 5 years after the treatment of primary breast cancer.

Methods.

A detailed description of the study protocol was published previously in THE JOURNAL.¹ Briefly, 1243 consecutive patients surgically treated for unilateral invasive breast carcinoma with no evidence of metastases were included in the study and randomized in a 2-year period (1985-1986) by 12 participating centers in Italy. Overall, 622 patients were assigned to the intensive follow-up group and invited to have a periodic physical examination (every 3 months in the first 2 years and every 6 months thereafter) and . . . [Full Text of this Article]

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