INTENSIVE DIAGNOSTIC FOLLOW-UP AFTER TREATMENT OF PRIMARY BREAST-CANCER - A RANDOMIZED TRIAL

Objective.-To evaluate the effectiveness of early detection of intrath oracic and bone metastases in reducing mortality in breast cancer pati ents. Design.-Randomized clinical trial allocating breast cancer patie nts to two alternative follow-up protocols (intensive vs clinical) for at least 5 years. Setting.-Twelve breast clinics (referral centers) i n different areas in Italy.Patients.-A total of 1243 consecutive patie nts (either premenopausal or postmenopausal) surgically treated for un ilateral invasive breast carcinoma with no evidence of metastases. The two study groups were well balanced in terms of clinical and prognost ic characteristics. Intervention.-Patients in both treatment groups ha d physical examination and mammography, while patients of the intensiv e follow-up group had, in addition, chest roentgenography and bone sca n every 6 months. Main Outcome Measures.-Vital status at 5 years was t he main outcome; information was available for all except five patient s (0.4%). Relapse-free survival was also analyzed. Results.-Overall, 3 93 recurrences (104 local and 289 distant) were observed during the st udy. Increased detection of isolated intrathoracic and bone metastases was evident in the intensive follow-up group compared with the clinic al follow-up group (112 vs 71 cases), while no difference was observed for other sites and for local and/or regional recurrences. The 5-year relapse-free survival rate was significantly higher for the clinical follow-up group, with patients in the intensive follow-up group showin g earlier detection of recurrences. No difference in 5-year overall mo rtality (18.6% vs 19.5%) was observed between the two follow-up groups . Conclusions.-Periodic chest roentgenography and bone scan allow earl ier detection of distant metastases, but anticipated diagnosis appears to be the only effect of intensive follow-up, and no impact on progno sis is evident after 5 years. Periodic intensive follow-up with chest roentgenography and bone scan should not be recommended as a routine p olicy.