[Symptom-oriented follow-up of early breast cancer compared to intensive surveillance. Results of a prospective multicentre study: update and 10-year overall survival]. / Symptomorientierte Nachsorge nach Mammakarzinom im Vergleich zur intensiv-apparativen Nachsorge. Ergebnisse einer prospektiven multizentrischen Studie: Update und 10-Jahres-Überlebenszeit.

BACKGROUND AND OBJECTIVE: In a prospective, non-randomised, multicentre cohort study we compared intensive surveillance to symptom-oriented control in the follow-up of patients with early breast cancer after curative surgical treatment. Five-year overall survival had shown that symptom-oriented follow-up was not inferior to intensive control. However, a more intensive, instrumental based follow-up is still claimed by many patients and their physicians. In this context the recent data of 10-year overall survival (OS) are reported. PATIENTS AND METHODS: In the prospective, non-randomised, multicentre cohort study carried out between 1995 and 2000, 244 patients underwent an intensive follow-up (scheduled laboratory tests including CEA and CA 15-3, chest X-rays and liver ultrasound). 426 patients were monitored in a symptom-oriented manner (additional tests only in the case of symptoms indicating possible recurrence). Mammography, structured histories and physical examinations were done regularly in both groups. RESULTS: In the clinical follow-up group, 90 deaths (21.2 %) were observed with an estimated 10-year overall survival rate of 83.0 % (95 % CI 79.1 -86.3 %).  In the intensive follow-up group, 59 deaths (24.2 %) were observed with an estimated 10-year overall survival rate of 78.5 % (95 % CI 72.6 -83.2 %). The Cox proportional hazards model for OS includes the variables follow-up form, stage of primary tumor and lymph nodes, hormone receptor status, grading and age at diagnosis. This model resulted in a hazard ratio of 1.10 (95 % CI 0.78-1.54) for the follow-up protocol (intensive vs. clinical). Welleks' test for non-inferiority showed that clinical follow-up is not inferior in comparison to intensive follow-up (p < 0.05) for a non-inferiority limit of + 7 % at 10-years. CONCLUSION: This analysis of 10-year overall survival of patients with early breast cancer after curative primary treatment confirms that follow-up without regular imaging and laboratory tests is not inferior in the sense of a relevant higher mortality. To what extent new concepts in the treatment of breast cancer have any influence on follow-up care has to be examined in further studies.