gms | German Medical Science

The ADEBAR study is a prospective multicenter Phase III trial to examine whether high-risk breast cancer patients (> 4 involved axillary lymph nodes) benefit from a sequential anthracycline-docetaxel regimen (E90C-D: 4 cycles epirubicin [E] 90mg/m2 BSA plus cyclophosphamide [C] 600mg/m2 BSA q21d, followed by 4 cycles docetaxel [D] 100mg/m2 BSA q21d) compared to standard chemotherapy with anthracyclines (FE120C: 6 cycles E60 mg/m2 BSA d1+8, 5- FU 500mg/m2 BSA d1+8 and C 75mg/m2 BSA d1-14, q28days). With a median recruitment of 33 patients per month at 198 actively recruiting centers, the ADEBAR study was the best recruiting study in Germany in this indication up to the end of the trial.

Methods: A standardized questionnaire was sent to all participating centers in order to find out the extent to which treatment strategies and patient care are affected by participation in the ADEBAR study. The questionnaire comprised 5 questions: previous inclusion of patients at the same tumor stage in studies, the type of chemotherapy received by comparable patients previously outside the study, change in the intensity of medical care since participating in the ADEBAR study, the information gained through participation in the study and changes in the overall quality of medical care.

Results: 51.0% (n=98) of the questionnaires were returned. 3 of the returned questionnaires were not included in the analysis because of incomplete answers. In the year preceding the ADEBAR study, 63.2% of participating centers had not entered their high-risk patients into a clinical trial. Before participating in the ADEBAR protocol, 44.2% of patients with the same indication had received inadequate therapy by today’s standard, such as CMF, EC/CMF or 4x EC. 59.0% of the centers noted an increase in the intensity of patient care as a result of participation in the study, independent of the care provided purely because of the study. By being part of a research network, with a regular flow of information via newsletters, study meetings, etc., 80.0% noted an improvement in their professional knowledge in the field of breast cancer. Moreover, 31.6% of the centers reported an improvement in the overall quality of their patient care since the start of the trial.

Conclusion: The results of the survey demonstrate that both physicians and patients benefit from participation in clinical trials as this is associated with optimized therapeutic decision-making and patient care.