Janni W, Kiechle M, Sommer H, Rack B, Gauger K, Heinrigs M, Steinfeld D, Augustin D, Simon W, Harbeck N, Friese K
Frauenklinik Innenstadt of the LMU Munich, Germany.
Anticancer Res. 2006 Sep-Oct;26(5B):3661-7.
The ADEBAR study is a prospective multicenter Phase III trial to examine whether high-risk breast cancer patients > or =4 involved axillary lymph nodes) benefit from a sequential anthracycline-docetaxel regimen compared to standard chemotherapy with anthracyclines. With a median recruitment of 33 patients per month at 198 actively-recruiting centers, the ADEBAR study was the best recruiting study in Germany until the end of the trial.
A standardized questionnaire was sent to all participating centers in order to determine the extent to which treatment strategies and patient care are affected by participation in the ADEBAR study. The questionnaire covered 5 areas of interest: previous inclusion of patients at the same tumor stage in other 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.
51.0% (n=98) of the questionnaires were returned, from which 3 were excluded from the analysis due to being incomplete. 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 standards, 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 and the like, 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.
The results of the survey demonstrate that both physicians and patients benefit from participation in clinical trials as this is associated with optimized decision-making as regards therapy and patient care.
ADEBAR研究是一项前瞻性多中心III期试验，旨在研究高危乳腺癌患者（腋窝淋巴结转移≥4个）与接受蒽环类药物标准化疗相比，序贯使用蒽环类药物和多西他赛方案是否更有益。在198个积极招募患者的中心，每月平均招募33名患者，直到试验结束，ADEBAR研究一直是德国招募情况最好的研究。
向所有参与中心发送一份标准化问卷，以确定参与ADEBAR研究对治疗策略和患者护理的影响程度。问卷涵盖5个感兴趣的领域：之前其他研究中相同肿瘤分期患者的纳入情况、之前研究外类似患者接受的化疗类型、自参与ADEBAR研究以来医疗护理强度的变化、通过参与研究获得的信息以及医疗护理总体质量的变化。
共收回51.0%（n = 98）的问卷，其中3份因不完整被排除在分析之外。在进行ADEBAR研究的前一年，63.2%的参与中心未将其高危患者纳入临床试验。在参与ADEBAR方案之前，按照如今的标准，44.2%具有相同适应症的患者接受了不充分的治疗，如CMF、EC/CMF或4x EC。59.0%的中心指出，参与研究后患者护理强度有所增加，这与纯粹因研究而提供的护理无关。通过成为研究网络的一部分，通过时事通讯、研究会议等定期信息流，80.0%的中心指出其在乳腺癌领域的专业知识有所提高。此外，31.6%的中心报告自试验开始以来患者护理的总体质量有所提高。
调查结果表明，医生和患者都能从参与临床试验中受益，因为这与治疗和患者护理方面的优化决策相关。
