Comprehensive Cancer Center Munich, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
Department of Radiation Oncology, Comprehensive Cancer Center Munich, University Hospital Munich, LMU Munich, Munich, Germany.
J Cancer Res Clin Oncol. 2023 Aug;149(10):7601-7608. doi: 10.1007/s00432-022-04559-0. Epub 2023 Mar 30.
Major national and international oncological societies generally recommend treating a significant proportion of oncological patients in clinical trials to improve therapy strategies for cancer patients. At cancer centers, the recommendation about the appropriate therapy for the individual tumor patient is usually made in interdisciplinary case discussions in multidisciplinary tumor boards (MDT). In this study, we examined the impact of MDTs for the inclusion of patients in therapy trials.
A prospective, explorative study of the Comprehensive Cancer Center Munich (CCCM) was conducted at both university hospitals in 2019. In the first phase, various MDTs' case discussions about oncological situations and their decisions regarding possible therapy trials were recorded in a structured manner. In the second phase, the actual inclusion rates of patients in therapy trials and reasons for non-inclusion were examined. Finally, the data of the respective university hospitals were anonymized, pooled and analyzed.
A total of 1797 case discussions were reviewed. Therapy recommendations were made in 1527 case presentations. 38 (2.5%) of 1527 patients were already included in a therapy trial at the time of case presentation. The MDTs recommended inclusion of an additional 107 cases (7%), for a therapy trial. Of these patients, 41 were finally enrolled in a therapy trial which resulted in a total recruitment rate of 5.2%. Despite MDTs' recommendations, 66 patients were not included in a therapy trial. The main reason for non-inclusion was insufficient inclusion or existing exclusion criteria (n = 18, 28%). In 48% of all cases (n = 31), the reason for non-inclusion could not be determined.
The potential of MDTs as an instrument for the inclusion of patients in therapy trials is high. To increase the enrollment of patients in oncological therapy trials, structural measures such as the central use of trial administration and MTB software in addition to standardized tumor board discussions must be established to ensure a seamless flow of information about actual recruiting trials and the current status of trial participation of patients.
大多数国家和国际肿瘤学会通常建议将相当一部分肿瘤患者纳入临床试验中,以改善癌症患者的治疗策略。在癌症中心,在多学科肿瘤委员会(MDT)的多学科病例讨论中,通常会对个体肿瘤患者的适当治疗方法提出建议。在这项研究中,我们研究了 MDT 对患者入组治疗试验的影响。
2019 年,在慕尼黑综合癌症中心(CCCM)的两家大学医院进行了一项前瞻性、探索性研究。在第一阶段,以结构化的方式记录了各种 MDT 的病例讨论,内容涉及肿瘤情况及其对可能的治疗试验的决策。在第二阶段,检查了患者实际入组治疗试验的比例以及未入组的原因。最后,对各自大学医院的数据进行了匿名、汇总和分析。
共审查了 1797 次病例讨论。在 1527 次病例介绍中有治疗建议。在病例介绍时,38 名(2.5%)患者已经参加了一项治疗试验。MDT 建议再纳入 107 例(7%)患者参加治疗试验。其中 41 名患者最终入组治疗试验,总入组率为 5.2%。尽管 MDT 建议,但仍有 66 名患者未参加治疗试验。未入组的主要原因是纳入标准不足或存在排除标准(n=18,28%)。在所有病例的 48%(n=31)中,无法确定未入组的原因。
MDT 作为将患者纳入治疗试验的工具具有很大的潜力。为了增加肿瘤患者入组参与治疗试验,必须采取结构性措施,如集中使用试验管理和 MDT 软件,以及标准化肿瘤委员会讨论,以确保关于正在进行的招募试验和患者参与试验现状的信息能够顺利传递。