Multimodal treatment strategies for patients with rectal cancer are increasingly including the possibility of organ preservation, through nonoperative management or local excision. Organ preservation strategies can enable patients with a complete response or near-complete clinical responses after radiotherapy with or without concomitant chemotherapy to safely avoid the morbidities associated with radical surgery, and thus to maintain anorectal function and quality of life. However, standardization of the key outcome measures of organ preservation strategies is currently lacking; this includes a lack of consensus of the optimal definitions and selection of primary end points according to the trial phase and design; the optimal time points for response assessment; response-based decision-making; follow-up schedules; use of specific anorectal function tests; and quality of life and patient-reported outcomes. Thus, a consensus statement on outcome measures is necessary to ensure consistency and facilitate more accurate comparisons of data from ongoing and future trials. Here, we have convened an international group of experts with extensive experience in the management of patients with rectal cancer, including organ preservation approaches, and used a Delphi process to establish the first international consensus recommendations for key outcome measures of organ preservation, in an attempt to standardize the reporting of data from both trials and routine practice in this emerging area.

直肠癌患者的多模式治疗策略越来越多地包括通过非手术治疗或局部切除来保存器官的可能性。器官保存策略可以使放疗伴或不伴化疗后完全缓解或接近完全临床缓解的患者安全避免根治性手术相关的并发症，从而维持肛门直肠功能和生活质量。然而，目前缺乏器官保存策略关键结果指标的标准化；这包括根据试验阶段和设计对主要终点的最佳定义和选择缺乏共识；反应评估的最佳时间点；基于反应的决策；后续时间表；使用特定的肛门直肠功能测试；生活质量和患者报告的结果。因此，有必要就结果测量达成共识，以确保一致性并促进对正在进行和未来试验的数据进行更准确的比较。在这里，我们召集了一个在直肠癌患者管理（包括器官保存方法）方面具有丰富经验的国际专家组，并使用 Delphi 流程建立了第一个关于器官保存关键结果措施的国际共识建议，试图使这一新兴领域的试验和常规实践数据报告标准化。有必要就结果措施达成共识声明，以确保一致性并促进对正在进行的试验和未来试验的数据进行更准确的比较。在这里，我们召集了一个在直肠癌患者管理（包括器官保存方法）方面具有丰富经验的国际专家组，并使用 Delphi 流程建立了第一个关于器官保存关键结果措施的国际共识建议，试图使这一新兴领域的试验和常规实践数据报告标准化。有必要就结果措施达成共识声明，以确保一致性并促进对正在进行的试验和未来试验的数据进行更准确的比较。在这里，我们召集了一个在直肠癌患者管理（包括器官保存方法）方面具有丰富经验的国际专家组，并使用 Delphi 流程建立了第一个关于器官保存关键结果措施的国际共识建议，试图使这一新兴领域的试验和常规实践数据报告标准化。