García-Alfonso Pilar, Alcaide-Garcia Julia, Aranda Aguilar Enrique, Elez Elena, Fernández Montes Ana, García Escobar Ignacio, Grávalos Cristina, Matos García Ignacio, Montagut Viladot Clara, Santos Vivas Cristina, Sastre Javier, Tarazona Noelia, Jimenez-Fonseca Paula
Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Universidad Complutense, Madrid, Spain.
Medical Oncology Department, Hospital Universitario Regional de Málaga, IBIMA, Málaga, Spain.
Clin Transl Oncol. 2025 Aug 11. doi: 10.1007/s12094-025-03986-y.
Metastatic colorectal cancer (mCRC) presents significant therapeutic challenges, with variability in the definition and classification of lines of treatment (LoTs). This study aimed to achieve consensus among Spanish oncology experts on the classification of LoTs through the application of the Delphi methodology.
A nationwide Delphi study was conducted in three phases. Twelve experts designed a two-round online survey that consisted of 41 statements across 11 sections. Statements were evaluated with a five-point Likert scale, with ≥ 70% agreement or disagreement as the criterion of consensus.
A total of 110 and 92 oncologists participated in the first and second rounds, respectively, with consensus achieved on 32 of 41 statements. Key agreements included definition of treatment lines before systemic therapy (98.18%), classification of relapses after six months of adjuvant therapy as first line (92.73%), and the inclusion of maintenance therapy as part of first-line treatment (98.18%). Variability arose on the use of biologics in perioperative settings (67.39% disagreement) and progression criteria, and 75% of experts agreed that a switch in biologics constitutes a new line. Thus, it is needed to standardize definitions in clinical practice.
This study highlights significant variability in the definition of LoTs for mCRC, which reflects the evolution of therapeutic landscape. The divergence between clinical trial criteria and real-world practices underscores the need for standardized definitions to enhance consistency in clinical decision-making. Refinement of guidelines on biologic agents, rechallenge strategies, and therapy classification is critical to advance mCRC management and improve patient outcomes. This consensus serves as a foundation for future research and guideline development.
转移性结直肠癌（mCRC）带来了重大的治疗挑战，治疗线（LoT）的定义和分类存在差异。本研究旨在通过应用德尔菲法，使西班牙肿瘤学专家就LoT的分类达成共识。
在全国范围内分三个阶段进行了德尔菲研究。12位专家设计了一项两轮在线调查，该调查由11个部分的41条陈述组成。陈述采用五点李克特量表进行评估，以≥70%的同意或不同意作为达成共识的标准。
分别有110名和92名肿瘤学家参与了第一轮和第二轮调查，41条陈述中有32条达成了共识。主要共识包括全身治疗前治疗线的定义（98.18%）、辅助治疗6个月后复发作为一线治疗的分类（92.73%）以及将维持治疗纳入一线治疗的一部分（98.18%）。围手术期生物制剂的使用（67.39%不同意）和疾病进展标准存在差异，75%的专家同意生物制剂的更换构成新的治疗线。因此，需要在临床实践中规范定义。
本研究突出了mCRC中LoT定义的显著差异，这反映了治疗格局的演变。临床试验标准与实际临床实践之间的差异强调了需要标准化定义，以提高临床决策的一致性。完善生物制剂、再治疗策略和治疗分类的指南对于推进mCRC的管理和改善患者预后至关重要。这一共识为未来的研究和指南制定奠定了基础。
