Background:Despite the development of advanced cancer therapies, achieving cancer eradication remains challenging. Radioimmunotherapy (RIT) is an innovative approach that combines radionuclides with monoclonal antibodies targeting tumour-associated antigens or those expressed by the tumour microenvironment. Over the past two decades, RIT has been extensively researched, along with two RIT products—90Y-ibritumomab tiuxetan and131I-tositumomab. However, despite its demonstrated efficacy in non-solid tumours, RIT’s clinical use remains limited, and its effectiveness in solid tumours is inconclusive. This study aimed to analyse randomised controlled trials (RCTs) to evaluate the overall clinical effectiveness of RIT across different cancer types and its impact on treatment outcomes.Methods:A systematic search of PubMed, EMBASE, Scopus, CENTRAL, and Google Scholar was conducted from January 2000 to October 2024 in accordance with PRISMA guidelines and the PICOS framework. Studies were included if they were RCTs evaluating RIT for cancer treatment and reported treatment outcomes such as overall survival (OS), progression-free survival (PFS), disease-free survival, or time to progression (TTP). Data extraction was performed using a standardised Excel form, and study quality was assessed with the Joanna Briggs Institute Critical Appraisal Tool for RCTs. A narrative synthesis of the data was complemented by meta-analyses where feasible, particularly for progression- and survival-related endpoints.Results:Out of 2241 records identified, 20 RCTs encompassing approximately 3562 patients were included. The majority of trials focused on non-solid tumours, particularly non-Hodgkin’s lymphoma (NHL), while a smaller subset evaluated solid tumours such as lung, pancreatic, ovarian, and prostate cancers. Most non-solid tumour studies employed90Y-ibritumomab tiuxetan or131I-tositumomab, targeting the CD20 antigen, whereas limited evidence exists for RIT efficacy in solid tumours. Meta-analysis of progression-related outcomes yielded a pooled hazard ratio (HR) of 0.48 (95% CI: 0.39–0.59), indicating a 52% reduction in the risk of progression. In contrast, overall survival outcomes were more variable, with a pooled OS HR of 0.80 (95% CI: 0.60–1.07). Adverse events, predominantly haematological and nonhaematological toxicities, were common yet generally reversible. The findings suggest that RIT, especially when used as part of combination regimens, significantly improves treatment outcomes in non-solid tumours but has an inconsistent effect in solid tumour settings.Conclusions:The results underscore the clinical promise of RIT in treating non-solid tumours like NHL, where combination regimens yield superior outcomes compared to monotherapy. However, the inconclusive evidence in solid tumours highlights the need for further large-scale, well-designed RCTs to define the optimal use, dosing, and patient selection for RIT in these settings. Additionally, standardisation in outcome reporting and longer follow-up periods are essential for more accurate economic and clinical assessments. Overall, RIT represents a valuable therapeutic modality, yet its integration into cancer treatment regimens should be guided by further research aimed at mitigating toxicity and optimising combination strategies.
**背景：**尽管先进癌症疗法不断发展，实现癌症根除仍具挑战性。放射免疫疗法是一种创新方法，它将放射性核素与靶向肿瘤相关抗原或肿瘤微环境表达抗原的单克隆抗体相结合。过去二十年间，放射免疫疗法以及两种RIT产品——90Y-替伊莫单抗和131I-托西莫单抗——得到了广泛研究。然而，尽管其在非实体瘤中显示出疗效，RIT的临床应用仍然有限，其在实体瘤中的有效性尚无定论。本研究旨在通过分析随机对照试验，评估RIT在不同癌症类型中的总体临床有效性及其对治疗结局的影响。 **方法：**根据PRISMA指南和PICOS框架，于2000年1月至2024年10月期间，系统检索了PubMed、EMBASE、Scopus、CENTRAL和Google Scholar数据库。纳入标准为评估RIT用于癌症治疗的RCT，并报告了总生存期、无进展生存期、无病生存期或疾病进展时间等治疗结局。使用标准化Excel表格进行数据提取，并使用乔安娜·布里格斯研究所RCT批判性评估工具评估研究质量。对数据进行叙述性综合，并在可行时辅以荟萃分析，特别是针对疾病进展和生存相关终点。 **结果：**在识别出的2241条记录中，纳入了20项RCT，共涉及约3562名患者。大多数试验集中于非实体瘤，特别是非霍奇金淋巴瘤，而较少部分试验评估了肺癌、胰腺癌、卵巢癌和前列腺癌等实体瘤。大多数非实体瘤研究使用了靶向CD20抗原的90Y-替伊莫单抗或131I-托西莫单抗，而关于RIT在实体瘤中疗效的证据有限。对疾病进展相关结局的荟萃分析得出合并风险比为0.48（95% CI: 0.39–0.59），表明疾病进展风险降低了52%。相比之下，总生存期结局的变异性更大，合并OS HR为0.80（95% CI: 0.60–1.07）。不良事件，主要是血液学和非血液学毒性，常见但通常可逆。研究结果表明，RIT，特别是作为联合方案的一部分使用时，能显著改善非实体瘤的治疗结局，但在实体瘤环境中的效果不一致。 **结论：**结果强调了RIT在治疗非霍奇金淋巴瘤等非实体瘤方面的临床前景，其中联合方案相比单药疗法能产生更优的结局。然而，在实体瘤中证据尚无定论，这凸显了需要进行进一步大规模、设计良好的RCT，以明确RIT在这些情况下的最佳使用方式、剂量和患者选择。此外，结局报告的标准化和更长的随访期对于更准确的经济和临床评估至关重要。总体而言，RIT代表了一种有价值的治疗模式，但其整合到癌症治疗方案中应基于旨在减轻毒性和优化联合策略的进一步研究来指导。
肿瘤(癌症)患者之家