Using Response Evaluation Criteria in Solid Tumors in real-world evidence cancer research
Using Response Evaluation Criteria in Solid Tumors in real-world evidence cancer research
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DOI：
10.2217/fon-2018-0317
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发表时间：
2018-11-01
期刊：
影响因子：
3.3
通讯作者：
Phatak, Hemant
中科院分区：
文献类型：
--
作者：
Feinberg, Bruce A.;Bharmal, Murtuza;Phatak, Hemant
目的：根据实体肿瘤反应评价标准（RECIST），将癌症药物治疗反应图表的真实证据与医疗记录衍生的靶病变放射测量进行比较。材料与方法：15名治疗59例转移性默克尔细胞癌（mMCC）患者的医生提供了患者水平的数据。医疗记录的比较报告了治疗前和治疗后靶病变的放射学测量与RECIST的最佳反应。结果：与病历报告相比，RECIST应答率显著降低，一致性为43.2% （95%CI: 28.0 ~ 58.4%）。结论：通过传统的图表抽象收集的对肿瘤反应的主观评估可能高估了益处，限制了现实世界证据在基于价值的护理研究中的潜在作用。使用靶病变测量提供了一个有吸引力的替代方案，更好地与试验结果一致。
Aim: Real-world evidence of charted treatment responses to cancer drug therapy was compared with medical record derived radiographic measurements of target lesions per Response Evaluation Criteria in Solid Tumors (RECIST). Materials & methods: 15 physicians treating 59 metastatic Merkel cell cancer (mMCC) patients contributed patient-level data. A comparison of medical record reported best response with radiographic measurements per RECIST of pre- and post-treatment target lesions. Results: RECIST response rates were significantly lower compared with medical record reported with a concordance of 43.2% (95%CI: 28.0-58.4%). Conclusion: Subjective assessment of tumor response collected via traditional chart abstraction may overestimate benefit and limit the potential role of real-world evidence in value-based care research. The use of target lesion measurements presents an attractive alternative that better aligns with trial results.