Real-world evidence in diagnostics and treatment of patients with multiple myeloma

J. Bila, A. Sretenović, O. Markovic, N. Stanisavljevic, Nada Vlaisavljević, I. Savić
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Abstract

Introduction. Multiple myeloma is the second most common malignant hemopathy. The average incidence of this disease in our country is 4.2-6.7/100,000 inhabitants per year. Despite significant progress in the overall survival over the past 20 years, only 10-15% of patients achieve long-term remission and an average survival that corresponds to the average life expectancy of the general human population. The current recommendations for the treatment of multiple myeloma are globally based on the results of randomized clinical trials in which only 10-40% of patients are treated, which is why the analysis of the results of the patients treated outside of randomized clinical trials, the so-called ?Real-World Evidence? data, is very important. Diagnosis and treatment of multiple myeloma - Real-World Evidence. Through presentations of the cases from routine clinical practice, multiple myeloma treatment modalities are presented in accordance with modern recommendations for diagnosis and treatment, as well as the multiple myeloma phase of the disease: treatment approach in newly diagnosed patients; treatment of the first relapse; and treatment of the second and subsequent relapses. Conclusion. The analysis of Real-World Evidence data indicates significant differences between clinical and laboratory characteristics of patients treated outside randomized clinical trials in comparison to the randomized clinical trials participants, with an significant impact to the therapeutic approach, course and outcome of the disease, consequently leading to the necessity of further Real- World Evidence analyzes and their inclusion in the current recommendations for multiple myeloma diagnosis and treatment
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多发性骨髓瘤患者诊断和治疗的真实世界证据
介绍。多发性骨髓瘤是第二常见的恶性血液病。我国每年的平均发病率为4.2-6.7/10万居民。尽管在过去20年中总生存率有了显著的进步,但只有10-15%的患者实现了长期缓解,平均生存率相当于一般人群的平均预期寿命。目前多发性骨髓瘤的治疗建议是基于随机临床试验的结果,其中只有10-40%的患者接受了治疗,这就是为什么对随机临床试验之外接受治疗的患者的结果进行分析,即所谓的“真实世界证据”。数据,非常重要。多发性骨髓瘤的诊断和治疗-真实世界的证据。通过对来自常规临床实践的病例的介绍,根据现代诊断和治疗建议,以及新诊断患者的多发性骨髓瘤阶段的治疗方法,介绍了多发性骨髓瘤的治疗方式;第一次复发的治疗;治疗第二次及以后的复发。结论。对真实世界证据数据的分析表明,与随机临床试验参与者相比,随机临床试验外接受治疗的患者的临床和实验室特征存在显著差异,这对疾病的治疗方法、病程和结局有显著影响。因此,需要进一步的真实世界证据分析,并将其纳入当前多发性骨髓瘤诊断和治疗的建议中
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