Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany.
Oncologist. 2011;16(5):663-71. doi: 10.1634/theoncologist.2010-0393. Epub 2011 Apr 6.
The survival of patients with chronic myelocytic leukemia (CML) has improved during the past decades. However, there have been discrepancies between results reported from clinical trials and population-based studies. We aimed to elucidate the extent of these discrepancies.
We examined the 5-year survival rate of patients in clinical trials of CML treatment and compared these results with the survival of patients in the general population using the Surveillance, Epidemiology, and End Results (SEER) database, correcting for differences in the age structure of the patient populations.
Twenty-nine trials were identified for data extraction. The survival rate calculated from SEER data was lower than the survival rate in clinical trials in the corresponding period, with differences of 2.1%-50.7%. Age-adapted survival was similar for four trials, but differences up to 35.8% were seen in most. Limitations of the study include the lack of information on chemotherapy in the SEER database and possible heterogeneity of cases.
The survival rate in clinical trials of CML treatment is higher than the survival rate of all patients with CML. We speculate that the difference may be a result of access to better medications, selection of healthier patients for trials, and the time necessary for adoption of new treatments. This finding underscores the need for population-based studies to give a more realistic idea of survival for patients with a given malignancy in the general population.
在过去几十年中,慢性髓细胞白血病(CML)患者的生存率有所提高。然而,临床试验报告的结果与基于人群的研究结果之间存在差异。我们旨在阐明这些差异的程度。
我们检查了 CML 治疗临床试验中患者的 5 年生存率,并使用监测、流行病学和最终结果(SEER)数据库比较了这些结果与一般人群中患者的生存率,同时校正了患者人群年龄结构的差异。
确定了 29 项试验进行数据提取。从 SEER 数据计算出的生存率低于同期临床试验中的生存率,差异为 2.1%-50.7%。四项试验的年龄适应性生存率相似,但大多数试验的差异高达 35.8%。研究的局限性包括 SEER 数据库中缺乏化疗信息以及病例的可能异质性。
CML 治疗临床试验中的生存率高于所有 CML 患者的生存率。我们推测,这种差异可能是由于更好的药物的可及性、对试验中更健康患者的选择以及采用新治疗方法所需的时间。这一发现强调了需要进行基于人群的研究,以更真实地了解一般人群中特定恶性肿瘤患者的生存率。