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High rates of durable response are achieved with imatinib after treatment with interferon alpha plus cytarabine: results from the International Randomized Study of Interferon and STI571 (IRIS) trial.伊马替尼治疗干扰素 α 加阿糖胞苷后的持久缓解率高:来自国际干扰素和 STI571(IRIS)随机研究的结果。
Haematologica. 2009 Dec;94(12):1669-75. doi: 10.3324/haematol.2009.010629. Epub 2009 Jul 31.
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Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study.慢性髓性白血病患者伊马替尼治疗不依从的患病率、决定因素及结局:ADAGIO研究
Blood. 2009 May 28;113(22):5401-11. doi: 10.1182/blood-2008-12-196543. Epub 2009 Apr 6.
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Results of high-dose imatinib mesylate in intermediate Sokal risk chronic myeloid leukemia patients in early chronic phase: a phase 2 trial of the GIMEMA CML Working Party.高剂量甲磺酸伊马替尼治疗慢性期早期中等Sokal风险慢性髓性白血病患者的结果:GIMEMA慢性髓性白血病工作组的2期试验
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The long-term durability of cytogenetic responses in patients with accelerated phase chronic myeloid leukemia treated with imatinib 600 mg: the GIMEMA CML Working Party experience after a 7-year follow-up.接受600毫克伊马替尼治疗的加速期慢性髓性白血病患者细胞遗传学反应的长期持久性:GIMEMA慢性髓性白血病工作组7年随访经验
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Chronic myeloid leukemia in blast crisis treated with imatinib 600 mg: outcome of the patients alive after a 6-year follow-up.使用600毫克伊马替尼治疗的急变期慢性髓性白血病:6年随访后存活患者的结局
Haematologica. 2008 Dec;93(12):1792-6. doi: 10.3324/haematol.13068. Epub 2008 Oct 6.
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A phase II study of continuous infusion homoharringtonine and cytarabine in newly diagnosed patients with chronic myeloid leukemia: CALGB study 19804.一项关于持续输注高三尖杉酯碱和阿糖胞苷治疗新诊断慢性髓性白血病患者的II期研究:癌症和白血病B组研究19804
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Recent trends in long-term survival of patients with chronic myelocytic leukemia: disclosing the impact of advances in therapy on the population level.慢性粒细胞白血病患者长期生存的近期趋势:揭示治疗进展对总体人群的影响。
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Front-line treatment of Philadelphia positive chronic myeloid leukemia with imatinib and interferon-alpha: 5-year outcome.伊马替尼与α干扰素一线治疗费城染色体阳性慢性髓性白血病:5年疗效
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Favorable long-term follow-up results over 6 years for response, survival, and safety with imatinib mesylate therapy in chronic-phase chronic myeloid leukemia after failure of interferon-alpha treatment.甲磺酸伊马替尼治疗α-干扰素治疗失败后的慢性期慢性髓性白血病,在反应、生存和安全性方面有长达6年的良好长期随访结果。
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慢性髓性白血病患者的生存情况:临床试验环境和基于人群的癌症登记处估计值的比较。

Survival of patients with chronic myelocytic leukemia: comparisons of estimates from clinical trial settings and population-based cancer registries.

机构信息

Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany.

出版信息

Oncologist. 2011;16(5):663-71. doi: 10.1634/theoncologist.2010-0393. Epub 2011 Apr 6.

DOI:10.1634/theoncologist.2010-0393
PMID:21471276
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3228188/
Abstract

INTRODUCTION

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.

METHODS

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.

RESULTS

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.

DISCUSSION

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.

摘要

简介

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。

方法

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。

结果

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。

讨论

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。