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基于人群的研究:新的靶向和免疫治疗对转移性或不可切除黑色素瘤的生存影响。

A Population-based Study of Survival Impact of New Targeted and Immune-based Therapies for Metastatic or Unresectable Melanoma.

机构信息

Division of Cancer Care and Epidemiology, Cancer Research Institute at Queen's University, Kingston, Ontario, Canada; Department of Oncology, Queen's University, Kingston, Ontario, Canada; Institute for Clinical Evaluative Sciences at Queen's University, Kingston, Ontario, Canada.

Institute for Clinical Evaluative Sciences at Queen's University, Kingston, Ontario, Canada.

出版信息

Clin Oncol (R Coll Radiol). 2018 Oct;30(10):609-617. doi: 10.1016/j.clon.2018.05.005. Epub 2018 Jun 28.

DOI:10.1016/j.clon.2018.05.005
PMID:30196844
Abstract

AIMS

New targeted drugs and immune therapies reported since 2010 for metastatic or unresectable melanoma (MM) have shown improved survival in randomised trials. We studied the uptake of these new drugs and their impact on population-based survival.

MATERIALS AND METHODS

This was a retrospective, population-based cohort study of all patients treated for MM in Ontario 2007-2015. Provincial administrative sources covering the whole population identified palliative systemic therapy, radiotherapy and metastasis surgery. Temporal trends in utilisation and survival were investigated, as was survival of treatments predefined as 'new drugs' (BRAF or MEK inhibitors, anti-CTLA4 and anti-PD-1 antibodies).

RESULTS

We identified 2793 treated MM patients. First treatment was systemic therapy (46%), radiotherapy (41%) and metastasis surgery (14%). Systemic treatment increased from 53% of patients (2007) to 75% (2015). New drug treatments increased from <6% of known first-line regimens in 2007 to 82% in 2015. One and 2 year overall survival was 28% and 15%, respectively, for all MM 2007-2009, rising to 46% and 35% for 2014-2015 (adjusted hazard ratio 0.56, 95% confidence interval 0.49-0.63, P < 0.0001). Survival gains were observed primarily among those cases initially treated with systemic therapy, which became dominated by the use of new drugs over the study period (2 year overall survival 16% 2007-2009 versus 44% 2014-2015; adjusted hazard ratio 0.46, 95% confidence interval 0.38-0.56, P < 0.0001).

CONCLUSIONS

Utilisation of new targeted drugs and immune therapies for MM has increased considerably in routine practice 2007-2015. Consistent with the results of clinical trials, adoption was associated with substantial increases in survival of patients in the general population.

摘要

目的

自 2010 年以来,针对转移性或不可切除黑色素瘤(MM)的新型靶向药物和免疫疗法在随机试验中显示出了改善生存的效果。我们研究了这些新型药物的应用情况及其对基于人群的生存率的影响。

材料和方法

这是一项回顾性、基于人群的队列研究,研究对象为 2007 年至 2015 年期间在安大略省接受 MM 治疗的所有患者。涵盖整个人群的省级行政来源确定了姑息性全身治疗、放疗和转移手术。研究了治疗方法的利用趋势和生存率,以及被定义为“新药”的治疗方法(BRAF 或 MEK 抑制剂、抗 CTLA4 和抗 PD-1 抗体)的生存率。

结果

我们确定了 2793 名接受治疗的 MM 患者。初次治疗为全身治疗(46%)、放疗(41%)和转移手术(14%)。全身治疗的比例从 2007 年的 53%增加到 2015 年的 75%。新型药物治疗从 2007 年已知一线方案的<6%增加到 2015 年的 82%。2007-2009 年所有 MM 的 1 年和 2 年总生存率分别为 28%和 15%,而 2014-2015 年则分别上升至 46%和 35%(调整后的危险比为 0.56,95%置信区间为 0.49-0.63,P<0.0001)。生存率的提高主要见于最初接受全身治疗的患者,在研究期间,新型药物的应用逐渐成为主导(2 年总生存率:2007-2009 年为 16%,2014-2015 年为 44%;调整后的危险比为 0.46,95%置信区间为 0.38-0.56,P<0.0001)。

结论

自 2007 年至 2015 年,新型靶向药物和免疫疗法在 MM 的常规治疗中得到了广泛应用。与临床试验的结果一致,采用这些疗法与普通人群中患者生存率的显著提高有关。

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