简要报告：是否应重新评估既往癌症病史，将其作为参与临床试验的排除因素？

IF 4.5 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2024-11-15 DOI:10.1016/j.lungcan.2024.108032

Oluwaseun Ayoade , Maureen E. Canavan , Giorgio Caturegli , Daniel J. Boffa

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引用次数: 0

摘要

背景：临床试验旨在最大限度地减少可能影响患者预后的因素，而不局限于所研究的特定疾病和治疗方法；然而，排除既往癌症（PC）患者可能会影响研究结果的普遍性。我们试图利用国家癌症数据库创建一个近期 III 期和 IV 期非小细胞肺癌（NSCLC）免疫疗法试验的真实世界代理，以了解 PC 病史的相关性：2017年至2020年间确诊的患者按是否有既往癌症病史进行分层，并进行倾向匹配，以比较接受免疫疗法和未接受免疫疗法的患者。我们使用卡普兰-梅耶尔分析和考克斯比例危险模型分析了总生存率：结果：无论III期NSCLC患者有PC病史（HR）：0.65（95% CI 0.59，0.71）还是无PC病史（HR：0.69 95% CI：0.66，0.72），在化疗和放疗方案中加入免疫疗法均可提高生存率。对于有PC病史（HR：0.78 95% CI：0.72, 0.85）或无PC病史（HR：0.75 95% CI：0.73, 0.78）的IV期患者，增加免疫疗法也与较高的生存率相关：讨论：对两种改变实践的试验方案的实际治疗效果的研究发现，无论患者是否有PC病史，创新治疗方法都更胜一筹。二次恶性肿瘤的风险是改进癌症治疗的一个现实问题，因此，为了根据患者的个人和肿瘤属性对其进行个体化治疗，需要将癌症幸存者纳入试验中。

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Brief Report: Should a prior cancer history be reevaluated as an exclusion for clinical trial participation?

Background

Clinical trials are designed to minimize factors capable of influencing patient outcomes beyond the specific diseases and treatments being studied; however, exclusion of prior cancer (PC) patients could potentially affect the generalizability of study results. We attempted to create a real-world proxy of recent immunotherapy trials in stage III and IV Non-Small Cell Lung Cancer (NSCLC) to understand the relevance of a PC history using the National Cancer Database.

Methods

Patients diagnosed between 2017 and 2020 were stratified by the presence of a prior cancer history and propensity matched to compare receipt of immunotherapy with those who did not. We analyzed overall survival using Kaplan Meier analysis and Cox proportional hazards models.

Results

The addition of immunotherapy to a regimen of chemotherapy and radiation was associated with superior survival whether stage III NSCLC patients had a PC history (HR): 0.65 (95% CI 0.59, 0.71) or had no PC history (HR:0.69 95% CI: 0.66, 0.72). The addition of immunotherapy was also associated with superior survival for stage IV patients with a PC history (HR) 0.78 95% CI 0.72, 0.85) or without PC history (HR:0.75 95% CI: 0.73, 0.78).

Discussion

Examination of real-world outcomes of two practice-changing trial regimens found the innovative treatment approach to be superior, regardless of patient PC history. Risk for a second malignancy is a reality of improving cancer treatment, thus, to individualize treatment for patients based on their personal and tumor attributes, cancer survivors will need to be included in trials.

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.