肺癌脊柱转移患者手术与非手术治疗的结局：一项前瞻性队列研究方案

The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study.

作者信息

Hu Panpan, Zhai Shuheng, Liu Xiaoxie, Chu Hongling, Wei Feng

机构信息

Department of Orthopedics, Peking University Third Hospital, Beijing, China.

Engineering Research Center of Bone and Joint Precision Medicine, Peking University Third Hospital, Beijing, China.

出版信息

JMIR Res Protoc. 2023 Jan 30;12:e38273. doi: 10.2196/38273.

DOI:10.2196/38273

PMID:36716088

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9926339/

Abstract

BACKGROUND

Spinal metastases of lung cancer (SMLC) usually have a high degree of malignancy and require multimodality treatment. Patients with SMLC who experience clinical symptoms (eg, local pain, emerging or potential spinal instability, and progressive neurological dysfunction) require surgical treatment. However, there are discrepancies in the comparison of outcomes between surgical treatment and nonsurgical treatment.

OBJECTIVE

This paper presents the protocol for a study that aims to compare the clinical outcomes of surgical treatment and nonsurgical treatment for SMLC, explore the prognostic factors of SMLC, and establish a survival prediction model based on these prognostic factors.

METHODS

This is a prospective cohort study, with an anticipated sample size of 240 patients (120 patients in the surgical group and 120 patients in the nonsurgical group). We will collect baseline data, including demographic, clinical, and radiological information, as well as data from patient-reported questionnaires. Patients will be followed up at 3, 6, 12, and 24 months after treatment, and survival status will be assessed every 3 months. The primary outcome is the overall survival period. Prognostic factors associated with overall survival will be analyzed by univariate and multivariate Cox proportional hazards regression. Odds ratios with 95% CIs will be presented. Statistical significance is set at P<.05.

RESULTS

This study has been approved by our institute's Medical Science Research Ethics Committee (IRB00006761-M2021085) after a careful audit of the design and content. Patient enrollment began in June 2022 at our hospital. Data collection is expected to be completed by early 2026, and the study results will be published by mid-2027.

CONCLUSIONS

In this study, we propose to set up a prospective cohort of patients with SMLC to investigate the outcomes between surgical treatment and nonsurgical treatment. We will explore the role of surgical treatment in SMLC and provide guidance to peer surgeons.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR2100048151; http://www.chictr.org.cn/showproj.aspx?proj=129450.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38273.

摘要

背景

肺癌脊柱转移（SMLC）通常具有高度恶性，需要多模式治疗。出现临床症状（如局部疼痛、新发或潜在脊柱不稳定以及进行性神经功能障碍）的SMLC患者需要手术治疗。然而，手术治疗与非手术治疗的疗效比较存在差异。

目的

本文介绍一项研究方案，旨在比较SMLC手术治疗与非手术治疗的临床疗效，探索SMLC的预后因素，并基于这些预后因素建立生存预测模型。

方法

这是一项前瞻性队列研究，预期样本量为240例患者（手术组120例患者，非手术组120例患者）。我们将收集基线数据，包括人口统计学、临床和放射学信息，以及患者报告问卷的数据。患者将在治疗后3、6、12和24个月进行随访，每3个月评估生存状态。主要结局是总生存期。将通过单因素和多因素Cox比例风险回归分析与总生存期相关的预后因素。将呈现具有95%置信区间的比值比。统计学显著性设定为P<0.05。