A prospective single-arm study of the efficacy and safety of lobaplatin-based HIPEC combined with optimal support in the treatment of abdominal metastatic cancer

Zhui KE; Jie GAO; Jingyi LU; Xinpei LUO; Xuemin HE; Zhuqing LIU; Min YUAN; Xianling GUO; Qing XU

doi:10.19401/j.cnki.1007-3639.2024.12.006

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A prospective single-arm study of the efficacy and safety of lobaplatin-based HIPEC combined with optimal support in the treatment of abdominal metastatic cancer

Article | 更新时间：2025-12-31

- A prospective single-arm study of the efficacy and safety of lobaplatin-based HIPEC combined with optimal support in the treatment of abdominal metastatic cancer
- China Oncology Vol. 34, Issue 12, Pages: 1115-1122(2024)
- 作者机构：
  
  同济大学附属第十人民医院肿瘤科，上海 200072
- 作者简介：
  
  XU Qing
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2024.12.006
  CLC：
- Received：03 October 2024，
  
  Published：30 December 2024
- 稿件说明：
移动端阅览
Zhui KE, Jie GAO, Jingyi LU, et al. A prospective single-arm study of the efficacy and safety of lobaplatin-based HIPEC combined with optimal support in the treatment of abdominal metastatic cancer[J]. China Oncology, 2024, 34(12): 1115-1122.
DOI：

Zhui KE, Jie GAO, Jingyi LU, et al. A prospective single-arm study of the efficacy and safety of lobaplatin-based HIPEC combined with optimal support in the treatment of abdominal metastatic cancer[J]. China Oncology, 2024, 34(12): 1115-1122. DOI： 10.19401/j.cnki.1007-3639.2024.12.006.

摘要

背景与目的：

洛铂作为一种传统的化疗药物，临床上应用广泛，近年来洛铂在腹腔热化疗领域的研究逐渐受到关注。本研究评价洛铂腹腔热灌注化疗在晚期腹腔转移癌中的疗效及安全性。

方法：

本研究收集2019年1月—2023年1月在上海市第十人民医院癌症中心就诊的晚期肿瘤伴恶性腹水的患者。对于不符合纳入标准的患者予以排除。本研究对纳入的患者的腹水量变化进行分析，评价腹腔热灌注治疗晚期腹腔转移癌的短期疗效。通过Kaplan-Meier法分析腹腔转移癌患者的长期生存。利用Pearson相关性分析评估治疗前后肿瘤标志物糖类抗原（carbohydrate 12-5，CA12-5）水平的相关性。患者的基线特征和治疗效果通过描述性统计呈现，同时采用显著性检验（

0.01）比较治疗前后肿瘤标志物的变化。数据录入与统计分析使用SPSS 26.0完成，图形化展示使用GraphPad Prism 10.4.0绘制生存曲线和疗效图表。本研究项目已获得上海市第十人民医院伦理委员会批准（伦理批准号：SHSY-IEC-5.0/24K134/P01）。本前瞻性单臂研究严格遵守临床试验报告的统一标准（Consolidated Standards of Reporting Trials，CONSORT）。

结果：

本研究共纳入21例符合入组标准的患者。患者的中位年龄为61岁（范围31~71岁）。21例患者中，5例（23.8%）实现完全缓解，5例（23.8%）实现部分缓解，8例（38.1%）病情稳定，3例（14.3%）病情进展。总体有效率为47.6%，疾病控制率为85.7%。生存分析显示，患者中位无进展生存期为12.33个月，中位总生存期为16.37个月。治疗前后的肿瘤标志物分析显示疗效与CA12-5的水平呈负相关（

0.01）。不良反应主要包括骨髓抑制、肝肾功能损伤及恶心呕吐。大多数不良反应为轻到中度。

结论：

洛铂腹腔热灌注治疗晚期胃肠道肿瘤恶性腹水患者疗效肯定，患者生存获益，安全性良好。CA12-5可能是预后不良的良好预测因素。

Abstract

Background and purpose:

Lobaplatin

as a traditional chemotherapeutic drug

is widely used in the treatment of malignant tumor. In recent years

its application in the field of hyperthermic intraperitoneal chemotherapy (HIPEC) has garnered increasing attention. This study evaluated the efficacy and safety of lobaplatin-based HIPEC in advanced abdominal metastatic cancer.

Methods:

This study collected data of pati

ents with advanced cancers and malignant ascites who treated in the Cancer Center of Shanghai Tenth People's Hospital

Tongji University School of Medicine

from January 2019 to January 2023. We excluded patients who did not meet the inclusion criteria. Short-term efficacy was assessed by changes in ascitic fluid volume

and long-term survival was analyzed using the Kaplan-Meier method. The correlation between CA12-5 levels before and after treatment was evaluated using Pearson correlation analysis. Baseline characteristics and treatment outcomes were described using descriptive statistics

and the changes in CA12-5 levels before and after treatment were compared using significance tests (

0.01). Data entry and statistical analyses were conducted using SPSS version 26.0

and survival curves and efficacy plots were generated with GraphPad Prism (10.4.0 version). The study was approved by the Ethics Committee of Shanghai Tenth People's Hospital (Ethics approval number: SHSY-IEC-5.0/24K134/P01). This prospective single-arm study strictly adhered to the guideline of Consolidated Standards of Reporting Trials (CONSORT) checklist.

Results:

A total of 21 patients were enrolled in this study. The median age of the patients was 61 years (ranging from 31 to 71 years). Among the 21 patients

5 (23.8%) achieved complete remission (CR)

5 (23.8%) achieved partial remission (PR)

8 (38.1%) had stable disease (SD)

and 3 (14.3%) experienced disease progression (PD). The overall response rate (ORR) was 47.6%

and the disease control rate (DCR) was 85.7%. Survival analysis revealed a median progression-free survival (PFS) of 12.33 months and a median overall survival (OS) of 16.37 months. Analysis of tumor markers showed a significant negative correlation between efficacy and CA12-5 levels (

0.01). Adverse reactions primarily included myelosuppression

hepatic and renal impairment

and nausea and vomiting

with most adverse events being mild to moderate.

Conclusion:

Lobaplatin-based HIPEC is effective in the treatment of advanced gastrointestinal malignancies with malignant ascites

providing survival benefits and demonstrating good safety. CA12-5 may serve as a valuable predictor of poor prognosis.

关键词

Keywords

references

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