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支气管动脉灌注化疗与 CalliSpheres 载药微球在 II-IV 期肺癌患者中的临床疗效:一项前瞻性队列研究。

Clinical effect of bronchial arterial infusion chemotherapy and CalliSpheres drug-eluting beads in patients with stage II-IV lung cancer: A prospective cohort study.

机构信息

Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.

Shandong Medical Imaging Research Institute Affiliated to Shandong University, Jinan, China.

出版信息

Thorac Cancer. 2020 Aug;11(8):2155-2162. doi: 10.1111/1759-7714.13522. Epub 2020 Jun 30.

Abstract

BACKGROUND

CalliSpheres are drug-eluting beads used for tumor artery embolization, with clinical benefits in a number of cancer types. The aim of the study was to examine the clinical benefits and complications of patients with stage II-IV lung cancer treated with CalliSpheres drug-eluting beads for embolization versus conventional vascular interventional treatment.

METHODS

This was a prospective cohort study conducted from August 2018 to May 2019. The patients were grouped according to traditional bronchial arterial infusion chemotherapy (infusion group) or bronchial arterial chemoembolization with CalliSpheres drug-eluting beads loaded with adriamycin (CallisSphere group). Short-term effects, serum tumor markers, and adverse reactions during follow-up were compared between the two groups.

RESULTS

There were 60 participants enrolled into the study with 30 in each group including 54 men and six women, 42-78 years of age. In the CalliSphere group, compared with the infusion group, the disease control rate was 93.3% versus 73.3% (P = 0.080) and the objective remission rate (ORR) was 86.7% versus 60.0% (P = 0.039); the three- and six-month progression-free survival (PFS) and six-month overall survival (OS) were better in the CalliSphere group (three-month PFS: 96.7% vs. 73.3%, P = 0.026; six-month PFS: 87.5% vs. 57.1%, P = 0.045; six-month OS: 87.5% vs. 52.7%, P = 0.024); after treatment, the tumor markers in the CalliSphere group were lower (CEA: P < 0.001; CYFRA21-1: P = 0.014). There were no differences in adverse reactions between the two groups.

CONCLUSIONS

The clinical effect of bronchial arterial chemoembolization with drug-eluting beads on lung cancer is probably significant and could improve the short-term response, PFS, and OS in patients with stage IIIV lung cancer, without increasing severe adverse reactions.

KEY POINTS

SIGNIFICANT FINDINGS OF THE STUDY: The clinical effect of bronchial arterial chemoembolization with drug-eluting beads on lung cancer is probably significant and could improve the short-term response, PFS, and OS in patients with stage II-IV lung cancer, without increasing severe adverse reactions.

WHAT THIS STUDY ADDS

The ORR, PFS, OS was better in the CalliSphere group than that of infusion group; CEA and CYFRA21-1 were significant lower in CalliSphere group.

摘要

背景

CalliSpheres 是一种用于肿瘤动脉栓塞的载药微球,在多种癌症类型中具有临床获益。本研究的目的是评估接受 CalliSpheres 载药微球栓塞与传统血管介入治疗的 II-IV 期肺癌患者的临床获益和并发症。

方法

这是一项前瞻性队列研究,于 2018 年 8 月至 2019 年 5 月进行。患者根据传统支气管动脉灌注化疗(灌注组)或载阿霉素的 CalliSpheres 载药微球支气管动脉化疗栓塞(CallisSphere 组)分组。比较两组患者的短期疗效、血清肿瘤标志物及随访期间的不良反应。

结果

共纳入 60 例患者,每组 30 例,包括 54 例男性和 6 例女性,年龄 42-78 岁。CalliSphere 组的疾病控制率为 93.3%,优于灌注组的 73.3%(P=0.080),客观缓解率(ORR)为 86.7%,优于灌注组的 60.0%(P=0.039);CalliSphere 组的 3 个月和 6 个月无进展生存期(PFS)和 6 个月总生存期(OS)更好(3 个月 PFS:96.7% vs. 73.3%,P=0.026;6 个月 PFS:87.5% vs. 57.1%,P=0.045;6 个月 OS:87.5% vs. 52.7%,P=0.024);治疗后,CalliSphere 组的肿瘤标志物水平更低(CEA:P<0.001;CYFRA21-1:P=0.014)。两组不良反应发生率无差异。

结论

支气管动脉化疗栓塞载药微球治疗肺癌的临床效果可能显著,并可改善 III-IV 期肺癌患者的短期反应、PFS 和 OS,而不增加严重不良反应。

重点

研究的重要发现:支气管动脉化疗栓塞载药微球治疗肺癌的临床效果可能显著,并可改善 II-IV 期肺癌患者的短期反应、PFS 和 OS,而不增加严重不良反应。

本研究的新增内容

CalliSphere 组的 ORR、PFS 和 OS 均优于灌注组;CalliSphere 组的 CEA 和 CYFRA21-1 显著降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a404/7396372/2072806fed35/TCA-11-2155-g001.jpg

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