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影响肝细胞癌患者经动脉放射性栓塞术后生存的因素:前瞻性CIRT研究结果

Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study.

作者信息

Kolligs Frank, Arnold Dirk, Golfieri Rita, Pech Maciej, Peynircioglu Bora, Pfammatter Thomas, Ronot Maxime, Sangro Bruno, Schaefer Niklaus, Maleux Geert, Munneke Graham, Pereira Helena, Zeka Bleranda, de Jong Niels, Helmberger Thomas

机构信息

Department of Internal Medicine and Gastroenterology, Helios Klinikum Berlin-Buch, Berlin, Germany.

Oncology and Hematology, Asklepios Tumorzentrum Hamburg, AK Altona, Hamburg, Germany.

出版信息

JHEP Rep. 2022 Nov 25;5(2):100633. doi: 10.1016/j.jhepr.2022.100633. eCollection 2023 Feb.

Abstract

BACKGROUND & AIMS: Transarterial radioembolization (TARE) with Yttrium-90 resin microspheres is an established treatment option for patients with hepatocellular carcinoma (HCC). However, optimising treatment application and patient selection remains challenging. We report here on the effectiveness, safety and prognostic factors, including dosing methods, associated with TARE for HCC in the prospective observational CIRT study.

METHODS

We analysed 422 patients with HCC enrolled between Jan 2015 and Dec 2017, with follow-up visits every 3 months for up to 24 months after first TARE. Patient characteristics and treatment-related data were collected at baseline; adverse events and time-to-event data (overall survival [OS], progression-free survival [PFS] and hepatic PFS) were collected at every 3-month follow-up visit. We used the multivariable Cox proportional hazard model and propensity score matching to identify independent prognostic factors for effectiveness outcomes.

RESULTS

The median OS was 16.5 months, the median PFS was 6.1 months, and the median hepatic PFS was 6.7 months. Partition model dosimetry resulted in improved OS compared to body surface area calculations on multivariable analysis (hazard ratio 0.65; 95% CI 0.46-0.92;  = 0.0144), which was confirmed in the exact matching propensity score analysis (hazard ratio 0.56; 95% CI 0.35-0.89; 0.0136). Other independent prognostic factors for OS were ECOG-performance status >0 ( 0.0018), presence of ascites ( 0.0152), right-sided tumours ( 0.0002), the presence of portal vein thrombosis ( 0.0378) and main portal vein thrombosis ( 0.0028), ALBI grade 2 ( 0.0043) and 3 ( 0.0014). Adverse events were recorded in 36.7% of patients, with 9.7% of patients experiencing grade 3 or higher adverse events.

CONCLUSIONS

This large prospective observational dataset shows that TARE is an effective and safe treatment in patients with HCC. Using partition model dosimetry was associated with a significant improvement in survival outcomes.

IMPACT AND IMPLICATIONS

Transarterial radioembolization (TARE) is a form of localised radiation therapy and is a potential treatment option for primary liver cancer. We observed how TARE was used in real-life clinical practice in various European countries and if any factors predict how well the treatment performs. We found that when a more complex but personalised method to calculate the applied radiation activity was used, the patient responded better than when a more generic method was used. Furthermore, we identified that general patient health, ascites and liver function can predict outcomes after TARE.

CLINICAL TRIAL NUMBER

NCT02305459.

摘要

背景与目的

使用钇-90树脂微球进行经动脉放射性栓塞术(TARE)是肝细胞癌(HCC)患者既定的治疗选择。然而,优化治疗应用和患者选择仍然具有挑战性。我们在此报告前瞻性观察性CIRT研究中与TARE治疗HCC相关的有效性、安全性和预后因素,包括给药方法。

方法

我们分析了2015年1月至2017年12月期间入组的422例HCC患者,首次TARE后每3个月进行随访,最长随访24个月。在基线时收集患者特征和治疗相关数据;在每3个月的随访中收集不良事件和事件发生时间数据(总生存期[OS]、无进展生存期[PFS]和肝脏无进展生存期)。我们使用多变量Cox比例风险模型和倾向评分匹配来确定有效性结局的独立预后因素。

结果

中位OS为16.5个月,中位PFS为6.1个月,中位肝脏PFS为6.7个月。多变量分析显示,与基于体表面积计算相比,分区模型剂量测定法可改善OS(风险比0.65;95%CI 0.46-0.92;P = 0.0144),精确匹配倾向评分分析也证实了这一点(风险比0.56;95%CI 0.35-0.89;P = 0.0136)。OS的其他独立预后因素包括东部肿瘤协作组(ECOG)体能状态>0(P = 0.0018)、腹水的存在(P = 0.0152)、右侧肿瘤(P = 0.0002)、门静脉血栓形成(P = 0.0378)和主门静脉血栓形成(P = 0.0028)、ALBI 2级(P = 0.0043)和3级(P = 0.0014)。36.7%的患者记录了不良事件,9.7%的患者经历了3级或更高等级的不良事件。

结论

这个大型前瞻性观察数据集表明,TARE是HCC患者一种有效且安全的治疗方法。使用分区模型剂量测定法与生存结局的显著改善相关。

影响与意义

经动脉放射性栓塞术(TARE)是一种局部放射治疗形式,是原发性肝癌的一种潜在治疗选择。我们观察了TARE在欧洲各国现实临床实践中的应用情况,以及是否有任何因素可预测该治疗的效果。我们发现,当使用更复杂但个性化的方法来计算应用的放射活性时,患者的反应比使用更通用的方法时更好。此外,我们确定患者的总体健康状况、腹水和肝功能可以预测TARE后的结局。

临床试验编号

NCT02305459。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eabf/9804139/bae7c1e4f2eb/ga1.jpg

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