肝细胞癌局部治疗加免疫疗法的完全应答。

IF 22.5 1区 医学 Q1 ONCOLOGY JAMA Oncology Pub Date : 2024-09-26 DOI:10.1001/jamaoncol.2024.4085
Chi Leung Chiang,Kenneth Sik Kwan Chan,Keith Wan Hang Chiu,Francis Ann Shing Lee,Wenqi Chen,Natalie Sean Man Wong,Ryan Lok Man Ho,Venus Wan Yan Lee,Kwan Man,Feng Ming Spring Kong,Albert Chi Yan Chan
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However, data on predictors of CR and long-term clinical outcomes without surgery and after discontinuation of IO are lacking.\r\n\r\nObjective\r\nTo assess the long-term clinical outcomes among patients with unresectable HCC who achieved CR after LRT-IO and were placed on a watch-and-wait protocol.\r\n\r\nDesign, Setting, and Participants\r\nThis cohort study included patients with unresectable HCC who achieved CR after LRT-IO in 2 prospective studies between January 2018 and December 2022. The time of data cutoff was June 2023. Radiologic CR was defined per modified Response Evaluation Criteria in Solid Tumors. All patients underwent close surveillance after CR without surgical interventions, and IO was discontinued.\r\n\r\nExposure\r\nAll patients had received stereotactic body radiotherapy followed by anti-programmed cell death protein 1 or anti-programmed death ligand 1 therapy. Forty-nine patients had received a dose of transarterial chemoembolization before stereotactic body radiotherapy.\r\n\r\nMain Outcomes and Measures\r\nThe primary outcome was the 3-year overall survival (OS) rate. Secondary outcomes included the 3-year time-to-progression rate, 3-year local control rate, and relapse pattern. Factors associated with CR were analyzed using multivariate analyses.\r\n\r\nResults\r\nA total of 63 patients were enrolled (58 male [92.1%]; median age, 69 years [range, 18-90 years]); 38 patients (60.3%) had macrovascular invasion, and the median tumor diameter was 10 cm (range, 3.8-31.1 cm). The median follow-up time was 34.7 months (95% CI, 6.5-64.6 months). Twenty-nine patients (46.0%) achieved CR. The patients achieving CR had a significantly better 3-year OS rate than patients not achieving CR (75.5% [95% CI, 58.2%-98.3%] vs 28.1% [95% CI, 7.4%-29.4%]; P < .001). Among the 29 patients with CR, the 3-year time-to-progression rate was 58.7% (95% CI, 38.7%-79.1%) and the 3-year local control rate was 90.5% (95% CI, 78.2%-100%). Ten patients (34.5%) developed recurrence; among them, 6 (60.0%) with solitary intrahepatic disease relapse underwent curative surgical treatment. The absence of tumor vascular invasion (odds ratio, 0.30; 95% CI, 0.10-0.89) and the sum of the largest lesion diameters of 8 cm or less (odds ratio, 0.26; 95% CI, 0.07-0.98) were associated with CR.\r\n\r\nConclusions and Relevance\r\nThis cohort study of LRT-IO with long-term follow-up data found a durable response in patients with locally advanced unresectable HCC. Long-term survival was attainable in patients with radiologic CR. 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引用次数: 0

摘要

重要性以往的研究表明,42%到50%的局部晚期肝细胞癌(HCC)患者在联合局部区域治疗(LRT)加免疫治疗(IO)后获得了完全缓解(CR)。然而,关于CR的预测因素以及不手术和停用IO后的长期临床结果的数据尚缺乏。目的评估在LRT-IO后达到CR并被置于观察和等待方案的不可切除HCC患者的长期临床结果。设计、设置和参与者这项队列研究纳入了2018年1月至2022年12月期间在2项前瞻性研究中LRT-IO后达到CR的不可切除HCC患者。数据截止时间为 2023 年 6 月。放射学 CR 根据修改后的实体瘤反应评价标准进行定义。所有患者均接受过立体定向体放疗,随后接受了抗程序性细胞死亡蛋白1或抗程序性死亡配体1治疗。主要结果和测量指标主要结果是3年总生存率(OS)。次要结果包括3年进展时间率、3年局部控制率和复发模式。结果共有63名患者入选(58名男性[92.1%];中位年龄69岁[18-90岁]);38名患者(60.3%)有大血管侵犯,中位肿瘤直径为10厘米(3.8-31.1厘米)。中位随访时间为 34.7 个月(95% CI,6.5-64.6 个月)。29名患者(46.0%)达到了CR。获得 CR 的患者的 3 年 OS 率明显高于未获得 CR 的患者(75.5% [95% CI, 58.2%-98.3%] vs 28.1% [95% CI, 7.4%-29.4%]; P < .001)。在 29 名获得 CR 的患者中,3 年进展时间率为 58.7%(95% CI,38.7%-79.1%),3 年局部控制率为 90.5%(95% CI,78.2%-100%)。10名患者(34.5%)复发,其中6名(60.0%)肝内单发复发患者接受了根治性手术治疗。无肿瘤血管侵犯(几率比 0.30;95% CI,0.10-0.89)和最大病灶直径之和小于或等于 8 厘米(几率比 0.26;95% CI,0.07-0.98)与 CR 相关。放射学 CR 患者可获得长期生存。有必要进一步开展随机临床试验。
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Complete Response to Locoregional Therapy Plus Immunotherapy for Hepatocellular Carcinoma.
Importance Previous studies showed that 42% to 50% of patients with locally advanced hepatocellular carcinoma (HCC) achieved complete remission (CR) after combined locoregional therapy (LRT) plus immunotherapy (IO). However, data on predictors of CR and long-term clinical outcomes without surgery and after discontinuation of IO are lacking. Objective To assess the long-term clinical outcomes among patients with unresectable HCC who achieved CR after LRT-IO and were placed on a watch-and-wait protocol. Design, Setting, and Participants This cohort study included patients with unresectable HCC who achieved CR after LRT-IO in 2 prospective studies between January 2018 and December 2022. The time of data cutoff was June 2023. Radiologic CR was defined per modified Response Evaluation Criteria in Solid Tumors. All patients underwent close surveillance after CR without surgical interventions, and IO was discontinued. Exposure All patients had received stereotactic body radiotherapy followed by anti-programmed cell death protein 1 or anti-programmed death ligand 1 therapy. Forty-nine patients had received a dose of transarterial chemoembolization before stereotactic body radiotherapy. Main Outcomes and Measures The primary outcome was the 3-year overall survival (OS) rate. Secondary outcomes included the 3-year time-to-progression rate, 3-year local control rate, and relapse pattern. Factors associated with CR were analyzed using multivariate analyses. Results A total of 63 patients were enrolled (58 male [92.1%]; median age, 69 years [range, 18-90 years]); 38 patients (60.3%) had macrovascular invasion, and the median tumor diameter was 10 cm (range, 3.8-31.1 cm). The median follow-up time was 34.7 months (95% CI, 6.5-64.6 months). Twenty-nine patients (46.0%) achieved CR. The patients achieving CR had a significantly better 3-year OS rate than patients not achieving CR (75.5% [95% CI, 58.2%-98.3%] vs 28.1% [95% CI, 7.4%-29.4%]; P < .001). Among the 29 patients with CR, the 3-year time-to-progression rate was 58.7% (95% CI, 38.7%-79.1%) and the 3-year local control rate was 90.5% (95% CI, 78.2%-100%). Ten patients (34.5%) developed recurrence; among them, 6 (60.0%) with solitary intrahepatic disease relapse underwent curative surgical treatment. The absence of tumor vascular invasion (odds ratio, 0.30; 95% CI, 0.10-0.89) and the sum of the largest lesion diameters of 8 cm or less (odds ratio, 0.26; 95% CI, 0.07-0.98) were associated with CR. Conclusions and Relevance This cohort study of LRT-IO with long-term follow-up data found a durable response in patients with locally advanced unresectable HCC. Long-term survival was attainable in patients with radiologic CR. Further randomized clinical trials are warranted.
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来源期刊
JAMA Oncology
JAMA Oncology Medicine-Oncology
自引率
1.80%
发文量
423
期刊介绍: JAMA Oncology is an international peer-reviewed journal that serves as the leading publication for scientists, clinicians, and trainees working in the field of oncology. It is part of the JAMA Network, a collection of peer-reviewed medical and specialty publications.
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