Introduction While combination of stereotactic body radiotherapy (SBRT) and immunotherapy are promising, their efficacy and safety have not been compared with SBRT-alone in patients with unresectable hepatocellular carcinoma (HCC). Methods This retrospective study included 100 patients with nonmetastatic, unresectable HCC in two hospitals. Eligible patients had tumor nodules ≤3 and Child-Pugh liver function score of A5 to B7. Seventy patients received SBRT-alone, and 30 patients underwent combined SBRT and immunotherapy (SBRT-IO). Overall survival (OS), time to progression (TTP), overall response rate (ORR), and toxicity were analyzed. We adjusted for the potential confounding factors using propensity score matching. Results The median tumor size was 7.3 cm (range, 2.6-18 cm). Twenty-five (25%) of patients had vascular invasion. Before propensity score matching, the 1-year and 3-year OS rate was 89.9% and 59.8% in the SBRT-IO group and 75.7% and 42.3% in SBRT-alone group (p = 0.039). After propensity score matching (1:2), 25 and 50 patients were selected from the SBRT-IO and SBRT-alone group. The 1-year and 3-year OS was 92.0% and 63.9% in the SBRT-IO group versus 74.0% and 43.3% in the SBRT-alone group (p = 0.034). The 1-year and 3-year TTP was better in SBRT-IO group (1-year: 68.9% vs. 58.9% and 3-year: 61.3% vs. 32.5%, p = 0.057). The ORR of 88% (complete response [CR]: 56%, partial response [PR]: 22%) in SBRT-IO arm was significantly better than 50% (CR: 20%, PR: 30%) in the SBRT-alone arm (p = 0.006). Three patients (12%) developed ≥grade 3 immune-related treatment adverse events (n = 2 hepatitis, n = 1 dermatitis) leading to permanent treatment discontinuation. Conclusion Adding immunotherapy to SBRT resulted in better survival with manageable toxicities. Prospective randomized trial is warranted.

中文翻译：

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立体定向全身放射治疗和免疫治疗 (SBRT-IO) 与单独 SBRT 在不可切除的肝细胞癌中的生存结果分析。


简介 虽然立体定向全身放射治疗 (SBRT) 和免疫治疗相结合的前景广阔，但在不可切除的肝细胞癌 (HCC) 患者中，其疗效和安全性尚未与单独 SBRT 进行比较。方法 这项回顾性研究纳入了两家医院的 100 名非转移性、不可切除的 HCC 患者。符合条件的患者肿瘤结节≤3个且Child-Pugh肝功能评分为A5至B7。 70 名患者接受单独 SBRT，30 名患者接受 SBRT 联合免疫治疗 (SBRT-IO)。分析了总生存期（OS）、进展时间（TTP）、总缓解率（ORR）和毒性。我们使用倾向得分匹配来调整潜在的混杂因素。结果肿瘤中位大小为7.3 cm（范围2.6-18 cm）。二十五名 (25%) 患者有血管侵犯。在倾向评分匹配之前，SBRT-IO 组的 1 年和 3 年 OS 率分别为 89.9% 和 59.8%，单独 SBRT 组分别为 75.7% 和 42.3% (p = 0.039)。经过倾向评分匹配（1:2）后，从 SBRT-IO 组和单独 SBRT 组中分别选出 25 名和 50 名患者。 SBRT-IO 组的 1 年和 3 年 OS 分别为 92.0% 和 63.9%，而单独 SBRT 组分别为 74.0% 和 43.3% (p = 0.034)。 SBRT-IO 组的 1 年和 3 年 TTP 较好（1 年：68.9% vs. 58.9%，3 年：61.3% vs. 32.5%，p = 0.057）。 SBRT-IO 组的 ORR 为 88%（完全缓解 [CR]：56%，部分缓解 [PR]：22%），显着优于 SBRT-IO 组的 50%（CR：20%，PR：30%）。单臂（p = 0.006）。三名患者 (12%) 出现 ≥ 3 级免疫相关治疗不良事件（n = 2 例肝炎，n = 1 例皮炎），导致永久停止治疗。结论 在 SBRT 的基础上添加免疫治疗可提高生存率，且毒性可控。 前瞻性随机试验是必要的。