Introduction: Prospective evidence supporting the safety and efficacy of carbon-ion radiotherapy (C-ion RT) for hepatocellular carcinoma (HCC) remains lacking. This prospective study aimed to evaluate the safety and efficacy of hypofractionated C-ion RT in patients with HCC. Methods: The inclusion criteria were as follows: (1) pathologically or clinically diagnosed HCC; (2) measurable tumor and tumor size ≤10 cm; (3) absence of major vascular invasion; (4) no extrahepatic metastasis; (5) the alimentary tract was not adjacent to the target lesion (#x3e;1 cm); (6) not suitable for or refusal to undergo surgery or local ablative therapies; (7) an interval ≥4 weeks from previous therapy; (8) no other intrahepatic lesion or at least 2 years after the previous curative therapy; (9) performance status score, 0–2; and (10) Child-Pugh score, 5–9. The prescribed C-ion RT dose was 52.8 Gy (relative biological effectiveness [RBE]) or 60.0 Gy (RBE) in 4 fractions. Results: In total, 35 patients with HCC were enrolled between October 2010 and May 2016. The median follow-up durations in the survivor group (n = 23) and in the whole cohort were 55.1 and 49.0 months, respectively. The 2-, 3-, and 4-year overall survival rates were 82.8%, 76.7%, and 69.4%, respectively. The 2-, 3-, and 4-year local control (LC) rates were 92.6%, 76.5%, and 76.5%, respectively. The median time-to-progression was 25.6 months (95% confidence interval, 13.7–37.5 months). Grade 4 or 5 toxicities were not observed. Grade 3 acute and late toxicities were observed in 2 patients. There was no significant deterioration in serum albumin, bilirubin, prothrombin time-international normalized ratio, platelet count, or Child-Pugh score after C-ion RT. Conclusion: Four fractions of C-ion RT for HCC did not yield serious adverse events and showed promising LC, thus making it a safe and effective modality for this type of malignancy.
Liver Cancer

中文翻译：

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4 次碳离子放射治疗肝细胞癌的疗效和安全性：一项前瞻性研究

引言：支持碳离子放疗 (C-ion RT) 治疗肝细胞癌 (HCC) 的安全性和有效性的前瞻性证据仍然缺乏。这项前瞻性研究旨在评估大分割 C 离子放疗在 HCC 患者中的安全性和有效性。方法：纳入标准如下：（1）病理或临床诊断为HCC；(2)可测量肿瘤且肿瘤大小≤10 cm；(3) 无大血管侵犯；(4)无肝外转移；(5) 消化道与目标病灶不相邻（#x3e;1 cm）；（六）不适合或拒绝接受手术或局部消融治疗的；(7) 与先前治疗间隔≥4 周；(8) 无其他肝内病变或在既往治愈性治疗后至少 2 年；(9) 表现状态评分，0-2；(10) Child-Pugh 评分，5-9。规定的 C 离子 RT 剂量为 52.8 Gy（相对生物有效性 [RBE]）或 60.0 Gy (RBE)，分 4 次。结果：2010 年 10 月至 2016 年 5 月期间共有 35 名 HCC 患者入组。幸存者组（ n = 23）和整个队列的中位随访时间分别为 55.1 个月和 49.0 个月。2年、3年和4年总生存率分别为82.8%、76.7%和69.4%。2 年、3 年和 4 年局部控制 (LC) 率分别为 92.6%、76.5% 和 76.5%。中位进展时间为 25.6 个月（95% 置信区间，13.7-37.5 个月）。未观察到 4 级或 5 级毒性。在 2 名患者中观察到 3 级急性和晚期毒性。C离子放疗后血清白蛋白、胆红素、凝血酶原时间-国际标准化比值、血小板计数或Child-Pugh评分没有显着恶化。结论：HCC 的四次 C 离子 RT 未产生严重的不良事件，并显示出有希望的 LC，因此使其成为此类恶性肿瘤的安全有效方式。
肝癌