Fukuda Kuniaki, Okumura Toshiyuki, Abei Masato, Fukumitsu Nobuyoshi, Ishige Kazunori, Mizumoto Masashi, Hasegawa Naoyuki, Numajiri Haruko, Ohnishi Kayoko, Ishikawa Hitoshi, Tsuboi Koji, Sakurai Hideyuki, Hyodo Ichinosuke
Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
Department of Radiation Oncology and Proton Medical Research Center, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
Cancer Sci. 2017 Mar;108(3):497-503. doi: 10.1111/cas.13145.
Long-term efficacy of proton beam therapy (PBT) remains unclear for patients with previously untreated hepatocellular carcinoma (HCC). We aimed to study the long-term outcomes of PBT according to Barcelona Clinic Liver Cancer (BCLC) staging classifications in patients with previously untreated HCC. The major eligibility criteria of this observational study were an Eastern Cooperative Oncology Group performance status (PS) 0-2, Child-Pugh grade A or B, previously untreated HCC covered within an irradiation field, and no massive ascites. A total of 66.0-77.0 GyE was administered in 10-35 fractions. Local tumor control (LTC), defined as no progression in the irradiated field, progression-free survival (PFS), and overall survival (OS) were assessed according to BCLC staging. From 2002 to 2009 at our institution, 129 patients were eligible. The 5-year LTC, PFS, and OS rates were 94%, 28%, and 69% for patients with 0/A stage disease (n = 9/21), 87%, 23%, and 66% for patients with B stage disease (n = 34), and 75%, 9%, and 25% for patients with C stage disease (n = 65), respectively. The 5-year LTC and OS rates of 15 patients with tumor thrombi in major vessels were 90% and 34%, respectively. Multivariate analyses revealed that PS (0 versus 1-2) was a significant prognostic factor for OS. No grade 3 or higher adverse effects were observed. PBT showed favorable long-term efficacies with mild adverse effects in BCLC stage 0 to C, and can be an alternative treatment for localized HCC especially when accompanied with tumor thrombi. This study was registered with UMIN Clinical Trials Registry (UMIN000025342).
对于先前未经治疗的肝细胞癌（HCC）患者，质子束治疗（PBT）的长期疗效尚不清楚。我们旨在根据巴塞罗那临床肝癌（BCLC）分期分类研究PBT对先前未经治疗的HCC患者的长期疗效。这项观察性研究的主要纳入标准为东部肿瘤协作组（ECOG）体能状态（PS）0 - 2、Child-Pugh A或B级、先前未经治疗且位于照射野内的HCC以及无大量腹水。总共给予66.0 - 77.0 GyE，分10 - 35次照射。根据BCLC分期评估局部肿瘤控制（LTC，定义为照射野内无进展）、无进展生存期（PFS）和总生存期（OS）。2002年至2009年在我们机构，129例患者符合条件。0/A期疾病患者（n = 9/21）的5年LTC、PFS和OS率分别为94%、28%和69%，B期疾病患者（n = 34）分别为87%、23%和66%，C期疾病患者（n = 65）分别为75%、9%和25%。15例大血管内有肿瘤血栓的患者的5年LTC和OS率分别为90%和34%。多因素分析显示PS（0对比1 - 2）是OS的显著预后因素。未观察到3级或更高级别的不良反应。PBT在BCLC 0至C期显示出良好的长期疗效且不良反应轻微，对于局限性HCC尤其是伴有肿瘤血栓时可作为一种替代治疗方法。本研究已在日本大学医学情报网络（UMIN）临床试验注册中心注册（UMIN000025342）。
