Lee Mark T, Kim John J, Dinniwell Robert, Brierley James, Lockwood Gina, Wong Rebecca, Cummings Bernard, Ringash Jolie, Tse Regina V, Knox Jennifer J, Dawson Laura A
Radiation Medicine Program, Department of Biostatistics and Medical Oncology, Princess Margaret Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.
J Clin Oncol. 2009 Apr 1;27(10):1585-91. doi: 10.1200/JCO.2008.20.0600. Epub 2009 Mar 2.
To report on the outcomes of a phase I study of stereotactic body radiotherapy (SBRT) for treatment of liver metastases.
Patients with liver metastases that were inoperable or medically unsuitable for resection, and who were not candidates for standard therapies, were eligible for this phase I study of individualized SBRT. Individualized radiation doses were chosen to maintain the same nominal risk of radiation-induced liver disease (RILD) for three estimated risk levels (5%, 10%, and 20%). Additional patients were treated at the maximal study dose (MSD) in an expanded cohort. Median SBRT dose was 41.8 Gy (range, 27.7 to 60 Gy) in six fractions over 2 weeks.
Sixty-eight patients with inoperable colorectal (n = 40), breast (n = 12), or other (n = 16) liver metastases were treated. Median tumor volume was 75.2 mL (range, 1.19 to 3,090 mL). The highest RILD risk level investigated was safe, with no dose-limiting toxicity. Two grade 3 liver enzyme changes occurred, but no RILD or other grade 3 to 5 liver toxicity was seen, for a low estimated risk of serious liver toxicity (95% CI, 0 to 5.3%). Six (9%) acute grade 3 toxicities (two gastritis, two nausea, lethargy, and thrombocytopenia) and one (1%) grade 4 toxicity (thrombocytopenia) were seen. The 1-year local control rate was 71% (95 CI, 58% to 85%). The median overall survival was 17.6 months (95% CI, 10.4 to 38.1 months).
Individualized six-fraction liver metastases SBRT is safe, with sustained local control observed in the majority of patients.
报告立体定向体部放射治疗（SBRT）治疗肝转移瘤的I期研究结果。
肝转移瘤无法手术切除或因医学原因不宜切除且不适合标准治疗的患者， eligible for this phase I study of individualized SBRT。针对三个估计风险水平（5%、10%和20%）选择个体化放射剂量，以维持相同的放射性肝病（RILD）名义风险。在扩大队列中，额外的患者接受最大研究剂量（MSD）治疗。SBRT中位剂量为41.8 Gy（范围27.7至60 Gy），分六次在2周内给予。
68例无法手术切除的结直肠癌（n = 40）、乳腺癌（n = 12）或其他（n = 16）肝转移瘤患者接受了治疗。中位肿瘤体积为75.2 mL（范围1.19至3090 mL）。所研究的最高RILD风险水平是安全的，无剂量限制毒性。发生了2例3级肝酶变化，但未观察到RILD或其他3至5级肝毒性，严重肝毒性估计风险较低（95% CI，0至5.3%）。观察到6例（9%）急性3级毒性（2例胃炎、2例恶心、嗜睡和血小板减少）和1例（1%）4级毒性（血小板减少）。1年局部控制率为71%（95% CI，58%至85%）。中位总生存期为17.6个月（95% CI，10.4至38.1个月）。
个体化六分割肝转移瘤SBRT是安全的，大多数患者观察到持续的局部控制。 （注：原文中“eligible for this phase I study of individualized SBRT”部分表述不完整，翻译时保留原文状态）
