Rusthoven Kyle E, Kavanagh Brian D, Cardenes Higinia, Stieber Volker W, Burri Stuart H, Feigenberg Steven J, Chidel Mark A, Pugh Thomas J, Franklin Wilbur, Kane Madeleine, Gaspar Laurie E, Schefter Tracey E
University of Colorado Denver, Department of Radiation Oncology, Pathology, and Medical Oncology, Aurora, CO 80045, USA.
J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.
To evaluate the efficacy and tolerability of high-dose stereotactic body radiation therapy (SBRT) for the treatment of patients with one to three hepatic metastases.
Patients with one to three hepatic lesions and maximum individual tumor diameters less than 6 cm were enrolled and treated on a multi-institutional, phase I/II clinical trial in which they received SBRT delivered in three fractions. During phase I, the total dose was safely escalated from 36 Gy to 60 Gy. The phase II dose was 60 Gy. The primary end point was local control. Lesions with at least 6 months of radiographic follow-up were considered assessable for local control. Secondary end points were toxicity and survival.
Forty-seven patients with 63 lesions were treated with SBRT. Among them, 69% had received at least one prior systemic therapy regimen for metastatic disease (range, 0 to 5 regimens), and 45% had extrahepatic disease at study entry. Only one patient experienced grade 3 or higher toxicity (2%). Forty-nine discrete lesions were assessable for local control. Median follow-up for assessable lesions was 16 months (range, 6 to 54 months). The median maximal tumor diameter was 2.7 cm (range, 0.4 to 5.8 cm). Local progression occurred in only three lesions at a median of 7.5 months (range, 7 to 13 months) after SBRT. Actuarial in-field local control rates at one and two years after SBRT were 95% and 92%, respectively. Among lesions with maximal diameter of 3 cm or less, 2-year local control was 100%. Median survival was 20.5 months.
This multi-institutional, phase I/II trial demonstrates that high-dose liver SBRT is safe and effective for the treatment of patients with one to three hepatic metastases.
评估大剂量立体定向体部放射治疗（SBRT）对一至三处肝转移患者的疗效和耐受性。
纳入有一至三处肝脏病灶且最大个体肿瘤直径小于6 cm的患者，并在一项多机构的I/II期临床试验中接受治疗，在该试验中他们接受分三次给予的SBRT。在I期，总剂量从36 Gy安全递增至60 Gy。II期剂量为60 Gy。主要终点是局部控制。具有至少6个月影像学随访的病灶被认为可评估局部控制情况。次要终点是毒性和生存情况。
47例有63处病灶的患者接受了SBRT治疗。其中，69%的患者此前至少接受过一种针对转移性疾病的全身治疗方案（范围为0至5种方案），45%的患者在研究入组时有肝外疾病。仅1例患者出现3级或更高等级的毒性反应（2%）。49个独立病灶可评估局部控制情况。可评估病灶的中位随访时间为16个月（范围为6至54个月）。最大肿瘤直径的中位数为2.7 cm（范围为0.4至5.8 cm）。SBRT后仅3处病灶出现局部进展，中位时间为7.5个月（范围为7至13个月）。SBRT后1年和2年的精算野内局部控制率分别为95%和92%。最大直径为3 cm或更小的病灶中，2年局部控制率为100%。中位生存期为20.5个月。
这项多机构的I/II期试验表明，大剂量肝脏SBRT对一至三处肝转移患者的治疗是安全有效的。
