Dataset related to article "Phase II trial on SBRT for unresectable liver metastases long-term outcome and prognostic factors of survival after 5 years of follow-up"

This record contains raw data related to article "Phase II trial on SBRT for unresectable liver metastases long-term outcome and prognostic factors of survival after 5 years of follow-up" BACKGROUND: The aim of this study was to evaluate long-term efficacy and survival prognostic factors of stereotactic body radiation therapy (SBRT) for un-resectable liver metastases in patients enrolled in a prospective phase II trial. METHODS AND MATERIALS: 5-year local control (LC), overall survival (OS), progression free survival (PFS) and toxicity rates were analyzed in patients with un-resectable liver metastases enrolled in a Phase II Trial on liver SBRT, with a prescription dose of 75Gy in 3 consecutive fractions. RESULTS: A total of 61 patients with 76 lesions were enrolled, with a median follow-up time of 6.1 years. One, three and 5 year LC rates were 94 ± 3.1%, 78.0 ± 5.9% and 78.0 ± 5.9%, without reaching the median LC time. Median OS was 27.6 months and the survival rates were 85.2 ± 4.5%, 31.1 ± 5.9% and 18.0 ± 4.9% at 1, 3 and 5-year after SBRT, respectively. Univariate analysis showed that favorable primary site (colorectal, breast and gynecological) of metastases (p = 0.001) improved survival. Toxicity was moderate. One patient experienced G3 late chest wall pain, which resolved within 1 year from SBRT. No cases of Radiation Induced Liver Disease (RILD) were detected. CONCLUSIONS: Long-term results of this Phase II study suggest the efficacy and safety of SBRT for un-resectable liver metastases after 5-year of follow up. Selection of cases with positive prognostic factors may improve long-term survival of these oligo-metastastic patients and may confirm the role of SBRT as an effective alternative local therapy for liver metastases.本数据集包含与下述研究论文相关的原始数据：《不可切除肝转移灶立体定向体部放疗（SBRT，Stereotactic Body Radiation Therapy）II期临床试验：5年随访后的长期结局与生存预后因素》。 背景：本研究旨在评估前瞻性II期临床试验中纳入的不可切除肝转移灶患者接受立体定向体部放疗（SBRT）的长期疗效与生存预后因素。 方法与材料：本研究针对一项肝脏SBRT II期临床试验纳入的不可切除肝转移灶患者，分析其5年局部控制率（local control, LC）、总生存期（overall survival, OS）、无进展生存期（progression free survival, PFS）及毒性反应发生率，处方剂量为3次连续分割照射75Gy。 结果：本研究共纳入61例患者，共计76个病灶，中位随访时间为6.1年。1年、3年及5年局部控制率分别为94.0±3.1%、78.0±5.9%及78.0±5.9%，未达到中位局部控制时间。中位总生存期为27.6个月，SBRT治疗后1年、3年及5年生存率分别为85.2±4.5%、31.1±5.9%及18.0±4.9%。单因素分析显示，转移灶的有利原发部位（结直肠、乳腺及妇科来源，p=0.001）可改善患者生存。本次研究的毒性反应均为轻中度：1例患者出现3级晚期胸壁疼痛，于SBRT治疗后1年内缓解；未检测到放射性肝病（Radiation Induced Liver Disease, RILD）病例。 结论：本II期研究的长期随访结果证实，5年随访后SBRT用于不可切除肝转移灶的疗效与安全性均得到验证。筛选携带阳性预后因素的病例，可改善此类寡转移患者的长期生存，同时进一步确认SBRT作为肝转移灶有效局部治疗替代方案的临床价值。