射波刀Cyberknife治疗无法手术切除原发性肝内胆管细胞癌疗效观察

Clinical Observation on Cyberknife Radiosurgery Treatment for Unresectable Primary Intrahepatic Cholangiocarcinoma

目的观察立体定向放射治疗(SBRT)对无法手术切除原发性肝内胆管细胞癌(ICC)的疗效及不良反应。方法对28例原发性ICC患者行射波刀SBRT,给予总剂量为45 Gy(36~54 Gy),分割3~5次,处方剂量线范围为70%~92%。按照RECIST1.1标准进行实体瘤近期疗效评价,采用Kaplanmeier方法分析生存率及疾病控制率,Cox方法进行多因素分析评价影响预后的因素,美国放射肿瘤学协作组(RTOG 2.0)标准进行放射反应评级。结果 28例患者中,完全缓解(CR)3例(10.7%),部分缓解(PR)10例(35.7%),无变化(SD)12例(42.9%),进展(PD)3例(10.7%),疾病有效率(CR+PR)为46.4%,疾病控制率(CR+PR+SD)为89.3%。治疗后随访3~42月,中位随访时间为16月,1、2年生存率分别为57.1%、32.1%,28例患者的中位生存期15月(95%CI:7.22~22.78)。所有患者对治疗耐受良好,不良反应轻微,治疗不良反应主要局限于1~2级,未出现大于3级的不良反应。多因素分析显示肿瘤直径较大、淋巴结转移、临床分期较晚可能导致较差的预后(P<0.01)。结论对于无法手术切除的原发性ICC,射波刀SBRT疗效显著,安全性好,值得进一步临床推广。

Objective To report the outcomes of Cyberknife stereotactic body radiotherapy(SBRT) for patients with unresectable primary intrahepatic cholangiocarcinoma(ICC). Methods Twenty-eight patients with ICC were treated with Cyberknife SBRT. The median prescription dose was 45Gy(range, 36-54Gy). The prescribed radiation dosage was fractionated 3 to 5 times with a 70% to 92% isodose line. Treatment response was graded by RECIST v.1.1. The survival rate and disease control rate were compared by KaplanMeier analysis and toxicity was evaluated according to the Radiation Therapy Oncology Group(RTOG) Toxicity Criteria, Version 2.0. Patient records were reviewed and compared using multivariate analysis(Cox regression) to determine the factors that affected survival time of ICC patients. Results The median follow-up time was 16months(3-42 months). After SBRT, evaluated by CT or MRI, 3(10.7%) patients had complete response(CR), 10(35.7%) patients showed partial response(PR), 12(42.9%) patients were stable disease(SD), 3(10.7%) patients were progressive disease(PD). The local control rate(CR+PR) was 42.9% and disease control rate(CR+PR+SD) was 89.3%. Median survival time was 15 months(95%CI: 7.22-22.78). 1- and 2-year overall survival were 57.1% and 32.1%, respectively. Multivariate analysis revealed that larger tumor size, synchronous lymph node metastases and later clinical stage were associated with poorer prognosis(P<0.01). Toxicity mainly consisted of grade 1-2. No toxicity greater than grade 3 was observed. Conclusion Cyberknife SBRT is safe and effective for unresectable primary ICC with acceptable toxicity.