医学
临床终点
鼻咽癌
转移
骨转移
化疗
放射治疗
临床研究阶段
内科学
放射科
无进展生存期
不利影响
原发性肿瘤
肿瘤科
临床试验
癌症
作者
Re-Wen Wu,Li Gao,Xiaodong Huang,Jianping Xiao,K Wang,Yuan Qu,Q Liu,Jingqiao Wang,Y Zhang,J Zhang,Xuyu Chen,Jingwei Luo,Junlin Yi
标识
DOI:10.1016/j.ijrobp.2021.07.1337
摘要
Purpose/Objective(s)The current treatment strategy for patients with metastatic nasopharyngeal carcinoma (NPC) is mainly based on palliative chemotherapy, with low complete remission rate and poor progression-free survival (PFS). Radiation therapy has proven efficacy in the treatment of patients with nonmetastatic NPC, with emerging indication in the setting of limited metastatic disease. We proposed a single-arm phase II study to determine if metastasis-directed SBRT plus systemic treatment could prolong PFS compared with historical findings at first-line therapy for patients with oligometastatic NPC.Materials/MethodsWe enrolled metastatic NPC with 1-5 metastatic lesions, with all metastases amenable to SBRT. Prescribed doses ranged from 25–50 Gy administered in five fractions. All patients received systemic chemotherapy before or after SBRT. The primary endpoint was PFS at 1 year from the start of SBRT treatment.ResultsBetween October 2016 and January 2020, 24 patients with a median age of 48 years (range, 29-65 years) were recruited. A total of 44 sites were treated with 11 of 24 patients receiving SBRT to more than one site. Spinal bone was most often irradiated. By Kaplan-Meier actuarial analysis, 1-year PFS was 62% and overall survival rate 87%. Most patients progressed in new distant sites with only one local SBRT failures out of 44 lesions. Patients with lung metastasis had a lower chance of distant progression than those with bone metastasis or liver metastasis. There were no SBRT relevant grade 3-5 toxicity, and only one patient suffered from grade 2 adverse event.ConclusionUse of metastasis-directed SBRT with systemic chemotherapy for patients with oligometastatic NPC as first-line therapy was well tolerated, and resulted in high PFS, substantially greater than historical values for patients who only received systemic agents. The current treatment strategy for patients with metastatic nasopharyngeal carcinoma (NPC) is mainly based on palliative chemotherapy, with low complete remission rate and poor progression-free survival (PFS). Radiation therapy has proven efficacy in the treatment of patients with nonmetastatic NPC, with emerging indication in the setting of limited metastatic disease. We proposed a single-arm phase II study to determine if metastasis-directed SBRT plus systemic treatment could prolong PFS compared with historical findings at first-line therapy for patients with oligometastatic NPC. We enrolled metastatic NPC with 1-5 metastatic lesions, with all metastases amenable to SBRT. Prescribed doses ranged from 25–50 Gy administered in five fractions. All patients received systemic chemotherapy before or after SBRT. The primary endpoint was PFS at 1 year from the start of SBRT treatment. Between October 2016 and January 2020, 24 patients with a median age of 48 years (range, 29-65 years) were recruited. A total of 44 sites were treated with 11 of 24 patients receiving SBRT to more than one site. Spinal bone was most often irradiated. By Kaplan-Meier actuarial analysis, 1-year PFS was 62% and overall survival rate 87%. Most patients progressed in new distant sites with only one local SBRT failures out of 44 lesions. Patients with lung metastasis had a lower chance of distant progression than those with bone metastasis or liver metastasis. There were no SBRT relevant grade 3-5 toxicity, and only one patient suffered from grade 2 adverse event. Use of metastasis-directed SBRT with systemic chemotherapy for patients with oligometastatic NPC as first-line therapy was well tolerated, and resulted in high PFS, substantially greater than historical values for patients who only received systemic agents.
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