寡转移非小细胞肺癌患者原发灶和转移部位立体定向体部放疗的 II 期研究。
Phase II study of stereotactic body radiotherapy to primary tumor and metastatic locations in oligometastatic nonsmall-cell lung cancer patients.
机构信息
Department of Radiation Oncology, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Department of Radiation Oncology, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
出版信息
Ann Oncol. 2014 Oct;25(10):1954-1959. doi: 10.1093/annonc/mdu370. Epub 2014 Aug 11.
BACKGROUND
Stereotactic body radiotherapy (SBRT) has emerged as a treatment modality in patients presenting with oligometastatic nonsmall-cell lung cancer (NSCLC). SBRT is used as a local consolidative treatment to metastatic disease sites. The majority of patients included in SBRT trials for oligometastatic NSCLC have controlled primary tumors and brain metastases.
PATIENTS AND METHODS
Oligometastatic NSCLC patients with ≤5 metastatic lesions were included in a prospective phase II trial to evaluate efficacy and toxicity of SBRT to all disease sites, primary tumor and metastatic locations. SBRT to a dose of 50 Gy in 10 fractions was delivered. Positron emission tomography-computed tomography (PET-CT) was carried out at baseline and 3 months after SBRT to evaluate the metabolic response rate according to PET Response Criteria in Solid Tumors (PERCIST). The progression-free survival (PFS) and overall survival (OS) were calculated using Kaplan-Meier method from start of chemotherapy or radiotherapy. Side-effects were scored using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.
RESULTS
Twenty-six patients received SBRT after induction chemotherapy (n = 17) or as a primary treatment (n = 9). Median follow-up was 16.4 months. Overall metabolic response rate was 60% with seven patients (30%) achieving a complete metabolic remission and 7 (30%) a partial metabolic response. Any acute grade 2 toxicity was observed in four patients (15%) and grade 3 pulmonary toxicity in two patients (8%). Median PFS and OS were 11.2 and 23 months. The 1-year PFS and 1-year OS rate were 45% and 67%, respectively.
CONCLUSION
SBRT to all disease sites, primary tumor and metastatic locations, in oligometastatic NSCLC patients produced an acceptable median PFS of 11.2 months.
背景
立体定向体部放疗(SBRT)已成为治疗寡转移非小细胞肺癌(NSCLC)患者的一种治疗方式。SBRT 用于治疗转移性疾病部位的局部巩固治疗。大多数纳入寡转移 NSCLC 的 SBRT 试验的患者都有控制的原发性肿瘤和脑转移。
患者和方法
纳入了一项前瞻性 II 期试验,以评估 SBRT 对所有疾病部位、原发性肿瘤和转移性部位的疗效和毒性,这些患者的寡转移 NSCLC 患者有≤5 个转移病灶。给予 50Gy/10 次的 SBRT 剂量。在 SBRT 后基线和 3 个月进行正电子发射断层扫描-计算机断层扫描(PET-CT),根据实体瘤 PET 反应标准(PERCIST)评估代谢反应率。采用 Kaplan-Meier 法从化疗或放疗开始计算无进展生存(PFS)和总生存(OS)。使用国家癌症研究所不良事件通用术语标准(NCI CTCAE)第 3.0 版对副作用进行评分。
结果
26 例患者在诱导化疗后(n=17)或作为初始治疗(n=9)接受了 SBRT。中位随访时间为 16.4 个月。整体代谢缓解率为 60%,7 例(30%)患者完全代谢缓解,7 例(30%)患者部分代谢缓解。4 例(15%)患者出现任何急性 2 级毒性,2 例(8%)患者出现 3 级肺部毒性。中位 PFS 和 OS 分别为 11.2 个月和 23 个月。1 年 PFS 和 1 年 OS 率分别为 45%和 67%。
结论
SBRT 对寡转移 NSCLC 患者所有疾病部位、原发性肿瘤和转移性部位的治疗,产生了可接受的中位 PFS 为 11.2 个月。