Ⅰ期无法手术的小细胞肺癌行立体定向体部放疗（SBRT）后的临床结局：RSSearch 患者注册研究的多机构分析。

Clinical Outcomes Following Stereotactic Body Radiation Therapy (SBRT) for Stage I Medically Inoperable Small Cell Lung Carcinoma: A Multi-Institutional Analysis From the RSSearch Patient Registry.

机构信息

Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA.

Department of Radiation Oncology, University of Arizona, Tucson, AZ.

出版信息

Am J Clin Oncol. 2019 Jul;42(7):602-606. doi: 10.1097/COC.0000000000000561.

DOI:10.1097/COC.0000000000000561

PMID:31232723

Abstract

OBJECTIVES

To utilize the RSSearch Patient Registry (RSSPR) to examine local control (LC), overall survival (OS), and toxicities following stereotactic body radiation therapy (SBRT) for stage I (T1-T2/N0) medically inoperable small cell lung carcinoma (SCLC).

MATERIALS AND METHODS

We searched the RSSPR for medically inoperable stage I SCLC patients treated with definitive SBRT. Potential predictive factors of OS were estimated using the Kaplan-Meier method as well as a Cox proportional hazards model.

RESULTS

Twenty-one patients were identified with medically inoperable stage I SCLC that met inclusion criteria. Fourteen patients had stage IA SCLC (T1N0) and 7 patients had stage IB SCLC (T2N0) with a median gross tumor volume of 10.1 cm (range: 0.72 to 41.4 cm). The median number of fractions was 4 (range: 3 to 5), and the median BED10 was 105.6 Gy10 (range: 72 to 239.7 Gy10). Four patients received adjuvant chemotherapy. One- and 2-year actuarial OS rates were 73.1% (95% confidence interval [CI]: 36.8%-90.1%) and 36.6% (95% CI: 9.0%-65.7%), respectively. Factors found to be associated with 1-year OS on univariate analysis included T2 disease (85.5% vs. 33.3%; P=0.03), adjuvant chemotherapy (100% vs. 66.3%; P=0.11), and gross tumor volume ≥10 cm (100% vs. 52.5%; P=0.10). On multivariate analysis, adjuvant chemotherapy was associated with improved OS (hazard ratio=0.07 [95% CI: 0.13-0.37; P=0.002]). The 1-, 2-, and 3-year LC rates were 100%, and 1- and 2-year progression-free survival (PFS) rates were 85.7% (95% CI: 33.4-97.9%) and 42.9% (95% CI: 1.1-85.3%), respectively. Similar to OS, patients with T1N0 disease had superior PFS as compared to T2N0 disease (P=0.01). Toxicities were reported by 3/21 (14.3%) of patients with none ≥ grade 3 and no esophageal toxicities.

CONCLUSIONS

SBRT was well-tolerated in the treatment of stage I SCLC with excellent LC achieved. Patients with T1N0 stage IA SCLC were noted to have improved PFS and OS following SBRT as compared with T2N0 Stage IB SCLC. Adjuvant chemotherapy was found to result in improved OS for stage I SCLC patients over SBRT alone.

摘要

目的

利用 RSSearch 患者注册中心（RSSPR）来检查无法手术的 I 期（T1-T2/N0）小细胞肺癌（SCLC）患者接受立体定向体部放射治疗（SBRT）后的局部控制（LC）、总生存（OS）和毒性。

材料与方法

我们在 RSSPR 中搜索了接受根治性 SBRT 治疗的无法手术的 I 期 SCLC 患者。使用 Kaplan-Meier 方法和 Cox 比例风险模型估计 OS 的潜在预测因素。

结果

确定了 21 名患有无法手术的 I 期 SCLC 的患者，符合纳入标准。14 名患者为 IA 期 SCLC（T1N0），7 名患者为 IB 期 SCLC（T2N0），大体肿瘤体积中位数为 10.1cm（范围：0.72 至 41.4cm）。中位数的分割次数为 4 次（范围：3 至 5 次），中位数的 BED10 为 105.6Gy10（范围：72 至 239.7Gy10）。4 名患者接受了辅助化疗。1 年和 2 年的生存率分别为 73.1%（95%置信区间[CI]：36.8%-90.1%）和 36.6%（95% CI：9.0%-65.7%）。单因素分析发现与 1 年 OS 相关的因素包括 T2 疾病（85.5% 与 33.3%；P=0.03）、辅助化疗（100% 与 66.3%；P=0.11）和大体肿瘤体积≥10cm（100%与 52.5%；P=0.10）。多因素分析显示，辅助化疗与 OS 改善相关（风险比=0.07[95%CI：0.13-0.37；P=0.002]）。1 年、2 年和 3 年的 LC 率均为 100%，1 年和 2 年的无进展生存率（PFS）分别为 85.7%（95%CI：33.4-97.9%）和 42.9%（95%CI：1.1-85.3%）。与 OS 相似，T1N0 疾病患者的 PFS 优于 T2N0 疾病（P=0.01）。21 名患者中有 3 名（14.3%）报告了毒性反应，无一例≥3 级，无食管毒性。