Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai, China.
Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):707-715. doi: 10.1016/j.ijrobp.2020.05.003. Epub 2020 May 14.
This study aims to assess the safety and efficacy of stereotactic body radiation therapy (SBRT) for patients with oligometastatic esophageal squamous cell carcinoma (ESCC).
From April 2015 to December 2018, a prospective, single-arm, phase 2 trial was conducted. The main inclusion criteria were ESCC patients with 3 or fewer metastases and a controlled primary malignancy after radical treatment, with all metastatic lesions amenable to SBRT. The enrolled patients were assigned to SBRT for all metastatic lesions and then received chemotherapy for at least 4 cycles starting from 0 to 15 days after SBRT. The primary endpoint was progression-free survival (PFS). Overall survival, local control, and toxicities were assessed in all patients. The study is listed at clinicaltrials.gov, number NCT03000816.
Thirty-four patients with 40 oligometastatic lesions, including 25 in distant organs and 15 in nonregional lymph nodes, were treated with SBRT. All metastases belonged to genuine oligometastatic disease. Seventeen patients (50.0%) received a median of 4 cycles (interquartile range, 3-6 cycles) of chemotherapy after SBRT. At a median follow-up time of 18.2 months (interquartile range, 11.1-35.0 months), the median PFS time was 13.3 months (95% confidence interval, 10.7-15.9); the 1- and 2-year PFS rates were 55.9% and 33.8%, respectively. The 1- and 2-year overall survival rates were 76.2% and 58.0%, respectively. The 1- and 2-year local control rates were both 92.1%. Grade 3 acute toxicities were observed in only 1 patient. No grade ≥4 acute adverse events or grade ≥3 late adverse events due to SBRT occurred in this study.
For well-selected patients with oligometastatic ESCC, SBRT with or without chemotherapy is a well-tolerated and efficacious treatment modality. The prognosis of oligometastatic ESCC is quite different from that of extensively metastatic ESCC, so treatment with an accurate stratification for patients with metastatic ESCC is necessary.
本研究旨在评估立体定向体部放疗（SBRT）治疗寡转移性食管鳞癌（ESCC）患者的安全性和疗效。
本研究为一项前瞻性、单臂、2 期临床试验，于 2015 年 4 月至 2018 年 12 月开展。主要纳入标准为根治性治疗后存在 3 个或更少转移灶且原发性恶性肿瘤得到控制的 ESCC 患者，所有转移灶均适用于 SBRT。入组患者接受所有转移灶的 SBRT 治疗，然后在 SBRT 后 0 至 15 天开始至少接受 4 个周期的化疗。主要终点为无进展生存期（PFS）。所有患者评估总生存期、局部控制率和毒性。该研究在临床试验.gov 注册，编号为 NCT03000816。
34 例 40 个寡转移灶的患者接受了 SBRT 治疗，其中 25 个位于远处器官，15 个位于非区域性淋巴结。所有转移灶均属于真正的寡转移疾病。17 例（50.0%）患者在 SBRT 后接受了中位数为 4 个周期（四分位距，3-6 个周期）的化疗。中位随访时间为 18.2 个月（四分位距，11.1-35.0 个月），中位 PFS 时间为 13.3 个月（95%置信区间，10.7-15.9）；1 年和 2 年的 PFS 率分别为 55.9%和 33.8%。1 年和 2 年的总生存率分别为 76.2%和 58.0%。1 年和 2 年的局部控制率均为 92.1%。仅 1 例患者出现 3 级急性毒性。本研究中未发生因 SBRT 导致的任何≥4 级急性不良事件或≥3 级迟发性不良事件。
对于经精心选择的寡转移性 ESCC 患者，SBRT 联合或不联合化疗是一种耐受良好且有效的治疗方式。寡转移性 ESCC 的预后与广泛转移性 ESCC 明显不同，因此需要对转移性 ESCC 患者进行准确的分层治疗。
