三期多中心随机临床试验：60Gy 与 50Gy 放疗剂量在不可切除食管鳞癌同期放化疗中的比较。
A Phase III Multicenter Randomized Clinical Trial of 60 Gy versus 50 Gy Radiation Dose in Concurrent Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma.
机构信息
Department of Thoracic Radiotherapy, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Zhejiang Key Laboratory of Radiation Oncology, Hangzhou, China.
Department of Radiation Oncology, Huai'an First People's Hospital, Huai'an, China.
出版信息
Clin Cancer Res. 2022 May 2;28(9):1792-1799. doi: 10.1158/1078-0432.CCR-21-3843.
PURPOSE
In this multicenter phase 3 trial, the efficacy and safety of 60 Gy and 50 Gy doses delivered with modern radiotherapy technology for definitive concurrent chemoradiotherapy (CCRT) in patients with inoperable esophageal squamous cell carcinoma (ESCC) were evaluated.
PATIENTS AND METHODS
Patients with pathologically confirmed stage IIA‒IVA ESCC were randomized 1:1 to receive conventional fractionated 60 Gy or 50 Gy to the tumor and regional lymph nodes. Concurrent weekly chemotherapy (docetaxel 25 mg/m2; cisplatin 25 mg/m2) and two cycles of consolidation chemotherapy (docetaxel 70 mg/m2; cisplatin 25 mg/m2 days 1‒3) were administered.
RESULTS
A total of 319 patients were analyzed for survival, and the median follow-up was 34.0 months. The 1- and 3-year locoregional progression-free survival (PFS) rates for the 60 Gy group were 75.6% and 49.5% versus 72.1% and 48.4%, respectively, for the 50 Gy group [HR, 1.00; 95% confidence interval (CI), 0.75‒1.35; P = 0.98]. The overall survival rates were 83.7% and 53.1% versus 84.8% and 52.7%, respectively (HR, 0.99; 95% CI, 0.73‒1.35; P = 0.96), whereas the PFS rates were 71.2% and 46.4% versus 65.2% and 46.1%, respectively (HR, 0.97; 95% CI, 0.73‒1.30; P = 0.86). The incidence of grade 3+ radiotherapy pneumonitis was higher in the 60 Gy group (nominal P = 0.03) than in the 50 Gy group.
CONCLUSIONS
The 60 Gy arm had similar survival endpoints but a higher severe pneumonitis rate compared with the 50 Gy arm. Fifty Gy should be considered as the recommended dose in CCRT for ESCC.
目的
在这项多中心 3 期临床试验中，评估了现代放射治疗技术在不能手术的食管鳞状细胞癌（ESCC）患者中进行根治性同期放化疗（CCRT）时，60 Gy 和 50 Gy 剂量的疗效和安全性。
方法
将经病理证实的 IIA-IVA 期 ESCC 患者随机 1:1 分为两组，分别接受常规分割 60 Gy 和 50 Gy 照射肿瘤和区域淋巴结。同时给予每周一次的化疗（多西他赛 25 mg/m2；顺铂 25 mg/m2）和两个周期的巩固化疗（多西他赛 70 mg/m2；顺铂 25 mg/m2，第 1-3 天）。
结果
共有 319 例患者进行了生存分析，中位随访时间为 34.0 个月。60 Gy 组的 1 年和 3 年局部区域无进展生存率（PFS）分别为 75.6%和 49.5%，50 Gy 组分别为 72.1%和 48.4%[风险比（HR），1.00；95%置信区间（CI），0.75-1.35；P=0.98]。总生存率分别为 83.7%和 53.1%，84.8%和 52.7%（HR，0.99；95%CI，0.73-1.35；P=0.96），PFS 率分别为 71.2%和 46.4%，65.2%和 46.1%（HR，0.97；95%CI，0.73-1.30；P=0.86）。60 Gy 组放射性肺炎 3 级及以上发生率高于 50 Gy 组（名义 P=0.03）。
结论
与 50 Gy 组相比，60 Gy 组的生存终点相似，但严重放射性肺炎发生率更高。50 Gy 应被认为是 ESCC CCRT 的推荐剂量。
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