Li Xiao-Yang, Yan Bing, Zhang Jun-Qiang, Li Yan, Xia Da-Qing, Xie Wang, He Yuan, Wang Jian-Guo, Ma Jun, Cao Le-Jie, Qian Dong
Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Transl Lung Cancer Res. 2025 Aug 31;14(8):2996-3008. doi: 10.21037/tlcr-2025-281. Epub 2025 Aug 26.
Local-regional relapse remains high after the standard radiotherapy regimen for limited-stage small cell lung cancer (LS-SCLC). Short-course hypofractionated radiotherapy may improve disease control. In this single-institution open-label pilot trial, we aimed to explore the preliminary safety and efficacy of short-course hypofractionated radiotherapy with 4 Gy per fraction.
LS-SCLC patients (18 to 75 years old) with Karnofsky performance scale score (KPS) over 70 were enrolled. Patients were randomized with a ratio of 1:1 to receive radiotherapy of 48 Gy/12 f once daily (low-dose arm) or 60 Gy/15 f once daily (high-dose arm). Concurrent chemotherapy was administered for 4 to 6 cycles. The primary objective was the radiation-induced toxicity and the secondary objective was 2-year survival outcome.
From August 2022 to August 2023, 44 patients with a median age of 63.5 years old were prospectively enrolled with 22 patients in each of the low-dose arm and the high-dose arm. The median follow-up time was 20 months (interquartile range, 15.3-28.0 months). The incidence of Grade 3 and higher toxicity was 13.6% in the low-dose arm and 36.4% in the high-dose arm (P=0.16), among which the predominant one was myelosuppression. The incidence of atelectasis (50.0% 13.6%, P=0.02), cough (72.7% 36.4%, P=0.03) and dyspnea (45.5% 9.1%, P=0.02) was higher in the high-dose arm than the low-dose arm. The median overall survival was 30 months for all patients, not reached for the low-dose arm, and 30 months for the high-dose arm. The median progression-free survival was 23 months for all patients, 23 months for the low-dose arm, and 21 months for the high-dose arm, respectively. Only three patients developed local-regional relapse. Antitumor cytokines and cytotoxic CD8 T cell population increased after radiotherapy.
Short-course hypofractionated radiotherapy of 4 Gy per fraction was preliminarily safe and efficient for LS-SCLC with high local-regional control. For striking the balance of toxicity and efficacy, the regimen of 48 Gy/12 f might be a novel and promising radiation regimen for future exploration.
Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer: a randomized pilot trial (No. NCT05523908), registered on clinicaltrials.gov in August 2022.
对于局限期小细胞肺癌（LS-SCLC），标准放疗方案后的局部区域复发率仍然很高。短程大分割放疗可能会改善疾病控制。在这项单机构开放标签的试点试验中，我们旨在探索每次分割剂量为4 Gy的短程大分割放疗的初步安全性和疗效。
纳入卡氏功能状态评分（KPS）超过70分的18至75岁的LS-SCLC患者。患者按1:1的比例随机分组，分别接受每日一次的48 Gy/12 f放疗（低剂量组）或60 Gy/15 f放疗（高剂量组）。同时进行4至6个周期的化疗。主要目标是放疗引起的毒性，次要目标是2年生存结果。
2022年8月至2023年8月，前瞻性纳入了44例患者，中位年龄为63.5岁，低剂量组和高剂量组各22例。中位随访时间为20个月（四分位间距，15.3 - 28.0个月）。低剂量组3级及以上毒性的发生率为13.6%，高剂量组为36.4%（P = 0.16），其中主要为骨髓抑制。高剂量组肺不张（50.0%对13.6%，P = 0.02）、咳嗽（72.7%对36.4%，P = 0.03）和呼吸困难（45.5%对9.1%，P = 0.02）的发生率高于低剂量组。所有患者的中位总生存期为30个月，低剂量组未达到，高剂量组为30个月。所有患者的中位无进展生存期为23个月，低剂量组为23个月，高剂量组为21个月。仅3例患者出现局部区域复发。放疗后抗肿瘤细胞因子和细胞毒性CD8 T细胞群体增加。
每次分割剂量为4 Gy的短程大分割放疗对LS-SCLC初步安全且有效，局部区域控制良好。为平衡毒性和疗效，48 Gy/12 f方案可能是一种新型且有前景的放疗方案，有待未来探索。
局限期小细胞肺癌的大分割放疗：一项随机试点试验（编号NCT05523908），于2022年8月在clinicaltrials.gov注册。
