根治性切除术后局部区域性复发的非小细胞肺癌的低分割放疗联合化疗：一项前瞻性、单臂、Ⅱ期研究（GASTO-1017）。
Hypo-fractionated radiotherapy with concurrent chemotherapy for locoregional recurrence of non-small cell lung cancer after complete resection: A prospective, single-arm, phase II study (GASTO-1017).
机构信息
Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, China.
Department of Thoracic Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, China.
出版信息
Lung Cancer. 2021 Jun;156:82-90. doi: 10.1016/j.lungcan.2021.04.020. Epub 2021 Apr 27.
OBJECTIVES
To explore the efficacy and toxicities of split-course hypo-fractionated radiotherapy with concurrent chemotherapy (HFRT-CHT) with intensity modulated radiotherapy (IMRT) technique in non-small cell lung cancer (NSCLC) patients with postoperative locoregional recurrence (LRR).
MATERIALS AND METHODS
NSCLC patients were eligible if confirmed as LRR disease without distant metastasis after complete resection. HFRT-CHT using IMRT technique was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break. Patients with no disease progression and no persistent Grade ≥2 toxicities had the second course of 15 Gy in 5 fractions or 28 Gy in 7 fractions as a boost. The primary endpoint was progression-free survival (PFS).
RESULTS
Fifty-eight patients were enrolled and analyzed. With a median follow-up of 23.9 months for all, the 2-year and 3-year PFS rate was 59.7 % and 46.4 %, the 2-year and 3-year OS rate was 72.5 % and 52.2 %, respectively, and a favorable objective response rate of 95.9 % was obtained after the whole courses protocol. Grade 3 acute pneumonitis and esophagitis occurred in 2 (3.4 %) and 7 (12.1 %) patients, and fatal pneumonitis was reported in one case (1.7 %). Exploratory subgroup analysis showed that performance status (PS) (PS 0 vs. 1: 2-year PFS, 88.1 % vs. 46.9 %,P = 0.001; 2-year OS, 100 % vs. 59.4 %, P < 0.001), recurrence site (single vs. multiple: 2-year PFS, 93.8 % vs. 47.4 %, P = 0.008; 2-year OS, 100 % vs. 63.0 %, P = 0.001), and gross tumor volume (GTV) (<50cm vs. ≥ 50cm: 2-year PFS, 70.6 % vs. 46.2 %, P = 0.024; 2-year OS, 85.6 % vs. 57.4 %, P = 0.034) were significantly associated with PFS and OS.
CONCLUSION
Split-course HFRT-CHT with IMRT technique achieved promising disease control and satisfactory survival with moderate toxicities in postoperative LRR of NSCLC. Good PS, a single recurrence site and GTV<50cm tended to have prolonged PFS and OS. Early detection of LRR may improve the efficacy of HFRT-CHT.
目的
探索调强放疗（IMRT）技术下分割短程低分割放疗同步化疗（HFRT-CHT）在非小细胞肺癌（NSCLC）术后局部区域复发（LRR）患者中的疗效和毒性。
材料和方法
如果在完全切除后证实为 LRR 疾病且无远处转移，则符合 NSCLC 患者入选条件。采用 IMRT 技术进行 HFRT-CHT，第一疗程为 51Gy 分 17 次或 40Gy 分 10 次，随后休息。无疾病进展且无持续 2 级以上毒性的患者，进行第二疗程 15Gy 分 5 次或 28Gy 分 7 次作为推量。主要终点是无进展生存期（PFS）。
结果
共纳入并分析了 58 例患者。所有患者中位随访 23.9 个月，2 年和 3 年的 PFS 率分别为 59.7%和 46.4%，2 年和 3 年的 OS 率分别为 72.5%和 52.2%，整个疗程方案后获得了 95.9%的良好客观缓解率。2 例（3.4%）和 7 例（12.1%）患者发生 3 级急性肺炎和食管炎，1 例（1.7%）发生致命性肺炎。探索性亚组分析显示，体力状态（PS）（PS 0 与 1：2 年 PFS，88.1%与 46.9%，P=0.001；2 年 OS，100%与 59.4%，P<0.001）、复发部位（单发与多发：2 年 PFS，93.8%与 47.4%，P=0.008；2 年 OS，100%与 63.0%，P=0.001）和大体肿瘤体积（GTV）（<50cm 与≥50cm：2 年 PFS，70.6%与 46.2%，P=0.024；2 年 OS，85.6%与 57.4%，P=0.034）与 PFS 和 OS 显著相关。
结论
在 NSCLC 术后 LRR 中，采用 IMRT 技术的分割短程 HFRT-CHT 实现了有希望的疾病控制和令人满意的生存，且毒性适中。良好的 PS、单个复发部位和 GTV<50cm 往往具有更长的 PFS 和 OS。早期发现 LRR 可能会提高 HFRT-CHT 的疗效。
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