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Hypofractionated Intensity Modulated Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer: A Phase II Prospective Clinical Trial (GASTO1011)
Practical Radiation Oncology ( IF 3.3 ) Pub Date : 2021-06-20 , DOI: 10.1016/j.prro.2021.06.004
Bo Qiu 1 , Mai Xiong 2 , YiFeng Luo 3 , QiWen Li 1 , NaiBin Chen 1 , Li Chen 1 , SuPing Guo 1 , Bin Wang 1 , XiaoYan Huang 1 , MaoSheng Lin 1 , Nan Hu 1 , JinYu Guo 1 , Ying Liang 4 , Yi Fang 5 , JiBin Li 6 , YunPeng Yang 7 , Yan Huang 7 , Li Zhang 7 , SiYu Wang 8 , Hui Liu 1
Affiliation  

Purpose

We aimed to explore the efficacy and toxicity of split-course hypofractionated radiation therapy with concurrent chemotherapy (HRT-CHT) in patients with locally advanced non-small cell lung cancer (LANSCLC) in this single-arm, phase II study.

Methods and Materials

Patients with LANSCLC were considered eligible if their forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC%) and carbon monoxide diffusing capacity (DLCO%) were ≥40% and ≥45%, respectively. HRT-CHT using the intensity modulated radiation therapy technique was administered with 51 Gy in 17 fractions as the first course followed by a break. Patients without disease progression or persistent ≥grade 2 toxicities had an HRT-CHT of 15 to 18 Gy in 5 to 6 fractions as a boost. The primary endpoint was progression-free survival, and the secondary endpoint was overall survival (OS).

Results

Eighty-nine patients were enrolled and analyzed. The median follow-up was 29.5 months for all patients and 35.3 months for the survivors. The objective response rate was 97.8%; the median progression-free survival and OS were 11.0 and 27.0 months, respectively. Grade 3 acute esophagitis/pneumonitis occurred in 15 (16.9%)/7 (7.9%) patients. Grade 3/5 late pneumonitis occurred in 2 (2.2%)/1 (1.1%) patients. Of the 78 (87.6%) who completed the split-course HRT-CHT per protocol, patients with better FEV1/FVC% and DLCO% after the break had significantly better OS (for the FEV/FVC1% ≥ 80% vs 60%-79% vs 41%-59% groups, 2-year OS values were 57.2% vs 56.9% vs 0%, respectively, P = .024; for the DLCO% ≥ 80% vs 60%-79% vs 45%-59% groups, 2-year OS values were 70.4% vs 48.4% vs 37.5%, respectively, P = .049).

Conclusions

Split-course HRT-CHT achieved a promising response rate and survival with tolerable toxicity in LANSCLC. Pulmonary function tests are necessary indicators for radiation treatment planning and dose escalation.



中文翻译:

局部晚期非小细胞肺癌的大分割调强放射治疗与同步化疗:一项 II 期前瞻性临床试验 (GASTO1011)

目的

在这项单臂 II 期研究中,我们旨在探讨分程大分割放疗联合同步化疗 (HRT-CHT) 对局部晚期非小细胞肺癌 (LANSCLC) 患者的疗效和毒性。

方法和材料

如果 LANSCLC 患者的 1 秒用力呼气量/用力肺活量 (FEV 1 /FVC%) 和一氧化碳弥散量 (DLCO%) 分别≥40% 和 ≥45%,则认为符合条件。使用调强放射治疗技术的 HRT-CHT 以 51 Gy 分 17 次给药作为第一疗程,然后休息。没有疾病进展或持续≥2 级毒性的患者的 HRT-CHT 为 15 至 18 Gy,分 5 至 6 次作为加强。主要终点是无进展生存期,次要终点是总生存期(OS)。

结果

纳入并分析了 89 名患者。所有患者的中位随访时间为 29.5 个月,幸存者的中位随访时间为 35.3 个月。客观反应率为97.8%;中位无进展生存期和 OS 分别为 11.0 和 27.0 个月。15 (16.9%)/7 (7.9%) 名患者发生了 3 级急性食管炎/肺炎。2 (2.2%)/1 (1.1%) 名患者发生了 3/5 级晚期肺炎。谁完成每个协议分裂过程HRT-CHT的78(87.6%)中,患者具有更好的FEV 1 / FVC%和DLCO%的断裂后具有显著更好OS(对于FEV / FVC1%≥80%比60% -79% vs 41%-59% 组,2 年 OS 值分别为 57.2% vs 56.9% vs 0%,P = .024; 对于 DLCO% ≥ 80% vs 60%-79% vs 45%-59% 组,2 年 OS 值分别为 70.4% vs 48.4% vs 37.5%,P  = .049)。

结论

分程 HRT-CHT 在 LANSCLC 中获得了有希望的缓解率和存活率,且毒性可耐受。肺功能检查是放射治疗计划和剂量递增的必要指标。

更新日期:2021-06-20
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