Concurrent chemoradiotherapyof different radiation doses and different irradiation fields for locally advanced thoracic esophageal squamous cell carcinoma: A randomized, multicenter, phase III clinical trial

IF 20.1 1区医学 Q1 ONCOLOGY Cancer Communications Pub Date : 2024-08-19 DOI:10.1002/cac2.12601

Jian Zhang, Minghao Li, Kaixian Zhang, Anping Zheng, Guang Li, Wei Huang, Shaoshui Chen, Xiangming Chen, Xiaomin Li, Yanxing Sheng, Xinchen Sun, Liping Liu, Xiaowei Liu, Jie Li, Jun Wang, Hong Ge, Shucheng Ye, Qingsong Pang, Xianwen Zhang, Shengbin Dai, Richard Yu, Wendong Gu, Mingming Dai, Gaowa Siqin, Yunwei Han, Xiaolin Ge, Xin Yuan, Yongjing Yang, Haiwen Zhu, Juan Pu, Lihua Dong, Xiangdong Sun, Jundong Zhou, Weidong Mao, Fei Gao, Haiqun Lin, Heyi Gong, Tao Zhou, Zhenjiang Li, Hongsheng Li, Zhongtang Wang, Baosheng Li

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Abstract

Background

Concurrent chemoradiotherapy (CCRT) is the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC). However, the optimal radiotherapy regimen, particularly in terms of total dose and planned range of irradiation field, remains unclear. This phase III clinical trial aimed to compare the survival benefits between different radiation doses and different target fields.

Methods

This trial compared two aspects of radiation treatment, total dose and field, using a two-by-two factorial design. The high-dose (HD) group received 59.4 Gy radiation, and the standard-dose (SD) group received 50.4 Gy. The involved field irradiation (IFI) group and elective nodal irradiation (ENI) group adopted different irradiation ranges. The participants were assigned to one of the four groups (HD+ENI, HD+IFI, SD+ENI and SD+IFI). The primary endpoint was overall survival (OS), and the secondary endpoints included progression-free survival (PFS). The synergy indexwas used to measure the interaction effect between dose and field.

Results

The interaction analysis did not reveal significant synergistic effects between the dose and irradiation field. In comparison to the target field, patients in IFI or ENI showed similar OS (hazard ratio [HR] = 0.99, 95% CI: 0.80-1.23, p = 0.930) and PFS (HR = 1.02, 95% CI: 0.82–1.25). The HD treatment did not show significantly prolonged OS compared with SD (HR = 0.90, 95% CI: 0.72–1.11, p = 0.318), but it suggested improved PFS (25.2 months to 18.0 months). Among the four groups, the HD+IFI group presented the best survival, while the SD+IFI group had the worst prognosis. No significant difference in the occurrence of severe adverse events was found in dose or field comparisons.

Conclusions

IFI demonstrated similar treatment efficacy to ENI in CCRT of ESCC. The HD demonstrated improved PFS, but did not significantly improve OS. The dose escalation based on IFI (HD+IFI) showed better therapeutic efficacy than the current recommendation (SD+ENI) and is worth further validation.

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针对局部晚期胸腔食管鳞状细胞癌的不同放射剂量和不同照射野的同期化放疗：一项随机、多中心、III 期临床试验。

背景：同期放化疗（CCRT）是局部晚期食管鳞状细胞癌（ESCC）的标准治疗方法。然而，最佳放疗方案，尤其是总剂量和计划照射野范围，仍不明确。这项III期临床试验旨在比较不同放射剂量和不同靶区对患者生存的益处：该试验采用二乘二的因子设计，比较了放射治疗的两个方面，即总剂量和照射野。高剂量（HD）组接受59.4 Gy的放射治疗，标准剂量（SD）组接受50.4 Gy的放射治疗。介入野照射（IFI）组和选择性结节照射（ENI）组采用不同的照射范围。参与者被分配到四组（HD+ENI组、HD+IFI组、SD+ENI组和SD+IFI组）中的一组。主要终点是总生存期（OS），次要终点包括无进展生存期（PFS）。协同作用指数用于衡量剂量和领域之间的交互作用：结果：交互作用分析并未显示剂量和照射野之间有明显的协同效应。与靶区相比，IFI 或 ENI 患者的 OS（危险比 [HR] = 0.99，95% CI：0.80-1.23，p = 0.930）和 PFS（HR = 1.02，95% CI：0.82-1.25）相似。与 SD 相比，HD 治疗并没有明显延长 OS（HR = 0.90，95% CI：0.72-1.11，p = 0.318），但却改善了 PFS（25.2 个月至 18.0 个月）。在四组患者中，HD+IFI 组的生存率最高，而 SD+IFI 组的预后最差。在剂量或病区比较中，严重不良事件的发生率无明显差异：结论：在ESCC的CCRT治疗中，IFI与ENI的疗效相似。结论：在 ESCC 的 CCRT 治疗中，IFI 的疗效与 ENI 相似，HD 改善了 PFS，但并未显著改善 OS。基于IFI的剂量升级（HD+IFI）比目前的推荐方案（SD+ENI）显示出更好的疗效，值得进一步验证。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Communications Biochemistry, Genetics and Molecular Biology-Cancer Research

CiteScore

25.50

自引率

4.30%

发文量

153

审稿时长

4 weeks

期刊介绍： Cancer Communications is an open access, peer-reviewed online journal that encompasses basic, clinical, and translational cancer research. The journal welcomes submissions concerning clinical trials, epidemiology, molecular and cellular biology, and genetics.