中华放射医学与防护杂志

罗勋艳,刘宽奇,贺前勇,等.不同时间给药联合调强放疗治疗局部晚期鼻咽癌的前瞻性Ⅱ期临床研究[J].中华放射医学与防护杂志,2025,45(12):1245-1252.Luo Xunyan,Liu Kuanqi,He Qianyong,et al.Prospective phase Ⅱ clinical trial of different drug administration times combined with intensity-modulated radiotherapy for locally advanced nasopharyngeal carcinoma[J].Chin J Radiol Med Prot,2025,45(12):1245-1252

不同时间给药联合调强放疗治疗局部晚期鼻咽癌的前瞻性Ⅱ期临床研究

Prospective phase Ⅱ clinical trial of different drug administration times combined with intensity-modulated radiotherapy for locally advanced nasopharyngeal carcinoma

投稿时间：2025-01-13

DOI：10.3760/cma.j.cn112271-20250113-00020

中文关键词: 鼻咽癌时辰化疗不良反应生活质量长期生存

英文关键词:Nasopharyngeal carcinoma (NPC) Chrono-chemotherapy Quality of life (QoL) Adverse event Long-term survival

基金项目:国家自然科学基金(82060556)

作者	单位	E-mail
罗勋艳	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
刘宽奇	贵阳市第二人民医院, 贵阳 550004
贺前勇	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004 贵州医科大学附属肿瘤医院肿瘤科, 贵阳 550004
商凯	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
刘丽娜	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004 贵州医科大学附属肿瘤医院肿瘤科, 贵阳 550004
陈越	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
吴华静	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
周宇	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
宋嘉宇	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
吕丹丹	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004
金风	贵州医科大学附属医院肿瘤科, 贵阳 550004 贵州医科大学临床医学院肿瘤学教研室, 贵阳 550004 贵州医科大学附属肿瘤医院肿瘤科, 贵阳 550004	tjzlk2023@163.com

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中文摘要:

目的对比不同时间给药联合调强放疗对局晚期鼻咽癌患者不良反应、生活质量及长期生存的影响。方法将160例局晚期鼻咽癌患者按1 ∶1比例分为试验组及对照组，每组80例，两组均接受2周期的TPF(多西他赛、顺铂和氟尿嘧啶)诱导化疗序贯同步放化疗，试验组接受时辰化疗，对照组接受常规化疗。主要研究终点为≥3级急性不良反应，次要研究终点包括生活质量、8年总生存期(OS)、无进展生存期(PFS)、远处无转移生存期(DMFS)、局部无复发生存期(LRFS)。结果截至2024年10月10日，试验组≥3级急性呕吐、口腔黏膜炎、白细胞减少及中性粒细胞减少发生率为3.75%、6.25%、27.5%、35.0%；常规组为15.0%、16.25%、47.5%、52.5%，差异有统计学意义(χ²=0.03、0.05、0.01、0.03，P＜0.05)；试验组1~2级口干、听力下降发生率为63.2%、23.5%，对照组为80%，48.6%，差异有统计学意义(χ²=0.034、0.002，P＜0.05)，两组均无3~4级晚期不良反应；试验组的整体生活质量评分较常规组高，两组间的社会功能、一般健康状况和呕吐评分差异具有统计学意义(t=2.42、2.40、-2.69，P＜0.05)；两组间8年的OS、PFS、DMFS、LRFS差异无统计学意义(P＞0.05)。结论时辰化疗联合调强放疗可减轻局晚期鼻咽癌患者不良反应，提高生活质量，而不影响长期生存结果。

英文摘要:

Objective To compare the effects of different drug administration times combined with intensity-modulated radiotherapy (IMRT) on the adverse events, quality of life (QoL), and long-term survival of patients with locally advanced nasopharyngeal carcinoma (LA-NPC).Methods A total of 160 patients with LA-NPC were divided(1 ∶1) into an experimental group and a control group, with 80 patients in each group. Both groups received 2 cycles of TPF (docetaxel, cisplatin, and fluorouracil) induction chemotherapy followed by concurrent chemoradiotherapy. Nevertheless, the experimental group received chrono-chemotherapy, while the control group received conventional chemotherapy. In the study, the primary endpoint was grade ≥ 3 (G3+) acute adverse events, and the secondary endpoints included QoL, along with overall survival (OS), progression-free survival (PFS), distant metastasis-free survival (DMFS), and local recurrence-free survival (LRFS) at 8 years post-treatment.Results As of October 10, 2024, the incidence rates of four G3+ chemotherapy-related adverse events, i.e., acute vomiting, oral mucositis, leukopenia, and neutropenia, of the experimental group were determined at 3.75%, 6.25%, 27.5%, and 35.0%, respectively, while those of the control group were calculated at 15.0%, 16.25%, 47.5%, and 52.5%, respectively, with statistically significant differences (χ² = 0.03, 0.05, 0.01, 0.03, P < 0.05). The incidence rates of two grade 1-2 chemotherapy-related adverse events, i.e., xerostomia and hearing loss, of the experimental group were 63.2% and 23.5%, respectively, while those of the control group were 80% and 48.6%, respectively, with statistically significant differences (χ² = 0.034, 0.002, P < 0.05). Both groups showed an absence of grade 3-4 late adverse events. Compared to the control group, which received conventional chemotherapy, the experimental group demonstrated a higher overall QoL, with statistical significance observed in social functioning, general health, and vomiting between the two groups (t = 2.42, 2.40, -2.69, P < 0.05). However, no statistical significance was observed in OS, PFS, DMFS, and LRFS at eight years post-treatment between the groups (P > 0.05).Conclusions The combination of chrono-chemotherapy with IMRT can significantly reduce adverse events and improve QoL, without compromising the long-term survival of patients with LA-NPC.

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