| 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].Chinese Journal of Radiological Medicine and Protection,2025,45(12):1245-1252 |
| Prospective phase Ⅱ clinical trial of different drug administration times combined with intensity-modulated radiotherapy for locally advanced nasopharyngeal carcinoma |
| Received:January 13, 2025 |
| DOI：10.3760/cma.j.cn112271-20250113-00020 |
| KeyWords:Nasopharyngeal carcinoma (NPC) Chrono-chemotherapy Quality of life (QoL) Adverse event Long-term survival |
| FundProject:国家自然科学基金(82060556) |
| Author Name | Affiliation | E-mail | | Luo Xunyan | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Liu Kuanqi | Second People's Hospital of Guiyang, Guiyang 550004, China | | | He Qianyong | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China
Department of Oncology, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang 550004, China | | | Shang Kai | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Liu Lina | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China
Department of Oncology, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang 550004, China | | | Chen Yue | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Wu Huajing | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Zhou Yu | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Song Jiayu | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Lyu Dandan | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China | | | Jin Feng | Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
Department of Oncology, School of Clinical Medicine, Guizhou Medical University, Guiyang 550004, China
Department of Oncology, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang 550004, China | tjzlk2023@163.com |
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| Abstract:: |
| 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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