Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial,The BMJ

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Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial
The BMJ ( IF 93.6 ) Pub Date : 2023-02-06 , DOI: 10.1136/bmj-2022-072133
Yan-Ping Mao ₁ , Shun-Xin Wang ₁ , Tian-Sheng Gao ₂ , Ning Zhang ₃ , Xiao-Yu Liang ₁ , Fang-Yun Xie ₁ , Yuan Zhang ₁ , Guan-Qun Zhou ₁ , Rui Guo ₁ , Wei-Jie Luo ₄ , Yong-Jie Li ₂ , Shao-Qiang Liang ₃ , Li Lin ₁ , Wen-Fei Li ₁ , Xu Liu ₁ , Cheng Xu ₁ , Yu-Pei Chen ₁ , Jia-Wei Lv ₁ , Shao-Hui Huang ₅ , Li-Zhi Liu ₆ , Ji-Bin Li ₇ , Ling-Long Tang ₁ , Lei Chen ₁ , Ying Sun ₁ , Jun Ma _{8,

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Affiliation

Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
Department of Radiation Oncology, Wuzhou Red Cross Hospital, Wuzhou, China.
Department of Radiation Oncology, First People's Hospital of Foshan, Foshan, China.
Department of Medical Oncology, Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen, China.
Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Imaging Diagnosis and Interventional Center, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
Center for Precision Medicine, Sun Yat-sen University, Guangzhou, China.

Objectives To address whether sparing the medial retropharyngeal lymph node (MRLN) region from elective irradiation volume provides non-inferior local relapse-free survival versus standard radiotherapy in patients with nasopharyngeal carcinoma. Design Open-label, non-inferiority, multicentre, randomised, phase 3 trial. Setting Three Chinese hospitals between 20 November 2017 and 3 December 2018. Participants Adults (18-65 years) with newly diagnosed, non-keratinising, non-distant metastatic nasopharyngeal carcinoma without MRLN involvement. Interventions Randomisation was done centrally by the Clinical Trials Centre at Sun Yat-sen University Cancer Center. Eligible patients were randomly assigned (1:1; block size of four) to receive MRLN sparing radiotherapy or standard radiotherapy (both medial and lateral retropharyngeal lymph node groups), and stratified by institution and treatment modality as follows: radiotherapy alone; concurrent chemoradiotherapy; induction chemotherapy plus radiotherapy or concurrent chemoradiotherapy. Main outcome measures Non-inferiority was met if the lower limit of the one sided 97.5% confidence interval of the absolute difference in three year local relapse-free survival (MRLN sparing radiotherapy minus standard radiotherapy) was greater than −8%. Results 568 patients were recruited: 285 in the MRLN sparing radiotherapy group; 283 in the standard radiotherapy group. Median follow-up was 42 months (interquartile range 39-45), intention-to-treat analysis showed that the three year local relapse-free survival of the MRLN sparing radiotherapy group was non-inferior to that of the standard radiotherapy group (95.3% v 95.5%, stratified hazard ratio 1.04 (95% confidence interval 0.51 to 2.12), P=0.95) with a difference of −0.2% ((one sided 97.5% confidence interval –3.6 to ∞), Pnon-inferiority<0.001). In the safety set (n=564), the sparing group had a lower incidence of grade ≥1 acute dysphagia (25.5% v 35.1%, P=0.01) and late dysphagia (24.0% v 34.3%, P=0.008). Patient reported outcomes at three years after MRLN sparing radiotherapy were better in multiple domains after adjusting for the baseline values: global health status (mean difference −5.6 (95% confidence interval –9.1 to –2.0), P=0.002), role functioning (−5.5 (–7.4 to –3.6), P<0.001), social functioning (−6.2 (–8.9 to –3.6), P<0.001), fatigue (7.9 (4.0 to 11.8), P<0.001), and swallowing (11.0 (8.4 to 13.6), P<0.001). The difference in swallowing scores reached clinical significance (>10 points difference). Conclusion Compared with standard radiotherapy, MRLN sparing radiotherapy showed non-inferiority in terms of risk of local relapse with fewer radiation related toxicity and improved patient reported outcomes in patients with non-metastatic nasopharyngeal carcinoma. Trial registration ClinicalTrials.gov [NCT03346109][1] The key raw data underlying this study were uploaded to the Research Data Deposit public platform (RDDA2023145985). Reasonable requests for data sharing should be made to the corresponding author and will be handled in line with the data access and sharing policy of Human Genetic Resource Administration of China and other participating sites outside of China. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03346109&atom=%2Fbmj%2F380%2Fbmj-2022-072133.atom

更新日期：2023-02-06

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