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Clinical Trial
. 2020 Sep 1;6(9):1345-1352.
doi: 10.1001/jamaoncol.2020.1808.

Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial

Rui You  1   2   3 , You-Ping Liu  1   2   3 , Pei-Yu Huang  1   2   3 , Xiong Zou  1   2   3 , Rui Sun  1   2   3 , Yu-Xiang He  4 , Yi-Shan Wu  1   2   3 , Guo-Ping Shen  5 , Hong-Dan Zhang  6 , Chong-Yang Duan  7 , Sze Huey Tan  8 , Jing-Yu Cao  1   2   3 , Ji-Bin Li  2   9 , Yu-Long Xie  1   2   3 , Yi-Nuan Zhang  1   2   3 , Zhi-Qiang Wang  1   2   3 , Qi Yang  1   2   3 , Mei Lin  1   2   3 , Rou Jiang  1   2   3 , Meng-Xia Zhang  1   2   3 , Yi-Jun Hua  1   2   3 , Lin-Quan Tang  1   2   3 , Ai-Hua Zhuang  2 , Qiu-Yan Chen  1   2   3 , Ling Guo  1   2   3 , Hao-Yuan Mo  1   2   3 , Yong Chen  5 , Hai-Qiang Mai  1   2   3 , Li Ling  10 , Qing Liu  2   11 , Melvin Lee Kiang Chua  12   13 , Ming-Yuan Chen  1   2   3
Affiliations
Clinical Trial

Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial

Rui You et al. JAMA Oncol. .

Abstract

Importance: The role of locoregional radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma (mNPC) is unclear.

Objective: To investigate the efficacy and safety of locoregional radiotherapy in de novo mNPC.

Design, setting, and participants: Patients with biopsy-proven mNPC, who demonstrated complete or partial response (RECIST v1.1) following 3 cycles of cisplatin and fluorouracil chemotherapy, were enrolled. Eligible patients were randomly assigned (1:1) to receive either chemotherapy plus radiotherapy or chemotherapy alone. Overall, 126 of 173 patients screened were eligible to the study, and randomized to chemotherapy plus radiotherapy (n = 63) or chemotherapy alone (n = 63). Median (IQR) follow-up duration was 26.7 (17.2-33.5) months.

Interventions: The chemotherapy regimens were fluorouracil continuous intravenous infusion at 5 g/m2 over 120 hours and 100 mg/m2 intravenous cisplatin on day 1, administered every 3 weeks for 6 cycles. Patients assigned to the chemotherapy plus radiotherapy group received intensity-modulated radiotherapy (IMRT) after chemotherapy.

Main outcomes and measures: The primary end point of the study was overall survival (OS). The secondary end point was progression-free survival (PFS) and safety.

Results: Overall, 126 patients were enrolled (105 men [83.3%] and 21 women [16.7%]; median [IQR] age, 46 [39-52] years). The 24-month OS was 76.4% (95% CI, 64.4%-88.4%) in the chemotherapy plus radiotherapy group, compared with 54.5% (95% CI, 41.0%-68.0%) in the chemotherapy-alone group. The study met its primary end point of improved OS (stratified hazard ratio [HR], 0.42; 95% CI, 0.23-0.77; P = .004) in favor of chemotherapy plus radiotherapy. Progression-free survival was also improved in the chemotherapy plus radiotherapy group compared with the chemotherapy-alone group (stratified HR, 0.36; 95% CI, 0.23-0.57). No significant differences in acute hematological or gastrointestinal toxic effects were observed between the treatment arms. The frequency of acute grade 3 or higher dermatitis, mucositis, and xerostomia was 8.1%, 33.9%, and 6.5%, respectively, in the chemotherapy plus radiotherapy group. The frequency of late severe grade 3 or higher hearing loss and trismus was 5.2% and 3.4%, respectively, in the chemotherapy plus radiotherapy group.

Conclusions and relevance: In this randomized clinical trial, radiotherapy added to chemotherapy significantly improved OS in chemotherapy-sensitive patients with mNPC.

Trial registration: ClinicalTrials.gov Identifier: NCT02111460.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Flow Chart of Trial Participants
CR indicates complete response; PR, partial response.
Figure 2.
Figure 2.. Overall Survival and Progression-free Survival in the Intention-to-Treat Population
sHR indicates stratified hazard ratio.
See this image and copyright information in PMC

Comment in

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