Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial

You, Rui; Liu, You‐Ping; Xie, YuLong; Lin, Chao; Duan, Chongyang; Chen, Dongping; Pan, Y.; Qi, Bin; Zou, Xiong; Guo, Ling; Cao, Jingyu; Zhang, Yi-Nuan; Wang, Zhiqiang; Liu, Yong-Long; Ouyang, Yan-Feng; Wen, Ke; Yang, Qi; Xie, Ruo-Qi; Li, Huifeng; Duan, Xiao-Tong; Ding, Xi; Peng, Lan; Chen, Siyuan; Feng, Zhengkai; Xia, Tian-Liang; Xie, Ruiling; Jiang, Rou; Gu, Chen-Mei; Liu, Rong-Zeng; Sun, Rui; Yang, Xin; Liu, Lizhi; Li, Ling; Liu, Qing; Ng, Wai Tong; Hua, Yi-Jun; Huang, Pei-Yu; Chen, Ming‐Yuan

doi:10.1016/s0140-6736(23)00269-6

Cited by 25 publications

(19 citation statements)

References 31 publications

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“…In this trial, 65 Gy in 54 total fractions was delivered twice daily, at least 6 h apart. While the main goal of the trial was to assess for an improvement in the rates of severe late toxicities, the authors also reported that hyperfractionation led to an improvement in 3-year OS (75% vs. 55%) compared to standard fractionation [47]. Although the findings of this study were encouraging; a higher proportion of NPC in Asian patients is undifferentiated and nonkeratinizing SCCs compared to patients in North America and Europe.…”

Section: Text Of Reviewmentioning

confidence: 67%

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Radiation oncology for the rhinologist

Levyn,

Yang,

Lee

2023

Current Opinion in Otolaryngology &Amp; Head &Amp; Neck Surgery

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Purpose of review This comprehensive review explores evolving treatment strategies for sinonasal and nasopharyngeal malignancies. It analyzes the role of adjuvant radiotherapy, the potential of intensity-modulated proton therapy (IMPT), and the relevance of de-escalation strategies nasopharyngeal carcinoma (NPC). Additionally, it discusses hyperfractionation in re-irradiation in NPC. Recent findings Adjuvant radiotherapy remains pivotal for sinonasal tumors, improving locoregional control and survival, notably in squamous cell carcinomas, adenocarcinomas, and adenoid cystic carcinomas. IMPT promises enhanced outcomes by sparing healthy tissues, potentially improving patients’ quality of life. For select stage II/T3N0 NPC, radiotherapy alone offers comparable outcomes to concurrent chemoradiotherapy, with fewer adverse events and improved quality of life. Selective neck irradiation in NPC patients with uninvolved necks maintains oncologic outcomes while reducing late toxicity. Hyperfractionation in re-irradiation shows promise in lowering late toxicities and improving overall survival, particularly in undifferentiated sinonasal carcinomas. Summary This review underscores the significance of adjuvant radiotherapy and the potential of advanced radiation techniques in optimizing sinonasal and nasopharyngeal malignancy outcomes. It emphasizes evolving de-escalation methods and individualized, evidence-based approaches. Future research will further refine strategies for these challenging malignancies.

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Section: Text Of Reviewmentioning

confidence: 67%

“…In the re-irradiation setting, a recent phase III clinical trial from China reported significantly lower late-toxicities with hyperfractionation [47]. In this trial, 65 Gy in 54 total fractions was delivered twice daily, at least 6 h apart.…”

Section: Text Of Reviewmentioning

confidence: 99%

Radiation oncology for the rhinologist

Levyn,

Yang,

Lee

2023

Current Opinion in Otolaryngology &Amp; Head &Amp; Neck Surgery

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“…Recently, a randomized trial showed that hyperfractionated IMRT could improve the 3-year OS to 74.6% by significantly reducing the RT-induced toxicities. 4 CIRT, as an advanced radiation technique, could provide better clinical outcome for this group of patients due to its physical and biological advantages. Previously, we have summarized the clinical outcome of 206 LR NPC patients treated using CIRT.…”

Section: Discussionmentioning

confidence: 99%

“…2,3 Hyperfractionated IMRT was able to significantly improve the OS to over 70%, although the locoregional relapse-free survival rate remains at a relatively low level of 53.7%. 4 Carbon-ion radiation therapy (CIRT) is a newly emerging technique with both physical and biological advantages. 5 Physically, the highly conformal dose distribution of carbon-ion beam enables better protection of surrounding organs at risk (such as temporal lobe and brain stem).…”

Section: Introductionmentioning

confidence: 99%

A protocol for a randomized trial evaluating the role of carbon‐ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma

Hu,

Huang,

et al. 2024

Cancer Medicine

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PurposeManagement of locoregionally recurrent nasopharyngeal carcinoma (LR NPC) is difficult. Although carbon‐ion radiation therapy (CIRT) could substantially improve the overall survival (OS) of those patients, around 40% of the patients may still develop local failure. Further improvement of the disease control is necessary. Immunotherapy, such as immune checkpoint inhibitors (ICIs) becomes a promising antitumor treatment. The role of ICIs was proved in head and neck cancers including recurrent/metastatic NPC. Preclinical studies indicated potential synergistic effects between radiation therapy and ICIs. Therefore, we conduct a randomized phase 2 trial to evaluate the efficacy and safety of camrelizumab, an anti‐PD‐1 monoclonal antibody, along with CIRT in patients with LR NPC.MethodsPatients will be randomly assigned at 1:1 to receive either standard CIRT with 63 Gy (relatively biological effectiveness, [RBE]) in 21 fractions, or standard CIRT plus concurrent camrelizumab. Camrelizumab will be administered intravenously with a dose of 200 mg, every 2 week, for a maximum of 1 year. We estimate addition of camrelizumab will improve the 2‐year progression‐free survival (PFS) from 45% to 60%. A total of 146 patients (with a 5% lost to follow‐up rate) is required to yield a type I error of 0.2, and a power of 0.8.Results and ConclusionThe results of the trial may shed insights on the combined therapy with ICIs and CIRT.

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“…In an open-label randomized trial of almost 200 patients with locally recurrent, unresectable NPC, intensity-modulated RT (IMRT) using a hyperfractionated schedule (65 Gy in 54 fractions, given twice daily) improved three-year overall survival (75 versus 55 percent) and reduced grade ≥3 toxicities (34 versus 57 percent) compared with standard fractionation (60 Gy in 27 fractions, given daily). 3 Based on these data, for patients with locally recurrent unresectable NPC who are candidates for reirradiation, we administer IMRT using a hyperfractionated schedule rather than standard fractionation. nivolumab for advanced cutaneous squamous cell carcinoma (March 2023) Studies are investigating immune checkpoint inhibitors for advanced cutaneous squamous cell carcinoma (cSCC).…”

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confidence: 99%

UpToDate®

2023

Oncology Times

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Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial

Cited by 25 publications

References 31 publications

Radiation oncology for the rhinologist

Radiation oncology for the rhinologist

A protocol for a randomized trial evaluating the role of carbon‐ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma

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