Reduced‐volume radiotherapy versus conventional‐volume radiotherapy after induction chemotherapy in nasopharyngeal carcinoma: An open‐label, noninferiority, multicenter, randomized phase 3 trial

Background Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced‐volume radiotherapy is unc...

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Published inCA: a cancer journal for clinicians Vol. 75; no. 3; pp. 203 - 215
Main Authors Tang, Ling‐Long, Chen, Lin, Xu, Gui‐Qiong, Zhang, Ning, Huang, Cheng‐Long, Li, Wen‐Fei, Mao, Yan‐Ping, Zhou, Guan‐Qun, Lei, Feng, Chen, Lu‐Si, Huang, Shao Hui, Chen, Lei, Chen, Yu‐Pei, Zhang, Yuan, Liu, Xu, Xu, Cheng, Zhao, Yin, Li, Ji‐Bin, Liu, Na, Xie, Fang‐Yun, Guo, Rui, Sun, Ying, Ma, Jun
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.06.2025
John Wiley and Sons Inc
Subjects
Adult
Aged
Chemotherapy
clinical trial
Female
Humans
Induction Chemotherapy
Male
Middle Aged
Mucositis
Nasopharyngeal carcinoma
Nasopharyngeal Carcinoma - drug therapy
Nasopharyngeal Carcinoma - mortality
Nasopharyngeal Carcinoma - pathology
Nasopharyngeal Carcinoma - radiotherapy
Nasopharyngeal Neoplasms - drug therapy
Nasopharyngeal Neoplasms - mortality
Nasopharyngeal Neoplasms - pathology
Nasopharyngeal Neoplasms - radiotherapy
noninferiority
Otitis media
Public health
Quality of Life
Radiation Injuries - epidemiology
Radiation therapy
reduced‐volume radiotherapy
Saliva
Survival
Toxicity
Tumor Burden - drug effects
Tumor Burden - radiation effects
Tumors
clinical trial
nasopharyngeal carcinoma
reduced‐volume radiotherapy
noninferiority
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Abstract Background Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced‐volume radiotherapy is uncertain. Methods In this multi‐center, noninferiority, randomized, controlled trial, patients with LANPC who completed IC were randomly assigned (1:1) to receive reduced‐volume radiotherapy based on post‐IC tumor volume (Post‐IC group) or conventional volume radiotherapy based on pre‐IC tumor volume (Pre‐IC group). The primary endpoint was locoregional relapse‐free survival, with a noninferiority margin of 8%. Secondary endpoints comprised adverse events, and quality of life (QoL). Results Between August 7, 2020, and May 27, 2022, 445 patients were randomly assigned to Post‐IC (n = 225) or Pre‐IC (n = 220) groups. The average volume receiving radical dose was 66.6 cm3 in Post‐IC group versus 80.9 cm3. After a median follow‐up of 40.4 months, the 3‐year locoregional relapse‐free survival was 91.5% in the Post‐IC group versus 91.2%, with a difference of 0.3% (95% confidence interval −4.9% to 5.5%). The incidence of grade 3‐4 radiation‐related toxicity was lower in the Post‐IC group including: acute mucositis (19.8% vs 34.1%), late otitis media (9.5% vs 20.9%) and late dry month (3.6% vs 9.5%). The Post‐IC group had better QoL for global health status, physical functioning, emotional functioning, dry mouth and sticky saliva. Conclusions In this trial, reduced‐volume radiotherapy was noninferior to conventional volume radiotherapy in locoregional relapse‐free survival, and was associated with lower toxicities and improved QoL. (ClinicalTrials.gov identifier NCT04384627).
AbstractList Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced-volume radiotherapy is uncertain. In this multi-center, noninferiority, randomized, controlled trial, patients with LANPC who completed IC were randomly assigned (1:1) to receive reduced-volume radiotherapy based on post-IC tumor volume (Post-IC group) or conventional volume radiotherapy based on pre-IC tumor volume (Pre-IC group). The primary endpoint was locoregional relapse-free survival, with a noninferiority margin of 8%. Secondary endpoints comprised adverse events, and quality of life (QoL). Between August 7, 2020, and May 27, 2022, 445 patients were randomly assigned to Post-IC (n = 225) or Pre-IC (n = 220) groups. The average volume receiving radical dose was 66.6 cm in Post-IC group versus 80.9 cm . After a median follow-up of 40.4 months, the 3-year locoregional relapse-free survival was 91.5% in the Post-IC group versus 91.2%, with a difference of 0.3% (95% confidence interval -4.9% to 5.5%). The incidence of grade 3-4 radiation-related toxicity was lower in the Post-IC group including: acute mucositis (19.8% vs 34.1%), late otitis media (9.5% vs 20.9%) and late dry month (3.6% vs 9.5%). The Post-IC group had better QoL for global health status, physical functioning, emotional functioning, dry mouth and sticky saliva. In this trial, reduced-volume radiotherapy was noninferior to conventional volume radiotherapy in locoregional relapse-free survival, and was associated with lower toxicities and improved QoL. (ClinicalTrials.gov identifier NCT04384627).
Background Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced‐volume radiotherapy is uncertain. Methods In this multi‐center, noninferiority, randomized, controlled trial, patients with LANPC who completed IC were randomly assigned (1:1) to receive reduced‐volume radiotherapy based on post‐IC tumor volume (Post‐IC group) or conventional volume radiotherapy based on pre‐IC tumor volume (Pre‐IC group). The primary endpoint was locoregional relapse‐free survival, with a noninferiority margin of 8%. Secondary endpoints comprised adverse events, and quality of life (QoL). Results Between August 7, 2020, and May 27, 2022, 445 patients were randomly assigned to Post‐IC (n = 225) or Pre‐IC (n = 220) groups. The average volume receiving radical dose was 66.6 cm3 in Post‐IC group versus 80.9 cm3. After a median follow‐up of 40.4 months, the 3‐year locoregional relapse‐free survival was 91.5% in the Post‐IC group versus 91.2%, with a difference of 0.3% (95% confidence interval −4.9% to 5.5%). The incidence of grade 3‐4 radiation‐related toxicity was lower in the Post‐IC group including: acute mucositis (19.8% vs 34.1%), late otitis media (9.5% vs 20.9%) and late dry month (3.6% vs 9.5%). The Post‐IC group had better QoL for global health status, physical functioning, emotional functioning, dry mouth and sticky saliva. Conclusions In this trial, reduced‐volume radiotherapy was noninferior to conventional volume radiotherapy in locoregional relapse‐free survival, and was associated with lower toxicities and improved QoL. (ClinicalTrials.gov identifier NCT04384627).
Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced-volume radiotherapy is uncertain.BACKGROUNDNearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced-volume radiotherapy is uncertain.In this multi-center, noninferiority, randomized, controlled trial, patients with LANPC who completed IC were randomly assigned (1:1) to receive reduced-volume radiotherapy based on post-IC tumor volume (Post-IC group) or conventional volume radiotherapy based on pre-IC tumor volume (Pre-IC group). The primary endpoint was locoregional relapse-free survival, with a noninferiority margin of 8%. Secondary endpoints comprised adverse events, and quality of life (QoL).METHODSIn this multi-center, noninferiority, randomized, controlled trial, patients with LANPC who completed IC were randomly assigned (1:1) to receive reduced-volume radiotherapy based on post-IC tumor volume (Post-IC group) or conventional volume radiotherapy based on pre-IC tumor volume (Pre-IC group). The primary endpoint was locoregional relapse-free survival, with a noninferiority margin of 8%. Secondary endpoints comprised adverse events, and quality of life (QoL).Between August 7, 2020, and May 27, 2022, 445 patients were randomly assigned to Post-IC (n = 225) or Pre-IC (n = 220) groups. The average volume receiving radical dose was 66.6 cm3 in Post-IC group versus 80.9 cm3. After a median follow-up of 40.4 months, the 3-year locoregional relapse-free survival was 91.5% in the Post-IC group versus 91.2%, with a difference of 0.3% (95% confidence interval -4.9% to 5.5%). The incidence of grade 3-4 radiation-related toxicity was lower in the Post-IC group including: acute mucositis (19.8% vs 34.1%), late otitis media (9.5% vs 20.9%) and late dry month (3.6% vs 9.5%). The Post-IC group had better QoL for global health status, physical functioning, emotional functioning, dry mouth and sticky saliva.RESULTSBetween August 7, 2020, and May 27, 2022, 445 patients were randomly assigned to Post-IC (n = 225) or Pre-IC (n = 220) groups. The average volume receiving radical dose was 66.6 cm3 in Post-IC group versus 80.9 cm3. After a median follow-up of 40.4 months, the 3-year locoregional relapse-free survival was 91.5% in the Post-IC group versus 91.2%, with a difference of 0.3% (95% confidence interval -4.9% to 5.5%). The incidence of grade 3-4 radiation-related toxicity was lower in the Post-IC group including: acute mucositis (19.8% vs 34.1%), late otitis media (9.5% vs 20.9%) and late dry month (3.6% vs 9.5%). The Post-IC group had better QoL for global health status, physical functioning, emotional functioning, dry mouth and sticky saliva.In this trial, reduced-volume radiotherapy was noninferior to conventional volume radiotherapy in locoregional relapse-free survival, and was associated with lower toxicities and improved QoL. (ClinicalTrials.gov identifier NCT04384627).CONCLUSIONSIn this trial, reduced-volume radiotherapy was noninferior to conventional volume radiotherapy in locoregional relapse-free survival, and was associated with lower toxicities and improved QoL. (ClinicalTrials.gov identifier NCT04384627).
Background Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage. Radiotherapy always follows IC, and reduced volume has been proposed. However, the efficacy and safety of reduced-volume radiotherapy is uncertain. Methods In this multi-center, noninferiority, randomized, controlled trial, patients with LANPC who completed IC were randomly assigned (1:1) to receive reduced-volume radiotherapy based on post-IC tumor volume (Post-IC group) or conventional volume radiotherapy based on pre-IC tumor volume (Pre-IC group). The primary endpoint was locoregional relapse-free survival, with a noninferiority margin of 8%. Secondary endpoints comprised adverse events, and quality of life (QoL). Results Between August 7, 2020, and May 27, 2022, 445 patients were randomly assigned to Post-IC (n = 225) or Pre-IC (n = 220) groups. The average volume receiving radical dose was 66.6 cm3 in Post-IC group versus 80.9 cm3. After a median follow-up of 40.4 months, the 3-year locoregional relapse-free survival was 91.5% in the Post-IC group versus 91.2%, with a difference of 0.3% (95% confidence interval −4.9% to 5.5%). The incidence of grade 3-4 radiation-related toxicity was lower in the Post-IC group including: acute mucositis (19.8% vs 34.1%), late otitis media (9.5% vs 20.9%) and late dry month (3.6% vs 9.5%). The Post-IC group had better QoL for global health status, physical functioning, emotional functioning, dry mouth and sticky saliva. Conclusions In this trial, reduced-volume radiotherapy was noninferior to conventional volume radiotherapy in locoregional relapse-free survival, and was associated with lower toxicities and improved QoL. (ClinicalTrials.gov identifier NCT04384627).
Author Chen, Lu‐Si
Sun, Ying
Tang, Ling‐Long
Liu, Xu
Guo, Rui
Chen, Yu‐Pei
Zhao, Yin
Chen, Lin
Chen, Lei
Mao, Yan‐Ping
Xie, Fang‐Yun
Huang, Cheng‐Long
Li, Wen‐Fei
Lei, Feng
Liu, Na
Xu, Cheng
Xu, Gui‐Qiong
Zhang, Yuan
Huang, Shao Hui
Ma, Jun
Li, Ji‐Bin
Zhang, Ning
Zhou, Guan‐Qun
AuthorAffiliation 2 Nasopharyngeal Head and Neck Carcinoma Radiotherapy Department Zhongshan City People's Hospital Zhongshan China
1 Department of Radiation Oncology State Key Laboratory of Oncology in South China Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy Guangdong Provincial Clinical Research Center for Cancer Sun Yat‐sen University Cancer Center Guangzhou China
5 Clinical Trials Center Sun Yat‐sen University Cancer Center Guangzhou China
4 Department of Radiation Oncology Princess Margaret Cancer Center University of Toronto Toronto Ontario Canada
3 Department of Nasopharyngeal Oncology First People's Hospital of Foshan Foshan China
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– name: 3 Department of Nasopharyngeal Oncology First People's Hospital of Foshan Foshan China
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/39970442$$D View this record in MEDLINE/PubMed
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Keywords clinical trial
nasopharyngeal carcinoma
reduced‐volume radiotherapy
noninferiority
Language English
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2025 The Author(s). CA: A Cancer Journal for Clinicians published by Wiley Periodicals LLC on behalf of American Cancer Society.
This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
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Notes Ling‐Long Tang, Lin Chen, Gui‐Qiong Xu, Ning Zhang, and Cheng‐Long Huang contributed equally to this article.
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Snippet Background Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage....
Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage....
Background Nearly 90% locoregionally advanced nasopharyngeal carcinoma (LANPC) responds to induction chemotherapy (IC) with significant tumor volume shrinkage....
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StartPage 203
SubjectTerms Adult
Aged
Chemotherapy
clinical trial
Female
Humans
Induction Chemotherapy
Male
Middle Aged
Mucositis
Nasopharyngeal carcinoma
Nasopharyngeal Carcinoma - drug therapy
Nasopharyngeal Carcinoma - mortality
Nasopharyngeal Carcinoma - pathology
Nasopharyngeal Carcinoma - radiotherapy
Nasopharyngeal Neoplasms - drug therapy
Nasopharyngeal Neoplasms - mortality
Nasopharyngeal Neoplasms - pathology
Nasopharyngeal Neoplasms - radiotherapy
noninferiority
Otitis media
Public health
Quality of Life
Radiation Injuries - epidemiology
Radiation therapy
reduced‐volume radiotherapy
Saliva
Survival
Toxicity
Tumor Burden - drug effects
Tumor Burden - radiation effects
Tumors
Title Reduced‐volume radiotherapy versus conventional‐volume radiotherapy after induction chemotherapy in nasopharyngeal carcinoma: An open‐label, noninferiority, multicenter, randomized phase 3 trial
URI https://onlinelibrary.wiley.com/doi/abs/10.3322%2Fcaac.21881
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