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A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin

BACKGROUND: We conducted this study to evaluate if a reduced cumulative dose of induction and concurrent cisplatin conferred similar favorable outcomes when compared to trial NPC-0501. METHODS: Newly diagnosed nasopharyngeal carcinoma (NPC) with stage III-IVA were prospectively recruited from Januar...

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Autores principales: Xu, Zhiyuan, Yang, Li, Ng, Wai-Tong, Helali, Aya El, Lee, Victor Ho-Fun, Ma, Lingyu, Liu, Qin, Li, Jishi, Shen, Lin, Huang, Jijie, Zha, Jiandong, Zhou, Cheng, Lee, Anne W. M., Chen, Longhua
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9092977/
https://www.ncbi.nlm.nih.gov/pubmed/35574402
http://dx.doi.org/10.3389/fonc.2022.842281
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author Xu, Zhiyuan
Yang, Li
Ng, Wai-Tong
Helali, Aya El
Lee, Victor Ho-Fun
Ma, Lingyu
Liu, Qin
Li, Jishi
Shen, Lin
Huang, Jijie
Zha, Jiandong
Zhou, Cheng
Lee, Anne W. M.
Chen, Longhua
author_facet Xu, Zhiyuan
Yang, Li
Ng, Wai-Tong
Helali, Aya El
Lee, Victor Ho-Fun
Ma, Lingyu
Liu, Qin
Li, Jishi
Shen, Lin
Huang, Jijie
Zha, Jiandong
Zhou, Cheng
Lee, Anne W. M.
Chen, Longhua
author_sort Xu, Zhiyuan
collection PubMed
description BACKGROUND: We conducted this study to evaluate if a reduced cumulative dose of induction and concurrent cisplatin conferred similar favorable outcomes when compared to trial NPC-0501. METHODS: Newly diagnosed nasopharyngeal carcinoma (NPC) with stage III-IVA were prospectively recruited from January 2015 to September 2019. Induction chemotherapy (IC) consisted of cisplatin 80mg/m(2) on day 1 and capecitabine 1000mg/m(2) twice daily from day 1 to 14 every 3 weeks for 3 cycles followed by concurrent chemoradiotherapy (CCRT) with 2 cycles of cisplatin 100mg/m(2) given every 3 weeks. Tumor response was evaluated according to RECIST v1.1. Acute and late adverse events (AEs) were graded with CTCAE v4.0 and Late Radiation Morbidity Scoring of the RTOG, respectively. RESULTS: 135 patients were recruited. At 16 weeks after CCRT, all 130 patients who completed the entire course of radiotherapy (RT) had a complete response upon final assessment. With a median follow-up of 36.2 months, 22 treatment failures and 8 deaths were observed. The 3-year progression-free survival, overall survival, locoregional recurrence-free survival, and distant recurrence-free survival were 83.7%, 94.1%, 94.1%, and 85.9%, respectively. Our survival data outcomes were similar to those reported in the cisplatin and capecitabine (PX) induction arm of the 0501 trial. 103 patients (76.3%) reported acute grade 3-4 AEs. Two patients (1.5%) had late grade 3-4 complications, numerically fewer than those reported in the NPC-0501 trial. CONCLUSIONS: Induction PX and concurrent cisplatin with a reduced cumulative cisplatin dose yield survival outcomes comparable to those reported in the NPC-0501 trial with excellent tolerability. Therefore, a reduced cumulative dose of cisplatin is a promising treatment scheme for nasopharyngeal carcinoma.
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spelling pubmed-90929772022-05-12 A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin Xu, Zhiyuan Yang, Li Ng, Wai-Tong Helali, Aya El Lee, Victor Ho-Fun Ma, Lingyu Liu, Qin Li, Jishi Shen, Lin Huang, Jijie Zha, Jiandong Zhou, Cheng Lee, Anne W. M. Chen, Longhua Front Oncol Oncology BACKGROUND: We conducted this study to evaluate if a reduced cumulative dose of induction and concurrent cisplatin conferred similar favorable outcomes when compared to trial NPC-0501. METHODS: Newly diagnosed nasopharyngeal carcinoma (NPC) with stage III-IVA were prospectively recruited from January 2015 to September 2019. Induction chemotherapy (IC) consisted of cisplatin 80mg/m(2) on day 1 and capecitabine 1000mg/m(2) twice daily from day 1 to 14 every 3 weeks for 3 cycles followed by concurrent chemoradiotherapy (CCRT) with 2 cycles of cisplatin 100mg/m(2) given every 3 weeks. Tumor response was evaluated according to RECIST v1.1. Acute and late adverse events (AEs) were graded with CTCAE v4.0 and Late Radiation Morbidity Scoring of the RTOG, respectively. RESULTS: 135 patients were recruited. At 16 weeks after CCRT, all 130 patients who completed the entire course of radiotherapy (RT) had a complete response upon final assessment. With a median follow-up of 36.2 months, 22 treatment failures and 8 deaths were observed. The 3-year progression-free survival, overall survival, locoregional recurrence-free survival, and distant recurrence-free survival were 83.7%, 94.1%, 94.1%, and 85.9%, respectively. Our survival data outcomes were similar to those reported in the cisplatin and capecitabine (PX) induction arm of the 0501 trial. 103 patients (76.3%) reported acute grade 3-4 AEs. Two patients (1.5%) had late grade 3-4 complications, numerically fewer than those reported in the NPC-0501 trial. CONCLUSIONS: Induction PX and concurrent cisplatin with a reduced cumulative cisplatin dose yield survival outcomes comparable to those reported in the NPC-0501 trial with excellent tolerability. Therefore, a reduced cumulative dose of cisplatin is a promising treatment scheme for nasopharyngeal carcinoma. Frontiers Media S.A. 2022-04-27 /pmc/articles/PMC9092977/ /pubmed/35574402 http://dx.doi.org/10.3389/fonc.2022.842281 Text en Copyright © 2022 Xu, Yang, Ng, Helali, Lee, Ma, Liu, Li, Shen, Huang, Zha, Zhou, Lee and Chen https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Xu, Zhiyuan
Yang, Li
Ng, Wai-Tong
Helali, Aya El
Lee, Victor Ho-Fun
Ma, Lingyu
Liu, Qin
Li, Jishi
Shen, Lin
Huang, Jijie
Zha, Jiandong
Zhou, Cheng
Lee, Anne W. M.
Chen, Longhua
A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin
title A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin
title_full A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin
title_fullStr A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin
title_full_unstemmed A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin
title_short A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin
title_sort single-arm phase 2 trial on induction chemotherapy followed by concurrent chemoradiation in nasopharyngeal carcinoma using a reduced cumulative dose of cisplatin
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9092977/
https://www.ncbi.nlm.nih.gov/pubmed/35574402
http://dx.doi.org/10.3389/fonc.2022.842281
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