Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma : A phase II trial
Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved..
Locoregional radiotherapy added to chemotherapy has significantly improved survival in de novo metastatic nasopharyngeal carcinoma (mNPC). However, only 54% of de novo mNPC patients who received sequential chemoradiotherapy have complete or partial response 3 months after radiotherapy. This Simon's optimal two-stage design phase II study (NCT04398056) investigates whether PD-1 inhibitor could improve tumor control in combination with chemoradiation. The primary endpoint is objective response rate (ORR) at 3 months after radiotherapy. Twenty-two patients with primary mNPC are enrolled. The ORR at 3 months after radiotherapy is 81.8% (22.7% complete response, n = 5; 59.1% partial response, n = 13), and the disease control rate is 81.8%. The 3-year progression-free survival (PFS) rate is 44.9% (95% confidence interval 26.4%-76.3%). Fifteen patients (68.2%) experienced grade 3-4 adverse events. Patients with high baseline plasma Epstein-Barr virus DNA copy number (>104 cps/mL) show worse PFS. Addition of toripalimab to sequential chemoradiotherapy suggests promising tumor response in patients with primary mNPC.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:4 |
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| Enthalten in: |
Cell reports. Medicine - 4(2023), 11 vom: 21. Nov., Seite 101279 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chen, Si-Yuan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 27.11.2023 Date Revised 12.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT04398056 Citation Status MEDLINE |
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| doi: |
10.1016/j.xcrm.2023.101279 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364428783 |
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| 100 | 1 | |a Chen, Si-Yuan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma |b A phase II trial |
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| 500 | |a Date Revised 12.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04398056 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a Locoregional radiotherapy added to chemotherapy has significantly improved survival in de novo metastatic nasopharyngeal carcinoma (mNPC). However, only 54% of de novo mNPC patients who received sequential chemoradiotherapy have complete or partial response 3 months after radiotherapy. This Simon's optimal two-stage design phase II study (NCT04398056) investigates whether PD-1 inhibitor could improve tumor control in combination with chemoradiation. The primary endpoint is objective response rate (ORR) at 3 months after radiotherapy. Twenty-two patients with primary mNPC are enrolled. The ORR at 3 months after radiotherapy is 81.8% (22.7% complete response, n = 5; 59.1% partial response, n = 13), and the disease control rate is 81.8%. The 3-year progression-free survival (PFS) rate is 44.9% (95% confidence interval 26.4%-76.3%). Fifteen patients (68.2%) experienced grade 3-4 adverse events. Patients with high baseline plasma Epstein-Barr virus DNA copy number (>104 cps/mL) show worse PFS. Addition of toripalimab to sequential chemoradiotherapy suggests promising tumor response in patients with primary mNPC | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a PD-1 inhibitor | |
| 650 | 4 | |a combination modality therapy | |
| 650 | 4 | |a immune checkpoint inhibitors | |
| 650 | 4 | |a metastases | |
| 650 | 4 | |a nasopharyngeal carcinoma | |
| 650 | 4 | |a toripalimab | |
| 650 | 7 | |a toripalimab |2 NLM | |
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| 700 | 1 | |a Duan, Xiao-Tong |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Hui-Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Peng, Lan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Zhi-Qiang |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Gui-Qiong |e verfasserin |4 aut | |
| 700 | 1 | |a Hua, Yi-Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Zou, Xiong |e verfasserin |4 aut | |
| 700 | 1 | |a You, Rui |e verfasserin |4 aut | |
| 700 | 1 | |a Ouyang, Yan-Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, You-Ping |e verfasserin |4 aut | |
| 700 | 1 | |a Gu, Chen-Mei |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Qi |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, Rou |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Meng-Xia |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Mei |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Yu-Long |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Chao |e verfasserin |4 aut | |
| 700 | 1 | |a Ding, Xi |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Ruo-Qi |e verfasserin |4 aut | |
| 700 | 1 | |a Duan, Chong-Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Wei-Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Pei-Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Ming-Yuan |e verfasserin |4 aut | |
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