Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial

被引：74

作者：

Zhang, Yuan ^{[1
]}

Chen, Lei ^{[1
]}

Hu, Guo-Qing ^{[2
]}

Zhang, Ning ^{[3
]}

Zhu, Xiao-Dong ^{[4
]}

Yang, Kun-Yu ^{[5
]}

Jin, Feng ^{[6
]}

Shi, Mei ^{[7
]}

Chen, Yu-Pei ^{[1
]}

Hu, Wei-Han ^{[1
]}

Cheng, Zhi-Bin ^{[8
]}

Wang, Si-Yang ^{[9
]}

Tian, Ye ^{[10
]}

Wang, Xi-Cheng ^{[11
]}

Sun, Yan ^{[12
]}

Li, Jin-Gao ^{[13
]}

Li, Wen-Fei ^{[1
]}

Li, Yu-Hong ^{[14
]}

Mao, Yan-Ping ^{[1
]}

Zhou, Guan-Qun ^{[1
]}

Sun, Rui ^{[1
]}

Liu, Xu ^{[1
]}

Guo, Rui ^{[1
]}

Long, Guo-Xian ^{[2
]}

Liang, Shao-Qiang ^{[3
]}

Li, Ling ^{[4
]}

Huang, Jing ^{[5
]}

Long, Jin-Hua ^{[6
]}

Zang, Jian ^{[7
]}

Liu, Qiao-Dan ^{[9
]}

Zou, Li ^{[10
]}

Su, Qiong-Fei ^{[11
]}

Zheng, Bao-Min ^{[12
]}

Xiao, Yun ^{[13
]}

Guo, Ying ^{[15
]}

Han, Fei ^{[1
]}

Mo, Hao-Yuan ^{[16
]}

Lv, Jia-Wei ^{[1
]}

Du, Xiao-Jing ^{[1
]}

Xu, Cheng ^{[1
]}

Liu, Na ^{[1
]}

Li, Ying-Qin ^{[1
]}

Xie, Fang-Yun ^{[1
]}

Sun, Ying ^{[1
]}

Ma, Jun ^{[1
]}

Tang, Ling-Long ^{[1
]}

机构：

[1] Sun Yat Sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, Dept Radiat Oncol, State Key Lab Oncol South China,Guangdong Key Lab, Guangzhou, Peoples R China

[2] Huazhong Univ Sci & Technol, Tongji Hosp, Canc Ctr, Dept Oncol,Tongji Med Coll, Wuhan, Peoples R China

[3] First Peoples Hosp Foshan, Dept Radiat Oncol, Foshan, Peoples R China

[4] Guangxi Med Univ Canc Hosp, Dept Radiat Oncol, Nanning, Peoples R China

[5] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Peoples R China

[6] Guizhou Med Univ, Dept Head & Neck Oncol, Affiliated Canc Hosp, Guiyang, Peoples R China

[7] Air Force Med Univ, Dept Radiat Oncol, XiJing Hosp, Xian, Peoples R China

[8] Sun Yat Sen Univ, Canc Ctr, Affiliated Hosp 5, Zhuhai, Peoples R China

[9] Sun Yat Sen Univ, Dept Head & Neck Oncol, Canc Ctr, Affiliated Hosp 5, Zhuhai, Peoples R China

[10] Soochow Univ, Dept Radiat Oncol, Affiliated Hosp 2, Suzhou, Peoples R China

[11] Guangdong Pharmaceut Univ, Dept Radiat Oncol, Affiliated Hosp 1, Guangzhou, Peoples R China

[12] Peking Univ Canc Hosp, Dept Radiat Oncol, Beijing, Peoples R China

[13] Jiangxi Canc Hosp, Dept Radiat Oncol, Nanchang, Jiangxi, Peoples R China

[14] Sun Yat Sen Univ Canc Ctr, Dept Med Oncol, Guangzhou, Peoples R China

[15] Sun Yat Sen Univ Canc Ctr, Clin Trials Ctr, Guangzhou, Peoples R China

[16] Sun Yat Sen Univ Canc Ctr, Dept Nasopharyngeal Carcinoma, Guangzhou, Peoples R China

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2022年 / 40卷 / 22期

基金：

中国国家自然科学基金;

关键词：

D O I：

10.1200/JCO.22.00327

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P = .001) and a comparable risk of late toxicities (>= grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P = .005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P = .77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.

引用

页码：2420 / +

页数：7

共 12 条

[11] Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial
Yang, Yunpeng
Qu, Song
Li, Jingao
Hu, Chaosu
Xu, Mingjun
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Zou, Jianjun
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[J]. LANCET ONCOLOGY, 2021, 22 (08) : 1162 - 1174
[12] Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma
Zhang, Yuan
Chen, Lei
Hu, Guo-Qing
Zhang, Ning
Zhu, Xiao-Dong
Yang, Kun-Yu
Jin, Feng
Shi, Mei
Chen, Yu-Pei
Hu, Wei-Han
Cheng, Zhi-Bin
Wang, Si-Yang
Tian, Ye
Wang, Xi-Cheng
Sun, Yan
Li, Jin-Gao
Li, Wen-Fei
Li, Yu-Hong
Tang, Ling-Long
Mao, Yan-Ping
Zhou, Guan-Qun
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Liu, Xu
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Long, Guo-Xian
Liang, Shao-Qiang
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Huang, Jing
Long, Jin-Hua
Zang, Jian
Liu, Qiao-Dan
Zou, Li
Su, Qiong-Fei
Zheng, Bao-Min
Xiao, Yun
Guo, Ying
Han, Fei
Mo, Hao-Yuan
Lv, Jia-Wei
Du, Xiao-Jing
Xu, Cheng
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Li, Ying-Qin
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Xie, Fang-Yun
Sun, Ying
Ma, Jun
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