PMID- 30689735
OWN - NLM
STAT- MEDLINE
DCOM- 20200420
LR  - 20240229
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 30
IP  - 4
DP  - 2019 Apr 1
TI  - Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with 
      cisplatin and 5-fluorouracil in patients with metastatic nasopharyngeal carcinoma 
      after radical radiotherapy: a multicentre, open-label, phase II clinical trial.
PG  - 637-643
LID - S0923-7534(19)31116-0 [pii]
LID - 10.1093/annonc/mdz020 [doi]
AB  - BACKGROUND: We conducted a single-arm phase II trial to evaluate the efficacy and 
      adverse effects (AEs) of an anti-epidermal growth factor receptor monoclonal 
      antibody, nimotuzumab, combined with cisplatin and 5-fluorouracil (PF) as 
      first-line treatment in recurrent metastatic nasopharyngeal carcinoma after 
      radical radiotherapy. METHODS: Patients who met the eligibility criteria were 
      recruited from ten institutions (ClinicalTrials.gov; NCT01616849). A Simon 
      optimal two-stage design was used to calculate the sample size. All patients 
      received weekly nimotuzumab (200 mg) added to cisplatin (100 mg/m2 D1) and 
      5-fluorouracil (4 g/m2 continuous infusion D1-4) every 3-weekly for a maximum of 
      six cycles. Primary end point was objective response rate (ORR). Secondary end 
      points included disease control rate (DCR), progression-free survival (PFS), 
      overall survival (OS) and AEs. RESULTS: A total of 35 patients were enrolled (13 
      in stage 1 and 22 in stage 2). Overall ORR and DCR were 71.4% (25/35) and 85.7% 
      (30/35), respectively. Median PFS and OS were 7.0 (95% CI 5.8-8.2) months and 
      16.3 (95% CI 11.4-21.3) months, respectively. Unplanned exploratory analyses 
      suggest that patients who received >/=2400 mg nimotuzumab and >/=4 cycles of PF had 
      superior ORR, PFS and OS than those who did not (88.9% versus 12.5%, P < 0.001; 
      7.4 versus 2.7 months, P = 0.081; 17.0 versus 8.0 months, P = 0.202). Favourable 
      subgroups included patients with lung metastasis [HROS 0.324 (95% CI 
      0.146-0.717), P = 0.008] and disease-free interval of >12 months [HROS 0.307 (95% 
      CI 0.131-0.724), P = 0.004], but no difference was observed for metastatic 
      burden. The only major grade 3/4 AE was leukopenia (62.9%). CONCLUSION: 
      Combination nimotuzumab-PF chemotherapy demonstrates potential efficacy, and is 
      well tolerated as first-line chemotherapy regimen in recurrent metastatic 
      nasopharyngeal carcinoma.
CI  - (c) The Author(s) 2019. Published by Oxford University Press on behalf of the 
      European Society for Medical Oncology. All rights reserved. For permissions, 
      please email: journals.permissions@oup.com.
FAU - Zhao, C
AU  - Zhao C
AD  - Department of Radiation and Medical Oncology, Hubei Key Laboratory of Tumor 
      Biological Behaviors, Hubei Cancer Clinical Study Centre, Zhongnan Hospital of 
      Wuhan University, Wuhan; Department of Nasopharyngeal Carcinoma, Sun Yat-sen 
      University Cancer Centre, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation centre of Cancer Medicine, Guangdong Key Laboratory of 
      Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou.
FAU - Miao, J
AU  - Miao J
AD  - Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, 
      State Key Laboratory of Oncology in South China, Collaborative Innovation centre 
      of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma 
      Diagnosis and Therapy, Guangzhou.
FAU - Shen, G
AU  - Shen G
AD  - Department of Radiotherapy, Cancer Center of Guangzhou Medical University, 
      Guangzhou; Department of Radiation Oncology, The Third Affiliated Hospital of Sun 
      Yat-sen University, Guangzhou.
FAU - Li, J
AU  - Li J
AD  - Department of Radiation Oncology, Jiangxi Province Tumour Hospital, Nanchang.
FAU - Shi, M
AU  - Shi M
AD  - Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical 
      University, Xi'an.
FAU - Zhang, N
AU  - Zhang N
AD  - Department of Radiation Oncology, The First People's Hospital of Foshan, Foshan.
FAU - Hu, G
AU  - Hu G
AD  - Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan.
FAU - Chen, X
AU  - Chen X
AD  - Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou.
FAU - Hu, X
AU  - Hu X
AD  - Department of Radiation Oncology, The First People's Hospital of Foshan, Foshan.
FAU - Wu, S
AU  - Wu S
AD  - Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou.
FAU - Chen, J
AU  - Chen J
AD  - Departments of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous 
      Region, Nanning.
FAU - Shao, X
AU  - Shao X
AD  - Department of Radiotherapy, Cancer Center of Guangzhou Medical University, 
      Guangzhou.
FAU - Wang, L
AU  - Wang L
AD  - Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, 
      State Key Laboratory of Oncology in South China, Collaborative Innovation centre 
      of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma 
      Diagnosis and Therapy, Guangzhou.
FAU - Han, F
AU  - Han F
AD  - Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key 
      Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer 
      Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and 
      Therapy, Guangzhou.
FAU - Mai, H
AU  - Mai H
AD  - Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, 
      State Key Laboratory of Oncology in South China, Collaborative Innovation centre 
      of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma 
      Diagnosis and Therapy, Guangzhou.
FAU - Chua, M L K
AU  - Chua MLK
AD  - Division of Radiation Oncology, Division of Medical Sciences, National Cancer 
      Centre Singapore; Oncology Academic Programme, Duke-NUS Medical School, 
      Singapore. Electronic address: melvin.chua.l.k@singhealth.com.sg.
FAU - Xie, C
AU  - Xie C
AD  - Department of Radiation and Medical Oncology, Hubei Key Laboratory of Tumor 
      Biological Behaviors, Hubei Cancer Clinical Study Centre, Zhongnan Hospital of 
      Wuhan University, Wuhan. Electronic address: chxie_65@whu.edu.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT01616849
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 6NS400BXKH (nimotuzumab)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - Q20Q21Q62J (Cisplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/pharmacology/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use
MH  - Chemotherapy, Adjuvant/methods
MH  - Cisplatin/therapeutic use
MH  - ErbB Receptors/antagonists & inhibitors
MH  - Female
MH  - Fluorouracil/therapeutic use
MH  - Follow-Up Studies
MH  - Humans
MH  - Lung Neoplasms/mortality/secondary/*therapy
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngeal Carcinoma/mortality/secondary/*therapy
MH  - Nasopharyngeal Neoplasms/mortality/pathology/*therapy
MH  - Neoplasm Recurrence, Local/mortality/pathology/*therapy
MH  - Progression-Free Survival
OTO - NOTNLM
OT  - adverse effects
OT  - anti-epidermal growth factor receptor monoclonal antibody
OT  - chemotherapy
OT  - distant metastasis
OT  - efficacy
OT  - nasopharyngeal carcinoma
EDAT- 2019/01/29 06:00
MHDA- 2020/04/21 06:00
CRDT- 2019/01/29 06:00
PHST- 2019/01/29 06:00 [pubmed]
PHST- 2020/04/21 06:00 [medline]
PHST- 2019/01/29 06:00 [entrez]
AID - S0923-7534(19)31116-0 [pii]
AID - 10.1093/annonc/mdz020 [doi]
PST - ppublish
SO  - Ann Oncol. 2019 Apr 1;30(4):637-643. doi: 10.1093/annonc/mdz020.