PMID- 24710768
OWN - NLM
STAT- MEDLINE
DCOM- 20160520
LR  - 20221207
IS  - 1097-0347 (Electronic)
IS  - 1043-3074 (Linking)
VI  - 37
IP  - 8
DP  - 2015 Aug
TI  - Platinum-based chemotherapy plus cetuximab first-line for Asian patients with 
      recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results 
      of an open-label, single-arm, multicenter trial.
PG  - 1081-7
LID - 10.1002/hed.23707 [doi]
AB  - BACKGROUND: The purpose of this study was to assess the efficacy, safety, and 
      pharmacokinetics of cisplatin-based chemotherapy plus cetuximab as first-line 
      treatment in Chinese and Korean patients with recurrent and/or metastatic 
      squamous cell carcinoma of the head and neck (SCCHN). METHODS: Patients (n = 68) 
      received cetuximab weekly plus 3-week cycles of cisplatin/5-fluorouracil (5-FU) 
      chemotherapy for up to 6 cycles. The primary endpoint was overall response rate. 
      RESULTS: The overall response rate was 55.9%, including 2 complete responses 
      (CRs). Median overall survival (OS) was 12.6 months and median progression-free 
      survival (PFS) was 6.6 months. Grade 3/4 adverse events (AEs) were reported in 41 
      (60.3%) patients. The safety profile was in line with previous clinical 
      experience. The pharmacokinetic profile was in line with that observed with 
      cetuximab in white and Japanese patients. CONCLUSION: The efficacy, safety, and 
      pharmacokinetic findings from this study support the use of first-line 
      platinum-based chemotherapy plus cetuximab in Chinese and Korean patients with 
      recurrent and/or metastatic SCCHN (ClinicalTrials.gov NCT01177956).
CI  - (c) 2014 Wiley Periodicals, Inc.
FAU - Guo, Ye
AU  - Guo Y
AD  - Medical Oncology Department, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Shi, Mei
AU  - Shi M
AD  - Radiation Oncology Department, Xijing Hospital - The First Affiliated Hospital of 
      the Fourth Military Medical University, Shanxi Province, China.
FAU - Yang, Ankui
AU  - Yang A
AD  - Head and Neck Department, Sun Yat-sen University Cancer Center, Guangzhou, China.
FAU - Feng, Jifeng
AU  - Feng J
AD  - Medical Oncology Department, Jiangsu Cancer Hospital, Nanjing, Jiangsu Province, 
      China.
FAU - Zhu, Xiaodong
AU  - Zhu X
AD  - Radiotherapy Department, Affiliated Cancer Hospital, Guangxi Medical University, 
      Nanning, Guangxi Province, China.
FAU - Choi, Young-Jin
AU  - Choi YJ
AD  - Medical Oncology Department, Pusan National University Hospital, Seo-Gu, Busan, 
      Korea.
FAU - Hu, Guoqin
AU  - Hu G
AD  - Cancer Department, Tongji Hospital of Tongji Medical College of Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Pan, Jianji
AU  - Pan J
AD  - Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou, 
      China.
FAU - Hu, Chunhong
AU  - Hu C
AD  - Oncology Department, The Second Xiangya Hospital of Central South University, 
      Changsha, Hu'nan Province, China.
FAU - Luo, Rongcheng
AU  - Luo R
AD  - Cancer Medical Department, Nanfang Hospital, Guangzhou, China.
FAU - Zhang, Yiping
AU  - Zhang Y
AD  - Chemotherapy Center, Zhejiang Cancer Hospital, Hangzhou, Zhejiang Province, 
      China.
FAU - Zhou, Liang
AU  - Zhou L
AD  - Head and Neck Surgery Department, Eye and Ear, Nose, and Throat Hospital of Fudan 
      University, Xuhui District, Shanghai, China.
FAU - Cheng, Ying
AU  - Cheng Y
AD  - Medical Oncology Department, Jilin Cancer Hospital, Changchun, Jilin, China.
FAU - Lupfert, Christian
AU  - Lupfert C
AD  - Merck KGaA, Darmstadt, Germany.
FAU - Cai, Junliang
AU  - Cai J
AD  - Merck Serono (Beijing) Pharmaceutical R&D Company, The Center, Shanghai, China.
FAU - Shi, Yuankai
AU  - Shi Y
AD  - Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of 
      Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of 
      Clinical Study on Anticancer Molecular Targeted Drugs, Chaoyang District, 
      Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01177956
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140917
PL  - United States
TA  - Head Neck
JT  - Head & neck
JID - 8902541
RN  - PQX0D8J21J (Cetuximab)
RN  - Q20Q21Q62J (Cisplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Asian People
MH  - Carcinoma, Squamous Cell/mortality/*secondary/*therapy
MH  - Cetuximab/administration & dosage
MH  - China/epidemiology
MH  - Cisplatin/administration & dosage
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Head and Neck Neoplasms/mortality/*pathology/*therapy
MH  - Humans
MH  - Infusions, Intravenous/methods
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/mortality/pathology/*therapy
MH  - Radiotherapy, Adjuvant
MH  - Republic of Korea/epidemiology
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chinese
OT  - EXTREME trial
OT  - cetuximab
OT  - head and neck cancer
OT  - recurrent and metastatic squamous cell carcinoma
EDAT- 2014/04/09 06:00
MHDA- 2016/05/21 06:00
CRDT- 2014/04/09 06:00
PHST- 2013/08/27 00:00 [received]
PHST- 2014/01/28 00:00 [revised]
PHST- 2014/04/04 00:00 [accepted]
PHST- 2014/04/09 06:00 [entrez]
PHST- 2014/04/09 06:00 [pubmed]
PHST- 2016/05/21 06:00 [medline]
AID - 10.1002/hed.23707 [doi]
PST - ppublish
SO  - Head Neck. 2015 Aug;37(8):1081-7. doi: 10.1002/hed.23707. Epub 2014 Sep 17.