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.
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.


CONCLUSIONS
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).
Medical Oncology Department, Fudan University Shanghai Cancer Center, Shanghai, China.
Ye
Y
Guo
Radiation Oncology Department, Xijing Hospital - The First Affiliated Hospital of the Fourth Military Medical University, Shanxi Province, China.
Mei
M
Shi
Head and Neck Department, Sun Yat-sen University Cancer Center, Guangzhou, China.
Ankui
A
Yang
Medical Oncology Department, Jiangsu Cancer Hospital, Nanjing, Jiangsu Province, China.
Jifeng
J
Feng
Radiotherapy Department, Affiliated Cancer Hospital, Guangxi Medical University, Nanning, Guangxi Province, China.
Xiaodong
X
Zhu
Medical Oncology Department, Pusan National University Hospital, Seo-Gu, Busan, Korea.
Young-Jin
YJ
Choi
Cancer Department, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Guoqin
G
Hu
Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China.
Jianji
J
Pan
Oncology Department, The Second Xiangya Hospital of Central South University, Changsha, Hu'nan Province, China.
Chunhong
C
Hu
Cancer Medical Department, Nanfang Hospital, Guangzhou, China.
Rongcheng
R
Luo
Chemotherapy Center, Zhejiang Cancer Hospital, Hangzhou, Zhejiang Province, China.
Yiping
Y
Zhang
Head and Neck Surgery Department, Eye and Ear, Nose, and Throat Hospital of Fudan University, Xuhui District, Shanghai, China.
Liang
L
Zhou
Medical Oncology Department, Jilin Cancer Hospital, Changchun, Jilin, China.
Ying
Y
Cheng
Merck KGaA, Darmstadt, Germany.
Christian
C
Lüpfert
Merck Serono (Beijing) Pharmaceutical R&D Company, The Center, Shanghai, China.
Junliang
J
Cai
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.
Yuankai
Y
Shi
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000556:secondary* / Q000628:therapy*; D000068818:Cetuximab / Q000008:administration & dosage; D002681:China / Q000453:epidemiology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D007262:Infusions, Intravenous / Q000379:methods; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D018714:Radiotherapy, Adjuvant; D056910:Republic of Korea / Q000453:epidemiology; D016896:Treatment Outcome
D000068818:Cetuximab; D002945:Cisplatin; D005472:Fluorouracil
Chinese; EXTREME trial; cetuximab; head and neck cancer; recurrent and metastatic squamous cell carcinoma