Ye Guo1, Mei Shi2, Ankui Yang3, Jifeng Feng4, Xiaodong Zhu5, Young-Jin Choi6, Guoqin Hu7, Jianji Pan8, Chunhong Hu9, Rongcheng Luo10, Yiping Zhang11, Liang Zhou12, Ying Cheng13, Christian Lüpfert14, Junliang Cai15, Yuankai Shi16. 1. Medical Oncology Department, Fudan University Shanghai Cancer Center, Shanghai, China. 2. Radiation Oncology Department, Xijing Hospital - The First Affiliated Hospital of the Fourth Military Medical University, Shanxi Province, China. 3. Head and Neck Department, Sun Yat-sen University Cancer Center, Guangzhou, China. 4. Medical Oncology Department, Jiangsu Cancer Hospital, Nanjing, Jiangsu Province, China. 5. Radiotherapy Department, Affiliated Cancer Hospital, Guangxi Medical University, Nanning, Guangxi Province, China. 6. Medical Oncology Department, Pusan National University Hospital, Seo-Gu, Busan, Korea. 7. Cancer Department, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. 8. Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China. 9. Oncology Department, The Second Xiangya Hospital of Central South University, Changsha, Hu'nan Province, China. 10. Cancer Medical Department, Nanfang Hospital, Guangzhou, China. 11. Chemotherapy Center, Zhejiang Cancer Hospital, Hangzhou, Zhejiang Province, China. 12. Head and Neck Surgery Department, Eye and Ear, Nose, and Throat Hospital of Fudan University, Xuhui District, Shanghai, China. 13. Medical Oncology Department, Jilin Cancer Hospital, Changchun, Jilin, China. 14. Merck KGaA, Darmstadt, Germany. 15. Merck Serono (Beijing) Pharmaceutical R&D Company, The Center, Shanghai, China. 16. 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.
Abstract
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).
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).
Authors: T Magnes; T Melchardt; C Hufnagl; L Weiss; C Mittermair; D Neureiter; E Klieser; G Rinnerthaler; S Roesch; A Gaggl; R Greil; A Egle Journal: Pharmacogenomics J Date: 2017-07-18 Impact factor: 3.550
Authors: Teresa Magnes; Thomas Melchardt; Lukas Weiss; Christof Mittermair; Daniel Neureiter; Eckhard Klieser; Simon Gampenrieder; Gerhard Moser; Alexander Gaggl; Richard Greil; Alexander Egle Journal: PLoS One Date: 2017-07-07 Impact factor: 3.240