Title Sorafenib in combination with transarterial chemoembolization in Chinese patients with hepatocellular carcinoma: a subgroup interim analysis of the START trial
Authors Han, Guohong
Yang, Jijin
Shao, Guoliang
Teng, Gaojun
Wang, Maoqiang
Yang, Jianyong
Liu, Zhaoyu
Feng, Gansheng
Yang, Renjie
Lu, Ligong
Chao, Yee
Wang, Jianhua
Affiliation Fourth Mil Med Univ, Xijing Hosp, Xian 710032, Peoples R China.
Second Mil Med Univ, Changhai Hosp, Shanghai, Peoples R China.
Zhejiang Canc Hosp, Hangzhou, Zhejiang, Peoples R China.
Southeast Univ, Zhongda Hosp, Nanjing, Jiangsu, Peoples R China.
Peoples Liberat Army Gen Hosp, Beijing, Peoples R China.
Sun Yat Sen Univ, Affiliated Hosp 1, Guangzhou 510275, Guangdong, Peoples R China.
China Med Univ, Shengjing Hosp, Shenyang, Peoples R China.
Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Wuhan 430074, Peoples R China.
Peking Univ, Beijing Canc Hosp, Beijing 100871, Peoples R China.
Guangdong Gen Hosp, Guangzhou, Guangdong, Peoples R China.
Vet Gen Hosp, Taipei, Taiwan.
Fudan Univ, Zhongshan Hosp, Dept Radiol, Shanghai 200433, Peoples R China.
Keywords hepatocellular carcinoma
sorafenib
transarterial chemoembolization
TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION
RANDOMIZED CONTROLLED TRIAL
ENDOTHELIAL GROWTH-FACTOR
LIPIODOL CHEMOEMBOLIZATION
ANGIOGENESIS
MANAGEMENT
EXPRESSION
THERAPY
KINASES
COHORT
Issue Date 2013
Publisher future oncology
Citation FUTURE ONCOLOGY.2013,9,(3),403-410.
Abstract Aim: The third interim results of the START trial showed encouraging safety and efficacy profiles, with a median time to progression of 9 months. This subgroup analysis presents results in Chinese patients enrolled in the START trial. Materials & methods: Sixty two Chinese patients (median age 52 years) with unresectable hepatocellular carcinoma had transarterial chemoembolization (TACE) performed with an emulsion of Lipiodol (R) (Guerbet, Paris, France) and doxorubicin (30-60 mg) followed by embolization with absorbable particles. Sorafenib (400 mg twice-daily) was administered continuously with dose holidays 4 days prior to and post TACE procedures. TACE was performed every 6-8 weeks and responses were assessed after 4-6 weeks and then every 3 months if no further TACE was indicated. Patients continued receiving sorafenib until disease progression or unacceptable toxicity occurred. Results: Thirty seven patients (59.68%) received no more than two TACE procedures. During sorafenib treatment (median duration 6.4 months; mean daily dose 787.6 mg), 75.8% of patients experienced adverse events, most commonly pyrexia (37.1%), diarrhea (27.4%), skin reactions (22.6%), alopecia (19.4%) and abnormal hepatic function (16.1%). The most common grade 3-4 adverse events were abnormal hepatic function (6.5%) and diarrhea (3.2%). The median time to progression and overall survival were 10.6 and 16.5 months, respectively, and the objective response and stable disease rates were 44.3 and 42.6%, respectively. Conclusion: The combination of the TACE and sorafenib proved both safe and effective in the treatment of Chinese patients with unresectable hepatocellular carcinoma.
URI http://hdl.handle.net/20.500.11897/392071
ISSN 1479-6694
DOI 10.2217/FON.13.11
Indexed SCI(E)
Appears in Collections: 北京肿瘤医院

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