Future oncology (London, England) · 2013
Sorafenib in combination with transarterial chemoembolization in Chinese patients with hepatocellular carcinoma: a subgroup interim analysis of the START trial.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Han Guohong, Yang Jijin, Shao Guoliang, Teng Gaojun, Wang Maoqiang, Yang Jianyong, Liu Zhaoyu, Feng Gansheng, Yang Renjie, Lu Ligong, Chao Yee, Wang Jianhua
Аннотация
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(®) (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.
MATERIALS & METHODS: Sixty two Chinese patients (median age 52 years) with unresectable hepatocellular carcinoma had transarterial chemoembolization (TACE) performed with an emulsion of Lipiodol(®) (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.