Oncology · 2006
Phase II trial of docetaxel therapy in patients with advanced hepatocellular carcinoma.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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.
Hebbar Mohamed, Ernst Olivier, Cattan Stéphane, Dominguez Sophie, Oprea Corina, Mathurin Philippe, Triboulet Jean-Pierre, Paris Jean-Claude, Pruvot François-René
Аннотация
OBJECTIVES: We assessed the safety and efficacy of docetaxel, a microtubule inhibitor, in patients with advanced hepatocellular carcinoma (HCC).
METHODS: HCC patients that were not suitable for local therapy, but who possessed measurable disease, good performance status and adequate organ function were eligible. Docetaxel was administered every 3 weeks at a dose of 100 mg/m(2) (or 75 mg/m(2) if transaminase levels were between 1.5 and 3.5 times the upper normal limit). Efficacy was assessed radiologically every three cycles of chemotherapy.
RESULTS: Fifteen patients were enrolled: 11 males and 4 females; their median age was 64 years (range, 42-72 years). Nine patients had underlying cirrhosis. Four patients had been surgically treated before relapse (liver resection in 3 cases and transplantation in 1), 3 had been treated with arterial chemoembolization and 1 with arterial chemotherapy (doxorubicin). A total of 57 cycles of docetaxel were delivered (median 3, range 1-6). Significant toxicity was observed: mostly grade 3-4 neutropenia and fatigue (6 and 4 patients, respectively). Treatment had to be stopped because of toxicity in 6 patients, all having underlying cirrhosis. An important partial response was obtained in 1 patient, a result that enabled liver transplantation; this patient is still alive after 34 months. Five patients had transient stable disease.
CONCLUSION: When used in this schedule, docetaxel does not appear to be safe and effective enough in patients with advanced HCC and cirrhosis.
METHODS: HCC patients that were not suitable for local therapy, but who possessed measurable disease, good performance status and adequate organ function were eligible. Docetaxel was administered every 3 weeks at a dose of 100 mg/m(2) (or 75 mg/m(2) if transaminase levels were between 1.5 and 3.5 times the upper normal limit). Efficacy was assessed radiologically every three cycles of chemotherapy.
RESULTS: Fifteen patients were enrolled: 11 males and 4 females; their median age was 64 years (range, 42-72 years). Nine patients had underlying cirrhosis. Four patients had been surgically treated before relapse (liver resection in 3 cases and transplantation in 1), 3 had been treated with arterial chemoembolization and 1 with arterial chemotherapy (doxorubicin). A total of 57 cycles of docetaxel were delivered (median 3, range 1-6). Significant toxicity was observed: mostly grade 3-4 neutropenia and fatigue (6 and 4 patients, respectively). Treatment had to be stopped because of toxicity in 6 patients, all having underlying cirrhosis. An important partial response was obtained in 1 patient, a result that enabled liver transplantation; this patient is still alive after 34 months. Five patients had transient stable disease.
CONCLUSION: When used in this schedule, docetaxel does not appear to be safe and effective enough in patients with advanced HCC and cirrhosis.