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Phase II Trial of Docetaxel Therapy in Patients with Advanced Hepatocellular Carcinoma
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Phase II Trial of Docetaxel Therapy in Patients with Advanced Hepatocellular Carcinoma
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Phase II Trial of Docetaxel Therapy in Patients with Advanced Hepatocellular Carcinoma
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Journal Article
Phase II Trial of Docetaxel Therapy in Patients with Advanced Hepatocellular Carcinoma
2006
Overview
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.
Publisher
Karger,S. Karger AG
Subject
/ Aged
/ Antineoplastic Agents, Phytogenic - administration & dosage
/ Antineoplastic Agents, Phytogenic - adverse effects
/ Antineoplastic Agents, Phytogenic - therapeutic use
/ Biological and medical sciences
/ Cancer
/ Carcinoma, Hepatocellular - drug therapy
/ Carcinoma, Hepatocellular - secondary
/ Drug Administration Schedule
/ Female
/ Gastroenterology. Liver. Pancreas. Abdomen
/ Humans
/ Liver
/ Liver Cirrhosis - complications
/ Liver Neoplasms - drug therapy
/ Liver. Biliary tract. Portal circulation. Exocrine pancreas
/ Male
/ Safety
/ Taxoids - administration & dosage
/ Tumors
