Long-term results of sorafenib in advanced-stage hepatocellular carcinoma: what can we learn from routine clinical practice?
Expert Rev Anticancer Ther
; 12(7): 869-75, 2012 Jul.
Article
in En
| MEDLINE
| ID: mdl-22845401
ABSTRACT
BACKGROUND AND AIMS:
Prospective randomized trials have proven that sorafenib is a valid treatment option for patients with advanced-stage hepatocellular carcinoma (HCC). The aim of the present study is to evaluate the effectiveness and safety of sorafenib in patients encountered in routine clinical practice.METHODS:
From September 2008 to March 2011, 42 cirrhotic patients (30 male; 12 female; mean age 70.2 ± 7.6 years; range 56-85 years) with HCC of Barcelona Clinic Liver Cancer stage B (n = 5) or C (n = 37; mean size 66.6 ± 42.3 mm; mean number per patient 3.3 ± 2.8) were treated with sorafenib at either a standard dose of 800 mg/day (n = 29; 69.1%) or at 400 mg/day with subsequent dose escalation (ramp-up strategy; n = 13, 30.9%). Baseline clinical parameters were comparable. Clinical data and side effects, laboratory analyses (in particular, serum α-fetoprotein) and radiological data (tumor response according to amended RECIST criteria) were assessed every 3 months. Survival was calculated by Kaplan-Meier analysis.RESULTS:
Mean follow-up was 12.2 ± 9 months (range 1-32 months). Median overall survival was 26.1 months with overall 6- and 12-month survival rates of 92.1 and 85%, respectively. Median time to radiological progression was 8 months. The progression-free rate was 64.3%. Fatigue, skin disorders and diarrhea were the most frequent grade 3-4 side effects. Treatment discontinuation occurred in 25 patients. The starting dose for the last 13 enrolled patients was 400 mg/day; in the absence of toxicity this dosage was gradually increased to 800 mg/day after 3 weeks ('ramp-up strategy'). No grade 3/4 adverse events were observed in the ramp-up group.CONCLUSION:
Sorafenib is a valid treatment option for advanced-stage HCC. Starting at a lower dosage may allow prolonged compliance to treatment and might be considered according to patient tolerance.
Full text:
1
Database:
MEDLINE
Therapeutic Methods and Therapies TCIM:
Terapias_biologicas
/
Aromoterapia
Main subject:
Pyridines
/
Benzenesulfonates
/
Carcinoma, Hepatocellular
/
Liver Neoplasms
/
Antineoplastic Agents
Type of study:
Clinical_trials
/
Diagnostic_studies
Language:
En
Journal:
Expert Rev Anticancer Ther
Year:
2012
Type:
Article
Affiliation country:
Italy