in the name of alla. transarterial chemoembolization in combination with percutaneous ablation...
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In the In the name of name of
AllaAlla
Transarterial chemoembolization in
combination with percutaneous ablation therapy in
unresectable hepatocellular carcinoma:
a meta-analysisPrepared by: Dr. Samah Ali Mansoor Mater
Under supervision by : Ass. Prof. Dr. Abdul Hakeem Atamimi
May/2010
The contributersThe contributers::
Wei Wang, Jian Shi and Wei-fen xie
Department of Gasteroenterology,
Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China
INTRODUCTION
Hepatocellular carcinoma (HCC)
The 6th common cancer in the world
Small proportion with early stage may benefit from radical options
Surgical resection isn’t the 1st treatment of choice in the presence of large lesion or poor liver function
Transcatheter arterial chemoembolization (TACE) and percutaneous ablation (PA) are prescribed to prevent and relive suffering and improve qulity of life
Percutaneous ethanol injection (PEI) and radiofrequency ablation (RFA) are highly effective in the treatment of small lesion
Transcatheter arterial chemoembolization (TACE) improve the survival in large and multiple lesions
Some viable tumor cells remain after transcatheter arterial chemoembolization (TACE)
Recent evidence suggest that the combination of transcatheter arterial chemoembolization (TACE) with percutaneous ethanol injection (PEI) or radiofrequency ablation (RFA) may have a synergistic effect in treating large lesions that don’t response adequately to either procedure alone
For 5 cm lesions, 90-100% of complete response rate at 1 year was reported by applying radiofrequency ablation (RFA) after transcatheter arterial chemoembolization (TACE)
Kirioshi et al. reported better results in tumor response and overall survival with combination of transcatheter arterial chemoembolization (TACE) and percutaneous ablation (PA) as compared with either procedure alone
However, several studies found no significant difference in the overall survival between combination and monotherapy
Aim of the presented study
Identify the survival benefits of
this combination therapy for patients
with unresectable hepatocellular
carcinoma (HCC) with those of
either procedure alone.
PATIENTS AND
METHODS
Study objectives
The primary outcome The survival rate
The secondary outcome The initial complete response rate, and
The tumour recurrence rate
Search strategy Trials assesed the survival benefit or tumour recurrence
for patients with unresectable hepatocellular carcinoma (HCC) were searched :
- On PubMed, Embase and Web of Science ( all from 1990 to July 2009 )
- On Cochrane library database ( 2009, issue 2 )
- Manually, in general reviews on hepatocellular carcinoma (HCC) and references from published clinical trials
• A prospective randomized-controlled A prospective randomized-controlled clinical trialsclinical trials
• Above 18 years old patientsAbove 18 years old patients
• Patients were scheduled to undergo Patients were scheduled to undergo transcatheter arterial chemoembolization transcatheter arterial chemoembolization (TACE) with percutaneous ethanol (TACE) with percutaneous ethanol injection (PEI) or radiofrequency ablation injection (PEI) or radiofrequency ablation (RFA) (RFA)
Including critereaIncluding criterea
• Non-randomized studiesNon-randomized studies
• Recurrence of the tumour after Recurrence of the tumour after hepatectomy, liver metastaseshepatectomy, liver metastases
• Non of the three interventionNon of the three intervention procedures was appliedprocedures was applied
• No clinical data were collected forNo clinical data were collected for primary and secondary outcomesprimary and secondary outcomes
Exclusion critereaExclusion criterea
Jadad composite scale
used to score the included trials (from 0 to 5
points ) as assesses descriptions of :
Randomization ( 0-2 point )
Blinding ( 0-2 point )
dropouts or withdrawals ( 0-1 point )
_______________________________________
** High-quality reports at least with 3 points.
** Low-quality reports with 2 points or less.
Qualitative analysis
All calculations for the current meta-analysis were performed using REVIEW MANAGER (version 5.0 for Windows; the Cochrane Collaboration, Oxford, UK).
This article follows the QUARUM and the Cochrane Collection guidelines (http:// www.cochrane.de ) for reporting meta-analysis.
Statistical methods The meta-analysis was carried according to the Cochrane Reviewer’s Handbook recommended by Cochrane Collaboration. Pooled odd ratio (OR) was calculated using
DerSimonian and Laird method (random- affected model).
The quantitative heterogeneity between trials was evaluated by the DLQ statistic.
A funnel plot was used to test potential publication bias.
RESULTS
Identification of eligible randomized-controlled trials from different medicine databases.
-Clinical data from 595 patients from those 10 trials were pooled to comparing for the current
meta-analysis.
- One trial was with no difference in most baseline characteristics.
- Two trials involved 3 study arms. - No overlapping cases were among the 10 trials.
Baseline characteristics of randomized trials included in the meta-analysis
Qualitative analysis of randomized trials - 9 trials including 512 patients reported the
1-year survival rate.
- 7 trials reported the 2-years and 3-years survival rate separately.
- 1 trial assessed the qualiy of life and used in calculating the secondary outcome.
Treatment arms among the 10 selected randomized controlled studies
Methodological characteristics of randomized trials included in the meta-analysis
Child-Pugh scoreParameter 1 Point 2 Points 3 Points_________________________________________________
Serum bilirubin <2 2–3 >3 (mg/dL)Albumin (g/dL) >3.5 2.8–3.5 <2.8Prothrombin time 1–3 4–6 >6 ( ↑ S)Ascites None Slight SignificantEncephalopathy None 1–2 3–4_________________________________________________
Grades:A, 5 to 6 points B, 7 to 9 pointsC, 10 to 15 points
Sensitivity analysis of survival
Prognosis of patients reported in the randomized controlled trials included in the meta-analysis
DISCUSSION
The presented study demonstrated that the combination of transcatheter arterial chemoembolization (TACE) with percutaneous ablation (PA) was superior to transcatheter arterial chemoembolization (TACE) or percutaneous ablation (PA) alone for the significant benefit of survival and decrease of tumour recurrence for hepatocellular carcinoma patients.
No enough adverse events data can be pooled for systematic analysis among the selected randomized controlled trials (RCTs), so no safety profile and risk analysis with the different interventions was established in this meta-analysis presentation.
The conclusion The combination of transcatheter arterial
chemoembolization (TACE) with percutaneous
ablation (PA):
1. Improve the overall survival status, especially with percutaneous ethanol injection (PEI), more significantly than a single monotherapy.
2. Decrease the tumour recurrence rate compared with that of monotherapy.
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