A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria: trial

A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria

Needs review

N = 230

Population

HCC conforming to the Milan criteria and suitable for either resection or RFA

Design

Randomised controlled trial of radiofrequency ablation (RFA) versus surgical resection (RES) in patients who met the Milan criteria and were suitable for either treatment; follow-up for 5 years (except for those who died).

Primary endpoint

Arms

Radiofrequency ablation (experimental): Radiofrequency ablation (RFA)
Surgical resection (control): Surgical resection (RES)

People

Huang J

Δ 12-month OS−11.3 pointsΔ 12-month RFS−3.48 points

Show the numbers

Results reported for A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria
Endpoint	Analysis	Radiofrequency ablation	Surgical resection	Effect
OSPatients entered into the trial (the abstract does not use the term ITT)Overall survival at 1, 2, 3, 4 and 5 years (primary end point)	primaryHuang 2010	86.96% at 12 mo; 76.52% at 2 y; 69.57% at 3 y; 66.09% at 4 y; 54.78% at 5 y	98.26% at 12 mo; 96.52% at 2 y; 92.17% at 3 y; 82.6% at 4 y; 75.65% at 5 y	P=0.001Survival was significantly lower in the RFA group than in the resection group as stated in the abstract.
RFSPatients entered into the trial (the abstract does not use the term ITT)Recurrence-free survival at 1, 2, 3, 4 and 5 years (secondary end point)	primaryHuang 2010	81.74% at 12 mo; 59.13% at 2 y; 46.08% at 3 y; 33.91% at 4 y; 28.69% at 5 y	85.22% at 12 mo; 73.92% at 2 y; 60.87% at 3 y; 54.78% at 4 y; 51.3% at 5 y	P=0.017Recurrence-free survival was significantly lower in the RFA group as stated in the abstract. The abstract also reports overall recurrence rates at 5 years of 63.48% (RFA) and 41.74% (resection), P = 0.024.

Results reported for A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria
Endpoint	Analysis	Radiofrequency ablation	Surgical resection	Effect
OSPatients entered into the trial (the abstract does not use the term ITT)Overall survival at 1, 2, 3, 4 and 5 years (primary end point)	primaryHuang 2010	86.96% at 12 mo; 76.52% at 2 y; 69.57% at 3 y; 66.09% at 4 y; 54.78% at 5 y	98.26% at 12 mo; 96.52% at 2 y; 92.17% at 3 y; 82.6% at 4 y; 75.65% at 5 y	P=0.001Survival was significantly lower in the RFA group than in the resection group as stated in the abstract.
RFSPatients entered into the trial (the abstract does not use the term ITT)Recurrence-free survival at 1, 2, 3, 4 and 5 years (secondary end point)	primaryHuang 2010	81.74% at 12 mo; 59.13% at 2 y; 46.08% at 3 y; 33.91% at 4 y; 28.69% at 5 y	85.22% at 12 mo; 73.92% at 2 y; 60.87% at 3 y; 54.78% at 4 y; 51.3% at 5 y	P=0.017Recurrence-free survival was significantly lower in the RFA group as stated in the abstract. The abstract also reports overall recurrence rates at 5 years of 63.48% (RFA) and 41.74% (resection), P = 0.024.

Illustrative — modelled from reported values, not trial data. OS, primary.

Show curves

Radiofrequency ablation (experimental)
Surgical resection (control)

Data table (modelled values)

Months	Radiofrequency ablation	Surgical resection
0	100.0%	100.0%
16	83.2%	97.8%
32	71.5%	94.1%
49	65.4%	81.9%
65	54.8%	75.7%

Illustrative — modelled from reported values, not trial data. RFS, primary.

Show curves

Radiofrequency ablation (experimental)
Surgical resection (control)

Data table (modelled values)

Months	Radiofrequency ablation	Surgical resection
0	100.0%	100.0%
16	74.2%	81.3%
32	50.0%	64.8%
49	33.2%	54.4%
65	28.7%	51.3%

Appears in

2006 Resection versus ablation for small HCC: conflicting trials

Sources

Huang J, Yan L, Cheng Z, Wu H, Du L, Wang J, et al. A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria. Ann Surg. 2010;252(6):903-12.
PubMed DOI