acrin 6673: rf ablation in hcc patients - powerpoint presentation
TRANSCRIPT
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ACRIN 6673
MULTICENTER FEASIBILITY STUDY OF
PERCUTANEOUS RADIOFREQUENCY
ABLATION OF HEPATOCELLULAR
CARCINOMA IN CIRRHOTIC PATIENTS
Final Report
from Central Review Data
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6673 RFA of HCC
• Protocol Team– Gerald Dodd, III, MD (Principal Investigator)
– Fenghai Duan, PhD (Statistician)
– Damian Dupuy, MD (Radiologist)
– Glenn Halff, MD (Surgical Oncologist)
– David Lu, MD (Radiologist)
– Shahla Masood, MD (Central Pathologist)
– Anthony Shields, MD, PhD (Oncologist)
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6673 RFA of HCC
• ACRIN Staff– Lisa Cimino (Imaging)
– Vincent Girardi (Biostatistician)
– Jeremy Gorelick (Biostatistician)
– Donna Hartfeil (Project Manager)
– Benjamin Herman (Biostatistician)
– Mary Kelly-Trunan (Regulatory)
– Anthony Levering (Imaging)
– Robin McCall (Imaging)
– Maria Oh, (Protocol Development)
– Josephine Schloesser (Regulatory)
– Chris Steward (Regulatory)
– Tina Taylor (Data Manager)
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6673 RFA of HCC
University of Texas, Health Science Center, San Antonio / Gerald Dodd, III, MD
University of California, Los Angeles / David Lu, MD
Rhode Island Hospital / Damian Dupuy, MD
Hospital of the University of Pennsylvania / Aalpen Patel, MD
University of Massachusetts Medical Center, Worcester / Sri Shankar, MD
Cedar Sinai Medical Center / Peter Julien, MD and Frank Moser, MD
Mayo Clinic, Rochester / Matthew Callstrom, MD, PhD
Medical College of Wisconsin / Sean Tutton, MD
University of Wisconsin / Fred Lee, MD
University of Texas, MD Anderson / Kamran Ahrar, MD
University of North Carolina / Robert Dixon, MD
University of Alabama, Birmingham / J. Kevin Smith, MD
Scott and White Clinic and Hospital, Texas / Mark Montgomery, MD
University of California, Davis / John McGahan, MD
14 Participating Centers
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6673 RFA of HCC
• Primary study objective:
To estimate the proportion of patients
undergoing solitary or repetitive
percutaneous RFA treatment sessions
whose livers have no identifiable tumor
by CT scan at 18 months following
initiation of therapy
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6673 RFA of HCC
• Some secondary study objectives:
– Aim: Effects of tumor size, local recurrence,
remote occurrence, whether or not repeated
RFA, etc. on success rate at 18-month
• Notations:
– Local intrahepatic tumor: tumor was treated
but seen again at the ablated site
– Remote intrehepatic tumor: new tumor was
seen but remote from the ablated site(s).
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6673 RFA of HCC
• Enrollment Criteria
– Cirrhosis
–MELD Score < 15
– HCC = 1-3 tumors < 3cm,
or 1 tumor > 3 and < 5cm
– No previous treatment for HCC
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6673 RFA of HCC
• Treatment
– Percutaneous radiofrequency ablation
• Ablations permitted from enrollment
through 15th month
• Single vendor RFA unit (Covidien)
• Standardized ablation protocol
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6673 RFA of HCC
• Follow-up
– 3 phase CT
• Prior to treatment
• Immediately after ablation
• Every 3-months through 18 months post
ablation
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6673 RFA of HCC
• Central review
– To determine the presence/absence of tumor
– Scans were divide into two equal batches
and were reviewed by one of the two central
readers.
–Discrepancy from the local read were
adjudicated by the other central reader.
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6673 RFA of HCC
• Results
– 45 Eligible patients enrolled
• 29 men, 16 women
• Average age 61 (range, 40 to 81)
– Number of tumors
• 1 = 39
• 2 = 4
• 3 = 2
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6673 RFA of HCC
• Results
–Patient status
•33 dropped out prior to completion
•12 patients completed study
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6673 RFA of HCC
• Results
– Patient status
• 33 dropped out prior to completion
–15 were transplanted
–5 died
–5 withdrew from the study
–7 started nonprotocol treatment
–1 developed an extrahepatic tumor
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6673 RFA of HCC
• Results
– Patient status
• 15 were transplanted
–4 had tumor on last CT
»2 had a local tumor
»2 had a remote tumor
–11 had no tumor
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6673 RFA of HCC
• Results
– Patient status
• 5 patients died
–2 had tumor on last CT and was the cause
of death for 2 of those
–3 had no tumor
• 7 patients had non-protocol treatment
–7 had tumor on last CT
–0 had no tumor
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6673 RFA of HCC
• Results
– Patient status
• 12 patients completed study
–8 = 1 ablation
–2 = 2 ablations
–2= 3 ablations
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6673 RFA of HCC
• Results
– Patient status
• 12 patients completed study
–Tumor status on 18 month CT
» 10 = no tumor at treated sites (83%)
» 8 = tumor free (67%)
» 2 = local intrahepatic tumor (17%)
» 4 = remote intrahepatic tumor (33% )
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6673 RFA of HCC
• Results
– Aim: control disease at 18 months
• Out of 45 patients, 8 patients who completed
study without tumor
– success rate = 8/45 (18%)
(95% Exact CI: 0.08, 0.32)
• Only 12 patients who made it to 18 months
– success rate = 8/12 (67%)
(95% Exact CI: 0.35, 0.90)
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6673 RFA of HCC
• Results
– Aim: control disease at 18 months or
successful bridge to transplant
• Including the previous 8 tumor-free patients at
18 months plus 15 patients who made it to
transplant
– success rate = 23/45(51%)
(95% Exact CI: 36%, 66%)
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6673 RFA of HCC
• Results
Factors O.R. 95% CI P value
multiple RFA 44.3 5.36 367.1 0.0004
Tumor size (cm) 0.40 0.18 0.88 0.022
Local tumor 4.54 1.95 10.6 0.0005
Remote tumor 0.02 0.004 0.10 <.0001
Gender (Female) 0.97 0.07 13.3 0.9
Age 1.19 1.03 1.38 0.017
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6673 RFA of HCC
• Results
– Local tumor control
• Out of 60 ablated tumors, 36 were never seen
again.
–Local control rate = 36/60 (60%)
(95% Exact CI: 0.47, 0.72)
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6673 RFA of HCC
• ResultsKaplan-Meier Estimate of time until a local recurrence
Su
rviv
al D
istr
ibu
tio
n F
un
ctio
n
0.00
0.25
0.50
0.75
1.00
Months
0 5 10 15 20 25
Legend: Product-Limit Estimate Curve Censored Observations
Median time to recurrence is 12 months (95%
CI: 6 – 18 months)