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ACRIN 6673: RF Ablation in HCC Patients - PowerPoint Presentation

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    ACRIN 6673: RF Ablation in HCC Patients - PowerPoint Presentation ACRIN 6673: RF Ablation in HCC Patients - PowerPoint Presentation Presentation Transcript

    • ACRIN 6673
      MULTICENTER FEASIBILITY STUDY OF PERCUTANEOUS RADIOFREQUENCY
      ABLATION OF HEPATOCELLULAR CARCINOMA IN CIRRHOTIC PATIENTS
      Final Report from Central Review Data
    • 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)
    • 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)
    • 6673 RFA of HCC
      14 Participating Centers
      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
    • 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
    • 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).
    • 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
    • 6673 RFA of HCC
      Treatment
      Percutaneous radiofrequency ablation
      Ablations permitted from enrollment through 15th month
      Single vendor RFA unit (Covidien)
      Standardized ablation protocol
    • 6673 RFA of HCC
      Follow-up
      3 phase CT
      Prior to treatment
      Immediately after ablation
      Every 3-months through 18 months post ablation
    • 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.
    • 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
    • 6673 RFA of HCC
      Results
      Patient status
      33 dropped out prior to completion
      12 patients completed study
    • 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
    • 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
    • 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
    • 6673 RFA of HCC
      Results
      Patient status
      12 patients completed study
      8 = 1 ablation
      2 = 2 ablations
      2= 3 ablations
    • 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% )
    • 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)
    • 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%)
    • 6673 RFA of HCC
      Results
    • 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)
    • 6673 RFA of HCC
      Results
      Median time to recurrence is 12 months (95% CI: 6 – 18 months)